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

Tracking Information

First Received Date ^ICMJE

January 28, 2000

Last Updated Date

February 6, 2009

Start Date ^ICMJE

October 1999

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00004232 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Supportive Care

Condition ^ICMJE

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

Intervention ^ICMJE

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

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

10 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00004232

Responsible Party

Study ID Numbers ^ICMJE

CDR0000067474, NU-96H4, NCI-G99-1660

Study Sponsor ^ICMJE

Robert H. Lurie Cancer Center

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Richard K. Burt, MD

Robert H. Lurie Cancer Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

July 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP