Status:

COMPLETED

Laboratory-Treated Donor Bone Marrow in Treating Patients Who Are Undergoing a Donor Bone Marrow Transplant for Hematologic Cancer

Lead Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Graft Versus Host Disease

Leukemia

Eligibility:

All Genders

Up to 65 years

Phase:

PHASE3

Brief Summary

RATIONALE: Giving chemotherapy and total-body irradiation before a donor bone marrow transplant or peripheral blood stem cell transplant helps stop the growth of cancer and abnormal cells and helps st...

Detailed Description

OBJECTIVES: * Compare the effectiveness, in terms of incidence of graft failure and incidence of greater than grade 1 acute graft-vs-host disease, of ex vivo manipulation of bone marrow cells compris...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Diagnosis of 1 of the following hematologic malignancies or genetic disorders:
  • Acute myeloid leukemia (AML), meeting 1 of the following criteria
  • Primary resistant disease
  • Disease in complete remission (CR)
  • Disease in first early relapse
  • Secondary AML arising out of myelodysplastic syndrome
  • Acute lymphocytic leukemia (ALL), meeting 1 of the following criteria:
  • Primary resistant disease
  • Disease in CR
  • Disease in first early relapse
  • Chronic myelogenous leukemia
  • Myelodysplastic syndrome (MDS)
  • Chronic myelomonocytic leukemia
  • Philadelphia chromosome-negative myeloproliferative disorder
  • Multiple myeloma
  • Hodgkin's lymphoma
  • Non-Hodgkin's lymphoma
  • Genetic disorders or inborn errors of metabolism
  • Planning allogeneic bone marrow transplantation at the Sidney Kimmel Comprehensive Cancer Center at the Johns Hopkins Medical Center
  • Must have an HLA-identical sibling donor by serologic or molecular typing of HLA class I antigens and molecular typing of HLA class II antigens
  • PATIENT CHARACTERISTICS:
  • 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 transfusion from the same donor
  • Other
  • Concurrent participation in another clinical trial allowed

Exclusion

    Key Trial Info

    Start Date :

    December 1 2002

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    August 1 2007

    Estimated Enrollment :

    72 Patients enrolled

    Trial Details

    Trial ID

    NCT00265837

    Start Date

    December 1 2002

    End Date

    August 1 2007

    Last Update

    April 17 2014

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, United States, 21231-2410