Cyclophosphamide Versus Anti-thymocyte Globulin for GVHD Prophylaxis After RIC Allo-SCT
ATG-CyGVHD
2 other identifiers
interventional
94
1 country
1
Brief Summary
The study is designed as a two arm randomized Phase II, multicenter trial comparing cyclophosphamide to anti-thymocyte globulin for Graft-versus-Host Disease (GVHD) prophylaxis in patients with hematologic malignancies undergoing reduced intensity conditioning hematopoietic stem cell transplantation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2017
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2016
CompletedFirst Posted
Study publicly available on registry
August 24, 2016
CompletedStudy Start
First participant enrolled
April 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 12, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 12, 2020
CompletedNovember 20, 2020
November 1, 2020
3.5 years
August 12, 2016
November 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite endpoint of GVHD-free, relapse-free survival (GRFS)
Absence of grade 3-4 acute GVHD, chronic GVHD requiring systemic treatment, relapse, or death
12 Months
Secondary Outcomes (7)
Cumulative incidence of grade 2-4 and grade 3-4 severe acute GVHD
6 Months
Cumulative incidence of non-relapse mortality within the first 12 months after transplantation.
12 Months
Disease-free survival
12 months
Overall survival.
12 months
Quality of Life (QoL) with EORTC QLQ-C30
12 Months
- +2 more secondary outcomes
Study Arms (2)
Cyclophosphamide
EXPERIMENTAL50mg/Kg/day cyclophosphamide (day +3 and +4)
Anti-Thymocyte Globulin
ACTIVE COMPARATOR2.5 mg/Kg/day ATG (Thymoglobuline®) for 2 consecutive days (day -2 and -1)
Interventions
GVHD prophylaxis: All patients will receive post-transplant 50mg/Kg/day cyclophosphamide (day +3 and +4) AND cyclosporine-A alone in case of an HLA-sibling donor, or cyclosporine-A and mycophenolate-mofetil in case of an HLA-matched unrelated donor
GVHD prophylaxis: 2.5 mg/Kg/day ATG (Thymoglobuline®) for 2 consecutive days (day -2 and -1) All patients will receive cyclosporine-A alone in case of an HLA-sibling donor, or cyclosporine-A and mycophenolate-mofetil (MMF) in case of an HLA-matched unrelated donor.
30 mg/m2/day fludarabine for 5 days (day-6 to day-2) 130 mg/m2/day IV busulfan once daily for 2 days (day -4 and -3)
Eligibility Criteria
You may qualify if:
- Patients aged between 18 and 65 years
- Presence of a hematologic malignancy for which a reduced-intensity conditioning allo-SCT is indicated (eligibility criteria for RIC allo-SCT include at least one of the following parameters: (i) patient age older than 50 years; (ii) heavily pre-treated patients who received an autologous hematopoietic SCT (auto-SCT) or with more than 2 lines of chemotherapy before allo-SCT; and (iii) patients with poor performance status because of significant medical comorbidities as described by Sorror et al.
- Karnofsky index ≥ 70%
- Availability of a sibling or unrelated stem-cell donor (10/10-HLA matched unrelated donor)
- Efficient contraceptive method within 1 month for women and 3 months for men after the last dose of treatment
- Written informed consent.
You may not qualify if:
- Creatinine clearance less than 30 mL/min
- Bilirubin or amino-transferases above 3X upper normal limit
- Cardiac ejection fraction less than 40%
- Pulmonary impairment with \<50% lung carbon monoxide diffusing capacity (DLCO)
- Known hypersensitivity or contraindication to the use of post-transplant Cy and ATG
- Any circumstance that precludes the use of the drugs involved in the protocol
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Saint Antoine Hospital - Hematology Department
Paris, 75012, France
Related Publications (2)
Brissot E, Labopin M, Labussiere H, Fossard G, Chevallier P, Guillaume T, Yakoub-Agha I, Srour M, Bulabois CE, Huynh A, Chantepie S, Menard AL, Rubio MT, Ceballos P, Dulery R, Furst S, Malard F, Blaise D, Mohty M. Post-transplant cyclophosphamide versus anti-thymocyte globulin after reduced intensity peripheral blood allogeneic cell transplantation in recipients of matched sibling or 10/10 HLA matched unrelated donors: final analysis of a randomized, open-label, multicenter, phase 2 trial. Blood Cancer J. 2024 Feb 19;14(1):31. doi: 10.1038/s41408-024-00990-3.
PMID: 38374026DERIVEDDel Pozo Martin Y. 47th Annual Meeting of the EBMT. Lancet Haematol. 2021 May;8(5):e317-e318. doi: 10.1016/S2352-3026(21)00104-6. Epub 2021 Mar 31. No abstract available.
PMID: 33811823DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mohamad MOHTY, PU-PH
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2016
First Posted
August 24, 2016
Study Start
April 6, 2017
Primary Completion
October 12, 2020
Study Completion
October 12, 2020
Last Updated
November 20, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share