Clinical trial

Tacrolimus and Mycophenolate Mofetil With or Without Sirolimus in Preventing…

NCT00105001 · Fred Hutchinson Cancer Center, Other · Completed

Key facts

NCT number NCT00105001
Title Tacrolimus and Mycophenolate Mofetil With or Without Sirolimus in Preventing Acute Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer
Official title A Randomized Phase II Study to Determine the Most Promising Postgrafting Immunosuppression for Prevention of Acute GVHD After Unrelated Donor G-CSF Mobilized Peripheral Blood Mononuclear Cell (G-PBMC) Transplantation Using Nonmyeloablative Conditioning for Patients With Hematologic Malignancies A…
Lead sponsor Fred Hutchinson Cancer Center, Other
Collaborators National Cancer Institute (NCI) NIH
Status Completed
Phase Phase 2
Study type Interventional
Conditions Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Previously Treated Myelodysplastic Syndrome, Refractory Chronic Lymphocytic Leukemia, Refractory Plasma Cell Myeloma, Waldenstrom Macroglobulinemia, Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission and 119 more
Intervention type Drug, Procedure, Radiation
Interventions Fludarabine Phosphate, Total-Body Irradiation, Peripheral Blood Stem Cell Transplantation, Allogeneic Hematopoietic Stem Cell Transplantation, Tacrolimus, Mycophenolate Mofetil, Sirolimus
Enrollment 210
Start date Nov 1, 2004
Primary completion May 1, 2011
Completion May 8, 2015
First posted Mar 4, 2005
Last update posted Oct 30, 2019
Countries Denmark, Germany, United States

At a glance

  • 10–99 Study sites
  • Yes Results posted
  • None Linked FDA submissions

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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