Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

NCT03007147 | Active Not Recruiting Phase 3 FDA Drug

• 4 other identifiers: AALL1631NCI-2016-015882017-000705-20U10CA180886
• Study Type: interventional
• Target: 475
• Locations: 18 countries
• Sites: 225

Brief Summary

This randomized phase III trial studies how well imatinib mesylate works in combination with two different chemotherapy regimens in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (ALL). Imatinib mesylate has been shown to improve outcomes in children and adolescents with Philadelphia chromosome positive (Ph+) ALL when given with strong chemotherapy, but the combination has many side effects. This trial is testing whether a different chemotherapy regimen may work as well as the stronger one but have fewer side effects when given with imatinib. The trial is also testing how well the combination of chemotherapy and imatinib works in another group of patients with a type of ALL that is similar to Ph+ ALL. This type of ALL is called "ABL-class fusion positive ALL", and because it is similar to Ph+ ALL, is thought it will respond well to the combination of agents used to treat Ph+ ALL.

Conditions

Acute Lymphoblastic Leukemia; Mixed Phenotype Acute Leukemia; T Acute Lymphoblastic Leukemia; B Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

• Disease free survival (DFS) of Randomized Arms (standard risk [SR] Philadelphia chromosome [Ph+] acute lymphoblastic leukemia [ALL] patients)

  Three-year DFS and 95% confidence intervals (CI) of SR Ph+ ALL patients treated continuous imatinib mesylate with high risk Children's Oncology Group (COG)-ALL chemotherapy backbone or more intensive European (Es)PhALL chemotherapy backbone.

  Up to 3 years

Secondary Outcomes (11)

• DFS on Randomized Arms (SR Ph+ ALL and ABL-class fusion positive patients)

  Up to 3 years

• Feasibility of post hematopoietic stem cell transplantation (HSCT) imatinib mesylate administration after allogenic HSCT in high risk Ph+ ALL patients

  Up to 2 years

• Event free survival (EFS) of high risk pediatric Ph+ ALL patients treated with EsPhALL chemotherapy, HSCT in first complete remission, and post-HSCT imatinib mesylate

  Up to 3 years

• Incidence of grade 3 or higher infections in standard risk Ph+ ALL patients in the two randomized arms

  Up to 3 years

• EFS of all Ph+ patients

  Up to 3 years

Other Outcomes (19)

• Incidence of toxicities associated with post-HSCT administration of imatinib mesylate

  Up to 2 years

• Incidence of long-term toxicities in patients treated with chemotherapy plus imatinib mesylate (no transplant) in both arms

  Up to 3 years

• MRD measured by IGH-T cell receptor (TCR) polymerase chain reaction (PCR) and next generation sequencing (NGS) assay

  Up to 6 months

Study Arms (3)

Arm A (imatinib mesylate, EsPhALL chemotherapy)

EXPERIMENTAL

See Detailed Description

Drug: Calaspargase Pegol; Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Daunorubicin Hydrochloride; Drug: Dexamethasone; Drug: Dexrazoxane Hydrochloride; Drug: Doxorubicin; Drug: Etoposide; Biological: Filgrastim; Drug: Ifosfamide; Drug: Imatinib Mesylate; Other: Laboratory Biomarker Analysis; Drug: Leucovorin Calcium; Drug: Levoleucovorin; Drug: Mercaptopurine; Drug: Methotrexate; Drug: Methylprednisolone; Drug: Pegaspargase; Drug: Prednisolone; Other: Questionnaire Administration; Drug: Therapeutic Hydrocortisone; Drug: Thioguanine; Drug: Vincristine Sulfate

Arm B (imatinib mesylate, COG/BFM chemotherapy)

EXPERIMENTAL

See Detailed Description.

Drug: Calaspargase Pegol; Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Dexamethasone; Drug: Dexrazoxane Hydrochloride; Drug: Doxorubicin; Drug: Imatinib Mesylate; Other: Laboratory Biomarker Analysis; Drug: Leucovorin Calcium; Drug: Levoleucovorin; Drug: Mercaptopurine; Drug: Methotrexate; Drug: Methylprednisolone; Drug: Pegaspargase; Drug: Prednisolone; Other: Questionnaire Administration; Drug: Thioguanine; Drug: Vincristine Sulfate

Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)

EXPERIMENTAL

See Detailed Description

Procedure: Allogeneic Hematopoietic Stem Cell Transplantation; Drug: Calaspargase Pegol; Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Daunorubicin Hydrochloride; Drug: Dexamethasone; Drug: Dexrazoxane Hydrochloride; Drug: Doxorubicin; Drug: Etoposide; Biological: Filgrastim; Drug: Ifosfamide; Drug: Imatinib Mesylate; Other: Laboratory Biomarker Analysis; Drug: Leucovorin Calcium; Drug: Levoleucovorin; Drug: Mercaptopurine; Drug: Methotrexate; Drug: Methylprednisolone; Drug: Pegaspargase; Drug: Prednisolone; Other: Questionnaire Administration; Drug: Therapeutic Hydrocortisone; Drug: Thioguanine; Drug: Vincristine Sulfate

Interventions

Calaspargase Pegol DRUG

Given IV

Also known as: Asparaginase (Escherichia coli Isoenzyme II), Conjugate with alpha-(((2,5-Dioxo-1-pyrrolidinyl)oxy)carbonyl)-omega-methoxypoly(oxy-1,2-ethanediyl), Asparlas, Calaspargase Pegol-mknl, EZN-2285, SC-PEG E. Coli L-Asparaginase, Succinimidyl Carbonate Monomethoxypolyethylene Glycol E. coli L-Asparaginase

Arm A (imatinib mesylate, EsPhALL chemotherapy); Arm B (imatinib mesylate, COG/BFM chemotherapy); Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)

Cyclophosphamide DRUG

Given IV

Also known as: (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Asta B 518, B 518, B-518, B518, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamide Monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR 138719, WR- 138719, WR-138719, WR138719

Arm A (imatinib mesylate, EsPhALL chemotherapy); Arm B (imatinib mesylate, COG/BFM chemotherapy); Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)

Cytarabine DRUG

Given IV, SC, or IT

Also known as: .beta.-Cytosine arabinoside, 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-.beta.-D-Arabinofuranosylcytosine, 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-Beta-D-arabinofuranosylcytosine, 1.beta.-D-Arabinofuranosylcytosine, 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-, 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-, Alexan, Ara-C, ARA-cell, Arabine, Arabinofuranosylcytosine, Arabinosylcytosine, Aracytidine, Aracytin, Aracytine, Beta-Cytosine Arabinoside, CHX-3311, Cytarabinum, Cytarbel, Cytosar, Cytosine Arabinoside, Cytosine-.beta.-arabinoside, Cytosine-beta-arabinoside, Erpalfa, Starasid, Tarabine PFS, U 19920, U-19920, Udicil, WR-28453

Arm A (imatinib mesylate, EsPhALL chemotherapy); Arm B (imatinib mesylate, COG/BFM chemotherapy); Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)

Dexamethasone DRUG

Given PO or IV

Also known as: Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex, Alin, Alin Depot, Alin Oftalmico, Amplidermis, Anemul mono, Auricularum, Auxiloson, Baycadron, Baycuten, Baycuten N, Cortidexason, Cortisumman, Decacort, Decadrol, Decadron, Decadron DP, Decalix, Decameth, Decasone R.p., Dectancyl, Dekacort, Deltafluorene, Deronil, Desamethasone, Desameton, Dexa-Mamallet, Dexa-Rhinosan, Dexa-Scheroson, Dexa-sine, Dexacortal, Dexacortin, Dexafarma, Dexafluorene, Dexalocal, Dexamecortin, Dexameth, Dexamethasone Intensol, Dexamethasonum, Dexamonozon, Dexapos, Dexinoral, Dexone, Dinormon, Dxevo, Fluorodelta, Fortecortin, Gammacorten, Hemady, Hexadecadrol, Hexadrol, LenaDex, Lokalison-F, Loverine, Methylfluorprednisolone, Millicorten, Mymethasone, Orgadrone, Spersadex, TaperDex, Visumetazone, ZoDex

Arm A (imatinib mesylate, EsPhALL chemotherapy); Arm B (imatinib mesylate, COG/BFM chemotherapy); Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)

Allogeneic Hematopoietic Stem Cell Transplantation PROCEDURE

Undergo HSCT

Also known as: Allogeneic, Allogeneic Hematopoietic Cell Transplantation, Allogeneic Stem Cell Transplantation, HSC, HSCT, Stem Cell Transplantation, Allogeneic

Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)

Daunorubicin Hydrochloride DRUG

Given IV

Also known as: Cerubidin, Cerubidine, Cloridrato de Daunorubicina, Daunoblastin, Daunoblastina, Daunoblastine, Daunomycin Hydrochloride, Daunomycin, hydrochloride, Daunorubicin.HCl, Daunorubicini Hydrochloridum, FI-6339, Ondena, RP-13057, Rubidomycin Hydrochloride, Rubilem

Arm A (imatinib mesylate, EsPhALL chemotherapy); Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)

Dexrazoxane Hydrochloride DRUG

Given IV

Also known as: Cardioxane, Totect, Zinecard

Arm A (imatinib mesylate, EsPhALL chemotherapy); Arm B (imatinib mesylate, COG/BFM chemotherapy); Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)

Doxorubicin DRUG

Given IV

Also known as: Adriablastin, Hydroxydaunomycin, Hydroxyl Daunorubicin, Hydroxyldaunorubicin

Arm A (imatinib mesylate, EsPhALL chemotherapy); Arm B (imatinib mesylate, COG/BFM chemotherapy); Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)

Etoposide DRUG

Given IV

Also known as: Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar, Vepesid, VP 16, VP 16-213, VP 16213, VP-16, VP-16-213, VP-16213, VP16, VP16213

Arm A (imatinib mesylate, EsPhALL chemotherapy); Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)

Filgrastim BIOLOGICAL

Given SC or IV

Also known as: Filgrastim Biosimilar Filgrastim-sndz, Filgrastim Biosimilar Tbo-filgrastim, Filgrastim XM02, Filgrastim-aafi, Filgrastim-ayow, Filgrastim-sndz, G-CSF, Granix, Neupogen, Neutroval, Nivestim, Nivestym, r-metHuG-CSF, Recombinant Methionyl Human Granulocyte Colony Stimulating Factor, Releuko, rG-CSF, Tbo-filgrastim, Tevagrastim, XM02, Zarxio

Arm A (imatinib mesylate, EsPhALL chemotherapy); Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)

Ifosfamide DRUG

Given IV

Also known as: Asta Z 4942, Asta Z-4942, Cyfos, Holoxan, Holoxane, Ifex, IFO, IFO-Cell, Ifolem, Ifomida, Ifomide, Ifosfamidum, Ifoxan, IFX, Iphosphamid, Iphosphamide, Iso-Endoxan, Isoendoxan, Isophosphamide, Mitoxana, MJF 9325, MJF-9325, Naxamide, Seromida, Tronoxal, Z 4942, Z-4942

Arm A (imatinib mesylate, EsPhALL chemotherapy); Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)

Imatinib Mesylate DRUG

Given PO

Also known as: CGP 57148, CGP 57148B, CGP-57148, CGP-57148B, CGP57148, CGP57148B, Gleevec, Glivec, Imarech, Imat, Imkeldi, STI 571, STI-571, STI571

Arm A (imatinib mesylate, EsPhALL chemotherapy); Arm B (imatinib mesylate, COG/BFM chemotherapy); Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm A (imatinib mesylate, EsPhALL chemotherapy); Arm B (imatinib mesylate, COG/BFM chemotherapy); Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)

Leucovorin Calcium DRUG

Given PO or IV

Also known as: Adinepar, Calcifolin, Calcium (6S)-Folinate, Calcium Folinate, Calcium Leucovorin, Calfolex, Calinat, Cehafolin, Citofolin, Citrec, Citrovorum Factor, Cromatonbic Folinico, Dalisol, Disintox, Divical, Ecofol, Emovis, Factor, Citrovorum, Flynoken A, Folaren, Folaxin, FOLI-cell, Foliben, Folidan, Folidar, Folinac, Folinate Calcium, folinic acid, Folinic Acid Calcium Salt Pentahydrate, Folinoral, Folinvit, Foliplus, Folix, Imo, Lederfolat, Lederfolin, Leucosar, leucovorin, Rescufolin, Rescuvolin, Tonofolin, Wellcovorin

Arm A (imatinib mesylate, EsPhALL chemotherapy); Arm B (imatinib mesylate, COG/BFM chemotherapy); Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)

Levoleucovorin DRUG

Given PO or IV

Also known as: CL-307,782, Elvorine, Isovorin, Levofolene, Levorin, Isovorin, L-Leucovorin, Levofolinate, Levofolinic acid

Arm A (imatinib mesylate, EsPhALL chemotherapy); Arm B (imatinib mesylate, COG/BFM chemotherapy); Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)

Mercaptopurine DRUG

Given PO

Also known as: 3H-Purine-6-thiol, 6 MP, 6 Thiohypoxanthine, 6 Thiopurine, 6-Mercaptopurine, 6-Mercaptopurine Monohydrate, 6-MP, 6-Purinethiol, 6-Thiopurine, 6-Thioxopurine, 6H-Purine-6-thione, 1,7-dihydro- (9CI), 7-Mercapto-1,3,4,6-tetrazaindene, Alti-Mercaptopurine, Azathiopurine, Bw 57-323H, Flocofil, Ismipur, Leukerin, Leupurin, Mercaleukim, Mercaleukin, Mercaptina, Mercaptopurinum, Mercapurin, Mern, NCI-C04886, Puri-Nethol, Purimethol, Purine, 6-mercapto-, Purine-6-thiol (8CI), Purine-6-thiol, monohydrate, Purinethiol, Purinethol, U-4748, WR-2785

Arm A (imatinib mesylate, EsPhALL chemotherapy); Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)

Methotrexate DRUG

Given IT

Also known as: Abitrexate, Alpha-Methopterin, Amethopterin, Brimexate, CL 14377, CL-14377, Emtexate, Emthexat, Emthexate, Farmitrexat, Fauldexato, Folex, Folex PFS, Jylamvo, Lantarel, Ledertrexate, Lumexon, Maxtrex, Medsatrexate, Metex, Methoblastin, Methotrexate LPF, Methotrexate Methylaminopterin, Methotrexatum, Metotrexato, Metrotex, Mexate, Mexate-AQ, MTX, Novatrex, Rheumatrex, Texate, Tremetex, Trexeron, Trixilem, WR-19039

Arm A (imatinib mesylate, EsPhALL chemotherapy); Arm B (imatinib mesylate, COG/BFM chemotherapy); Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)

Methylprednisolone DRUG

Given IV

Also known as: Adlone, Caberdelta M, DepMedalone, Depo Moderin, Depo-Nisolone, Duralone, Emmetipi, Esametone, Firmacort, Medlone 21, Medrate, Medrol, Medrol Veriderm, Medrone, Mega-Star, Meprolone, Methylprednisolonum, Metilbetasone Solubile, Metrocort, Metypresol, Metysolon, Predni-M-Tablinen, Prednilen, Radilem, Sieropresol, Solpredone, Summicort, Urbason, Veriderm Medrol, Wyacort

Arm A (imatinib mesylate, EsPhALL chemotherapy); Arm B (imatinib mesylate, COG/BFM chemotherapy); Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)

Pegaspargase DRUG

Given IV

Also known as: L-Asparaginase with Polyethylene Glycol, Oncaspar, Oncaspar-IV, PEG-Asparaginase, PEG-L-Asparaginase, PEG-L-Asparaginase (Enzon - Kyowa Hakko), PEGLA, Polyethylene Glycol L-Asparaginase, Polyethylene Glycol-L-Asparaginase

Arm A (imatinib mesylate, EsPhALL chemotherapy); Arm B (imatinib mesylate, COG/BFM chemotherapy); Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)

Prednisolone DRUG

Given PO

Also known as: (11beta)-11,17,21-Trihydroxypregna-1,4-diene-3,20-dione, .delta.1-Hydrocortisone, Adnisolone, Aprednislon, Capsoid, Cortalone, Cortisolone, Dacortin H, Decaprednil, Decortin H, Delta(1)Hydrocortisone, Delta- Cortef, Delta-Cortef, Delta-Diona, Delta-F, Delta-Phoricol, Delta1-dehydro-hydrocortisone, Deltacortril, Deltahydrocortisone, Deltasolone, Deltidrosol, Dhasolone, Di-Adreson-F, Dontisolon D, Estilsona, Fisopred, Frisolona, Gupisone, Hostacortin H, Hydeltra, Hydeltrasol, Klismacort, Kuhlprednon, Lenisolone, Lepi-Cortinolo, Linola-H N, Linola-H-Fett N, Longiprednil, Metacortandralone, Meti Derm, Meticortelone, Opredsone, Panafcortelone, Precortisyl, Pred-Clysma, Predeltilone, Predni-Coelin, Predni-Helvacort, Prednicortelone, Prednisolonum, Prelone, Prenilone, Sterane

Arm A (imatinib mesylate, EsPhALL chemotherapy); Arm B (imatinib mesylate, COG/BFM chemotherapy); Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)

Questionnaire Administration OTHER

Ancillary studies

Arm A (imatinib mesylate, EsPhALL chemotherapy); Arm B (imatinib mesylate, COG/BFM chemotherapy); Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)

Therapeutic Hydrocortisone DRUG

Given IT

Also known as: Aeroseb-HC, Barseb HC, Barseb-HC, Cetacort, Cort-Dome, Cortef, Cortenema, Cortifan, Cortisol, Cortispray, Cortril, Dermacort, Domolene, Eldecort, Hautosone, Heb-Cort, Hydrocortisone, Hydrocortone, Hytone, Komed-HC, Nutracort, Proctocort, Rectoid

Arm A (imatinib mesylate, EsPhALL chemotherapy); Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)

Thioguanine DRUG

Given PO

Also known as: 2-Amino 6MP, 2-Amino-1,7-dihydro-6H-purine-6-thione, 2-Amino-6-mercaptopurine, 2-Amino-6-purinethiol, 2-Aminopurin-6-thiol, 2-Aminopurine-6(1H)-thione, 2-Aminopurine-6-thiol, 2-Aminopurine-6-thiol Hemihydrate, 2-Mercapto-6-aminopurine, 6-Amino-2-mercaptopurine, 6-Mercapto-2-aminopurine, 6-Mercaptoguanine, 6-TG, 6H-Purine-6-thione, 2-amino-1,7-dihydro- (9CI), BW 5071, Lanvis, Tabloid, Thioguanine Hemihydrate, Thioguanine Hydrate, Tioguanin, Tioguanine, Wellcome U3B, WR-1141, X 27

Arm A (imatinib mesylate, EsPhALL chemotherapy); Arm B (imatinib mesylate, COG/BFM chemotherapy); Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)

Vincristine Sulfate DRUG

Given IV

Also known as: Kyocristine, Leurocristine Sulfate, Leurocristine, sulfate, Oncovin, Vincasar, Vincosid, Vincrex, Vincristine, sulfate

Arm A (imatinib mesylate, EsPhALL chemotherapy); Arm B (imatinib mesylate, COG/BFM chemotherapy); Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• For patients enrolled on APEC14B1 prior to enrollment on AALL1631, the required diagnostic bone marrow sample has been fulfilled
• For patients who have not previously enrolled on APEC14B1 prior to enrollment on AALL1631, a baseline diagnostic sample (or peripheral blood sample with blasts if marrow sample unavailable) must be available to develop an MRD probe
• In addition, laboratory reports detailing evidence of BCR::ABL1 fusion or ABL-class fusion must be submitted for rapid central review within 72 hours of study enrollment
• \>= 1 year (365 days) and =\< 21 years at ALL diagnosis
• Ph+ (BCR::ABL1 fusion): newly diagnosed de novo ALL (B-ALL or T-ALL) or mixed phenotypic acute leukemia (MPAL meeting 2016 World Health Organization \[WHO\] definition) with definitive evidence of BCR::ABL1 fusion by karyotype, fluorescence in situ hybridization (FISH) and/or molecular methodologies
• ABL-class fusion: newly diagnosed B-ALL with definitive evidence of ABL-class fusions. ABL-class fusions are defined as those involving the following genes: ABL1, ABL2, CSF1R, PDGFRB, PDGFRA. Methods of detection include fluorescence in-situ hybridization (\[FISH\], e.g. using break-apart or colocalization signals probes), multiplex or singleplex reverse-transcription polymerase chain reaction (RT-PCR), whole transcriptome or panel-based RNA-sequencing (e.g. TruSight RNA Pan-Cancer Panel; Illumina, San Diego, California \[CA\], United States of America \[USA\] or similar)
• Ph+ patients must have previously started Induction therapy, which includes vincristine, a corticosteroid, pegaspargase, with or without anthracycline, and/or other standard cytotoxic chemotherapy
• Ph+ patients have not received more than 14 days of multiagent Induction therapy beginning with the first dose of vinCRIStine
• Ph+ patients may have started imatinib prior to study entry but have not received more than 14 days of imatinib
• ABL-class fusion patients must have previously completed the 4 or 5 weeks of multiagent Induction chemotherapy (Induction IA phase)
• ABL-class fusion patients may have started imatinib during Induction IA, at the same time of or after the first vinCRIStine dose
• Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2
• Direct bilirubin =\< 2.0 mg/dL
• Shortening fraction of \>= 27% by echocardiogram
• Ejection fraction of \>= 50% by radionuclide angiogram or echocardiogram

You may not qualify if:

• Known history of chronic myelogenous leukemia (CML)
• ALL developing after a previous cancer treated with cytotoxic chemotherapy
• Active, uncontrolled infection, or active systemic illness that requires ongoing vasopressor support or mechanical ventilation
• Down syndrome
• Pregnancy and breast feeding
• Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential
• Lactating females who plan to breastfeed their infants
• Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of treatment according to protocol
• Patients with congenital long QT syndrome, history of ventricular arrhythmias or heart block
• Prior treatment with dasatinib, or any TKI other than imatinib

Sponsors & Collaborators

• Children's Oncology Group: lead
• EsPhALL: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (226)

Children's Hospital of Alabama

Birmingham, Alabama, 35233, United States

Location

USA Health Strada Patient Care Center

Mobile, Alabama, 36604, United States

Location

Providence Alaska Medical Center

Anchorage, Alaska, 99508, United States

Location

Banner Children's at Desert

Mesa, Arizona, 85202, United States

Location

Phoenix Childrens Hospital

Phoenix, Arizona, 85016, United States

Location

Banner University Medical Center - Tucson

Tucson, Arizona, 85719, United States

Location

Arkansas Children's Hospital

Little Rock, Arkansas, 72202-3591, United States

Location

Kaiser Permanente Downey Medical Center

Downey, California, 90242, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Miller Children's and Women's Hospital Long Beach

Long Beach, California, 90806, United States

Location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Valley Children's Hospital

Madera, California, 93636, United States

Location

UCSF Benioff Children's Hospital Oakland

Oakland, California, 94609, United States

Location

Kaiser Permanente-Oakland

Oakland, California, 94611, United States

Location

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

Lucile Packard Children's Hospital Stanford University

Palo Alto, California, 94304, United States

Location

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

Rady Children's Hospital - San Diego

San Diego, California, 92123, United States

Location

UCSF Medical Center-Mission Bay

San Francisco, California, 94158, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center

Denver, Colorado, 80218, United States

Location

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

Alfred I duPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Broward Health Medical Center

Fort Lauderdale, Florida, 33316, United States

Location

Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida, 33908, United States

Location

UF Health Cancer Institute - Gainesville

Gainesville, Florida, 32610, United States

Location

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood, Florida, 33021, United States

Location

Nemours Children's Clinic-Jacksonville

Jacksonville, Florida, 32207, United States

Location

Palms West Radiation Therapy

Loxahatchee Groves, Florida, 33470, United States

Location

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136, United States

Location

Nicklaus Children's Hospital

Miami, Florida, 33155, United States

Location

Miami Cancer Institute

Miami, Florida, 33176, United States

Location

AdventHealth Orlando

Orlando, Florida, 32803, United States

Location

Arnold Palmer Hospital for Children

Orlando, Florida, 32806, United States

Location

Nemours Children's Hospital

Orlando, Florida, 32827, United States

Location

Sacred Heart Hospital

Pensacola, Florida, 32504, United States

Location

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Saint Joseph's Hospital/Children's Hospital-Tampa

Tampa, Florida, 33607, United States

Location

Saint Mary's Medical Center

West Palm Beach, Florida, 33407, United States

Location

Children's Healthcare of Atlanta - Arthur M Blank Hospital

Atlanta, Georgia, 30329, United States

Location

Augusta University Medical Center

Augusta, Georgia, 30912, United States

Location

Atrium Health Navicent

Macon, Georgia, 31201, United States

Location

Memorial Health University Medical Center

Savannah, Georgia, 31404, United States

Location

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States

Location

Saint Luke's Cancer Institute - Boise

Boise, Idaho, 83712, United States

Location

Lurie Children's Hospital-Chicago

Chicago, Illinois, 60611, United States

Location

University of Illinois

Chicago, Illinois, 60612, United States

Location

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

Advocate Children's Hospital-Oak Lawn

Oak Lawn, Illinois, 60453, United States

Location

Advocate Children's Hospital-Park Ridge

Park Ridge, Illinois, 60068, United States

Location

Saint Jude Midwest Affiliate

Peoria, Illinois, 61637, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

Location

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

Ascension Saint Vincent Indianapolis Hospital

Indianapolis, Indiana, 46260, United States

Location

Blank Children's Hospital

Des Moines, Iowa, 50309, United States

Location

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States

Location

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location

Norton Children's Hospital

Louisville, Kentucky, 40202, United States

Location

Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121, United States

Location

Eastern Maine Medical Center

Bangor, Maine, 04401, United States

Location

Maine Children's Cancer Program

Scarborough, Maine, 04074, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889-5600, United States

Location

Tufts Children's Hospital

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

UMass Memorial Medical Center - University Campus

Worcester, Massachusetts, 01655, United States

Location

C S Mott Children's Hospital

Ann Arbor, Michigan, 48109, United States

Location

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

Henry Ford Health Saint John Hospital

Detroit, Michigan, 48236, United States

Location

Michigan State University

East Lansing, Michigan, 48823, United States

Location

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

Grand Rapids, Michigan, 49503, United States

Location

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States

Location

Corewell Health Children's

Royal Oak, Michigan, 48073, United States

Location

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota, 55404, United States

Location

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

University of Missouri Children's Hospital

Columbia, Missouri, 65212, United States

Location

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Mercy Hospital Saint Louis

St Louis, Missouri, 63141, United States

Location

Children's Hospital and Medical Center of Omaha

Omaha, Nebraska, 68114, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

Location

Sunrise Hospital and Medical Center

Las Vegas, Nevada, 89109, United States

Location

Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Las Vegas, Nevada, 89135, United States

Location

Summerlin Hospital Medical Center

Las Vegas, Nevada, 89144, United States

Location

Renown Regional Medical Center

Reno, Nevada, 89502, United States

Location

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, 03756, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

Jersey Shore Medical Center

Neptune City, New Jersey, 07753, United States

Location

Saint Peter's University Hospital

New Brunswick, New Jersey, 08901, United States

Location

Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08903, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

Saint Joseph's Regional Medical Center

Paterson, New Jersey, 07503, United States

Location

Presbyterian Hospital

Albuquerque, New Mexico, 87106, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

NYU Langone Hospital - Long Island

Mineola, New York, 11501, United States

Location

The Steven and Alexandra Cohen Children's Medical Center of New York

New Hyde Park, New York, 11040, United States

Location

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, 10016, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

State University of New York Upstate Medical University

Syracuse, New York, 13210, United States

Location

Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

Mission Hospital

Asheville, North Carolina, 28801, United States

Location

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, 28203, United States

Location

Novant Health Presbyterian Medical Center

Charlotte, North Carolina, 28204, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

East Carolina University

Greenville, North Carolina, 27834, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Sanford Broadway Medical Center

Fargo, North Dakota, 58122, United States

Location

Children's Hospital Medical Center of Akron

Akron, Ohio, 44308, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Rainbow Babies and Childrens Hospital

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Dayton Children's Hospital

Dayton, Ohio, 45404, United States

Location

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

Toledo, Ohio, 43606, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Legacy Emanuel Children's Hospital

Portland, Oregon, 97227, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, 18103, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Penn State Children's Hospital

Hershey, Pennsylvania, 17033, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Saint Christopher's Hospital for Children

Philadelphia, Pennsylvania, 19134, United States

Location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Prisma Health Richland Hospital

Columbia, South Carolina, 29203, United States

Location

BI-LO Charities Children's Cancer Center

Greenville, South Carolina, 29605, United States

Location

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134, United States

Location

T C Thompson Children's Hospital

Chattanooga, Tennessee, 37403, United States

Location

East Tennessee Childrens Hospital

Knoxville, Tennessee, 37916, United States

Location

The Children's Hospital at TriStar Centennial

Nashville, Tennessee, 37203, United States

Location

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Texas Tech University Health Sciences Center-Amarillo

Amarillo, Texas, 79106, United States

Location

Dell Children's Medical Center of Central Texas

Austin, Texas, 78723, United States

Location

Driscoll Children's Hospital

Corpus Christi, Texas, 78411, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390, United States

Location

El Paso Children's Hospital

El Paso, Texas, 79905, United States

Location

Cook Children's Medical Center

Fort Worth, Texas, 76104, United States

Location

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, 77030, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Covenant Children's Hospital

Lubbock, Texas, 79410, United States

Location

UMC Cancer Center / UMC Health System

Lubbock, Texas, 79415, United States

Location

Children's Hospital of San Antonio

San Antonio, Texas, 78207, United States

Location

Methodist Children's Hospital of South Texas

San Antonio, Texas, 78229, United States

Location

Scott and White Memorial Hospital

Temple, Texas, 76508, United States

Location

Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

Location

University of Vermont and State Agricultural College

Burlington, Vermont, 05405, United States

Location

University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Children's Hospital of The King's Daughters

Norfolk, Virginia, 23507, United States

Location

Naval Medical Center - Portsmouth

Portsmouth, Virginia, 23708-2197, United States

Location

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, 23298, United States

Location

Carilion Children's

Roanoke, Virginia, 24014, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington, 99204, United States

Location

Mary Bridge Children's Hospital and Health Center

Tacoma, Washington, 98405, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

Edwards Comprehensive Cancer Center

Huntington, West Virginia, 25701, United States

Location

West Virginia University Healthcare

Morgantown, West Virginia, 26506, United States

Location

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, 54301, United States

Location

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, 53792, United States

Location

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449, United States

Location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

John Hunter Children's Hospital

Hunter Regional Mail Centre, New South Wales, 2310, Australia

Location

Sydney Children's Hospital

Randwick, New South Wales, 2031, Australia

Location

The Children's Hospital at Westmead

Westmead, New South Wales, 2145, Australia

Location

Queensland Children's Hospital

South Brisbane, Queensland, 4101, Australia

Location

Princess Margaret Hospital for Children

Perth, Western Australia, 6008, Australia

Location

Perth Children's Hospital

Perth, Western Australia, 6009, Australia

Location

St. Anna Children's Hospital

Vienna, 1090, Austria

Location

Hospitals Leuven

Leuven, Flemish Brabant, 3000, Belgium

Location

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

McMaster Children's Hospital at Hamilton Health Sciences

Hamilton, Ontario, L8N 3Z5, Canada

Location

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

Location

Children's Hospital

London, Ontario, N6A 5W9, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

The Montreal Children's Hospital of the MUHC

Montreal, Quebec, H3H 1P3, Canada

Location

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Jim Pattison Children's Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)

Québec, G1V 4G2, Canada

Location

Hospital Roberto del Rio-Universidad de Chile

Santiago, Chile

Location

University Hospital Motol

Prague, 15018, 5-Motol, Czechia

Location

Tampere University Hospital

Tampere, 33521, Finland

Location

CHU Hopital Sud

Rennes, 35203, France

Location

University Medical Center chleswig- Campus Kiel

Kiel, Schleswig-Holstein, 24105, Germany

Location

Universitätsklinik Eppendorf

Hamburg, 20246, Germany

Location

Hong Kong Children's Hospital

Kowloon Bay, Kowloon, Hong Kong

Location

Schneider Children's Medical Center of Israel

Petah Tikva, Central District, 4920235, Israel

Location

Clinica Pediatrica Università Milano-Bicocca Ospedale S. Gerardo/Fondazione MBBM

Monza, 20900, Italy

Location

Princess Máxima Center for Pediatric Oncology

Utrecht, 3584 CT, Netherlands

Location

Starship Children's Hospital

Grafton, Auckland, 1145, New Zealand

Location

Christchurch Hospital

Christchurch, 8011, New Zealand

Location

HIMA San Pablo Oncologic Hospital

Caguas, 00726, Puerto Rico

Location

San Jorge Children's Hospital

San Juan, 00912, Puerto Rico

Location

University Pediatric Hospital

San Juan, 00926, Puerto Rico

Location

King Faisal Specialist Hospital and Research Centre

Riyadh, 11211, Saudi Arabia

Location

Skane University Hospital

Lund, Skåne County, 22185, Sweden

Location

University Children's Hospital

Zurich, CH8032, Switzerland

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Burkitt Lymphoma; Leukemia, Biphenotypic, Acute; Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Stem Cell Transplantation; calaspargase pegol; Asparaginase; Cyclophosphamide; Cytarabine; Daunorubicin; Dexamethasone; Calcium Dobesilate; auricularum; dexamethasone acetate; dexamethasone 21-phosphate; Dexrazoxane; Razoxane; Doxorubicin; Etoposide; Filgrastim; Granulocyte Colony-Stimulating Factor; Ifosfamide; Imatinib Mesylate; Leucovorin; Levoleucovorin; Mercaptopurine; azathiopurine; Methotrexate; merphos; Methylprednisolone; exifone; Medrol Veriderm; pegaspargase; Prednisolone; Hydrocortisone; Thioguanine; Vincristine

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma

Intervention Hierarchy (Ancestors)

Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative; Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Diketopiperazines; Piperazines; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Oxazines; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Sulfhydryl Compounds; Purines; Aminopterin; Pregnenediones; Pregnenes; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines

Study Officials

• Lewis B Silverman

  Children's Oncology Group

  PRINCIPAL INVESTIGATOR

• Prof. Andrea Biondi

  EsPhALL Network/ BFM Study Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2016
• First Posted: January 2, 2017
• Study Start: August 8, 2017
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

CA (16); IT (1); CH (1); SA (1); SE (1); NZ (2); HK (1); CZ (1); NL (1); IL (1); BE (1); PR (3); US (184); AU (6); FI (1); FR (1); DE (2); CL (1)