RecruitingPhase 2NCT03852407

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)


Sponsor

University of Liege

Enrollment

114 participants

Start Date

Feb 4, 2019

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a type of bone marrow transplant from a matched donor using a reduced-intensity (gentler) pre-transplant conditioning approach, for older patients or those who are too sick for a full-strength transplant — to treat a range of blood cancers and bone marrow disorders. **You may be eligible if...** - You have been diagnosed with a blood cancer or bone marrow disorder such as leukemia (AML, ALL, CML), MDS, lymphoma (Hodgkin's or non-Hodgkin's), multiple myeloma, CLL, or a related condition - You need a bone marrow transplant but are not a candidate for a full-strength (standard) transplant because of your age (over 50), organ function, or your doctor's assessment - You are between 18 and 75 years old - You have a suitable matched donor available - You have given informed consent **You may NOT be eligible if...** - You are under 18 years old - You do not have a suitable matched donor - Your disease is rapidly progressing and requires urgent treatment not compatible with the transplant protocol - You have significant health conditions that prevent safe participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGThymoglobulin

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

DRUGMelphalan

100mg/m² on day -2

DRUGFludarabine

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

DRUGCyclophosphamid

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

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NCT03852407


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