NCT00004232

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

Augmenting Bone Marrow With CD34 Enriched Peripheral Blood Hematopoietic Stem Cells for Allogeneic Transplantation of Hematologic Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 10 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim
DRUG	cyclosporine
DRUG	methylprednisolone
DRUG	prednisone
PROCEDURE	allogeneic bone marrow transplantation
PROCEDURE	peripheral blood stem cell transplantation

Timeline

• Start date: 1999-10-01
• Primary completion: 2002-10-01
• Completion: 2002-10-01
• First posted: 2003-05-09
• Last updated: 2012-06-01

Locations

1 site across 1 country: United States