Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-24 @ 9:32 PM
NCT ID:
NCT00004232
Brief Summary:
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.
Detailed Description:
OBJECTIVES:
* 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.
Study:
NCT00004232
Study Brief:
Protocol Section:
NCT00004232