Non Hodgkin Lymphoma Clinical Trial

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

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.

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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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Study ID:

NCT00004232

Recruitment Status:

Completed

Sponsor:

Northwestern University

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There is 1 Location for this study

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Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago Illinois, 60611, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Study ID:

NCT00004232

Recruitment Status:

Completed

Sponsor:


Northwestern University

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