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

This study is no longer recruiting patients.

Sponsored by: Sidney Kimmel Cancer Center
Information provided by: National Cancer Institute (NCI)

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 Treatment or Intervention
Leukemia
Lymphoma
Plasma Cell Neoplasm
Aplastic Anemia
Solid Tumor
Graft Versus Host Disease
 Procedure: allogeneic bone marrow transplantation
 Procedure: biological response modifier therapy
 Procedure: bone marrow ablation with stem cell support
 Procedure: bone marrow transplantation
 Procedure: graft versus host disease prophylaxis/therapy
 Procedure: supportive care/therapy

MedlinePlus related topics:  Anemia;   Immune System and Disorders;   Leukemia, Adult Acute;   Leukemia, Adult Chronic;   Leukemia, Childhood;   Lymphoma;   Multiple Myeloma

Study Type: Interventional
Study Design: Treatment

Official Title: Study of Stem Cell Augmented, Elutriated Grafts for Prevention of Graft Versus Host Disease in Patients Undergoing Allogeneic Bone Marrow Transplantation

Further Study Details: 

OBJECTIVES:

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

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:

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Location Information


Maryland
      Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore,  Maryland,  21231-2410,  United States

Study chairs or principal investigators

Richard J. Jones, MD,  Study Chair,  Sidney Kimmel Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Publications

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
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003538
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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