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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00003538
First received: November 1, 1999
Last updated: May 1, 2014
Last verified: May 2014

November 1, 1999
May 1, 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 ClinicalTrials.gov 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.

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

Interventional
Not Provided
Primary Purpose: Supportive Care
Cancer
  • Biological: graft versus host disease prophylaxis/therapy
  • Procedure: allogeneic bone marrow transplantation
Not Provided
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.
 
Completed
Not Provided
May 2004
May 2004   (final data collection date for primary outcome measure)

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
Both
up to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003538
CDR0000066589, J9711, P30CA006973, JHOC-97021903, JHOC-J9711, NCI-V98-1460
Not Provided
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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