Sargramostim Following Allogeneic Bone Marrow Transplantation in Treating Patients With Chronic Myelogenous Leukemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00002778|
Recruitment Status : Terminated (subject accrual and data analysis is completed.)
First Posted : January 27, 2003
Last Update Posted : July 20, 2011
RATIONALE: 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.
PURPOSE: Phase II trial to study the effectiveness of allogeneic bone marrow transplantation followed by sargramostim in treating patients who have chronic myelogenous leukemia.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Biological: sargramostim Biological: therapeutic allogeneic lymphocytes Procedure: allogeneic bone marrow transplantation Procedure: in vitro-treated bone marrow transplantation||Phase 2|
- Determine whether the use of sargramostim (GM-CSF) after T-cell depleted, CD34-positive cell-supplemented allogeneic bone marrow transplantation can reduce leukemic relapse in patients with chronic myelogenous leukemia.
OUTLINE: Patients receive myeloablation with busulfan and cyclophosphamide on an approved protocol. Allogeneic bone marrow is harvested and treated in vitro with anti-CD34 antibody. T-cell depleted, CD34-positive cell-supplemented bone marrow is infused on day 0. Patients receive high-dose sargramostim (GM-CSF) subcutaneously (SC) beginning on day 5 and continuing until blood counts recover and then low-dose GM-CSF SC continuing until day 60.
Donor lymphocyte infusions or second unmodified allogeneic bone marrow transplantation without GM-CSF is considered in case of primary or secondary engraftment failure.
Patients are followed every month for 3 months, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within approximately 6-10 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||February 1995|
|Actual Primary Completion Date :||February 2005|
|Actual Study Completion Date :||July 2010|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002778
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231|
|Principal Investigator:||B. Douglas Smith, MD||Sidney Kimmel Comprehensive Cancer Center|