Combination Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma

Recruiting in Palo Alto (17 mi)

+80 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Alliance for Clinical Trials in Oncology

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining rituximab with combination chemotherapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining rituximab with combination chemotherapy in treating patients who have previously untreated non-Hodgkin's lymphoma.

Research Team

Wyndham H. Wilson, MD, PhD

Principal Investigator

National Cancer Institute (NCI)

Eligibility Criteria

Inclusion Criteria

Histologically confirmed stage II, III, or IV diffuse large cell lymphoma and WHO variants

CD20+ large B-cell lymphoma, including those with immunoblastic features

CD20+ thymic B-cell lymphoma

Treatment Details

Interventions

• Cyclophosphamide (Alkylating agents)
• Doxorubicin Hydrochloride (Anti-tumor antibiotic)
• Etoposide (Other)
• Prednisone (Corticosteroid)
• Rituximab (Monoclonal Antibodies)
• Vincristine Sulfate (Other)

Participant Groups

Group I: EPOCH-Rituximab Experimental Treatment 7 Interventions

Addition of monoclonal antibody therapy to chemotherapy for treatment of pts with aggressive CD20+ NHL

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?

Alliance for Clinical Trials in Oncology

Lead Sponsor

Trials

521

Recruited

224,000+

Suzanne George

Alliance for Clinical Trials in Oncology

Chief Medical Officer since 2015

MD from Harvard Medical School

Evanthia Galanis

Alliance for Clinical Trials in Oncology

Chief Executive Officer since 2022

MD from Mayo Clinic

National Cancer Institute (NCI)

Collaborator

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