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ATG Plus PTCy vs ATG for CGVHD Prophylaxis

PHASE2RECRUITING

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.

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Study details:

Patients with acute leukemia or myelodysplastic syndrome will be randomized to receive, or not receive, post transplant cyclophosphamide in addition to anti-thymocyte globulin.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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

Exclusion criteria

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.

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

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Eligibility

Age eligible for study : 16 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2020-10-13

Primary completion: 2024-10-13

Study completion finish: 2024-12-31

Study type

PREVENTION

Phase

PHASE2

Trial ID

NCT04202835

Intervention or treatment

DRUG: Cyclophosphamide

DRUG: Anti-Thymocyte globulin (rabbit)

Conditions

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

Condition: Acute Leukemia, Myelodysplasia and more
DRUG: Cyclophosphamide and other drugs
Darlinghurst, New South Wales, Australia and more
Sponsor: McMaster University

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Kinghorn Cancer Centre, St Vincent's Health Network

Research sites nearby

Select from list below to view details:

Kinghorn Cancer Centre, St Vincent's Health Network
Darlinghurst, New South Wales, Australia
Royal North Shore Hospital
St. Leonards, New South Wales, Australia
Australasian Leukaemia and Lymphoma Group
Melbourne, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: ATG/PTCy 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 Post Transplant Cyclophosphamide
ACTIVE_COMPARATOR: ATG 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) Anti-Thymocyte Globulin (rabbit, Thymoglobulin)

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Registration of 80 patients within twenty four months	Registration will be documented by the Clinical Research Organization (Ozmosis Research Inc.)	24 months

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
CRFS	Chronic graft versus host disease free- and relapse-free survival (CRFS)	27 months
GRFS	Graft versus host disease-, and relapse-, free survival (GRFS)	27 months
Survival	Survival (dead/alive) at 100 days for each patient	27 months
Complete data collection	The Clinical Research Organization (Ozmosis Research Inc.) will document completeness of data collection	27 months
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

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: ATG Plus PTCy vs ATG for CGVHD Prophylaxis