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

This study is ongoing, but not recruiting participants.

Sponsored by: Sidney Kimmel Comprehensive Cancer Center
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003538
  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
 Procedure: allogeneic bone marrow transplantation
Procedure: graft versus host disease prophylaxis/therapy

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Bone Marrow Transplantation    Cancer    Hodgkin's Disease    Leukemia, Adult Acute    Leukemia, Adult Chronic    Leukemia, Childhood    Lymphoma    Multiple Myeloma   

U.S. FDA Resources

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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   March 1997

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
Ages Eligible for Study:   up to 65 Years
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

Investigators
Study Chair:     Richard J. Jones, MD     Sidney Kimmel Comprehensive Cancer Center    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:
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.
 

Study ID Numbers:   CDR0000066589, JHOC-97021903, JHOC-J9711, NCI-V98-1460
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003538
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Philadelphia Chromosome
Blast Crisis
Chronic myelogenous leukemia
Chronic myelomonocytic leukemia
Graft versus host disease
Hodgkin lymphoma, adult
Lymphoma, Mantle-Cell
Lymphoma, small cleaved-cell, diffuse
Ovarian epithelial cancer
Small non-cleaved cell lymphoma
Lymphoma, large-cell, immunoblastic
Central nervous system lymphoma, primary
Preleukemia
Leukemia, Prolymphocytic
Multiple myeloma
Neoplasm Metastasis
Lymphoma, Large-Cell, Anaplastic
Acute myeloid leukemia, adult
Hodgkin Disease
Rhabdomyosarcoma
Myelodysplastic syndromes
Lymphoma, Large B-Cell, Diffuse
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Leukemia, B-cell, chronic
Leukemia, Myelomonocytic, Chronic
Acute myelogenous leukemia
Breast Neoplasms
Renal cancer
Leukemia, Myeloid

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on September 05, 2008

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