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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003538
First Posted: January 27, 2003
Last Update Posted: May 2, 2014
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Sidney Kimmel Comprehensive Cancer Center
  Purpose

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.


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

Study Type: Interventional
Study Design: Primary Purpose: Supportive Care
Official Title: Stem Cell Augmented, Elutriated Grafts for Allogeneic Bone Marrow Transplantation

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Study Start Date: March 1997
Study Completion Date: May 2004
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003538


Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Richard J. Jones, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00003538     History of Changes
Other Study ID Numbers: CDR0000066589, J9711
P30CA006973 ( U.S. NIH Grant/Contract )
JHOC-97021903
JHOC-J9711
NCI-V98-1460
First Submitted: November 1, 1999
First Posted: January 27, 2003
Last Update Posted: May 2, 2014
Last Verified: May 2014

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
stage IV breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
recurrent childhood acute lymphoblastic leukemia
recurrent adult Hodgkin lymphoma
recurrent childhood rhabdomyosarcoma
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer
disseminated neuroblastoma
recurrent neuroblastoma
recurrent Wilms tumor and other childhood kidney tumors
Waldenstrom macroglobulinemia
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
stage I childhood lymphoblastic lymphoma
stage III childhood lymphoblastic lymphoma
stage IV childhood lymphoblastic lymphoma
recurrent childhood lymphoblastic lymphoma
recurrent childhood acute myeloid leukemia
recurrent adult acute myeloid leukemia
recurrent adult acute lymphoblastic leukemia
relapsing chronic myelogenous leukemia
stage III malignant testicular germ cell tumor

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases