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ATG Plus PTCy vs ATG for CGVHD Prophylaxis
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.
Study details:
Patients with acute leukemia or myelodysplastic syndrome will be randomized to receive, or not receive, post transplant cyclophosphamide in addition to anti-thymocyte globulin.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 16 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2020-10-13
Primary completion: 2024-10-13
Study completion finish: 2024-12-31
Study type
PREVENTION
Phase
PHASE2
Trial ID
NCT04202835
Intervention or treatment
DRUG: Cyclophosphamide
DRUG: Anti-Thymocyte globulin (rabbit)
Conditions
- • Acute Leukemia
- • Myelodysplasia
- • Chronic Graft-versus-host-disease
Find a site
Closest Location:
Kinghorn Cancer Centre, St Vincent's Health Network
Research sites nearby
Select from list below to view details:
Kinghorn Cancer Centre, St Vincent's Health Network
Darlinghurst, New South Wales, Australia
Royal North Shore Hospital
St. Leonards, New South Wales, Australia
Australasian Leukaemia and Lymphoma Group
Melbourne, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: ATG/PTCy
| DRUG: Cyclophosphamide
|
ACTIVE_COMPARATOR: ATG
| DRUG: Anti-Thymocyte globulin (rabbit)
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Registration of 80 patients within twenty four months | Registration will be documented by the Clinical Research Organization (Ozmosis Research Inc.) | 24 months |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
CRFS | Chronic graft versus host disease free- and relapse-free survival (CRFS) | 27 months |
GRFS | Graft versus host disease-, and relapse-, free survival (GRFS) | 27 months |
Survival | Survival (dead/alive) at 100 days for each patient | 27 months |
Complete data collection | The Clinical Research Organization (Ozmosis Research Inc.) will document completeness of data collection | 27 months |
Cost of study | The sponsor (McMaster University) and the Clinical Research Organization (Ozmosis Research Inc.) will compare actual total trial costs in Canadian dollars at trial completion (at completion of outcomes analysis and report) with expected costs as determined for the trial budget. | 27 months |
Frequently Asked Questions
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