Clinical Trials Directory

Trials / Recruiting

RecruitingNCT03852407

Allogeneic Hematopoietic Cell Transplantation From HLA-matched Donor After Flu-Mel-PTCy Versus Flu-Mel-ATG Reduced-intensity Conditioning

Allogeneic Hematopoietic Cell Transplantation From HLA-matched Donor After Flu-Mel-PTCy Versus Flu-Mel-ATG Reduced-intensity Conditioning: a Phase II Randomized Study From the Belgian Hematology Society (BHS)

Status
Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
114 (estimated)
Sponsor
University of Liege · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

The present project aims at comparing two conditioning regimens (FM-PTCy vs FM-ATG). The hypothesis is that one or the two regimens will lead to a 2-year cGRFS rate improvement from 30% (the cGRFS rate with FM without ATG/PTCy) to 45% (Pick-a-winner phase 2 randomized study).

Detailed description

This study is a multicenter, randomized, open-label, phase II study pick-a-winner study, comparing 2 conditioning regimens. A total of 114 eligible patients with HLA-matched donors will be randomized 1:1 between the FM-PTCy arm and the FM-ATG arm, with stratification for donor type (related or unrelated). The recruitment period is 3 years with a 5-year follow-up plus a 10-year additional long-term follow-up (for GVHD status, disease status, second malignancy and QOL). The whole study will be completed within 18 years.

Conditions

Interventions

TypeNameDescription
DRUGThymoglobulinATG: 2.5 mg /kg/day on day -2 and -1 (day 0 is allogenic transplantation)
DRUGMelphalan100mg/m² on day -2
DRUGFludarabine30mg/m² on days -6, -5, -4, -3, and -2
DRUGCyclophosphamid50 mg/kg on days +3 and +4.

Timeline

Start date
2019-02-04
Primary completion
2033-11-01
Completion
2038-11-01
First posted
2019-02-25
Last updated
2022-10-12

Locations

10 sites across 1 country: Belgium

Source: ClinicalTrials.gov record NCT03852407. Inclusion in this directory is not an endorsement.