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ATG Plus PTCy vs ATG for CGVHD Prophylaxis

Primary Purpose

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

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Cyclophosphamide
Anti-Thymocyte globulin (rabbit)
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Leukemia focused on measuring post transplant cyclophosphamide, anti-thymocyte globulin

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Kinghorn Cancer Centre, St Vincent's Health NetworkRecruiting
  • Royal North Shore HospitalRecruiting
  • Australasian Leukaemia and Lymphoma GroupRecruiting
  • CancerCare ManitobaRecruiting
  • Queen Elizabeth II Health Sciences CentreRecruiting
  • Juravinski Hospital and Cancer CentreRecruiting
  • London Health Sciences CentreRecruiting
  • Hôpital de l'Enfant-JésusRecruiting
  • Saskatchewan Cancer AgencyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ATG/PTCy

ATG

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Registration of 80 patients within twenty four months
Registration will be documented by the Clinical Research Organization (Ozmosis Research Inc.)

Secondary Outcome Measures

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

Full Information

First Posted
November 29, 2019
Last Updated
March 14, 2023
Sponsor
McMaster University
Collaborators
Cell Therapy Transplant Canada, Sanofi, Ozmosis Research Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04202835
Brief Title
ATG Plus PTCy vs ATG for CGVHD Prophylaxis
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 13, 2020 (Actual)
Primary Completion Date
October 13, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
Cell Therapy Transplant Canada, Sanofi, Ozmosis Research Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Leukemia, Myelodysplasia, Chronic Graft-versus-host-disease
Keywords
post transplant cyclophosphamide, anti-thymocyte globulin

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized pilot trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ATG/PTCy
Arm Type
Experimental
Arm Description
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.
Arm Title
ATG
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Post Transplant Cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
Anti-Thymocyte globulin (rabbit)
Other Intervention Name(s)
Thymoglobulin
Intervention Description
Anti-Thymocyte Globulin (rabbit, Thymoglobulin)
Primary Outcome Measure Information:
Title
Registration of 80 patients within twenty four months
Description
Registration will be documented by the Clinical Research Organization (Ozmosis Research Inc.)
Time Frame
24 months
Secondary Outcome Measure Information:
Title
CRFS
Description
Chronic graft versus host disease free- and relapse-free survival (CRFS)
Time Frame
27 months
Title
GRFS
Description
Graft versus host disease-, and relapse-, free survival (GRFS)
Time Frame
27 months
Title
Survival
Description
Survival (dead/alive) at 100 days for each patient
Time Frame
27 months
Title
Complete data collection
Description
The Clinical Research Organization (Ozmosis Research Inc.) will document completeness of data collection
Time Frame
27 months
Title
Cost of study
Description
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.
Time Frame
27 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Garisto, BSc
Phone
1 416 634 8300
Email
sarah.garisto@ozmosisresearch.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irwin R Walker, MBBS
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kristjan Paulson, MD
Organizational Affiliation
CancerCare Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kinghorn Cancer Centre, St Vincent's Health Network
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louise Christophersen
Facility Name
Royal North Shore Hospital
City
St. Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Molly Forbes
Facility Name
Australasian Leukaemia and Lymphoma Group
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3121
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nada Hamad, MBBS MSc
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristjan Paulson, MD
Facility Name
Queen Elizabeth II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahmoud Elsawy, MD
Facility Name
Juravinski Hospital and Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irwin Walker, MBBS
Phone
905 521 2100
Ext
76384
Email
walkeri@mcmaster.ca
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Uday Deotare, MD
Facility Name
Hôpital de l'Enfant-Jésus
City
Québec City
State/Province
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Genevieve Gallagher, MD
Facility Name
Saskatchewan Cancer Agency
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Elemary, MD

12. IPD Sharing Statement

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ATG Plus PTCy vs ATG for CGVHD Prophylaxis

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