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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 Induction and Maintenance Chemotherapy Regimens With Different Doses and Schedules of Methotrexate From the Berlin-Frankfurt-Munster-K2 Protocol With or Without Vinblastine in Children With Anaplastic Large Cell Lymphoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Active Under 22 Other FRE-IGR-ALCL99 EU-20031, NHL2000/06, NCT00006455

Trial Description

Purpose:

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective for treating anaplastic large cell lymphoma.

This randomized phase III trial is studying several different regimens of combination chemotherapy to compare how well they work in treating children with anaplastic large cell lymphoma.

Eligibility:

Eligibility criteria include the following:

• Younger than 22 years old
• No CNS involvement
• No previous organ transplantation
• No previous therapy other than steroids
• 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:

Patients will be randomly assigned to receive one of several combination chemotherapy regimens for approximately 1 year. Patients will receive follow-up evaluations every 2 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, 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

Institut Gustave Roussy

Laurence Brugieres, MD, Protocol chair		Ph: 33-1-4211-4180

Austria
	Vienna
	St. Anna Children's Hospital
		Helmut Gadner, MD, FRCPG	Ph:  43-1-401-70-1250
Belgium
	Leuven
	U.Z. Gasthuisberg
		Anne Uyttebroeck, MD	Ph:  321-634-3841
France
	Villejuif
	Institut Gustave Roussy
		Laurence Brugieres, MD	Ph:  33-1-4211-4180
Germany
	Giessen
	Kinderklinik
		Alfred Reiter, MD	Ph:  49-641-994-3420
Italy
	Padova
	Azienda Ospedaliera di Padova
		Angelo Rosolen, MD	Ph:  39-049-821-3579
Netherlands
	Den Haag
	Dutch Childhood Leukemia Study Group
		Inge Appel, MD	Ph:  31-10-463-6691
Spain
	Valencia
	Hospital Clinico Universitario de Valencia
		Rafael Delgado, MD	Ph:  34-96-386-2624
Sweden
	Stockholm
	Karolinska University Hospital - Huddinge
		Olle Bjork, MD	Ph:  46-8-517-747-17
Switzerland
	Zurich
	University Children's Hospital
		Felix Niggli, MD	Ph:  41-44-266-7823
United Kingdom
England
	Cambridge
	Addenbrooke's Hospital
		Denise Williams, MD	Ph:  44-1223-216-878

Registry Information
Official Title		International Protocol for the Treatment of Childhood Anaplastic Large Cell Lymphoma
Trial Start Date		1999-12-01
Registered in ClinicalTrials.gov		NCT00006455
Date Submitted to PDQ		2000-07-06
Information Last Verified		2008-02-12