Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • Recurrent Chronic Lymphocytic Leukemia
  • Aggressive Non-Hodgkin Lymphoma
  • Blastic Plasmacytoid Dendritic Cell Neoplasm
  • Chronic Lymphocytic Leukemia
  • Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Recurrent Waldenstrom Macroglobulinemia
  • Diffuse Large B Cell Lymphoma
  • Hematologic and Lymphocytic Disorder
  • Mantle Cell Lymphoma
  • Myelodysplastic Syndrome
  • Recurrent Small Lymphocytic Lymphoma
  • Recurrent Hodgkin Lymphoma
  • Myelodysplastic/Myeloproliferative Neoplasm
  • Recurrent Plasma Cell Myeloma
  • Prolymphocytic Leukemia
Type
Interventional
Phase
Phase 2
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

PRIMARY OBJECTIVES: I. Compare chronic graft versus host disease (GVHD)-free and relapse-free survival (CRFS) after transplant between the 2 GVHD prophylaxis regimens. SECONDARY OBJECTIVES: I. Compare rates of acute (grades II-IV and III-IV) and moderate and severe chronic GVHD (based on National In...

PRIMARY OBJECTIVES: I. Compare chronic graft versus host disease (GVHD)-free and relapse-free survival (CRFS) after transplant between the 2 GVHD prophylaxis regimens. SECONDARY OBJECTIVES: I. Compare rates of acute (grades II-IV and III-IV) and moderate and severe chronic GVHD (based on National Institutes of Health [NIH] consensus criteria), relapse, non-relapse mortality, progression or relapse-free survival, and overall survival between the 2 regimens. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo allogeneic hematopoietic stem cell transplant (HCT) at day 0. Patients with an HLA-matched unrelated donor receive mycophenolate mofetil orally (PO) on days 0 to 40, cyclosporine PO every 12 hours twice daily (BID) on days -3 to 96 then tapered to day 150, and sirolimus PO once daily (QD) on days -3 to day 150 then tapered to day 180. Patients with an HLA-mismatched donor receive mycophenolate mofetil PO on days 0-100 then tapered to day 150, cyclosporine PO BID on days -3 to 150 then tapered to day 180, and sirolimus PO QD on days -3 to 180 then tapered to day 365. ARM II: Patients undergo HCT at day 0. Patients with an HLA-matched unrelated donor receive cyclosporine PO BID on days 5-96 then tapered to day 150, sirolimus PO QD on days 5-150 then tapered to day 180, and cyclophosphamide intravenously (IV) on days 3 and 4. Patients with an HLA-mismatched donor receive cyclosporine PO BID on days 5-150 then tapered to day 180, sirolimus PO QD on days 5-180 then tapered to day 365, and cyclophosphamide IV on days 3 and 4. After completion of study treatment, patients are followed up at 6 months and every year thereafter.

Tracking Information

NCT #
NCT03246906
Collaborators
  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)
Investigators
Principal Investigator: Masumi Ueda Oshima Fred Hutch/University of Washington Cancer Consortium