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Acute LeukemiaPhase 2NCT04202835

ATG Plus PTCy vs ATG for CGVHD Prophylaxis

A Phase 2 study testing Cyclophosphamide and Anti-Thymocyte globulin (rabbit) in people with Acute Leukemia and Myelodysplasia, run by McMaster University at 9 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 16 to 70 years
What is being tested?
Cyclophosphamide and Anti-Thymocyte globulin (rabbit)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
9 sitesin 2 countries
Study dates
14 Oct 2020to 7 Feb 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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%)
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  • 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

Who cannot join

  • 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
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  • 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.
  • The participant is in complete remission with incomplete recovery (CRi)

Trial locations and contacts

9 sites in 2 countries.

9 sites in 2 countries

Canada6 sites

  • Queen Elizabeth II Health Sciences Centre

    Halifax, Nova Scotia, B3H 2Y9

  • Juravinski Hospital and Cancer Centre

    Hamilton, Ontario, L8V 1C3

  • London Health Sciences Centre

    London, Ontario, N6A 5W9

  • Hôpital de l'Enfant-Jésus

    Québec, Quebec, G1R 2J6

  • Saskatchewan Cancer Agency

    Saskatoon, Saskatchewan, S7N 4H4

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Australia3 sites

  • Kinghorn Cancer Centre, St Vincent's Health Network

    Darlinghurst, New South Wales, 2010

  • Australasian Leukaemia and Lymphoma Group

    Melbourne, Victoria, 3121

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

Other trials in Australia

About this study

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)

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.

Read the 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.

Being tested
Cyclophosphamide, Anti-Thymocyte globulin (rabbit)
Keywords
post transplant cyclophosphamide, anti-thymocyte globulin
Medical subject headings
Anemia, Refractory, with Excess of Blasts, Bronchiolitis Obliterans Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CyclophosphamideDrug

    Post Transplant Cyclophosphamide

  • Anti-Thymocyte globulin (rabbit)Drug

    Also called Thymoglobulin

    Anti-Thymocyte Globulin (rabbit, Thymoglobulin)

Study groups in NCT04202835
Study groupRoleWhat they receive
ATG/PTCyExperimentalAnti-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.
Receives: Drug: Cyclophosphamide; Drug: Anti-Thymocyte globulin (rabbit)
ATGActive comparatorAnti-Thymocyte Globulin (ATG, Thymoglobulin) 4.5 mg/kg IV (divided 0.5, 2.0, 2.0 mg/kg on days -2, -1 and +1).
Receives: Drug: Anti-Thymocyte globulin (rabbit)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Registration of 80 patients within twenty four months

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

    Measured: 24 months

Secondary outcomes (5)

  1. CRFS

    Chronic graft versus host disease free- and relapse-free survival (CRFS)

    Measured: 27 months

  2. GRFS

    Graft versus host disease-, and relapse-, free survival (GRFS)

    Measured: 27 months

  3. Survival

    Survival (dead/alive) at 100 days for each patient

    Measured: 27 months

  4. Complete data collection

    The Clinical Research Organization (Ozmosis Research Inc.) will document completeness of data collection

    Measured: 27 months

  5. 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.

    Measured: 27 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2019
  2. Study start14 Oct 2020
  3. Primary completion18 May 2024
  4. Study completion7 Feb 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized pilot trial
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04202835
Sponsor's protocol ID
CTTC1901
Other IDs
OZM-099
Status last verified
May 2025
First submitted
29 Nov 2019
Last updated
11 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Walker I, Deotare U, Elemary M, Elsawy M, Gallagher G, Kliman D, Panzarella T, Hamad N, Schultz KR, Storek J, Paulson K. A randomized pilot trial comparing anti-thymocyte globulin with anti-thymocyte globulin plus post transplant cyclophosphamide for prophylaxis against acute and chronic graft versus host disease in matched donor hematopoietic cell transplants - a study from the Cell Therapy Transplant Canada/ Australasian Leukemia Lymphoma Group Consortium. Bone Marrow Transplant. 2026 Aug 21. doi: 10.1038/s41409-026-03024-7. Online ahead of print.

    PubMed 42629427

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cyclophosphamide and Anti-Thymocyte globulin (rabbit) in people with Acute Leukemia and Myelodysplasia, run by McMaster University at 9 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Canada, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Registration of 80 patients within twenty four months (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04202835, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025; AzTrials last refreshed its copy on 30 Oct 2026.

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