Clinical trial NCT04202835: ATG Plus PTCy vs ATG for CGVHD Prophylaxis
Official title: 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Acute Leukemia
Myelodysplasia
Chronic Graft-versus-host-disease
Keywords: post transplant cyclophosphamide
anti-thymocyte globulin
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Cell Therapy Transplant Canada
name: Sanofi
name: Ozmosis Research Inc.
First posted: 2019-12-18
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized pilot trial
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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: Inclusion Criteria:

1. The participant is aged ≥ 16 and deemed medically fit per investigator for protocol
2. The participant has either acute myeloid leukemia in 1st or 2nd complete remission (CR), or has myelodysplastic syndrome
3. The participant will receive a blood progenitor cell graft ("HPC, Apheresis")
4. The participant has a related or unrelated donor, who is fully MHC matched with the recipient at HLA-A, B, C and DRB1.
5. The participant meets the transplant centre's criteria for transplantation, using either myeloablative or reduced intensity conditioning.
6. The participant has good performance status (Karnofsky ≥60%)
7. The participant is able to understand and sign the informed consent form
8. Ability and willingness to comply with study procedures and schedule, in the Investigator's opinion.
9. The participant is receiving their first transplant

Exclusion Criteria:

1. The participant is HIV antibody positive
2. The participant has a hypersensitivity to rabbit proteins or Thymoglobulin® pharmaceutical excipients, glycine or mannitol.
3. The participant has active or chronic infection (i.e. infection requiring oral or IV therapy)
4. The participant (if female and of childbearing potential) is pregnant or breast-feeding at the time of enrollment
5. 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
6. 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
7. The participant has urinary outflow obstruction
8. The participant is in poor condition (determined per institutional guidelines)
9. The participant has acute leukemia in relapse
10. The participant has myelodysplastic syndrome with \> 10% marrow blasts
11. The participant is having their second transplant
12. The participant is taking T-cell antibody prophylaxis (anti-CD52)
13. The participant is receiving a cord blood graft or T-cell depleted grafts
14. The participant has mixed phenotype acute leukemia
15. 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.
16. The participant is in complete remission with incomplete recovery (CRi)

Primary outcomes:
measure: Registration of 80 patients within twenty four months
timeFrame: 24 months
Secondary outcomes:
measure: CRFS
timeFrame: 27 months
measure: GRFS
timeFrame: 27 months
measure: Survival
timeFrame: 27 months
measure: Complete data collection
timeFrame: 27 months
measure: Cost of study
timeFrame: 27 months
Other outcomes:
Locations:
city: Darlinghurst
country: Australia
facility: Kinghorn Cancer Centre, St Vincent's Health Network
state: New South Wales
city: St. Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Melbourne
country: Australia
facility: Australasian Leukaemia and Lymphoma Group
state: Victoria
city: Winnipeg
country: Canada
facility: CancerCare Manitoba
state: Manitoba
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: Juravinski Hospital and Cancer Centre
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Québec City
country: Canada
facility: Hôpital de l'Enfant-Jésus
state: Quebec
city: Saskatoon
country: Canada
facility: Saskatchewan Cancer Agency
state: Saskatchewan
Study officials:
affiliation: McMaster University
name: Irwin R Walker, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: CancerCare Manitoba
name: Kristjan Paulson, MD
role: PRINCIPAL_INVESTIGATOR
References: