Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT03852407
PHASE2

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

Sponsor: University of Liege

View on ClinicalTrials.gov

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).

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

114

Start Date

2019-02-04

Completion Date

2038-11-01

Last Updated

2022-10-12

Healthy Volunteers

No

Interventions

DRUG

Thymoglobulin

ATG: 2.5 mg /kg/day on day -2 and -1 (day 0 is allogenic transplantation)

DRUG

Melphalan

100mg/m² on day -2

DRUG

Fludarabine

30mg/m² on days -6, -5, -4, -3, and -2

DRUG

Cyclophosphamid

50 mg/kg on days +3 and +4.

Locations (10)

ZNA Stuivenberg

Antwerp, Belgium

AZ Sint Jan Brugge

Bruges, Belgium

IJ Bordet

Brussels, Belgium

UZ Brussel

Brussels, Belgium

UCL St Luc

Brussels, Belgium

UZ Gent

Ghent, Belgium

UZ Leuven

Leuven, Belgium

CHU de Liège

Liège, Belgium

AZ Delta Roeselare

Roeselare, Belgium

CHU UCL Namur Godinne

Yvoir, Belgium