Blinatumomab + Dasatinib/Imatinib for Acute Lymphoblastic Leukemia

Recruiting at 15 trial locations

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: National Cancer Institute (NCI)

Must be taking: Tyrosine kinase inhibitors

Must not be taking: Other TKIs

Disqualifiers: Chronic myeloid leukemia, Down syndrome, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 13

222 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase III trial compares the effect of the combination of blinatumomab with dasatinib or imatinib and standard chemotherapy versus 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 compared to dasatinib or imatinib and chemotherapy alone.

Who Is on the Research Team?

Thai Hoa Tran

Principal Investigator

Children's Oncology Group

Are You a Good Fit for This Trial?

This trial is for young patients with a specific type of leukemia called Ph+ or Ph-like ABL-class B-ALL. They must have started treatment but not received more than 14 days of dasatinib, and their cancer cells should express CD19. Patients need to have begun standard chemotherapy and have an acceptable level of physical functioning. Kidney function must also meet certain criteria.

Inclusion Criteria

My test results show I have ABL-class fusions.

I started treatment with specific drugs for my cancer.

I have taken dasatinib for no more than 14 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Induction

Patients receive dasatinib and other chemotherapy agents to induce remission

4 weeks

Multiple visits for drug administration

Consolidation

Patients receive dasatinib and blinatumomab to consolidate remission

8 weeks

Multiple visits for drug administration

Interim Maintenance

Patients receive maintenance therapy to prevent relapse

9 weeks

Regular visits for drug administration

Delayed Intensification

Patients receive intensified therapy to eliminate residual disease

9 weeks

Regular visits for drug administration

Maintenance

Long-term maintenance therapy to sustain remission

2 years

Regular visits every 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

Periodic follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Blinatumomab
• Dasatinib
• Imatinib

Trial Overview The study tests if adding blinatumomab (an antibody that helps the immune system fight cancer) to dasatinib or imatinib (drugs blocking cancer cell growth signals) plus standard chemo works better than just dasatinib/imatinib with chemo in treating this leukemia.

How Is the Trial Designed?

Group I: Arm III (non-PDGFRB ABL-Class fusions)(blinatumomab+dasitinib) Experimental Treatment 20 Interventions

See detailed description.

Group II: Arm II (PDGFRB ABL-Class fusions) (blinatumomab + imatinib) Experimental Treatment 20 Interventions

See detailed description.

Group III: Arm I (dasatinib, standard chemo) Active Control 17 Interventions

See detailed description.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+