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

Alternate Title

Phase I/II Study of Autologous Peripheral Blood Stem Cell Transplantation Followed by Nonmyeloablative Allogeneic PBSC Transplantation in Patients With Refractory or Relapsed Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Active	65 and under	NCI	FHCRC-1409.00 4903, NCI-G00-1776, NCT00005803

Trial Description

Purpose:

Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with autologous or syngeneic and allogeneic peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs to kill more tumor cells.

This phase I/II trial is studying the side effects of autologous peripheral stem cell transplantation followed by allogeneic peripheral stem cell transplantation and to see how well they work in treating patients with refractory or relapsed lymphoma.

Eligibility:

Eligibility criteria include the following:

• Younger than 66 years old
• Matched brother, sister, or unrelated donor available
• No previous autologous peripheral stem cell transplantation
• At least 3 months since radiation therapy to the mediastinum
• 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:

Peripheral stem cells will be collected. Patients will receive chemotherapy once or twice a day for 2-6 days. Some patients will also receive total-body irradiation twice a day for 3 days. Peripheral stem cells will then be reinfused. Within 40-120 days, patients will receive cyclosporine by mouth twice a day for 60 days or 104 days plus total-body irradiation and infusion of donor stem cells on day 4. Some patients will receive an infusion of fludarabine on days 3-5. They will receive mycophenolate mofetil by mouth twice a day for up to 28 days or 96 days. Patients may receive an infusion of donor white blood cells every 65 days for up to four doses. Patients will be evaluated once a week for 3 months, at 4 and 6 months, every 6 months for 2 years, and then once a year until 5 years after transplantation.

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

Fred Hutchinson Cancer Research Center

David Maloney, MD, PhD, Protocol chair		Ph: 206-667-5616 Email: dmaloney@fhcrc.org

U.S.A.
Texas
	Dallas
	Charles A. Sammons Cancer Center
		Edward Agura, MD	Ph:  214-820-1800
			Email: edwarda@baylorhealth.edu
Utah
	Salt Lake City
	Huntsman Cancer Institute at University of Utah
		Michael Pulsipher, MD	Ph:  801-585-3229
			Email: michael.pulsipher@hsc.utah.edu
Washington
	Seattle
	Fred Hutchinson Cancer Research Center
		David Maloney, MD, PhD	Ph:  206-667-5616
			Email: dmaloney@fhcrc.org
	Seattle Cancer Care Alliance
		Clinical Trials Office - Seattle Cancer Care Alliance	Ph:  800-804-8824
	Veterans Affairs Medical Center - Seattle
		William Schubach, MD	Ph:  206-764-2265 800-329-8387
Germany
	Leipzig
	Universitaet Leipzig
		Dietger Niederwieser, MD	Ph:  49-341-971-3050
			Email: dietger@medizin.uni_leipzig.de

Registry Information
Official Title		A Phase I/II Study of Autologous Stem Cell Transplantation Followed by Non-myeloablative Allogeneic Stem Cell Transplantation for Patients with Relapsed or Refractory Lymphoma - A Multi Center Trial
Trial Start Date		1999-09-02
Trial Completion Date		2010-09-02 (estimated)
Registered in ClinicalTrials.gov		NCT00005803
Date Submitted to PDQ		2000-03-08
Information Last Verified		2009-07-05
NCI Grant/Contract Number		CA15704, CA78902

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