Rituximab + Chemotherapy +/- Lenalidomide for Lymphoma

Recruiting at576 trial locations

Overseen by Grzegorz S Nowakowski

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This randomized phase II trial studies how well rituximab and combination chemotherapy with or without lenalidomide work in treating patients with newly diagnosed stage II-IV diffuse large B cell lymphoma. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, 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. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether rituximab and combination chemotherapy are more effective when given with or without lenalidomide in treating patients with diffuse large B cell lymphoma.

Research Team

Grzegorz S Nowakowski

Principal Investigator

ECOG-ACRIN Cancer Research Group

Eligibility Criteria

This trial is for adults with newly diagnosed stage II-IV diffuse large B cell lymphoma. Participants must have a performance status of 0-2, meaning they can perform daily activities without significant limitations. They should not have had previous treatments for lymphoma or other active cancers requiring therapy, no history of heart issues like recent myocardial infarction, and be able to take blood thinners if necessary.

Inclusion Criteria

I have a tumor tissue sample from my initial biopsy ready for analysis.

I am willing and able to take blood thinning medication as prescribed.

I do not have AIDS or conditions related to it, and if HIV positive, I am on certain antiretrovirals with a CD4 count over 400.

Exclusion Criteria

Patient is living outside the US

I have had a condition where my lymphocytes grow abnormally.

I have a history of cancer.

Treatment Details

Interventions

• Cyclophosphamide (Anti-tumor antibiotic, Anti-metabolites)
• Doxorubicin Hydrochloride (Anti-tumor antibiotic, Anti-metabolites)
• Lenalidomide (Immunomodulatory Agent)
• Prednisone (Corticosteroid)
• Rituximab (Monoclonal Antibodies)
• Vincristine Sulfate (Anti-tumor antibiotic, Anti-metabolites)

Trial Overview The study is testing the effectiveness of rituximab combined with chemotherapy drugs (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, prednisone) versus the same combination with an additional drug called lenalidomide. The goal is to see which regimen works better at treating diffuse large B cell lymphoma.

Participant Groups

Group I: Arm A (rituximab, combination chemotherapy, lenalidomide) Experimental Treatment 7 Interventions

Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1; prednisone PO on days 1-5; and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Group II: Arm B (rituximab, combination chemotherapy) Active Control 6 Interventions

Patients receive rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone as in Arm A. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

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+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School