Bone Marrow and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer

Phase 1

Completed

• Conditions: Chronic Myeloproliferative Disorders; Graft Versus Host Disease; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Precancerous/Nonmalignant Condition

• Registration Number: NCT00004232
• Lead Sponsor: Northwestern University

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 Timeline

• Study Start: 1999-10
• Study First Submitted: 2000-01-28
• Primary Completion: 2002-10
• Study Completion: 2002-10
• Study First Submitted QC: 2003-05-08
• Study First Posted: 2003-05-09
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-31
• Last Update Posted: 2012-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Robert H. Lurie Comprehensive Cancer Center, Northwestern University; 🇺🇸 Chicago, Illinois, United States