Study on Combination Chemotherapy with Monoclonal Antibody Therapy for Newly Diagnosed Non-Hodgkin's Lymphoma

Sponsor: SWOG Cancer Research Network

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT00006721

Provider View

This clinical trial is comparing two different treatments that combine chemotherapy with monoclonal antibodies to see which works better for patients newly diagnosed with Non-Hodgkin's Lymphoma.

Patient Parameters

Program Overview

The study aims to find out which combination of chemotherapy and monoclonal antibody therapy is more effective in treating newly diagnosed Non-Hodgkin's Lymphoma. Chemotherapy drugs work by stopping cancer cells from growing, while monoclonal antibodies can target and kill cancer cells or deliver cancer-killing substances directly to them without harming normal cells.

Description

This study is designed to compare the effectiveness of two different treatment combinations for patients with newly diagnosed follicular Non-Hodgkin's Lymphoma. The treatments involve a chemotherapy regimen known as CHOP, which includes the drugs cyclophosphamide, doxorubicin, vincristine, and prednisone, combined with either rituximab or iodine I 131 tositumomab, both of which are monoclonal antibodies.

The main goals are to compare how long patients live without the cancer getting worse (progression-free survival) and overall survival between the two treatment groups. The study will also look at how well patients respond to the treatments, the side effects they experience, and the rates of molecular remission, which means no signs of cancer at the molecular level.

Patients are randomly assigned to one of two treatment groups:

  • Arm II (CHOP + rituximab): Patients receive the CHOP chemotherapy drugs on specific days, along with rituximab, which is given through an IV on certain days.
  • Arm III (CHOP + tositumomab): Patients receive the CHOP chemotherapy drugs and tositumomab, followed by iodine I 131 tositumomab, which is given through an IV on specific days.

Patients will be monitored regularly after treatment to assess their health and the effectiveness of the therapy. The study aims to enroll about 500 patients over 5.5 years, with 250 patients in each treatment group.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed previously untreated bulky stage II or stage III or IV follicular non-Hodgkin's lymphoma

    • Grade I-III disease

  • Cluster of differentiation antigen 20 (CD20) antigen positive

  • Fewer than 5,000/mm^3 circulating lymphoid cells on a white blood cell (WBC) differential count

  • Bidimensionally measurable disease

  • Bone marrow aspiration and biopsy within the past 42 days

  • No clinical evidence of central nervous system (CNS) involvement by lymphoma

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Zubrod 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • See Disease Characteristics
  • Granulocyte count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic:

  • Not specified

Renal:

  • Not specified

Cardiovascular:

  • No impaired cardiac status, including:

    • Severe coronary artery disease
    • Cardiomyopathy
    • Congestive heart failure
    • Serious arrhythmia

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

Other:

  • No hypersensitivity to iodine
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 6 months after study participation
  • HIV negative
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior monoclonal antibodies for cancer

Chemotherapy:

  • No prior chemotherapy for lymphoma

    • Prior prednisone for non-lymphoma related illnesses allowed

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy for lymphoma

Surgery:

  • See Disease Characteristics

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