Chemotherapy + Immunotherapy for Acute Lymphoblastic Leukemia

Recruiting at 615 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: National Cancer Institute (NCI)

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

Compensation: Varies

Number of Visits: 9

488 Participants Needed

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Induction Chemotherapy

Patients receive a combination of chemotherapy drugs including cytarabine, daunorubicin, vincristine, dexamethasone, methotrexate, and pegaspargase.

4 weeks

Weekly visits for drug administration

Intensification Therapy

Patients receive high-dose methotrexate and pegaspargase to intensify treatment.

2 weeks

Visits on days 1, 8, and 9 for drug administration

Consolidation Therapy

Patients receive cytarabine, etoposide, methotrexate, and pegaspargase to consolidate treatment gains.

8 weeks

Visits every 4 weeks for drug administration

Maintenance Therapy

Patients receive mercaptopurine, methotrexate, vincristine, and prednisone to maintain remission.

2.5 years

Monthly visits for drug administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 years

Every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years

Treatment Details

Interventions

• Blinatumomab
• Cyclophosphamide
• Daunorubicin
• Dexamethasone
• Etoposide
• Mercaptopurine
• Methotrexate
• Prednisone
• Rituximab
• Vincristine

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 United States, European Union, Canada, Japan for the following indications:

Approved in United States as Cytoxan for:

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

Approved in European Union as Endoxan for:

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

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+