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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)
Led by University of Liege · Updated on 2022-10-12
114
Participants Needed
10
Research Sites
260 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
Researchers are evaluating two conditioning regimens, FM-PTCy and FM-ATG, in patients undergoing allogeneic hematopoietic cell transplantation with HLA-matched donors. The study aims to improve the 2-year current GVHD-free, relapse-free survival (cGRFS) rate from 30% to 45%. This is a phase II, multicenter, randomized, open-label trial with 114 patients, including a 3-year recruitment period and long-term follow-up extending up to 18 years to monitor outcomes like GVHD status, disease progression, second malignancies, and quality of life. Participants will be randomly assigned to one of two treatment groups: FM-PTCy or FM-ATG. The FM-PTCy group receives intravenous fludarabine on days -6 to -2, melphalan on day -2, and cyclophosphamide on days +3 and +4. The FM-ATG group receives the same fludarabine and melphalan schedule but replaces cyclophosphamide with ATG (Thymoglobulin®) on days -2 and -1. Both regimens are reduced-intensity conditioning treatments before transplantation. During the study, participants will undergo regular assessments including monitoring for GVHD, relapse, survival rates, and other health outcomes over 15 years and beyond. Evaluations include relapse rates, acute and chronic GVHD rates, non-relapse mortality, leukemia-free survival, overall survival, and quality of life. Long-term follow-up up to 18 years will track disease status and potential late effects. This extensive monitoring aims to provide comprehensive data on the effectiveness and safety of the two conditioning regimens.
CONDITIONS
Brief 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...
- Adults aged 18 to 75 years
- Diagnosed with hematological malignancies including AML in remission or stable, MDS, CML, MPD, MDS/MPD overlap, ALL in remission, multiple myeloma, CLL, non-Hodgkin lymphoma (chemosensitive), or Hodgkin lymphoma responding to treatment
- Suitable for allogeneic stem cell transplantation with reduced-intensity conditioning
- Male or female patients; fertile patients must use reliable contraception
- Have an HLA-identical sibling donor or a fully HLA-matched unrelated donor
- Donors must weigh over 15 kg and meet standard criteria for peripheral blood stem cell donation
- Informed consent provided by patient and donor as appropriate
You will not qualify if you...
- HIV positive patients
- Active non-hematological cancers within 3 years prior to transplantation (except non-melanoma skin cancer)
- Life expectancy severely limited by diseases other than malignancy
- Central nervous system disease refractory to intrathecal chemotherapy
- Terminal organ failure except for renal failure requiring dialysis
- Significant cardiac issues including symptomatic coronary artery disease, low ejection fraction (<40%), uncontrolled arrhythmia or hypertension
- Severe lung impairment (DLCO or FEV1 <40%) or need for continuous oxygen
- Severe liver diseases including fulminant failure, cirrhosis with portal hypertension, alcoholic hepatitis, varices, encephalopathy, or active infections
- Uncontrolled infection
- Karnofsky Performance Score less than 70%
- Unwillingness to use contraception for 12 months after treatment if fertile
- Pregnant or breastfeeding women
- Conditions preventing use of melphalan or Thymoglobulin
- Donors unable to undergo leukapheresis due to poor vein access or other reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 weeks including conditioning and transplantation
Participants receive conditioning with either Fludarabine-Melphalan-Cyclophosphamide or Fludarabine-Melphalan-Thymoglobulin before undergoing allogeneic hematopoietic cell transplantation.
Daily visits during conditioning and transplantation period
Duration - Up to 15 years
Participants are monitored long-term for graft-versus-host disease status, disease status, second malignancy, and quality of life.
Regular visits scheduled over 5 years plus additional long-term follow-up visits up to 15 years
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
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4
UZ Brussel
Brussels, Belgium, 1090
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5
UCL St Luc
Brussels, Belgium, 1200
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6
UZ Gent
Ghent, Belgium, 9000
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7
UZ Leuven
Leuven, Belgium, 3000
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8
CHU de Liège
Liège, Belgium, 4000
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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
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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