ATG Plus PTCy vs ATG for CGVHD Prophylaxis

Acute Leukemia Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04202835
• Other study ID #: CTTC1901
• Secondary ID: OZM-099
• Status: Recruiting
• Phase: Phase 2
• 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
• 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)

Related Conditions & MeSH terms

• Acute Leukemia
• Chronic Graft-versus-host-disease
• Graft vs Host Disease
• Myelodysplasia
• Myelodysplastic Syndromes
• Preleukemia

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