NCT03314974View on ClinicalTrials.gov

Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders

PHASE2RecruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

March 30, 2018

Primary Completion Date

June 10, 2026

Study Completion Date

June 10, 2027

Conditions
Acute LeukemiaAcute Myeloid LeukemiaAcute Lymphoblastic LeukemiaLymphomaChronic Myelogenous LeukemiaPlasma Cell LeukemiaMyeloproliferative NeoplasmsMyelofibrosisMyelodysplasiaRefractory AnemiaHigh Risk AnemiaChronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaMarginal Zone B-Cell LymphomaFollicular LymphomaLymphoplasmacytic LymphomaMantle-Cell LymphomaProlymphocytic LeukemiaDiffuse Large Cell Non Hodgkins LymphomaLymphoblastic LymphomaBurkitt LymphomaHigh Grade Non-Hodgkin's Lymphoma, AdultMultiple MyelomaJuvenile Myelomonocytic LeukemiaBiphenotypic/Undifferentiated/Prolymphocytic LeukemiasMRD Positive LeukemiaNatural Killer Cell MalignanciesAcquired Bone Marrow Failure Syndromes
Interventions
BIOLOGICAL

HSCT with TBI Regimen

Day -5 to -2: Total Body Irradiation Day 0: Hematopoietic Stem Cell Transplantation Day +3 to +4: Cyclophosphamide Day +5: Tacrolimus from day +5 until taper day +100 (day +60 for peds if no acute or chronic GVHD present) Day +5: Mycophenolate mofetil through day +35 or 7 days after engraftment, whichever day is later, if no acute GVHD

BIOLOGICAL

HSCT with Non-TBI Regimen

Day -5 to Day -2: Busulfan and Fludaribine Day 0: Hematopoietic Stem Cell Transplantation Day +3 to +4: Cyclophosphamide Day +5: Tacrolimus from day +5 until taper day +100 (day +60 for peds if no acute or chronic GVHD present) Day +5: Mycophenolate mofetil through day +35 or 7 days after engraftment, whichever day is later, if no acute GVHD

Trial Locations (1)

55337

RECRUITING

Masonic Cancer Center at University of Minnesota, Minneapolis

All Listed Sponsors
lead

Masonic Cancer Center, University of Minnesota

OTHER