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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04202835


Additional trial details provided through ANZCTR are available at the end of this record.


Registration number
NCT04202835
Ethics application status
Date submitted
29/11/2019
Date registered
18/12/2019
Date last updated
15/03/2023

Titles & IDs
Public title
ATG Plus PTCy vs ATG for CGVHD Prophylaxis
Scientific 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)
Secondary ID [1] 0 0
OZM-099
Secondary ID [2] 0 0
CTTC1901
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Leukemia 0 0
Myelodysplasia 0 0
Chronic Graft-versus-host-disease 0 0
Condition category
Condition code
Blood 0 0 0 0
Haematological diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Anti-Thymocyte globulin (rabbit)

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.

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).


Treatment: Drugs: Cyclophosphamide
Post Transplant Cyclophosphamide

Treatment: Drugs: Anti-Thymocyte globulin (rabbit)
Anti-Thymocyte Globulin (rabbit, Thymoglobulin)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Registration of 80 patients within twenty four months
Timepoint [1] 0 0
24 months
Secondary outcome [1] 0 0
CRFS
Timepoint [1] 0 0
27 months
Secondary outcome [2] 0 0
GRFS
Timepoint [2] 0 0
27 months
Secondary outcome [3] 0 0
Survival
Timepoint [3] 0 0
27 months
Secondary outcome [4] 0 0
Complete data collection
Timepoint [4] 0 0
27 months
Secondary outcome [5] 0 0
Cost of study
Timepoint [5] 0 0
27 months

Eligibility
Key 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
Minimum age
16 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Kinghorn Cancer Centre, St Vincent's Health Network - Darlinghurst
Recruitment hospital [2] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment hospital [3] 0 0
Australasian Leukaemia and Lymphoma Group - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2065 - St. Leonards
Recruitment postcode(s) [3] 0 0
3121 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Manitoba
Country [2] 0 0
Canada
State/province [2] 0 0
Nova Scotia
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
Canada
State/province [4] 0 0
Quebec
Country [5] 0 0
Canada
State/province [5] 0 0
Saskatchewan

Funding & Sponsors
Primary sponsor type
Other
Name
McMaster University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Cell Therapy Transplant Canada
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Sanofi
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/Industry
Name [3] 0 0
Ozmosis Research Inc.
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04202835
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Irwin R Walker, MBBS
Address 0 0
McMaster University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sarah Garisto, BSc
Address 0 0
Country 0 0
Phone 0 0
1 416 634 8300
Fax 0 0
Email 0 0
sarah.garisto@ozmosisresearch.ca
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04202835

Additional trial details provided through ANZCTR
Accrual to date
Recruiting in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 43
St Vincent's Hospital (Darlinghurst)
Recruitment hospital [2] 44
Royal North Shore Hospital
Recruitment postcode(s) [1] 45
2065
Recruitment postcode(s) [2] 47
2010
Funding & Sponsors
Funding source category [1] 55
Other Collaborative groups
Name [1] 55
Ozmosis
Address [1] 55
Ozmosis Research 700 University Avenue, Suite 2017-2N Toronto, Ontario Canada, M5G 1Z5
Country [1] 55
Canada
Funding source category [2] 56
University
Name [2] 56
McMaster University
Address [2] 56
1280 Main St W Hamilton ON L8S 4L8 Canada
Country [2] 56
Canada
Primary sponsor
Other Collaborative groups
Primary sponsor name
Ozmosis Research
Primary sponsor address
Ozmosis Research
700 University Avenue,
Suite 2017-2N
Toronto, Ontario
Canada, M5G 1Z5
Primary sponsor country
Canada
Ethics approval
Ethics application status
Approved
Ethics committee name [1] 39
St Vincent's Hospital Melbourne
Address [1] 39
Research Governance Unit St Vincent's Hospital Melbourne 41 Victoria Parade Fitzroy, VIC 3065
Country [1] 39
Australia
Date submitted for ethics approval [1] 39
30/11/2020
Approval date [1] 39
18/03/2021
Ethics approval number [1] 39
St Vincent's HREC Ref Number 005/21
 
Public notes

Contacts
Principal investigator
Title 285 0
A/Prof
Name 285 0
Nada Hamad
Address 285 0
St Vincent's Hospital Sydney 390 Victoria St Darlinghurst, NSW, 2010
Country 285 0
Australia
Phone 285 0
+61293555656
Fax 285 0
Email 285 0
nada.hamad@svha.org.au
Contact person for public queries
Title 286 0
Ms
Name 286 0
Delaine Smith
Address 286 0
Australasian Leukaemia & Lymphoma Group Ground Floor 35 Elizabeth St Richmond Vic 312
Country 286 0
Australia
Phone 286 0
+61 3 8373 9701
Fax 286 0
Email 286 0
delaine.smith@allg.org.au
Contact person for scientific queries
Title 287 0
Ms
Name 287 0
Delaine Smith
Address 287 0
Australasian Leukaemia & Lymphoma Group Ground Floor 35 Elizabeth St Richmond Vic 312
Country 287 0
Australia
Phone 287 0
+61 3 8373 9701
Fax 287 0
Email 287 0
delaine.smith@allg.org.au