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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	Under 21	NCI	COG-ANHL0131 NCT00059839, ANHL0131

Trial Description

Purpose:

Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known if combination chemotherapy with vinblastine is more effective than combination chemotherapy with vincristine in treating advanced anaplastic large cell lymphoma.

Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens with either vinblastine or vincristine in treating patients who have newly diagnosed advanced anaplastic large cell lymphoma.

Eligibility:

Eligibility criteria include the following:

• Younger than 21 years old
• No B-cell lymphoma
• No lymphoma involving only the skin
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

During the first 6 weeks, all patients will receive an infusion of doxorubicin in weeks 1 and 4 and an infusion of vincristine in weeks 1-5. They will also receive prednisone by mouth three times a day for 4 weeks and intrathecal methotrexate either in weeks 1, 2, and 4 or weeks 1-6. In week 7, patients will be randomly assigned to one of two groups.

Patients in group one will receive combination chemotherapy by infusion, by mouth, and intrathecally over a 5-day period in week 1. They will receive an infusion of vincristine on day 1 of each course. Treatment will be repeated every 3 weeks for up to 15 courses.

Patients in group two will receive combination chemotherapy by infusion, by mouth, and intrathecally over a 5-day period in week 1. They will receive an infusion of vinblastine once a week for 3 weeks. Treatment will be repeated every 3 weeks for up to 15 courses.

Patients will be evaluated once a month for 1 year, every 3 months for 1 year, every 6 months for 1 year, and once a year thereafter.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Children's Oncology Group

Jacqueline Kraveka, DO, Protocol chair		Ph: 843-792-2957 Email: kravekjm@musc.edu

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		2009-07-03
NCI Grant/Contract Number		CA98543

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