Chemotherapy + Immunotherapy for Acute Lymphoblastic Leukemia

Recruiting at 614 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This randomized phase III trial studies combination chemotherapy with blinatumomab to see how well it works compared to induction chemotherapy alone in treating patients with newly diagnosed breakpoint cluster region (BCR)-c-abl oncogene 1, non-receptor tyrosine kinase (ABL)-negative B lineage acute lymphoblastic leukemia. Drugs used in chemotherapy 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. Immunotherapy with monoclonal antibodies, such as blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether combination chemotherapy is more effective with or without blinatumomab in treating newly diagnosed acute lymphoblastic leukemia.

Research Team

Mark R Litzow

Principal Investigator

ECOG-ACRIN Cancer Research Group

Eligibility Criteria

Adults aged 30-70 with a new diagnosis of BCR-ABL-negative B lineage acute lymphoblastic leukemia (ALL) are eligible. They must have normal kidney and liver function, not be pregnant or breastfeeding, use contraception if necessary, and have no recent severe heart issues. HIV-positive patients can join under certain conditions.

Inclusion Criteria

My bone marrow sample will be tested for minimal residual disease.

I can care for myself but may not be able to do heavy physical work.

I am between 30 and 70 years old.

Exclusion Criteria

I do not have Burkitt's-like leukemia and had a bone marrow test within the last week.

I do not have any major health issues that could affect my treatment.

I do not have any significant brain or nervous system conditions.

Treatment Details

Interventions

• Blinatumomab (Monoclonal Antibodies)
• Cyclophosphamide (Alkylating agents)
• Daunorubicin (Topoisomerase Inhibitor)
• Dexamethasone (Corticosteroid)
• Etoposide (Topoisomerase Inhibitor)
• Mercaptopurine (Antimetabolites)
• Methotrexate (Antimetabolites)
• Prednisone (Corticosteroid)
• Rituximab (Monoclonal Antibodies)
• Vincristine (Vinca Alkaloids)

Trial Overview The trial is testing whether adding the immunotherapy drug Blinatumomab to standard combination chemotherapy improves outcomes in treating newly diagnosed ALL compared to chemotherapy alone.

Participant Groups

Group I: Arm I (blinatumomab, chemotherapy) Experimental Treatment 21 Interventions

See Detailed Description

Group II: Arm II (chemotherapy) Active Control 20 Interventions

See Detailed Description

Cyclophosphamide is already approved in Canada, Japan for the following indications:

Approved in Canada as Neosar for:

• Breast cancer
• Ovarian cancer
• Multiple myeloma
• Leukemia
• Lymphoma
• Rheumatoid arthritis

Approved in Japan as Endoxan for:

• Breast cancer
• Ovarian cancer
• Multiple myeloma
• Leukemia
• Lymphoma

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Canadian Cancer Trials Group

Collaborator

Trials

135

Recruited

70,300+