NCT04202835Active, not recruitingPhase 2
ATG Plus PTCy vs ATG for CGVHD Prophylaxis
A Randomized Pilot Trial Comparing Anti-Thymocyte Globulin (ATG) With ATG Plus Post Transplant Cyclophosphamide (PTCy) for Prophylaxis Against Acute and Chronic Graft Versus Host Disease (GVHD)
Source: ClinicalTrials.gov · Last updated 11 May 2025
Brief summary (registry, in English)
A Randomized Pilot Trial to test the feasibility of comparing anti-thymocyte globulin plus post transplant cyclophosphamide with anti-thymocyte globulin alone to prevent chronic graft versus host disease.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 29 Nov 2019
- Start date
- 14 Oct 2020
- Primary completion date
- 18 May 2024
- Lead sponsor
- McMaster University
- NCT number
- NCT04202835
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 80
- From 14 Oct 2020 to the primary completion date, 18 May 2024
- 9 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The participant is having their second transplant
- The participant is taking T-cell antibody prophylaxis (anti-CD52)
- The participant is receiving a cord blood graft or T-cell depleted grafts
Other illness
- The participant is HIV antibody positive
- The participant has a hypersensitivity to rabbit proteins or Thymoglobulin® pharmaceutical excipients, glycine or mannitol.
- The participant has active or chronic infection (i.e. infection requiring oral or IV therapy)
- The participant is in poor condition (determined per institutional guidelines)
- The participant has myelodysplastic syndrome with \> 10% marrow blasts
Age
- The participant has prior malignancies, except resected nonmelanoma or treated cervical carcinoma in situ. Cancer treated with curative intent ≥ 5 years previously will be allowed. Cancer treated with curative intent \< 5 years previously must be reviewed and approved by the sponsors.
Other
- The participant (if female and of childbearing potential) is pregnant or breast-feeding at the time of enrollment
- The participant (if female and of childbearing potential) does not agree to use an adequate contraceptive method from the time of enrollment until a minimum of one year following transplant3
- The participant (if male and fertile) does not agree to use an adequate contraceptive method from the time of enrollment until a minimum of one year following transplant3
- The participant has urinary outflow obstruction
- The participant has acute leukemia in relapse
- The participant has mixed phenotype acute leukemia
- The participant is in complete remission with incomplete recovery (CRi)
Who the study is looking for
- The participant is aged ≥ 16 and deemed medically fit per investigator for protocol
- The participant has either acute myeloid leukemia in 1st or 2nd complete remission (CR), or has myelodysplastic syndrome
- The participant will receive a blood progenitor cell graft ("HPC, Apheresis")
- The participant has a related or unrelated donor, who is fully MHC matched with the recipient at HLA-A, B, C and DRB1.
- The participant meets the transplant centre's criteria for transplantation, using either myeloablative or reduced intensity conditioning.
- The participant has good performance status (Karnofsky ≥60%)
- The participant is able to understand and sign the informed consent form
- Ability and willingness to comply with study procedures and schedule, in the Investigator's opinion.
- The participant is receiving their first transplant
Age in the registry: 16 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kinghorn Cancer Centre, St Vincent's Health Network Coordinator of this site? Confirm its status | Darlinghurst | Australia | Unknown status |
| Australasian Leukaemia and Lymphoma Group Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Royal North Shore Hospital Coordinator of this site? Confirm its status | St Leonards | Australia | Unknown status |
| Queen Elizabeth II, Health Sciences Centre Coordinator of this site? Confirm its status | Halifax | Canada | Unknown status |
| Juravinski Hospital and Cancer Centre Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| London Health Sciences Centre Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| Hopital de L'enfant Jesus Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Saskatchewan Cancer Agency Coordinator of this site? Confirm its status | Saskatoon | Canada | Unknown status |
| CancerCare Manitoba Coordinator of this site? Confirm its status | Winnipeg | Canada | Unknown status |
Related publications
- A randomized pilot trial comparing anti-thymocyte globulin with anti-thymocyte globulin plus post transplant cyclophosphamide for prophylaxis against acute and chronic graft versus host disease in matched donor hematopoietic cell transplants - a study from the Cell Therapy Transplant Canada/ Australasian Leukemia Lymphoma Group Consortium.Bone Marrow Transplant · 2026 · PMID 42629427
This page is information, not medical advice. Discuss any trial with your doctor.