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Phase III Randomized Study of Consolidation Chemotherapy Comprising Doxorubicin and Prednisone in Combination With Vincristine Versus Vinblastine in Patients With Advanced Anaplastic Large Cell Lymphoma
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Alternate Title
Comparison of Two Combination Chemotherapy Regimens With Either Vincristine or Vinblastine in Treating Patients With Advanced Anaplastic Large Cell Lymphoma
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase III | Treatment | Temporarily closed | Under 21 | COG-ANHL0131
NCT00059839, ANHL0131 |
Objectives - Compare the efficacy of a consolidation chemotherapy regimen comprising doxorubicin and prednisone in combination with vincristine vs vinblastine, in terms of event-free survival, in patients with advanced anaplastic large cell lymphoma.
- Compare overall survival of patients treated with these regimens.
- Compare the toxic effects of these regimens in these patients.
- Correlate biological tumor characteristics and outcome in patients treated with these regimens.
Entry Criteria Disease Characteristics:
- Newly diagnosed advanced anaplastic large cell lymphoma
- CD30+ disease
- Murphy stage III or IV
- No B-cell large cell lymphoma
- No disease limited to the skin (regardless of how wide-spread)
Prior/Concurrent Therapy:
Biologic therapy Chemotherapy Endocrine therapy - Prior steroids for management of a mediastinal mass allowed
Radiotherapy - Prior limited-dose radiotherapy for a mediastinal mass allowed
Surgery Patient Characteristics:
Age Performance status Life expectancy Hematopoietic Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST or ALT less than 2.5 times ULN (unless due to lymphoma)
Renal Cardiovascular - Shortening fraction at least 27% by echocardiogram
OR - Ejection fraction at least 50% by radionuclide angiogram
Other - Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
Expected Enrollment 200A total of 200-250 patients (100-125 per treatment arm) will be accrued for this study within 5 years. Outcomes Primary Outcome(s)Event-free survival
Toxicity
Secondary Outcome(s)Overall survival
Disease response
Outline This is a randomized, multicenter study. - Induction therapy: Patients receive doxorubicin IV over 15 minutes on days 1 and 22; vincristine IV on days 1, 8, 15, 22, and 29; oral prednisone 3 times daily on days 1-28; and intrathecal (IT) methotrexate on days 1, 8, and 22 (patients with CNS disease at diagnosis receive additional methotrexate IT on days 15, 29, and 36).
Patients then begin consolidation therapy on day 43.
- Consolidation therapy: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive course-specific regimens.
- Courses 1-3: Patients receive doxorubicin IV over 15 minutes, vincristine IV, and methotrexate IT on day 1 and oral prednisone three times daily and oral mercaptopurine once daily on days 1-5.
- Courses 4-5: Patients receive doxorubicin, vincristine, prednisone, and mercaptopurine as in courses 1-3.
- Courses 6-15: Patients receive vincristine, prednisone, and mercaptopurine as in courses 1-3 and methotrexate IV on day 1.
- Arm II: Patients receive course-specific regimens.
- Courses 1-3: Patients receive doxorubicin, methotrexate IT, prednisone, and mercaptopurine as in arm I and vinblastine IV over 1 minute on days 1, 8, and 15.
- Courses 4-5: Patients receive doxorubicin, prednisone, and mercaptopurine as in arm I and vinblastine as in arm II (courses 1-3).
- Courses 6-15: Patients receive prednisone and mercaptopurine as in arm I, vinblastine as in arm II (courses 1-3), and methotrexate IV on day 1.
In both arms and all courses, treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed monthly for 1 year, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.
Trial Contact Information
Trial Lead Organizations Children's Oncology Group | | | | Jacqueline Kraveka, DO, Protocol chair | | | |
| Registry Information | | | Official Title | | A Phase III Trial of Treatment of Advanced-Stage Anaplastic Large Cell Lymphoma (ALCL) with Standard APO (Doxorubicin, Prednisone, Vincristine) Versus Consolidation with a Regimen Including Vinblastine | | | Trial Start Date | | 2003-11-03 | | | Trial Completion Date | | 2008-12-21 (estimated) | | | Registered in ClinicalTrials.gov | | NCT00059839 | | | Date Submitted to PDQ | | 2003-03-06 | | | Information Last Verified | | 2009-05-13 | | | NCI Grant/Contract Number | | CA98543 |
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. |
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