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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 Fludarabine and Cyclophosphamide Followed By Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With Chronic Lymphocytic Leukemia, Prolymphocytic Leukemia, Low-Grade Non-Hodgkin's Lymphoma, or Mantle Cell Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	Under 70	NCI	CALGB-109901 NCT00006252

Trial Description

Purpose:

Giving chemotherapy drugs, such as fludarabine and cyclophosphamide, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient’s immune system from rejecting the donor’s stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient’s bone marrow make stem cells, red blood cells, white blood cells, and platelets.

This phase II trial is studying how well fludarabine and cyclophosphamide followed by peripheral stem cell transplant works in treating patients with leukemia or lymphoma.

Eligibility:

Eligibility criteria include the following:

• Younger than 70 years old
• Brother or sister donor available
• No previous autologous transplant for non-Hodgkin's lymphoma
• At least 4 weeks since chemotherapy, radiation therapy, or surgery
• 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 infusions of fludarabine on days 1-5 and a 1- to 2-hour infusion of cyclophosphamide on days 3-5. Donor stem cells will be infused on days 8 and 9. Patients will receive injections of filgrastim beginning on day 13 and continuing until blood counts return to normal. Some patients may receive up to three infusions of donor lymphocytes at least 8 weeks apart.

Patients will be evaluated every 3 months for 2 years and every 6 months 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

Cancer and Leukemia Group B

Thomas Shea, MD, Protocol chair		Ph: 919-966-7746 Email: sheaT@med.unc.edu

Registry Information
Official Title		Minimal Ablation and Cellular Immune Therapy of Chronic Lymphocytic Leukemia, Prolymphocytic Leukemia, Low-Grade Non-Hodgkin's Lymphoma, and Mantle Cell Lymphoma with Allogeneic Donor Stem Cells
Trial Start Date		2001-02-05
Registered in ClinicalTrials.gov		NCT00006252
Date Submitted to PDQ		2000-07-19
Information Last Verified		2006-05-18
NCI Grant/Contract Number		CA31946

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