NCT00003960

Donor Bone Marrow Transplantation in Treating Patients With Hematologic Cancer

Matched Unrelated and Haploidentical Bone Marrow Transplantation for Hematologic Malignancies

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus donor bone marrow transplantation in treating patients who have hematologic cancer.

Detailed description

OBJECTIVES: I. Determine the 1-year survival rate of patients with hematologic malignancies after treatment with HLA-matched allogeneic bone marrow transplantation after high-dose chemotherapy. OUTLINE: Patients receive oral busulfan four times a day on days -8 to -5, cyclophosphamide IV over 1 hour on days -4 to -1, and methylprednisolone IV over 1 hour every 12 hours on days -2 to 0. CD34+ stem cell augmented donor bone marrow is infused on day 0. Methylprednisolone is administered IV over 1 hour on days 5-16, and then tapered. Patients are followed every 6 months for 1 year and then annually thereafter. PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 3 years.

Conditions

• Leukemia
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	busulfan
DRUG	cyclophosphamide
DRUG	methylprednisolone
PROCEDURE	allogeneic bone marrow transplantation
PROCEDURE	in vitro-treated bone marrow transplantation

Timeline

• Start date: 1998-04-01
• Primary completion: 2001-09-01
• Completion: 2001-09-01
• First posted: 2004-04-28
• Last updated: 2014-05-02

Locations

2 sites across 1 country: United States