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

Northwestern University

Status and phase: Completed; Phase 1

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

Treatments: Drug: cyclosporine; Drug: prednisone; Procedure: allogeneic bone marrow transplantation; Biological: filgrastim; Procedure: peripheral blood stem cell transplantation; Drug: methylprednisolone

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00004232

NU FDA96H4

NCI-G99-1660

NU-96H4

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 10 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Diagnosed hematologic malignancy that is eligible for an active allogeneic bone marrow transplantation protocol and leukemia, lymphoma, myeloma, and aplastic anemia treatment protocols
• HLA-identical or one antigen-mismatched related donor

PATIENT CHARACTERISTICS:

Age:

• 10 to 65

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• No known sensitivity to E. coli derivatives

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics