CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 300 target
Drug / intervention
HSCT with TBI Regimen +1 morebiological
Likely dose
Not stated in record
Key inclusion· 32
  • ✓Age 60 years or younger
  • ✓Karnofsky performance status ≥70% or Lansky play score ≥70
  • ✓Voluntary written informed consent from patient or legally authorized representative
  • ✓Renal function: creatinine <2x ULN or creatinine clearance ≥40 ml/min/1.73m2
Key exclusion· 9
  • ✕Chemotherapy-refractory large cell or high-grade NHL (progressive disease after >2 salvage regimens)
  • ✕CML in blast crisis
  • ✕Large cell lymphoma, mantle cell lymphoma, or Hodgkin disease progressing on salvage therapy
  • ✕Progressive disease by imaging or biopsy (persistent PET activity alone without CT changes is not exclusionary)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03314974
NCT03314974Phase 2RecruitingOn Track
Long Recruiting
CompareCT.gov

Myeloablative Allogeneic Hematopoietic Cell Transplantation Using a Related or Unrelated Donor for the Treatment of Hematological Diseases

Masonic Cancer Center, University of Minnesota·interventional·Posted Oct 19, 2017·Updated Jun 25, 2026

In Brief

A Phase 2 clinical trial evaluating HSCT with TBI Regimen and HSCT with Non-TBI Regimen for Acute Leukemia and 27 related conditions. Currently recruiting, targeting 300 participants across 1 site.

Detailed Summary

This is a Phase II study of allogeneic hematopoietic stem cell transplant (HCT) using a myeloablative preparative regimen (of either total body irradiation (TBI); or, fludarabine/busulfan for patients unable to receive further radiation). followed by a post-transplant graft-versus-host disease (GVHD) prophylaxis regimen of post-transplant cyclophosphamide (PTCy), tacrolimus (Tac), and mycophenolate mofetil (MMF).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Leukemia, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Lymphoma, Chronic Myelogenous Leukemia, Plasma Cell Leukemia, Myeloproliferative Neoplasms, Myelofibrosis, Myelodysplasia, Refractory Anemia, High Risk Anemia, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Marginal Zone B-Cell Lymphoma, Follicular Lymphoma, Lymphoplasmacytic Lymphoma, Mantle-Cell Lymphoma, Prolymphocytic Leukemia, Diffuse Large Cell Non Hodgkins Lymphoma, Lymphoblastic Lymphoma, Burkitt Lymphoma, High Grade Non-Hodgkin's Lymphoma, Adult, Multiple Myeloma, Juvenile Myelomonocytic Leukemia, Biphenotypic/Undifferentiated/Prolymphocytic Leukemias, MRD Positive Leukemia, Natural Killer Cell Malignancies, Acquired Bone Marrow Failure Syndromes
CountriesUnited States
Collaborators--

Timeline

Phase 2Recruiting
20182019202020212022202320242025202620272028
First PostedOct 19, 2017
Enrollment StartMar 30, 2018
Primary CompletionJun 10, 2027
Study CompletionJun 10, 2028
TodayJul 2, 2026
Enrollment to primary: 9.2 yearsPosted 8.7 years agoPrimary completion in 11 months

Arms & Interventions

TBI Regimenexperimental

Biological: HSCT with TBI Regimen
Non-TBI Regimenexperimental

Biological: HSCT with Non-TBI Regimen

Interventions

HSCT with TBI Regimenbiological

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

HSCT with Non-TBI Regimenbiological

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