CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 78 enrolled
Drug / intervention
Haplo HCT <55 years old +4 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT02988466
NCT02988466Phase 2Completed
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Reduced Intensity (RIC) Conditioning And Transplantation of HLA-Haploidentical Related Hematopoietic Cells (Haplo-HCT) For Patients With Hematologic Malignancies

Masonic Cancer Center, University of Minnesota·interventional·Posted Dec 9, 2016·Updated May 28, 2025

In Brief

A Phase 2 clinical trial evaluating Haplo HCT <55 years old, Haplo HCT ≥55 years old, and 3 other interventions for Hematologic Malignancies. Completed, enrolled 78 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHematologic Malignancies
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 9, 2016
Enrollment StartJan 24, 2017
Primary CompletionMay 2, 2023
Study CompletionMar 24, 2025
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 9.6 years ago

Interventions

Haplo HCT <55 years oldbiological

* Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel) * Total body irradiation (TBI) * Non-T-cell depleted donor bone marrow stem cell infusion Day 0

Haplo HCT ≥55 years oldbiological

* Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel): Dose reduction by 30% * Total body irradiation (TBI) * Non-T-cell depleted donor bone marrow stem cell infusion

GVHD Prophylaxisdrug

* Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF)

Haplo HCT ≥55 and < 65 years oldbiological

* Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel) * Total body irradiation (TBI) * non-T-cell depleted donor bone marrow stem cells

Haplo HCT ≥65 and ≤75 years oldbiological

* Fludarabine (Flu) * Cyclophosphamide (Cy) * Total body irradiation (TBI)