Testing Blinatumomab With or Without Revumenib in Patients With B-cell Acute Lymphoblastic Leukemia With a Genetic Change Requiring More Treatment

NCT07636564 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: S2507NCI-2026-03381U10CA180888
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

This phase II trial tests how well adding revumenib to usual treatment (blinatumomab) compared to usual treatment alone works in treating patients with B-cell acute lymphoblastic leukemia (B-ALL) or acute leukemia with ambiguous lineage (ALAL) with KMT2A-translocation. Revumenib binds to a protein called menin and keeps it from binding to another protein called KMT2A. This stops or slows the growth of leukemia cells with changes in the KMT2A gene. Blinatumomab binds to CD19, which is found on most B cells (a type of white blood cell) and some types of leukemia cells. It also binds to a protein called CD3, which is found on T cells (another type of white blood cell). This may help the immune system kill cancer cells. In addition to blinatumomab, usual treatment also includes dexamethasone, methotrexate, cyclophosphamide, cytarabine, mercaptopurine, calaspargase pegol, doxorubicin, thioguanine, daunorubicin, vincristine and leucovorin. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Methotrexate is in a class of medications called antimetabolites. It is also a type of antifolate. Methotrexate stops cells from using folic acid to make deoxyribonucleic acid (DNA) and may kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Chemotherapy drugs, such as cytarabine, mercaptopurine, calaspargase pegol, doxorubicin, thioguanine, and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Leucovorin is also being studied in the treatment of cancer. It is a type of chemoprotective agent and a type of chemosensitizing agent. Adding revumenib to usual treatment with blinatumomab may be safe, tolerable and more effective than blinatumomab alone in lowering the amount of leukemia in patients with B-ALL or ALAL with the KMT2A translocation.

Conditions

B Acute Lymphoblastic Leukemia; B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative; T Acute Lymphoblastic Leukemia; Acute Leukemia of Ambiguous Lineage

Outcome Measures

Primary Outcomes (4)

• Dose limiting toxicities (Safety run-in: Cohort A)

  Will be evaluated using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 6.0. Will evaluate the proportion of participants with dose limiting toxicities and exact confidence intervals.

  During cycle 1 (cycle 1 length = 28 days)

• Measurable residual disease (MRD) negativity rate (Cohort A)

  Difference in proportion of participants who achieve clonoSEQ MRD status between the two arms will be compared using a two-sample proportion test.

  Up to 35 days after start of therapy

• MRD-event-free survival (EFS) (Cohort A)

  Will be compared using unstratified log-rank test.

  From date of randomization and up to 10 years

• Incidence of toxicities of interest (TOI) (Cohort B)

  TOI rates will be reported with exact 90% confidence intervals.

  Up to 30 days after last dose of study treatment

Secondary Outcomes (16)

• Incidence of adverse events

  Up to 30 days after last dose of study treatment

• MRD negative complete remission (CR) rate (Cohort A)

  Up to 70 days after start of therapy

• EFS (Cohort A)

  At 6 months

• MRD-EFS (Cohort A)

  At 6 months

• Composite morphological CR rate (Cohort B)

  Up to 35 days after start of therapy

Other Outcomes (5)

• Frequency of MEN1 mutations

  Up to 10 years after start of therapy

• Rate of KMT2A fusion reverse transcriptase (RT)-PCR MRD negativity within treatment arms (Cohort A)

  After the first and second cycle of blinatumomab (cycle length = 28 days)

• KMT2A fusion RT-PCR MRD negativity (Cohort B)

  Up to 90 days after start of therapy

Study Arms (3)

Cohort A, Arm 1 (revumenib and blinatumomab)

EXPERIMENTAL

See Detailed Description.

Procedure: Biospecimen Collection; Biological: Blinatumomab; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Drug: Calaspargase Pegol; Procedure: Chest Radiography; Procedure: Computed Tomography; Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Dexamethasone; Drug: Doxorubicin; Procedure: Echocardiography Test; Drug: Leucovorin Calcium; Drug: Mercaptopurine; Drug: Methotrexate; Procedure: Multigated Acquisition Scan; Procedure: Positron Emission Tomography; Drug: Revumenib; Drug: Thioguanine; Drug: Vincristine

Cohort A, Arm 2 (blinatumomab)

ACTIVE COMPARATOR

See Detailed Description.

Procedure: Biospecimen Collection; Biological: Blinatumomab; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Drug: Calaspargase Pegol; Procedure: Chest Radiography; Procedure: Computed Tomography; Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Dexamethasone; Drug: Doxorubicin; Procedure: Echocardiography Test; Drug: Leucovorin Calcium; Drug: Mercaptopurine; Drug: Methotrexate; Procedure: Multigated Acquisition Scan; Procedure: Positron Emission Tomography; Drug: Thioguanine; Drug: Vincristine

Cohort B (revumenib and blinatumomab)

EXPERIMENTAL

See Detailed Description.

Procedure: Biospecimen Collection; Biological: Blinatumomab; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Procedure: Computed Tomography; Drug: Cytarabine; Drug: Daunorubicin Hydrochloride; Drug: Dexamethasone; Drug: Methotrexate; Procedure: Positron Emission Tomography; Drug: Revumenib; Drug: Vincristine

Interventions

Biospecimen Collection PROCEDURE

Undergo CSF and blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

Cohort A, Arm 1 (revumenib and blinatumomab); Cohort A, Arm 2 (blinatumomab); Cohort B (revumenib and blinatumomab)

Blinatumomab BIOLOGICAL

Given IV

Also known as: AMG 103, AMG-103, AMG103, Anti-CD19 x Anti-CD3 Bispecific Monoclonal Antibody, Anti-CD19/Anti-CD3 Recombinant Bispecific Monoclonal Antibody MT103, Blincyto, MEDI 538, MEDI-538, MEDI538, MT 103, MT-103, MT103

Cohort A, Arm 1 (revumenib and blinatumomab); Cohort A, Arm 2 (blinatumomab); Cohort B (revumenib and blinatumomab)

Bone Marrow Aspiration PROCEDURE

Undergo bone marrow biopsy and aspiration

Cohort A, Arm 1 (revumenib and blinatumomab); Cohort A, Arm 2 (blinatumomab); Cohort B (revumenib and blinatumomab)

Bone Marrow Biopsy PROCEDURE

Undergo bone marrow biopsy and aspiration

Also known as: Biopsy of Bone Marrow, Biopsy, Bone Marrow

Cohort A, Arm 1 (revumenib and blinatumomab); Cohort A, Arm 2 (blinatumomab); Cohort B (revumenib and blinatumomab)

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

Cohort A, Arm 1 (revumenib and blinatumomab); Cohort A, Arm 2 (blinatumomab)

Computed Tomography PROCEDURE

Undergo CT or PET/CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

Cohort A, Arm 1 (revumenib and blinatumomab); Cohort A, Arm 2 (blinatumomab); Cohort B (revumenib and blinatumomab)

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

Cohort A, Arm 1 (revumenib and blinatumomab); Cohort A, Arm 2 (blinatumomab)

Cytarabine DRUG

Given IV or SC

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

Cohort A, Arm 1 (revumenib and blinatumomab); Cohort A, Arm 2 (blinatumomab); Cohort B (revumenib and blinatumomab)

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

Cohort A, Arm 1 (revumenib and blinatumomab); Cohort A, Arm 2 (blinatumomab); Cohort B (revumenib and blinatumomab)

Doxorubicin DRUG

Given IV

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

Cohort A, Arm 1 (revumenib and blinatumomab); Cohort A, Arm 2 (blinatumomab)

Echocardiography Test PROCEDURE

Undergo ECHO

Also known as: EC, Echocardiography

Cohort A, Arm 1 (revumenib and blinatumomab); Cohort A, Arm 2 (blinatumomab)

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

Cohort A, Arm 1 (revumenib and blinatumomab); Cohort A, Arm 2 (blinatumomab)

Methotrexate DRUG

Given IT or IV

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

Cohort A, Arm 1 (revumenib and blinatumomab); Cohort A, Arm 2 (blinatumomab); Cohort B (revumenib and blinatumomab)

Multigated Acquisition Scan PROCEDURE

Undergo MUGA

Also known as: Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan, MUGA, MUGA Scan, Multi-Gated Acquisition Scan, Radionuclide Ventriculogram Scan, Radionuclide Ventriculography, RNV Scan, RNVG, SYMA Scanning, Synchronized Multigated Acquisition Scanning

Cohort A, Arm 1 (revumenib and blinatumomab); Cohort A, Arm 2 (blinatumomab)

Revumenib DRUG

Given PO

Also known as: Menin-Mixed Lineage Leukemia Protein-Protein Interaction Inhibitor SNDX-5613, Menin-MLL Inhibitor SNDX-5613, Menin-MLL Interaction Inhibitor SNDX-5613, SNDX 5613, SNDX-5613, SNDX5613

Cohort A, Arm 1 (revumenib and blinatumomab); Cohort B (revumenib and blinatumomab)

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

Cohort A, Arm 1 (revumenib and blinatumomab); Cohort A, Arm 2 (blinatumomab)

Vincristine DRUG

Given IV

Also known as: LCR, Leurocristine, VCR, Vincrystine

Cohort A, Arm 1 (revumenib and blinatumomab); Cohort A, Arm 2 (blinatumomab); Cohort B (revumenib and blinatumomab)

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

Cohort A, Arm 1 (revumenib and blinatumomab); Cohort A, Arm 2 (blinatumomab)

Positron Emission Tomography PROCEDURE

Undergo PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

Cohort A, Arm 1 (revumenib and blinatumomab); Cohort A, Arm 2 (blinatumomab); Cohort B (revumenib and blinatumomab)

Chest Radiography PROCEDURE

Undergo chest x-ray

Also known as: Chest X-ray

Cohort A, Arm 1 (revumenib and blinatumomab); Cohort A, Arm 2 (blinatumomab)

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

Cohort B (revumenib and blinatumomab)

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• COHORT A: Participants must meet diagnostic criteria for either B-cell acute lymphoblastic leukemia (ALL) with KMT2A-translocation or acute leukemia with ambiguous lineage (ALAL) with KMT2A-translocation
• COHORT A: Participants must have KMT2A-translocation documented locally by conventional cytogenetics, fluorescence in situ hybridization (FISH) or molecular studies such as next generation sequencing (NGS)
• COHORT A: Participants must have achieved morphological first complete remission (CR1) after induction cycle (s) as defined bone marrow lymphoblasts \< 5%
• COHORT A: Participants must have either known trackable clone(s) by clonoSEQ that was identified at initial diagnosis, or a banked diagnostic sample, which can include clinical samples from the treating institution, available that can be used to identify trackable clone(s)
• Participants must not be known not to have trackable clones by clonoSEQ
• Participants must not be known already to have MRD-negativity by clonoSEQ prior to enrollment
• COHORT A: Participants must have evidence of CD19 expression at any level in ALL or ALAL documented locally by flow cytometry or immunohistochemistry in bone marrow or peripheral blood at the time of initial diagnosis. Immunophenotyping of the blood or marrow lymphoblasts must be performed to determine lineage. Appropriate marker studies including CD19 (B cell) must be performed. If a bone marrow aspirate cannot be obtained despite an attempt (dry tap), appropriate Immunohistochemistry (IHC) testing, including CD19, must be performed on the bone marrow biopsy to determine lineage
• COHORT A: Participants must have Philadelphia-chromosome negative ALL or ALAL
• COHORT A: Participants must not have known lymphoid blast crisis arising from chronic myeloid leukemia (CML) or have received previous tyrosine kinase inhibitor (TKI) therapy for their chronic myeloid leukemia (CML)
• COHORT B: Participants must meet diagnostic criteria for either newly diagnosed with acute lymphoblastic leukemia (ALL) or acute leukemia with ambiguous lineage (ALAL)
• Participants with either B or T-cell subtypes of ALL are permitted on Cohort B
• Participants must have KMT2A-translocation documented locally by conventional cytogenetics, fluorescence in situ hybridization (FISH) or molecular studies such as next generation sequencing (NGS)
• COHORT B: Participants must have Philadelphia-chromosome negative ALL or ALAL
• COHORT B: Participants must not have known lymphoid blast crisis arising from CML or have received previous TKI therapy for their chronic myeloid leukemia (CML)
• COHORT A: Participants ≥ 18 years may have received 1 to 3 cycles of induction/consolidation before entering the study. It is encouraged to enroll participants immediately after completing the first induction cycle if the patient achieves morphological CR. For pediatric patients \< 18 years of age, enrollment must occur after induction therapy

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

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

Interventions

Specimen Handling; blinatumomab; N,N-dicyclohexyl-isoborneol-10-sulfonamide; Biopsy; calaspargase pegol; Asparaginase; X-Rays; Cyclophosphamide; Cytarabine; Daunorubicin; Dexamethasone; Calcium Dobesilate; auricularum; dexamethasone acetate; dexamethasone 21-phosphate; Doxorubicin; Leucovorin; Mercaptopurine; azathiopurine; Methotrexate; merphos; Magnetic Resonance Spectroscopy; revumenib; 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; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Cytodiagnosis; Cytological Techniques; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; 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; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Sulfhydryl Compounds; Purines; Aminopterin; Spectrum Analysis; Chemistry Techniques, Analytical; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines

Study Officials

• Ibrahim Aldoss

  SWOG Cancer Research Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: June 9, 2026
• Study Start (Estimated): October 14, 2026
• Primary Completion (Estimated): April 16, 2031
• Study Completion (Estimated): April 16, 2032
• Last Updated: June 9, 2026

Record last verified: 2026-06