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Combination Chemotherapy With Monoclonal Antibody Therapy in Treating Patients With Newly Diagnosed Non-Hodgkin's Lymphoma
This study is ongoing, but not recruiting participants.
Study NCT00006721   Information provided by National Cancer Institute (NCI)
First Received: December 6, 2000   Last Updated: April 14, 2009   History of Changes

December 6, 2000
April 14, 2009
March 2001
August 2004   (final data collection date for primary outcome measure)
Compare progression-free survival rates of patients treated with CHOP chemotherapy alone, CHOP with rituximab, or CHOP followed by iodine-131 anti-CD20 antibody by Kaplan Meier survival curves at 2 or 5 years [ Designated as safety issue: No ]
Compare progression-free survival rates of patients treated with CHOP chemotherapy alone, CHOP with rituximab, CHOP followed by Iodine-131 anti-CD20 antibody by Kaplan Meier survival curves at 2 or 5 years
Complete list of historical versions of study NCT00006721 on ClinicalTrials.gov Archive Site
  • Compare response rates (confirmed and unconfirmed complete and partial responses) by Cheson criteria at 4 weeks and 6 months after completion of therapy and then annually [ Designated as safety issue: No ]
  • Compare toxicities by NCI CTC at 4 weeks and 6 months after completion of therapy and then annually [ Designated as safety issue: Yes ]
  • Compare response rates (confirmed and unconfirmed complete and partial responses) by Cheson criteria at 4 weeks and 6 months after completion of therapy and then annually
  • Compare toxicities by NCI CTC at 4 weeks and 6 months after completion of therapy and then annually
 
Combination Chemotherapy With Monoclonal Antibody Therapy in Treating Patients With Newly Diagnosed Non-Hodgkin's Lymphoma
A Phase III Trial of CHOP Plus Rituximab vs CHOP Plus Iodine-131-Labeled Monoclonal Anti-B1 Antibody (Tositumomab) for Treatment of Newly Diagnosed Follicular Non-Hodgkin's Lymphomas

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.

OBJECTIVES:

  • Compare the progression-free survival and overall survival of patients with newly diagnosed follicular non-Hodgkin's lymphoma treated with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) with or without either rituximab or iodine I 131 tositumomab (monoclonal antibody anti-B1). (CHOP chemotherapy alone arm closed to accrual as of 12/15/02)
  • Compare the response rate of these patients treated with these regimens.
  • Compare the toxic effects of these regimens in these patients.
  • Compare the molecular remission rates of this patient population treated with these regimens.
  • Determine the incidence and time to development of human anti-mouse antibody positivity.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to whether microglobulin is greater than upper limit of normal (yes vs no). Patients are randomized to 1 of 3 treatment arms. (Arm I closed to accrual as of 12/15/02)

  • Arm I (CHOP only): 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)
  • Arm II (CHOP + rituximab): 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.
  • Arm III (CHOP + tositumomab): 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.

Patients are followed on day 200, at 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 500 patients (250 per treatment arm) will be accrued for this study within 5.5 years. (Arm I closed to accrual as of 12/15/02)

Phase III
Interventional
Treatment, Randomized, Active Control
Lymphoma
  • Biological: rituximab
  • Drug: cyclophosphamide
  • Drug: doxorubicin hydrochloride
  • Drug: prednisone
  • Drug: vincristine sulfate
  • Radiation: tositumomab and iodine I 131 tositumomab
  • Active Comparator:

    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)

  • Experimental: 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.
  • Experimental: 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.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
500
 
August 2004   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

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

    • Grade I-III disease
  • CD20 antigen positive
  • Fewer than 5,000/mm^3 circulating lymphoid cells on a WBC differential count
  • Bidimensionally measurable disease
  • Bone marrow aspiration and biopsy within the past 42 days
  • No clinical evidence of 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 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006721
Laurence H. Baker, Southwest Oncology Group - Group Chair's Office
CDR0000068321, SWOG-S0016, CALGB-50102, ECOG-SWOG-S0016
Southwest Oncology Group
  • National Cancer Institute (NCI)
  • Cancer and Leukemia Group B
  • Eastern Cooperative Oncology Group
Study Chair: Oliver W. Press, MD, PhD Fred Hutchinson Cancer Research Center
Study Chair: Myron S. Czuczman, MD Roswell Park Cancer Institute
Study Chair: Sandra J. Horning, MD Stanford University
National Cancer Institute (NCI)
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP