A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL)

Conditions

• B Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex

ALL

Age

366 Days - 46 Years

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo blood and CSF sample collection
• Blinatumomab — BIOLOGICAL
  Receive IV
• Bone Marrow Biopsy — PROCEDURE
  Undergo bone marrow biopsy
• Calaspargase Pegol — DRUG
  Receive IV
• Cyclophosphamide — DRUG
  Receive IV
• Cytarabine — DRUG
  Receive IV or subcutaneously
• Dasatinib — DRUG
  Receive PO
• Daunorubicin — DRUG
  Receive IV
• Doxorubicin — DRUG
  Receive IV
• Echocardiography Test — PROCEDURE
  Undergo ECHO
• Imatinib — DRUG
  Given PO
• Leucovorin — DRUG
  Receive PO or IV
• Mercaptopurine — DRUG
  Receive PO
• Methotrexate — DRUG
  Receive IT or IV or PO
• Multigated Acquisition Scan — PROCEDURE
  Undergo MUGA
• Pegaspargase — DRUG
  Receive IV or intramuscularly
• Prednisolone — DRUG
  Receive PO
• Prednisone — DRUG
  Receive PO
• Radiation Therapy — RADIATION
  Undergo radiation therapy
• Thioguanine — DRUG
  Receive PO
• Vincristine — DRUG
  Receive IV

Study Details

This pilot trial assesses the effect of the combination of blinatumomab with dasatinib or imatinib and standard chemotherapy for treating patients with Philadelphia chromosome positive (Ph+) or ABL-class Philadelphia chromosome-like (Ph-like) B-Cell acute lymphoblastic leukemia (B-ALL). Blinatumomab is a bispecific antibody that binds to two different proteins-one on the surface of cancer cells and one on the surface of cells in the immune system. An antibody is a protein made by the immune system to help fight infections and other harmful processes/cells/molecules. Blinatumomab may bind to the cancer cell and a T cell (which plays a key role in the immune system's fighting response) at the same time. Blinatumomab may strengthen the immune system's ability to fight cancer cells by activating the body's own immune cells to destroy the tumor. Dasatinib and imatinib are in a class of medications called tyrosine kinase inhibitors. They work by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Giving blinatumomab and dasatinib or imatinib in combination with standard chemotherapy may work better in treating patients with Ph+ or Ph-like ABL-class B-ALL than dasatinib or imatinib with chemotherapy.

Key Dates

Start date

May 30, 2025

Status verified

Apr 2026

Primary completion

Dec 1, 2030

Completion

Dec 1, 2030

Study Design

Enrollment

222 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Stratum I (Ph+ ALL)
  See detailed description
• Experimental: Stratum II (PDGFRB ABL-Class fusions)
  See detailed description.
• Experimental: Stratum III (non-PDGFRB ABL-Class fusions)
  See detailed description.

Primary Outcome Measure

Philadelphia chromosome-positive (Ph+) (BCR::ABL1-rearranged) 3-year event free survival (EFS) [ Time Frame: Time from enrollment to first event, relapse, second malignancy, or death in complete remission, or last contact for those who are event-free, assessed up to 3 years ]

Locations (137)

Find similar trials in Birmingham, AL

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