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

Alternate Title

Phase I/II Study of Alemtuzumab-Based Conditioning Followed By HLA-Matched Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With Advanced Mycosis Fungoides/Sezary Syndrome

Basic Trial Information

Special Category: NIH Clinical Center trial

Trial Description

Purpose:

Monoclonal antibodies such as alemtuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Allogeneic peripheral stem cell transplantation may be able to replace immune cells that were destroyed by the anticancer therapy. Sometimes the transplanted cells are rejected by the body's normal tissues. Mycophenolate mofetil and cyclosporine may prevent this rejection.

This phase I/II trial is studying how well giving alemtuzumab together with chemotherapy and donor peripheral stem cell transplantation works in treating patients with advanced mycosis fungoides and/or Sezary syndrome.

Eligibility:

Eligibility criteria include the following:

• 18-70 years old
• Evaluable disease
• No CNS metastases
• At least 1 month since previous therapy for mycosis fungoides or Sezary syndrome
• 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 2-hour infusion of alemtuzumab on days 1-3, 5, 7, 10, 12, and 14 and an infusion of fludarabine on days 24-28. Some patients may also receive a 1-hour infusion of cyclophosphamide on days 22 and 23. Patients will then undergo donor peripheral stem cell transplantation on day 29. Beginning on day 25, patients will receive cyclosporine and mycophenolate mofetil by mouth for the prevention of graft-versus-host disease continuing for approximately 4 months.

After finishing treatment, patients will be evaluated every 2 months for 6 months, every 3 months for 1.5 years, and every 6 months for 3 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

Ramaprasad Srinivasan, MD, Protocol chair		Ph: 301-594-8396

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

Registry Information
Official Title		A Phase I/II Study Of HLA-Matched Mobilized Peripheral Blood Hematopoetic Stem Cell Transplantation For Advanced Mycosis Fungoides/Sezary Using NonMyeloablative Conditioning With Campath-1H
Trial Start Date		2002-07-30
Trial Completion Date		2012-12-28 (estimated)
Registered in ClinicalTrials.gov		NCT00047060
Date Submitted to PDQ		2002-08-09
Information Last Verified		2009-06-21

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