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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004232
• Other study ID #: NU FDA96H4
• Secondary ID: NU-96H4NCI-G99-1
• Status: Completed
• Phase: Phase 1
• First received: January 28, 2000
• Last updated: May 31, 2012
• Start date: October 1999
• Est. completion date: October 2002

Study information

• Verified date: May 2012
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2002
• Est. primary completion date: October 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 65 Years

Eligibility

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 Design

Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Myeloproliferative Disorders
• Graft Versus Host Disease
• Graft vs Host Disease
• Leukemia
• Lymphoma
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Myeloproliferative Disorders
• Neoplasms, Plasma Cell
• Plasmacytoma
• Precancerous Conditions
• Precancerous/Nonmalignant Condition
• Preleukemia

Intervention

Biological:
• filgrastim

Drug:
• cyclosporine

• methylprednisolone

• prednisone

Procedure:
• allogeneic bone marrow transplantation

• peripheral blood stem cell transplantation

Locations

Country	Name	City	State
United States	Robert H. Lurie Comprehensive Cancer Center, Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,