This is a single institution phase II study of a reduced intensity conditioning (RIC) followed by a haploidentical hematopoietic cell transplant (haplo-HCT) in persons with diagnosis of hematologic malignancy. Conditioning will consists of fludarabine, cyclophosphamide, melphalan and total body irradiation (TBI) preparative regimen with a melphalan dose reduction for patients ≥55 years old and those with HCT Comorbidity Index (CI) \>3. This study uses a two-stage phase II design with accrual goal of 84 patients, using 28 patients separately for arms A, C and D
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
78
* Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel) * Total body irradiation (TBI) * Non-T-cell depleted donor bone marrow stem cell infusion Day 0
* Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel): Dose reduction by 30% * Total body irradiation (TBI) * Non-T-cell depleted donor bone marrow stem cell infusion
* Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF)
* Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel) * Total body irradiation (TBI) * non-T-cell depleted donor bone marrow stem cells
* Fludarabine (Flu) * Cyclophosphamide (Cy) * Total body irradiation (TBI)
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States
Disease-free Survival (DFS)
Percentage of participants that were disease-free survival (DFS) at 1 year post-transplant
Time frame: 1 year
Incidence of Grade II-IV and Grade III-IV Acute Graft Versus-host-disease (GVHD)
Percentage of participants with incidence of grade II-IV and grade III-IV acute graft versus-host-disease (GVHD).
Time frame: day 100
Treatment Related Mortality (TRM)
Percentage of participants experiencing treatment related mortality (TRM).
Time frame: 6 month, 1 and 2 year
Relapse Incidence
Percentage of participants experiencing a relapse incidence at 1 and 2 years.
Time frame: 1 and 2 year
Incidence of Serious Fungal and Viral Infection
Percentage of participants experiencing incidence of serious fungal and viral infection post-HCT
Time frame: at day 100 and 1 year
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