Actively Recruiting
Allogeneic Hematopoietic Cell Transplantation From HLA-matched Donor After Flu-Mel-PTCy Versus Flu-Mel-ATG Reduced-intensity Conditioning
Led by University of Liege · Updated on 2022-10-12
114
Participants Needed
10
Research Sites
1030 weeks
Total Duration
On this page
Sponsors
U
University of Liege
Lead Sponsor
B
Belgian Hematological Society
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Allogeneic Hematopoietic Cell Transplantation From HLA-matched Donor After Flu-Mel-PTCy Versus Flu-Mel-ATG Reduced-intensity Conditioning
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with hematological malignancies such as AML in remission, MDS, CML in chronic or accelerated phase, MPD not in blast crisis, MDS/MPD overlap, ALL in remission, multiple myeloma, CLL, Non-Hodgkin lymphoma, or Hodgkin lymphoma with chemosensitive disease
- Indicated for standard allogeneic transplant but may require reduced-intensity conditioning due to age over 50, organ function, or physician/patient decision
- Male or female; fertile patients must use reliable contraception
- Age between 18 and 75 years
- Provided informed consent
- Donors must be HLA-identical siblings or fully matched unrelated donors, weigh over 15 kg, and meet donation criteria with consent
You will not qualify if you...
- Does not meet all inclusion criteria
- HIV positive
- Active non-hematological cancer within 3 years before transplant (except non-melanoma skin cancer)
- Severely limited life expectancy due to non-cancer disease
- Central nervous system disease resistant to chemotherapy
- Terminal organ failure except renal failure requiring dialysis
- Cardiac conditions such as symptomatic coronary artery disease, low ejection fraction, uncontrolled arrhythmia or hypertension
- Severe lung impairment or need for continuous oxygen
- Severe liver disease including fulminant failure, cirrhosis with portal hypertension, or other serious hepatic conditions
- Uncontrolled infection
- Karnofsky Performance Score below 70%
- Fertile patients unwilling to use contraception during and for 12 months after treatment
- Pregnant or breastfeeding women
- Conditions preventing use of melphalan or Thymoglobulin
- Donors with poor vein access or other issues preventing leukapheresis
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 10 locations
1
ZNA Stuivenberg
Antwerp, Belgium, 2060
Actively Recruiting
2
AZ Sint Jan Brugge
Bruges, Belgium, 8000
Actively Recruiting
3
IJ Bordet
Brussels, Belgium, 1000
Actively Recruiting
4
UZ Brussel
Brussels, Belgium, 1090
Actively Recruiting
5
UCL St Luc
Brussels, Belgium, 1200
Actively Recruiting
6
UZ Gent
Ghent, Belgium, 9000
Actively Recruiting
7
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
8
CHU de Liège
Liège, Belgium, 4000
Actively Recruiting
9
AZ Delta Roeselare
Roeselare, Belgium, 8800
Actively Recruiting
10
CHU UCL Namur Godinne
Yvoir, Belgium, 5530
Actively Recruiting
Research Team
F
Frédéric Baron, MD,Ph
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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