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Graft-Versus-Host Disease

Tacrolimus + Mycophenolate Mofetil Post Transplant (FHCRC-1898)
A Multi-Center Study of Nonmyeloablative Conditioning with TBI or Fludarabine/TBI for HLA-matched Related Hematopoietic Cell Transplantation for Treatment of Hematologic Malignancies with Post Grafting Immunosuppression with Tacrolimus and Mycophenolate Mofetil
Status Conditions Phase Study ID
Closed Chronic Myeloproliferative Disorders
Graft Versus Host Disease
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Phase II FHCRC-1898
NCT00089011
Summary

RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and radiation therapy before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus and mycophenolate mofetil after transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well giving tacrolimus together with mycophenolate mofetil works in preventing graft-versus-host disease in patients who have undergone total-body irradiation with or without fludarabine followed by donor stem cell transplant for hematologic cancer.


Investigator
David Maloney, MD, PhD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
Ages Eligible for Study:   up to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of one of the following hematologic or B-cell malignancies that are treatable with hematopoietic stem cell transplantation (HSCT):

    • Diffuse large B-cell non-Hodgkin's lymphoma (NHL)

      • Not eligible for conventional myeloablative HSCT OR undergone prior autologous HSCT
      • Other aggressive lymphomas allowed
    • Low-grade NHL

      • Less than 6 months duration of a complete remission (CR) between courses of conventional therapy
    • Mantle cell NHL

      • May be in first CR
    • Chronic lymphocytic leukemia

      • Meets one of the following criteria:

        • Failed to meet NCI Working Group criteria for complete or partial response OR relapsed within 12 months after completion of prior fludarabine-containing regimen (or another nucleoside analog [e.g., cladribine or pentostatin])
        • Failed FLU-CY-Rituximab (FCR) combination chemotherapy at any time point
        • Have "17p deletion" cytogenetic abnormality (patients should have received induction chemotherapy but could be transplanted in 1st CR)
    • Hodgkin's lymphoma

      • Failed prior front-line therapy AND failed or not eligible for autologous transplantation
    • Multiple myeloma

      • Undergone autograft or equivalent high-dose therapy without a graft OR failed after prior autograft
    • Acute myeloid leukemia

      • Less than 5% marrow blasts
      • No circulating leukemic blasts in the peripheral blood
    • Acute lymphoblastic leukemia (ALL)

      • Less than 5% marrow blasts
      • No circulating leukemic blasts in the peripheral blood
    • Chronic myelogenous leukemia (CML) OR myeloproliferative disorders

      • Less than 5% marrow blasts
      • No circulating leukemic blasts in the peripheral blood
    • Myelodysplastic syndromes

      • Less than 5% marrow blasts
    • Waldenstrom Macroglobulinemia

      • Must have failed 2 courses of therapy
  • Not eligible for conventional allogeneic HSCT
  • Patients who are ineligible for active disease-specific protocols OR unable to be enrolled in FHCRC-1813.00 are allowed
  • Not eligible for high-priority curative autologous transplantation
  • Refused treatment on a conventional HSCT protocol
  • Disease expected to be stable for ≥ 100 days without chemotherapy
  • HLA-matched related donor available, meeting the following criteria:

    • Genotypically identical for ≥ 1 haplotype
    • Phenotypical or genotypically identical at the allele level at HLA-A, -B, -C, -DRB1, and -DQB1
    • 12 years of age or older
    • Not an identical twin
  • No rapidly progressive aggressive NHL, unless in minimal disease state
  • No CNS involvement refractory to intrathecal chemotherapy NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
Last Updated
September 10, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.