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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003538
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 2, 2014
National Cancer Institute (NCI)
Information provided by:
Sidney Kimmel Comprehensive Cancer Center

November 1, 1999
January 27, 2003
May 2, 2014
March 1997
May 2004   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00003538 on Archive Site
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Prevention of Graft-Versus-Host Disease in Patients Undergoing Bone Marrow Transplantation
Stem Cell Augmented, Elutriated Grafts for Allogeneic Bone Marrow Transplantation

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.


  • 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.


Not Applicable
Primary Purpose: Supportive Care
  • Biological: graft versus host disease prophylaxis/therapy
  • Procedure: allogeneic bone marrow transplantation
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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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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May 2004
May 2004   (Final data collection date for primary outcome measure)


  • 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



  • 0.5 to 65

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


Biologic therapy:

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


  • Not specified

Endocrine therapy:

  • Not specified


  • Not specified


  • Not specified
Sexes Eligible for Study: All
up to 65 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
United States
CDR0000066589, J9711
P30CA006973 ( U.S. NIH Grant/Contract )
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Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Richard J. Jones, MD Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
May 2014

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