Prevention of Graft-Versus-Host Disease in Patients Undergoing Bone Marrow Transplantation

This study has been completed.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

Sidney Kimmel Comprehensive Cancer Center

ClinicalTrials.gov Identifier:

NCT00003538

First received: November 1, 1999

Last updated: March 9, 2010

Last verified: March 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

March 9, 2010

Start Date ^ICMJE

March 1997

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00003538 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Prevention of Graft-Versus-Host Disease in Patients Undergoing Bone Marrow Transplantation

Official Title ^ICMJE

Stem Cell Augmented, Elutriated Grafts for Allogeneic Bone Marrow Transplantation

Brief Summary

RATIONALE: Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. Sometimes the transplanted cells can make an immune response against the body's normal tissues. Stem cells that have been treated in the laboratory to remove lymphocytes may prevent this from happening.

PURPOSE: Clinical trial to prevent graft-versus-host disease in patients undergoing bone marrow transplantation.

Detailed Description

OBJECTIVES:

Determine whether stem cell augmented, elutriated grafts prevent graft versus host disease in patients undergoing allogeneic bone marrow transplantation.

OUTLINE: Patients receive elutriated CD34+ augmented donor bone marrow on day 0.

Bone marrow samples are obtained before day 100, around 6 months, and 1 year after transplant.

PROJECTED ACCRUAL: Not specified

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Primary Purpose: Supportive Care

Condition ^ICMJE

Cancer

Intervention ^ICMJE

Biological: graft versus host disease prophylaxis/therapy
Procedure: allogeneic bone marrow transplantation

Study Arm (s)

Not Provided

Publications *

O'Donnell PV, Jones RJ, Vogelsang GB, Seber A, Ambinder RF, Flinn I, Miller C, Marcellus DC, Griffin C, Abrams R, Braine HG, Grever M, Hess AD, Piantadosi S, Noga SJ. CD34+ stem cell augmentation of elutriated allogeneic bone marrow grafts: results of a phase II clinical trial of engraftment and graft-versus-host disease prophylaxis in high-risk hematologic malignancies. Bone Marrow Transplant. 1998 Nov;22(10):947-55.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Histologically confirmed diagnosis of one the following:
- Acute myelogenous leukemia in CR1, ER1, CR2, ER2, CR3
- Acute lymphocytic leukemia in CR1, ER1, CR2, ER2, CR3
- Non-Hodgkin's lymphoma
- Hodgkin's lymphoma
- Multiple myeloma with no more than 12 months of prior alkylator based chemotherapy
- Myelodysplastic syndrome (MDS)
- Acute leukemia arising out of MDS
- Primary resistant acute leukemia
- Chronic myelomonocytic leukemia
- Aplastic anemia (40 years of age and over)
- Solid tumor malignancy (germ cell, sarcoma, breast, etc.)
- Genetic disorders or inborn errors of metabolism as defined by preparative regimen protocol
- Chronic myelogenous leukemia
Must meet all inclusion criteria specified by the respective preparative regimen protocol
No aplastic anemia under 40 years of age or myelofibrosis

PATIENT CHARACTERISTICS:

Age:

0.5 to 65

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No prior red blood cell or platelet transfusions from a sibling donor

Chemotherapy:

Not specified

Endocrine therapy:

Not specified

Radiotherapy:

Not specified

Surgery:

Not specified

Gender

Both

Ages

up 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 Number ^ICMJE

NCT00003538

Other Study ID Numbers ^ICMJE

CDR0000066589, J9711, P30CA006973, JHOC-97021903, JHOC-J9711, NCI-V98-1460

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Sidney Kimmel Comprehensive Cancer Center

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Richard J. Jones, MD

Sidney Kimmel Comprehensive Cancer Center

Information Provided By

Sidney Kimmel Comprehensive Cancer Center

Verification Date

March 2010

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

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