Chemotherapy + Monoclonal Antibody Therapy for Non-Hodgkin's Lymphoma

Recruiting at 258 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: SWOG Cancer Research Network

Must not be taking: Monoclonal antibodies

Disqualifiers: CNS involvement, Cardiac disease, HIV, 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

Compensation: Varies

Number of Visits: 206

Duration: 18 weeks

571 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them or deliver radioactive tumor-killing substances to them without harming normal cells. It is not yet known which monoclonal antibody plus combination chemotherapy regimen is more effective in treating non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is comparing 2 different monoclonal antibodies given together with combination chemotherapy to see how well they work in treating patients with newly-diagnosed non-Hodgkin's lymphoma.

Who Is on the Research Team?

Oliver W. Press, MD, PhD

Principal Investigator

Fred Hutchinson Cancer Center

Myron S. Czuczman, MD

Principal Investigator

Roswell Park Cancer Institute

Sandra J. Horning, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with newly diagnosed, untreated stage II-IV follicular non-Hodgkin's lymphoma that tests positive for CD20 antigen. Participants must have good performance status, adequate blood counts, no severe heart issues or CNS involvement by lymphoma. They cannot be pregnant/nursing and must use effective contraception.

Inclusion Criteria

HIV negative

Not pregnant or nursing

Bidimensionally measurable disease

Exclusion Criteria

I have never received monoclonal antibody treatment for cancer.

Ejection fraction at least lower limit of normal by Multi Gated Acquisition Scan (MUGA) or 2-D echocardiogram for questionable cardiac history

I have been diagnosed with congestive heart failure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CHOP chemotherapy with or without rituximab or tositumomab for up to 6 courses

18 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Day 200, 1 year, every 6 months for 2 years, then annually

Long-term follow-up

Participants are monitored for progression-free and overall survival

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Cyclophosphamide
• Doxorubicin
• Rituximab
• Tositumomab
• Vincristine

Trial Overview The study compares two monoclonal antibodies (rituximab and tositumomab) combined with chemotherapy drugs (cyclophosphamide, doxorubicin, prednisone, vincristine) in treating patients with non-Hodgkin's lymphoma. It aims to find out which antibody works better when paired with chemo.

How Is the Trial Designed?

Group I: Arm III (CHOP + tositumomab) Experimental Treatment 5 Interventions

Patients receive chemotherapy as in arm I and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141.

Group II: Arm II (CHOP + rituximab) Experimental Treatment 5 Interventions

Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141.

Group III: Arm I (CHOP only) Active Control 4 Interventions

Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1. Patients also receive oral prednisone daily on days 1-5. Treatment continues every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. (Arm I closed to accrual as of 12/15/02)

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?

SWOG Cancer Research Network

Lead Sponsor

Trials

403

Recruited

267,000+

Southwest Oncology Group

Lead Sponsor

Trials

389

Recruited

260,000+

Cancer and Leukemia Group B

Collaborator

Trials

81

Recruited

118,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Eastern Cooperative Oncology Group

Collaborator

Trials

272

Recruited

153,000+