NCT02988466

Reduced Intensity (RIC) Conditioning And Transplantation of HLA-Haplo-HCT

Reduced Intensity (RIC) Conditioning And Transplantation of HLA-Haploidentical Related Hematopoietic Cells (Haplo-HCT) For Patients With Hematologic Malignancies

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Hematologic Malignancies

Interventions

Type	Name	Description
BIOLOGICAL	Haplo HCT <55 years old	* Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel) * Total body irradiation (TBI) * Non-T-cell depleted donor bone marrow stem cell infusion Day 0
BIOLOGICAL	Haplo HCT ≥55 years old	* Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel): Dose reduction by 30% * Total body irradiation (TBI) * Non-T-cell depleted donor bone marrow stem cell infusion
DRUG	GVHD Prophylaxis	* Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF)
BIOLOGICAL	Haplo HCT ≥55 and < 65 years old	* Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel) * Total body irradiation (TBI) * non-T-cell depleted donor bone marrow stem cells
BIOLOGICAL	Haplo HCT ≥65 and ≤75 years old	* Fludarabine (Flu) * Cyclophosphamide (Cy) * Total body irradiation (TBI)

Timeline

• Start date: 2017-01-24
• Primary completion: 2023-05-02
• Completion: 2025-03-24
• First posted: 2016-12-09
• Last updated: 2025-05-28
• Results posted: 2025-05-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study