Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
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|ClinicalTrials.gov Identifier: NCT00003396|
Recruitment Status : Completed
First Posted : June 3, 2004
Last Update Posted : September 24, 2009
RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells.
PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation from related donors to prevent graft-versus-host disease in treating patients with hematologic cancer.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes||Biological: anti-thymocyte globulin Biological: graft-versus-tumor induction therapy Drug: cyclophosphamide Drug: melphalan Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy||Phase 2|
OBJECTIVES: I. Evaluate the use of donor peripheral blood stem cells without graft-versus-host disease prophylaxis to maximize the probability of graft-versus-tumor effect in patients with hematologic malignancies refractory to standard chemotherapy and unlikely to be cured with high dose chemotherapy and radiotherapy.
OUTLINE: Prior to peripheral blood stem cell transplant, patients undergo preparative cytoreduction. Patients receive total body irradiation (TBI) beginning on day -5. Radiotherapy is administered in 9 doses over 3 days (3 doses per day for 3 days). Male patients with acute lymphocytic leukemia receive an additional dose of radiation to the testicles. Patients who are ineligible for TBI due to prior radiotherapy receive 2 doses of melphalan IV on day -3. All patients receive cyclophosphamide IV over 1 hour on days -2 and -1. Anti-thymocyte globulin is also administered IV over 6 hours on days -2 and -1. Approximately 24-36 hours after the last dose of cyclophosphamide, peripheral blood stem cells obtained from the HLA matched related donor are infused into the patient. Patients do not receive graft-versus-host disease prophylaxis after transplant; however, all other forms of supportive care are provided. Patients are followed for 1 year.
PROJECTED ACCRUAL: A maximum of 42 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Official Title:||Evaluation of Allogeneic Peripheral Blood Stem Cell Transplants From a Related Donor Without Graft-Versus-Host Prophylaxis in Patients With High Risk of Relapse|
|Study Start Date :||September 1998|
|Actual Primary Completion Date :||December 2002|
|Actual Study Completion Date :||December 2002|
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): NCT00003396
|United States, Maryland|
|Marlene & Stewart Greenebaum Cancer Center, University of Maryland|
|Baltimore, Maryland, United States, 21201|
|Study Chair:||Barry R. Meisenberg, MD||University of Maryland Greenebaum Cancer Center|