Rituximab Plus Cyclophosphamide in Treating Patients With Indolent Stage III or Stage IV Non-Hodgkin's Lymphoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

1998-05-31

Study Completion Date

2000-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy and monoclonal antibody therapy may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of rituximab plus cyclophosphamide in treating patients who have indolent stage III or stage IV non-Hodgkin's lymphoma.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

S0313 Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, and Radiation Therapy Followed By Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Stage I or Stage II Non-Hodgkin's Lymphoma

NCT00070018

Lymphoma

COMPLETED PHASE2

Combination Chemotherapy Plus Rituximab in Treating Patients With Intermediate-Grade or High-Grade Non-Hodgkin's Lymphoma

NCT00005959

Lymphoma

UNKNOWN PHASE2

Combination Chemotherapy Plus Interferon Alfa or Rituximab in Treating Patients With Stage III or Stage IV Lymphoma

NCT00004039

Lymphoma

WITHDRAWN PHASE2

S0016 Combination Chemotherapy With Monoclonal Antibody Therapy in Newly Diagnosed Non-Hodgkin's Lymphoma

NCT00006721

Lymphoma

ACTIVE_NOT_RECRUITING PHASE3

Rituximab and Cyclophosphamide Followed by Vaccine Therapy in Treating Patients With Relapsed Hodgkin Lymphoma

NCT00134082

Lymphoma

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

OBJECTIVES: I. Determine the toxicity associated with cyclophosphamide and rituximab (IDEC-C2B8 monoclonal antibody) as first line treatment in patients with stage III or IV indolent B-cell lymphoma. II. Determine the objective tumor response rate and duration of response associated with this first line treatment in these patients. III. Determine the failure-free and overall survival for these patients. IV. Compare the response rate and survival rates for patients with indolent lymphoma who were treated with this treatment as the first systemic therapy for their disease with response rates and survival observed for similar patients treated in published trials. V. Determine the quality of life associated with this treatment in this patient population.

OUTLINE: This is an open label study. Patients receive oral cyclophosphamide daily and rituximab (IDEC-C2B8 monoclonal antibody) IV on days 1, 8, 15, and 22 for the first 4-week course. Patients then receive oral cyclophosphamide daily and rituximab IV monthly until 2 months beyond maximum response. Patients are treated for at least 6 months but no more than 18 months in the absence of disease progression. Patients are followed every 3 months for 2 years, then every 6 months for the next 2 years, and then annually for up to 10 years.

PROJECTED ACCRUAL: There will be 20-40 patients accrued into this study.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lymphoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Primary Study Purpose

TREATMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

rituximab

Intervention Type BIOLOGICAL

cyclophosphamide

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV indolent B-cell lymphoma Diffuse small cleaved cell lymphoma Follicular small cleaved cell lymphoma Follicular mixed cell lymphoma Follicular large cell lymphoma At least 1 lymph node or visceral lesion at least 2 cm in diameter

PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Lymphocyte count less than 5,000/mm3 Hepatic: Not specified Renal: Not specified Other: No active infection No concurrent life threatening disease Not pregnant Effective contraception required of all fertile patients

PRIOR CONCURRENT THERAPY: No prior therapy for lymphoma

Eligible Sex

ALL

Accepts Healthy Volunteers

No