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

NCT ID: NCT00003538

Last Updated: 2014-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

1997-03-31

Study Completion Date

2004-05-31

Brief Summary

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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

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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

Conditions

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Cancer

Study Design

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Primary Study Purpose

SUPPORTIVE_CARE

Interventions

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graft versus host disease prophylaxis/therapy

Intervention Type BIOLOGICAL

allogeneic bone marrow transplantation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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
Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role lead

Principal Investigators

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Richard J. Jones, MD

Role: STUDY_CHAIR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Locations

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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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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. doi: 10.1038/sj.bmt.1701476.

Reference Type RESULT
PMID: 9849691 (View on PubMed)

Other Identifiers

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P30CA006973

Identifier Type: NIH

Identifier Source: secondary_id

View Link

JHOC-97021903

Identifier Type: -

Identifier Source: secondary_id

JHOC-J9711

Identifier Type: -

Identifier Source: secondary_id

NCI-V98-1460

Identifier Type: -

Identifier Source: secondary_id

CDR0000066589, J9711

Identifier Type: -

Identifier Source: org_study_id

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