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

Alternate Title

Phase II Study of Nonmyeloablative Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With Hematologic Disease or Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Active 8 to 80 NHLBI NHLBI-99-H-0050 NCT00003838

Special Category: NIH Clinical Center trial

Trial Description

Purpose:

Giving low doses of chemotherapy, such as fludarabine and cyclophosphamide, before a donor stem cell transplant helps stop the growth of abnormal cells and cancer. It also stops the patient’s immune system from rejecting the donor’s stem cells. The donated stem cells may replace the patient’s immune system and help destroy any remaining abnormal or cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can make an immune response against the body’s normal cells. Giving antithymocyte globulin before transplant and cyclosporine after transplant may stop this from happening.

This phase II trial is studying how well giving chemotherapy followed by a donor peripheral stem cell transplant works in treating patients with hematologic disease or hematologic cancer.

Eligibility:

Eligibility criteria include the following:

• 8-80 years old
• 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 receive a 1-hour infusion of cyclophosphamide once a day for 2 days followed by an infusion of fludarabine once a day for 5 days. Some patients will also receive an infusion of antithymocyte globulin once a day for 4 days. Patients will then undergo a donor peripheral stem cell transplant. They will receive cyclosporine beginning 4 days before the transplant and continuing for approximately 3½ months.

Patients will be evaluated at 3 and 6 months, every 6 months for 2½ years, and once a year for 5 years.

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

National Heart, Lung, and Blood Institute

Richard Childs, MD, Protocol chair		Ph: 301-594-8008 Email: childsr@nih.gov

U.S.A.
Maryland
	Bethesda
	NIH - Warren Grant Magnuson Clinical Center
		Patient Recruitment	Ph:  800-411-1222

Registry Information
Official Title		Non-Myeloablative Allogeneic Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Hematologic Malignancies in High Risk Patients and in Patients with Debilitating Hematologic Diseases
Trial Start Date		1999-02-19
Trial Completion Date		2009-12-30 (estimated)
Registered in ClinicalTrials.gov		NCT00003838
Date Submitted to PDQ		1999-03-30
Information Last Verified		2008-11-30