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Clinical Trial Summary

This phase II trial studies how well sirolimus, cyclosporine and mycophenolate mofetil works in preventing graft-vs-host disease (GVHD) in patients with blood cancer undergoing donor peripheral blood stem cell (PBSC) transplant. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving total-body irradiation together with sirolimus, cyclosporine, and mycophenolate mofetil before and after transplant may stop this from happening.


Clinical Trial Description

PRIMARY OBJECTIVES:

I. To determine whether the incidence of acute GVHD grades II-IV can be reduced to less than the historical rate of 70% with the triple-immunosuppressant combination of cyclosporine (CSP)/mycophenolate mofetil (MMF) with sirolimus in human leukocyte antigens (HLA) class I or class II mismatched related or unrelated donor hematopoietic cell transplantation (HCT) using nonmyeloablative conditioning. The evaluation will be carried out separately among class I and class II mismatched patients.

SECONDARY OBJECTIVES:

I. To evaluate the incidence of non-relapse mortality before day 100.

II. To evaluate the incidences of grades III-IV acute GVHD.

OUTLINE:

CONDITIONING: Patients receive fludarabine phosphate intravenously (IV) over 30 minutes on days -4 to -2. Patients also undergo total-body irradiation on day 0.

TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation.

IMMUNOSUPPRESSION: Patients receive sirolimus orally (PO) once daily (QD) on days -3 to 180 with taper to day 365; cyclosporine PO twice daily (BID) on days -3 to 150 with taper to day 180; and mycophenolate mofetil PO thrice daily (TID) on days 0-30 and then BID to day 100 with taper to day 150.

After completion of study treatment, patients are followed up at 6 months and every year thereafter. ;


Study Design


Related Conditions & MeSH terms

  • Adult Acute Lymphoblastic Leukemia
  • Adult Acute Myeloid Leukemia
  • Adult Diffuse Large B-Cell Lymphoma
  • Adult Myelodysplastic Syndrome
  • Adult Non-Hodgkin Lymphoma
  • Aggressive Non-Hodgkin Lymphoma
  • Childhood Acute Lymphoblastic Leukemia
  • Childhood Acute Myeloid Leukemia
  • Childhood Diffuse Large B-Cell Lymphoma
  • Childhood Myelodysplastic Syndrome
  • Childhood Non-Hodgkin Lymphoma
  • Chronic Lymphocytic Leukemia
  • Chronic Lymphocytic Leukemia in Remission
  • Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Hematopoietic and Lymphoid Cell Neoplasm
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid, Chronic-Phase
  • Leukemia, Prolymphocytic
  • Leukemia, Prolymphocytic, T-Cell
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Mantle-Cell
  • Lymphoma, Non-Hodgkin
  • Mantle Cell Lymphoma
  • Multiple Myeloma
  • Myelodysplastic Syndromes
  • Plasma Cell Myeloma
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Preleukemia
  • Prolymphocytic Leukemia
  • Recurrent Chronic Lymphocytic Leukemia
  • Recurrent Diffuse Large B-Cell Lymphoma
  • Recurrent Hodgkin Lymphoma
  • Refractory Chronic Lymphocytic Leukemia
  • Syndrome
  • T-Cell Prolymphocytic Leukemia
  • Waldenstrom Macroglobulinemia

NCT number NCT01251575
Study type Interventional
Source Fred Hutchinson Cancer Research Center
Contact
Status Completed
Phase Phase 2
Start date December 1, 2010
Completion date February 11, 2019

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