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Clinical Trial Questions?
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Phase II Randomized Study of Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone With or Without Oblimersen in Patients With Advanced Diffuse Large B-Cell Non-Hodgkin's Lymphoma
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Alternate Title
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone With or Without Oblimersen in Treating Patients With Advanced Diffuse Large B-Cell Non-Hodgkin's Lymphoma
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase II | Treatment | Closed | 18 to 59 | SWOG-S0349
S0349, NCT00080847 |
Objectives - Compare the 1-year progression-free survival probability rate in patients with low- or low-intermediate-risk advanced diffuse large B-cell non-Hodgkin's lymphoma treated with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone with or without oblimersen.
- Compare the response (complete, unconfirmed complete, and partial) in patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare the 1-year progression-free survival and response rate in a subset of patients overexpressing bcl-2 protein treated with these regimens.
Entry Criteria Disease Characteristics:
- Histologically confirmed diffuse large B-cell non-Hodgkin's lymphoma
- Stage III, IV, or bulky stage II disease
- Needle aspiration or cytology not considered adequate for biopsy
- CD20-positive disease
- Previously untreated disease
- Bidimensionally measurable disease
- No prior diagnosis of indolent lymphoma, including histologic transformation
- Nodal diffuse large cell lymphoma with bone marrow involvement and small lymphocytes allowed
- International Prognostic Index 0-1
- No clinical evidence of CNS involvement by lymphoma
Prior/Concurrent Therapy:
Biologic therapy - No prior antibody therapy for lymphoma
Chemotherapy - No prior chemotherapy for lymphoma
Endocrine therapy Radiotherapy - No prior radiotherapy for lymphoma
Surgery - No prior solid organ transplantation
Other - No concurrent supplemental oxygen therapy
- Concurrent enrollment on SWOG-8947 and/or SWOG-8819 allowed
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic Hepatic Renal Cardiovascular - Cardiac ejection fraction ≥ 45% by MUGA or ECHO
- No significant cardiac abnormalities
Other - Not pregnant or nursing
- Fertile patients must use effective contraception
- HIV negative
- No other malignancy within the past 5 years except any of the following:
- Adequately treated basal cell or squamous cell skin cancer
- Carcinoma in situ of the cervix
- Adequately treated stage I or II cancer currently in complete remission
Expected Enrollment A total of 160 patients (80 per treatment arm) (arm I closed to accrual as of 9/21/04) will be accrued for this study within 2 years. Outcomes Primary Outcome(s)Progression-free survival at 1 year
Secondary Outcome(s)Overall survival
Response
Outline This is a randomized, multicenter study. Patients are stratified according to age-adjusted International Prognostic Index (0 vs 1). Patients are randomized to 1 of 2 treatment arms. (Arm I closed to accrual as of 9/21/04.) - Arm I (closed to accrual as of 9/21/04): Patients receive rituximab IV over 6 hours, cyclophosphamide IV over 15-45 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1 and oral prednisone on days 1-5.
- Arm II: Patients receive oblimersen IV continuously on days 1-7; rituximab IV over 6 hours, cyclophosphamide IV over 15-45 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 5; and oral prednisone on days 5-10.
In both arms, treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for up to 5 years.
Trial Contact Information
Trial Lead Organizations Southwest Oncology Group | | | | Steven Bernstein, MD, Protocol chair | | | | | Richard Fisher, MD, Protocol co-chair | | | |
| Registry Information | | | Official Title | | Standard Dose Cyclosphosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) And Rituximab And G3139 Phosphorothioate Oligonucleotide [Anti-BCL-2 Antisense] Therapy For Young Patients (< Age 60) With Advanced Stage Diffuse Larg B-Cell NHL Of Low And Low-Intermediate IPI Risk | | | Trial Start Date | | 2004-03-01 | | | Registered in ClinicalTrials.gov | | NCT00080847 | | | Date Submitted to PDQ | | 2004-02-10 | | | Information Last Verified | | 2006-05-11 | | | NCI Grant/Contract Number | | CA32102 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
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