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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04202835
Other study ID # CTTC1901
Secondary ID OZM-099
Status Recruiting
Phase Phase 2
First received
Last updated
Start date October 13, 2020
Est. completion date December 31, 2024

Study information

Verified date March 2023
Source McMaster University
Contact Sarah Garisto, BSc
Phone 1 416 634 8300
Email sarah.garisto@ozmosisresearch.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 31, 2024
Est. primary completion date October 13, 2024
Accepts healthy volunteers No
Gender All
Age group 16 Years to 70 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Cyclophosphamide
Post Transplant Cyclophosphamide
Anti-Thymocyte globulin (rabbit)
Anti-Thymocyte Globulin (rabbit, Thymoglobulin)

Locations

Country Name City State
Australia Kinghorn Cancer Centre, St Vincent's Health Network Darlinghurst New South Wales
Australia Australasian Leukaemia and Lymphoma Group Melbourne Victoria
Australia Royal North Shore Hospital St. Leonards New South Wales
Canada Queen Elizabeth II Health Sciences Centre Halifax Nova Scotia
Canada Juravinski Hospital and Cancer Centre Hamilton Ontario
Canada London Health Sciences Centre London Ontario
Canada Hôpital de l'Enfant-Jésus Québec City Quebec
Canada Saskatchewan Cancer Agency Saskatoon Saskatchewan
Canada CancerCare Manitoba Winnipeg Manitoba

Sponsors (4)

Lead Sponsor Collaborator
McMaster University Cell Therapy Transplant Canada, Ozmosis Research Inc., Sanofi

Countries where clinical trial is conducted

Australia,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Registration of 80 patients within twenty four months Registration will be documented by the Clinical Research Organization (Ozmosis Research Inc.) 24 months
Secondary CRFS Chronic graft versus host disease free- and relapse-free survival (CRFS) 27 months
Secondary GRFS Graft versus host disease-, and relapse-, free survival (GRFS) 27 months
Secondary Survival Survival (dead/alive) at 100 days for each patient 27 months
Secondary Complete data collection The Clinical Research Organization (Ozmosis Research Inc.) will document completeness of data collection 27 months
Secondary 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
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