Combination Chemotherapy With or Without Peripheral Stem Cell Transplant in Treating Children With Acute Lymphoblastic Leukemia

NCT00022737 | Completed Phase 3

• 5 other identifiers: NCI-2012-01862CDR0000068859COG-AALL0031AALL0031U10CA098543
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial is studying how well combination chemotherapy with or without donor peripheral stem cell transplant works in treating children with acute lymphoblastic leukemia. Giving combination chemotherapy before a donor peripheral stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.

Conditions

Childhood Acute Lymphoblastic Leukemia in Remission; Recurrent Childhood Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (2)

• Feasibility, in terms of patient accrual

  As a target goal, we wish to enroll at least 80% of the potential available patients. The accrual duration for this pilot study will be based on accruing adequate numbers to complete the dose escalation study in the Ph+ subset. The planned study accrual duration should be approximately 1.75 years.

  Up to 1.75 years

• Feasibility, in terms of incidence of adverse events graded according to NCI CTC v 2.0

  The use of imatinib as given in combination with other agents in a particular cohort will be considered feasible initially if 5 or more of the first 6 evaluable patients complete the phase(s) without evidence of grade 3 or 4 targeted toxicities.

  Up to 7 years

Secondary Outcomes (1)

• Event-free survival

  Up to 7 years

Study Arms (1)

Arm I

EXPERIMENTAL

See Design Details.

Biological: filgrastim; Drug: asparaginase; Drug: cyclophosphamide; Drug: cyclosporine; Drug: cytarabine; Drug: daunorubicin hydrochloride; Drug: dexamethasone; Drug: etoposide; Drug: ifosfamide; Drug: imatinib mesylate; Drug: leucovorin calcium; Drug: mercaptopurine tablet; Drug: methotrexate; Drug: pegaspargase; Drug: vincristine sulfate; Procedure: allogeneic bone marrow transplantation; Procedure: peripheral blood stem cell transplantation; Procedure: umbilical cord blood transplantation; Radiation: radiation therapy

Interventions

filgrastim BIOLOGICAL

Given SC

Also known as: G-CSF, Neupogen

Arm I

asparaginase DRUG

Given IM

Also known as: ASNase, Colaspase, Crasnitin, Elspar, L-ASP

Arm I

cyclophosphamide DRUG

Given IV

Also known as: CPM, CTX, Cytoxan, Endoxan, Endoxana

Arm I

cyclosporine DRUG

Given IV

Also known as: ciclosporin, cyclosporin, cyclosporin A, CYSP, Sandimmune

Arm I

cytarabine DRUG

Given IT and IV

Also known as: ARA-C, arabinofuranosylcytosine, arabinosylcytosine, Cytosar-U, cytosine arabinoside

Arm I

daunorubicin hydrochloride DRUG

Given IV

Also known as: Cerubidin, Cerubidine, daunomycin hydrochloride, daunorubicin, RP-13057

Arm I

dexamethasone DRUG

Given orally

Also known as: Aeroseb-Dex, Decaderm, Decadron, DM, DXM

Arm I

etoposide DRUG

Given IV

Also known as: EPEG, VP-16, VP-16-213

Arm I

ifosfamide DRUG

Given IV

Also known as: Cyfos, Holoxan, IFF, IFX, IPP

Arm I

imatinib mesylate DRUG

Given orally

Also known as: CGP 57148, Gleevec, Glivec

Arm I

leucovorin calcium DRUG

Given IV or orally

Also known as: CF, CFR, LV

Arm I

mercaptopurine tablet DRUG

Given orally

Also known as: 6-mercaptopurine, 6-MP, Leukerin, MP

Arm I

methotrexate DRUG

Given IT, IV, and orally

Also known as: amethopterin, Folex, methylaminopterin, Mexate, MTX

Arm I

pegaspargase DRUG

Given IM

Also known as: L-asparaginase with polyethylene glycol, Oncaspar, PEG-ASP, PEG-L-asparaginase

Arm I

vincristine sulfate DRUG

Given IV

Also known as: leurocristine sulfate, VCR, Vincasar PFS

Arm I

allogeneic bone marrow transplantation PROCEDURE

Undergo allogeneic bone marrow, peripheral blood stem cell, or umbilical cord blood transplantation

Also known as: bone marrow therapy, allogeneic, bone marrow therapy, allogenic, transplantation, allogeneic bone marrow, transplantation, allogenic bone marrow

Arm I

peripheral blood stem cell transplantation PROCEDURE

Undergo allogeneic bone marrow, peripheral blood stem cell, or umbilical cord blood transplantation

Also known as: PBPC transplantation, PBSC transplantation, peripheral blood progenitor cell transplantation, transplantation, peripheral blood stem cell

Arm I

umbilical cord blood transplantation PROCEDURE

Undergo allogeneic bone marrow, peripheral blood stem cell, or umbilical cord blood transplantation

Also known as: cord blood transplantation, transplantation, umbilical cord blood, UCB transplantation

Arm I

radiation therapy RADIATION

Undergo radiation therapy

Also known as: irradiation, radiotherapy, therapy, radiation

Arm I

Eligibility Criteria

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

You may qualify if:

• Diagnosis of acute lymphoblastic leukemia
• Received prior front-line therapy on a Pediatric Oncology Group (POG),Children's Cancer Group (CCG), or Central Oncology Group (COG) study
• Received induction therapy comprising vincristine, asparaginase, prednisone/dexamethasone, and daunorubicin as in CCG, POG, or COG protocols
• M1 or M2 bone marrow status after front-line induction therapy and presenting with at least 1of the following:
• Philadelphia chromosome positive (Ph+) with t(9;22)(q34;q11) by cytogenetics or fluorescence in situ hybridization
• bcr-abl fusion transcript by reverse transcription polymerase chain reaction
• Hypodiploid with less than 44 chromosomes and/or DNA index less than0.81
• MLL translocation (11q23) by cytogenetics and a slow early response (SER) to induction therapy, defined as at least 5% blasts at day 15 of induction and/or at least .1% minimal residual disease (MRD) after induction therapy
• Failed to achieve remission after front-line induction therapy
• M3 bone marrow status (greater than 25% blasts) after induction therapy
• M2 bone marrow status (5-25% blasts) or at least 1% MRD after induction therapy and M2 or M3or at least 1% MRD after consolidation therapy (CCG studies) or extended induction therapy (POG or COG studies)
• See Disease Characteristics
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Children's Oncology Group

Arcadia, California, 91006-3776, United States

Location

Related Publications (1)

• Tasian SK, Peters C. Targeted therapy or transplantation for paediatric ABL-class Ph-like acute lymphocytic leukaemia? Lancet Haematol. 2020 Dec;7(12):e858-e859. doi: 10.1016/S2352-3026(20)30369-0. No abstract available.

  PMID: 33242441 DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Filgrastim; Granulocyte Colony-Stimulating Factor; Asparaginase; palmitoyl-L-asparaginase; Cyclophosphamide; Cyclosporine; Cytarabine; Daunorubicin; Dexamethasone; Calcium Dobesilate; Etoposide; Ifosfamide; indolepropanol phosphate; Imatinib Mesylate; Leucovorin; Mercaptopurine; Methotrexate; merphos; pegaspargase; Vincristine; Transplantation; Peripheral Blood Stem Cell Transplantation; Cord Blood Stem Cell Transplantation; Radiotherapy; Radiation

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

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic 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; Aminoglycosides; Glycosides; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Oxazines; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Piperazines; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Sulfhydryl Compounds; Purines; Aminopterin; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Surgical Procedures, Operative; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Physical Phenomena

Study Officials

• Kirk Schultz

  Children's Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2001
• First Posted: January 27, 2003
• Study Start: October 1, 2002
• Primary Completion: October 1, 2006
• Last Updated: February 27, 2014

Record last verified: 2012-11

Locations

US (1)