ATG Plus PTCy vs ATG for CGVHD Prophylaxis

NCT04202835 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: CTTC1901OZM-099
• Study Type: interventional
• Target: 80
• Locations: 2 countries
• Sites: 9

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.

Conditions

Acute Leukemia; Myelodysplasia; Chronic Graft-versus-host-disease

Keywords

post transplant cyclophosphamide; anti-thymocyte globulin

Outcome Measures

Primary Outcomes (1)

• Registration of 80 patients within twenty four months

  Registration will be documented by the Clinical Research Organization (Ozmosis Research Inc.)

  24 months

Secondary Outcomes (5)

• CRFS

  27 months

• GRFS

  27 months

• Survival

  27 months

• Complete data collection

  27 months

• Cost of study

  27 months

Study Arms (2)

ATG/PTCy

EXPERIMENTAL

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.

Drug: Cyclophosphamide; Drug: Anti-Thymocyte globulin (rabbit)

ATG

ACTIVE COMPARATOR

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).

Drug: Anti-Thymocyte globulin (rabbit)

Interventions

Cyclophosphamide DRUG

Post Transplant Cyclophosphamide

ATG/PTCy

Anti-Thymocyte globulin (rabbit) DRUG

Anti-Thymocyte Globulin (rabbit, Thymoglobulin)

Also known as: Thymoglobulin

ATG; ATG/PTCy

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• McMaster University: lead
• Cell Therapy Transplant Canada: collaborator
• Sanofi: collaborator
• Ozmosis Research Inc.: collaborator

Study Sites (9)

Kinghorn Cancer Centre, St Vincent's Health Network

Darlinghurst, New South Wales, 2010, Australia

Location

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

Australasian Leukaemia and Lymphoma Group

Melbourne, Victoria, 3121, Australia

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Juravinski Hospital and Cancer Centre

Hamilton, Ontario, L8V 1C3, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Hôpital de l'Enfant-Jésus

Québec, Quebec, G1R 2J6, Canada

Location

Saskatchewan Cancer Agency

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

MeSH Terms

Conditions

Anemia, Refractory, with Excess of Blasts; Bronchiolitis Obliterans Syndrome

Interventions

Cyclophosphamide; Antilymphocyte Serum; thymoglobulin

Condition Hierarchy (Ancestors)

Anemia, Refractory; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Myelodysplastic Syndromes; Bone Marrow Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Immune Sera; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Biological Products; Complex Mixtures

Study Officials

• Irwin R Walker, MBBS

  McMaster University

  PRINCIPAL INVESTIGATOR

• Kristjan Paulson, MD

  CancerCare Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized pilot trial

Study Record Dates

• First Submitted: November 29, 2019
• First Posted: December 18, 2019
• Study Start: October 14, 2020
• Primary Completion: May 18, 2024
• Study Completion: February 7, 2026
• Last Updated: May 11, 2025

Record last verified: 2025-05

Locations

AU (3); CA (6)