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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

Full criteria on ClinicalTrials.gov

Sites (9)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Kinghorn Cancer Centre, St Vincent's Health Network
Coordinator of this site? Confirm its status
DarlinghurstAustraliaUnknown status
Australasian Leukaemia and Lymphoma Group
Coordinator of this site? Confirm its status
MelbourneAustraliaUnknown status
Royal North Shore Hospital
Coordinator of this site? Confirm its status
St LeonardsAustraliaUnknown status
Queen Elizabeth II, Health Sciences Centre
Coordinator of this site? Confirm its status
HalifaxCanadaUnknown status
Juravinski Hospital and Cancer Centre
Coordinator of this site? Confirm its status
HamiltonCanadaUnknown status
London Health Sciences Centre
Coordinator of this site? Confirm its status
LondonCanadaUnknown status
Hopital de L'enfant Jesus
Coordinator of this site? Confirm its status
QuébecCanadaUnknown status
Saskatchewan Cancer Agency
Coordinator of this site? Confirm its status
SaskatoonCanadaUnknown status
CancerCare Manitoba
Coordinator of this site? Confirm its status
WinnipegCanadaUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.