NCT00003398

Bone Marrow Transplantation in Treating Patients With Hematologic Cancer

Evaluation of Allogeneic Marrow Transplants Depleted of T-Cells by CD34+ Selection in Patients Undergoing Transplantation With an Unrelated Matched or 1 Antigen Mismatched Donor or a 1 Antigen Mismatched Related Donor

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Bone marrow that has been treated to remove certain white blood cells may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy, and may reduce the chance of developing graft-versus-host disease following bone marrow transplantation. PURPOSE: Phase IV trial to study the incidence of graft-versus-host disease in patients who have hematologic cancer and who are undergoing bone marrow transplantation from a donor.

Detailed description

OBJECTIVES: I. Evaluate the incidence of acute graft versus host disease in patients undergoing transplantation with an unrelated or related matched or mismatched antigen donor. II. Evaluate the rapidity of engraftment and CD4 count recovery post-transplantation in this patient population. OUTLINE: Patients receive total body irradiation (TBI) three or two times a day on days -8 to -5. Following TBI, patients receive thiotepa IV over 4 hours daily on days -4 and -3 plus cyclophosphamide IV over 1 hour daily on days -2 and -1. Antithymocyte globulin is administered by IV over at least 4 hours on days -4 to -1. Patients undergo an allogenic bone marrow transplantation on day 0. Bone marrow is harvested from patient's donor, depleted of T-cells, and infused. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 4. PROJECTED ACCRUAL: Approximately 26-45 patients will be accrued for this study within 3-4 years.

Conditions

• Anemia
• Graft Versus Host Disease
• Leukemia
• Lymphoma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes

Interventions

Type	Name	Description
BIOLOGICAL	anti-thymocyte globulin
BIOLOGICAL	filgrastim
DRUG	cyclophosphamide
DRUG	thiotepa
PROCEDURE	allogeneic bone marrow transplantation
PROCEDURE	bone marrow ablation with stem cell support
RADIATION	radiation therapy

Timeline

• Start date: 1998-09-01
• Primary completion: 2000-05-01
• Completion: 2000-05-01
• First posted: 2004-04-27
• Last updated: 2019-10-17

Locations

1 site across 1 country: United States