Bone Marrow Transplantation in Treating Patients With Hematologic Cancer

Phase 4

Completed

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

• Registration Number: NCT00003398
• Lead Sponsor: University of Maryland, Baltimore

Brief 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.

Study Timeline

• Study Start: 1998-09
• Study First Submitted: 1999-11-01
• Primary Completion: 2000-05
• Study Completion: 2000-05
• Study First Submitted QC: 2004-04-26
• Study First Posted: 2004-04-27
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-15
• Last Update Posted: 2019-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Marlene & Stewart Greenebaum Cancer Center, University of Maryland; 🇺🇸 Baltimore, Maryland, United States