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

Sponsor
SWOG Cancer Research Network
Study ID
NCT07636564
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
1 Year - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo CSF and blood sample collection
  • Blinatumomab — BIOLOGICAL
    Given IV
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow biopsy and aspiration
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy and aspiration
  • Calaspargase Pegol — DRUG
    Given IV
  • Chest Radiography — PROCEDURE
    Undergo chest x-ray
  • Computed Tomography — PROCEDURE
    Undergo CT or PET/CT
  • Cyclophosphamide — DRUG
    Given IV
  • Cytarabine — DRUG
    Given IV or SC
  • Daunorubicin Hydrochloride — DRUG
    Given IV
  • Dexamethasone — DRUG
    Given PO or IV
  • Doxorubicin — DRUG
    Given IV
  • Echocardiography Test — PROCEDURE
    Undergo ECHO
  • Leucovorin Calcium — DRUG
    Given PO or IV
  • Mercaptopurine — DRUG
    Given PO
  • Methotrexate — DRUG
    Given IT or IV
  • Multigated Acquisition Scan — PROCEDURE
    Undergo MUGA
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT
  • Revumenib — DRUG
    Given PO
  • Thioguanine — DRUG
    Given PO
  • Vincristine — DRUG
    Given IV

Study Details

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.

Key Dates

Start date
Oct 14, 2026
Status verified
Jun 2026
Primary completion
Apr 16, 2031
Completion
Apr 16, 2032

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A, Arm 1 (revumenib and blinatumomab)
    See Detailed Description.
  • Active Comparator: Cohort A, Arm 2 (blinatumomab)
    See Detailed Description.
  • Experimental: Cohort B (revumenib and blinatumomab)
    See Detailed Description.

Primary Outcome Measure

Dose limiting toxicities (Safety run-in: Cohort A) [ Time Frame: During cycle 1 (cycle 1 length = 28 days) ]

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