Bone Marrow and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
RATIONALE: Bone marrow and 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 I trial to study the effectiveness of bone marrow and peripheral stem cell transplantation in treating patients who have hematologic cancer.
|Chronic Myeloproliferative Disorders Graft Versus Host Disease Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Precancerous/Nonmalignant Condition||Biological: filgrastim Drug: cyclosporine Drug: methylprednisolone Drug: prednisone Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation||Phase 1|
|Study Design:||Primary Purpose: Supportive Care|
|Official Title:||Augmenting Bone Marrow With CD34 Enriched Peripheral Blood Hematopoietic Stem Cells for Allogeneic Transplantation of Hematologic Malignancies|
|Study Start Date:||October 1999|
|Study Completion Date:||October 2002|
|Primary Completion Date:||October 2002 (Final data collection date for primary outcome measure)|
- Determine the toxicity of unmanipulated bone marrow augmented with CD34+ enriched peripheral blood stem cells in patients with hematologic malignancies undergoing allogeneic transplantation.
- Evaluate this treatment regimen in terms of kinetics of hematopoietic engraftment, infection, severity of graft-vs-host disease, relapse rate, and cost effectiveness in this patient population.
OUTLINE: Patients undergo allogeneic transplantation comprising unmanipulated bone marrow with filgrastim (G-CSF)-mobilized, CD34+ enriched peripheral blood stem cells on day 0.
Patients receive graft-vs-host disease prophylaxis comprising cyclosporine IV over 24 hours on day -1 and methylprednisolone IV or oral prednisone daily on days 7-65. Patients also receive G-CSF subcutaneously daily until blood counts recover.
Patients are followed weekly for 3 months, at 6 months and 1 year, and then annually for 5 years.
PROJECTED ACCRUAL: A total of 30-60 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004232
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University|
|Chicago, Illinois, United States, 60611-3013|
|Study Chair:||Richard K. Burt, MD||Robert H. Lurie Cancer Center|