ATG + PTCy for Graft-versus-Host Disease Prophylaxis

Recruiting at 8 trial locations

Overseen By Sarah Garisto, BSc

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: McMaster University

Must not be taking: T-cell antibody

Disqualifiers: HIV, Pregnancy, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 5 days

80 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Irwin R Walker, MBBS

Principal Investigator

McMaster University

Kristjan Paulson, MD

Principal Investigator

CancerCare Manitoba

Eligibility Criteria

This trial is for individuals aged ≥16 with acute myeloid leukemia in remission or myelodysplastic syndrome, planning their first stem cell transplant from a fully matched donor. They must be medically fit, have good performance status, and agree to use contraception post-transplant. Exclusions include pregnancy, breastfeeding, HIV positivity, certain prior cancers or treatments.

Inclusion Criteria

I meet the criteria for a bone marrow transplant at my treatment center.

This is my first time receiving a transplant.

Ability and willingness to comply with study procedures and schedule, in the Investigator's opinion

Exclusion Criteria

I have difficulty urinating due to a blockage.

I am preparing for my second transplant.

I am not pregnant or breastfeeding.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive Anti-Thymocyte Globulin (ATG) with or without Post Transplant Cyclophosphamide (PTCy) for prophylaxis against GVHD

5 days

In-patient treatment on days -2, -1, +1, +3, and +4

Follow-up

Participants are monitored for safety and effectiveness after treatment

27 months

Treatment Details

Interventions

• Anti-Thymocyte globulin (rabbit)
• Cyclophosphamide

Trial Overview The study aims to compare the effectiveness of anti-thymocyte globulin (ATG) combined with cyclophosphamide versus ATG alone in preventing chronic graft-versus-host disease after stem cell transplantation in patients with specific blood disorders.

Participant Groups

Group I: ATG/PTCy Experimental Treatment 2 Interventions

Anti-Thymocyte Globulin (ATG, Thymoglobulin) 4.5 mg/kg IV (divided 0.5, 2.0, 2.0 mg/kg on days -2, -1 and +1); cyclophosphamide (Post Transplant Cyclophosphamide, PTCy) 50 mg/kg IV daily on days +3 and +4.

Group II: ATG Active Control 1 Intervention

Anti-Thymocyte Globulin (ATG, Thymoglobulin) 4.5 mg/kg IV (divided 0.5, 2.0, 2.0 mg/kg on days -2, -1 and +1).

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Cell Therapy Transplant Canada

Collaborator

Trials

1

Recruited

80+

Sanofi

Industry Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Ozmosis Research Inc.

Industry Sponsor

Trials

25

Recruited

5,200+