Related Links Educational Materials About Clinical Trials Clinical Trials Questions to Ask Your Doctor Drug Information from MedlinePlus

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

Alternate Title

Phase II Study of Sargramostim (GM-CSF) After T-Cell Depleted Allogeneic Bone Marrow Transplantation in Patients With Chronic Myelogenous Leukemia

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 to 65	Pharmaceutical / Industry	JHOC-J9449 BRLX-001.0649, JHOC-94110404, NCI-V96-0900, NCT00002778

Trial Description

Purpose:

Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with allogeneic bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood, and may help a person's immune system recover from the side effects of chemotherapy.

Phase II trial to study the effectiveness of allogeneic bone marrow transplantation followed by sargramostim in treating patients who have chronic myelogenous leukemia.

Eligibility:

• 18-65 years old
• Brother or sister bone marrow donor available
• 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 high-dose chemotherapy followed by infusions of donated bone marrow. Daily injections of sargramostim will begin 5 days later and continue for 7-8 weeks. Patients will be evaluated once a month for 3 months, every 3 months for 1 year, every 6 months for 1 year, 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

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

B. Douglas Smith, MD, Principal investigator		Ph: 410-614-5068 Email: smithdo@jhmi.edu

Registry Information
Official Title		GRANULOCYTE-MACROPHAGE COLONY STIMULATING FACTOR (rhu-GM-CSF) FOR REDUCTION OF LEUKEMIC RELAPSE AFTER T-LYMPHOCYTE DEPLETED ALLOGENEIC BMT FOR CHRONIC MYELOID LEUKEMIA
Trial Start Date		1995-02-07
Registered in ClinicalTrials.gov		NCT00002778
Date Submitted to PDQ		1995-02-07
Information Last Verified		2004-11-18
NCI Grant/Contract Number		P01-CA15396, P30-CA06973

Back to Top