Back to resultsComparison of PT-Cy at a Dose of 25 mg/kg/Day and PT-Cy at a Dose of 50 mg/kg/Day in GVHD Prophylaxis (CY25)
Primary Purpose
Graft Versus Host Disease, Hematologic Malignancy, Cyclophosphamide Adverse Reaction
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Post-transplantation Cyclophosphamide at dose 25 mg/kg/day
Post-transplantation Cyclophosphamide at dose 50 mg/kg/day
Sponsored by
About this trial
This is an interventional prevention trial for Graft Versus Host Disease focused on measuring Allogeneic transplantation, Graft-versus-host-disease prophylaxis, Post-transplant cyclophosphamide
Eligibility Criteria
Inclusion Criteria:
- Patients who have an indication for allogeneic hematopoietic stem cell transplantation
Exclusion Criteria:
- Uncontrolled bacterial or fungal infection at the time of enrollment
- Requirement for vasopressor support at the time of enrollment
- Karnofsky index <30%
- Pregnancy
- Somatic or psychiatric disorder making the patient unable to sign informed consent
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Cyclophosphamide on day +3,+4 at dose 50 mg/kg/day
Cyclophosphamide on day +3,+4 at dose 25 mg/kg/day
Arm Description
Post-transplantation Cyclophosphamide will be apply for GVHD prophylaxis on day +3,+4 at dose 50 mg/kg/day in combination with cyclosporine A at 3 mg/kg/day from day +5 and mycophenolate mofetil at dose 30-45mg/kg/day from day +5.
Post-transplantation Cyclophosphamide will be apply for GVHD prophylaxis on day +3,+4 at dose 25 mg/kg/day in combination with cyclosporine A at 3 mg/kg/day from day +5 and mycophenolate mofetil at dose 30-45mg/kg/day from day +5.
Outcomes
Primary Outcome Measures
Incidence of acute graft-versus-host disease, grades II-IV
MAGIC criteria
Incidence of chronic GVHD, moderate and severe (NIH criteria)
NIH criteria
Secondary Outcome Measures
Overall survival analysis
Kaplan-Meier survival analysis
Event-free survival analysis
Kaplan-Meier survival analysis
Non-relapse mortality analysis
Kaplan-Meier survival analysis, competing risk analysis
Incidence of graft failure and poor graft function
Kaplan-Meier survival analysis, competing risk analysis
Incidence of 30-Day Readmission
Kaplan-Meier survival analysis, competing risk analysis
Full Information
NCT ID
NCT05158608
First Posted
December 12, 2021
Last Updated
December 17, 2021
Sponsor
National Research Center for Hematology, Russia
1. Study Identification
Unique Protocol Identification Number
NCT05158608
Brief Title
Comparison of PT-Cy at a Dose of 25 mg/kg/Day and PT-Cy at a Dose of 50 mg/kg/Day in GVHD Prophylaxis
Acronym
CY25
Official Title
A Randomized, Open-label, Single-center Study Comparing Cyclophosphamide at a Dose of 25 mg/kg/Day and Cyclophosphamide at a Dose of 50 mg/kg/Day in Graft Versus Host Disease Prophylaxis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2022 (Anticipated)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Research Center for Hematology, Russia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a two arm open label phase III clinical trial. Adult patients with hematological malignancies undergoing allogeneic HSCT from any donor are eligible for the study if they meet the standard criteria defined in the investigator's institutional standard operation procedures (SOPs), meet all inclusion criteria, and do not satisfy any exclusion criteria. Patients will receive reduced-intensity conditioning regimen of fludarabine, busulfan (treosulfan). Patients will receive PTCy at different dose (25 mg/kg/day vs 50 mg/kg/day on day +3,+4 in combination with calcineurin inhibitors and mofetil mycophenolate) as GvHD prophylaxis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft Versus Host Disease, Hematologic Malignancy, Cyclophosphamide Adverse Reaction
Keywords
Allogeneic transplantation, Graft-versus-host-disease prophylaxis, Post-transplant cyclophosphamide
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cyclophosphamide on day +3,+4 at dose 50 mg/kg/day
Arm Type
Active Comparator
Arm Description
Post-transplantation Cyclophosphamide will be apply for GVHD prophylaxis on day +3,+4 at dose 50 mg/kg/day in combination with cyclosporine A at 3 mg/kg/day from day +5 and mycophenolate mofetil at dose 30-45mg/kg/day from day +5.
Arm Title
Cyclophosphamide on day +3,+4 at dose 25 mg/kg/day
Arm Type
Experimental
Arm Description
Post-transplantation Cyclophosphamide will be apply for GVHD prophylaxis on day +3,+4 at dose 25 mg/kg/day in combination with cyclosporine A at 3 mg/kg/day from day +5 and mycophenolate mofetil at dose 30-45mg/kg/day from day +5.
Intervention Type
Drug
Intervention Name(s)
Post-transplantation Cyclophosphamide at dose 25 mg/kg/day
Other Intervention Name(s)
Endoxan, Cyphos
Intervention Description
Post-transplantation Cyclophosphamide will be apply for GVHD prophylaxis on day +3,+4 at dose 25 mg/kg/day in combination with cyclosporine A at 3 mg/kg/day from day +5 and mycophenolate mofetil at dose 30-45mg/kg/day from day +5.
Intervention Type
Drug
Intervention Name(s)
Post-transplantation Cyclophosphamide at dose 50 mg/kg/day
Other Intervention Name(s)
Endoxan, Cyphos
Intervention Description
Post-transplantation Cyclophosphamide will be apply for GVHD prophylaxis on day +3,+4 at dose 50 mg/kg/day in combination with cyclosporine A at 3 mg/kg/day from day +5 and mycophenolate mofetil at dose 30-45mg/kg/day from day +5.
Primary Outcome Measure Information:
Title
Incidence of acute graft-versus-host disease, grades II-IV
Description
MAGIC criteria
Time Frame
180 days
Title
Incidence of chronic GVHD, moderate and severe (NIH criteria)
Description
NIH criteria
Time Frame
365 days
Secondary Outcome Measure Information:
Title
Overall survival analysis
Description
Kaplan-Meier survival analysis
Time Frame
365 days
Title
Event-free survival analysis
Description
Kaplan-Meier survival analysis
Time Frame
365 days
Title
Non-relapse mortality analysis
Description
Kaplan-Meier survival analysis, competing risk analysis
Time Frame
365 days
Title
Incidence of graft failure and poor graft function
Description
Kaplan-Meier survival analysis, competing risk analysis
Time Frame
365 days
Title
Incidence of 30-Day Readmission
Description
Kaplan-Meier survival analysis, competing risk analysis
Time Frame
365 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who have an indication for allogeneic hematopoietic stem cell transplantation
Exclusion Criteria:
Uncontrolled bacterial or fungal infection at the time of enrollment
Requirement for vasopressor support at the time of enrollment
Karnofsky index <30%
Pregnancy
Somatic or psychiatric disorder making the patient unable to sign informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mikhail Drokov, MD, Ph.D
Phone
+74956149042
Email
mdrokov@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena Parovichnikova, MD, D.Sc
Organizational Affiliation
National Research Center for Hematology
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Comparison of PT-Cy at a Dose of 25 mg/kg/Day and PT-Cy at a Dose of 50 mg/kg/Day in GVHD Prophylaxis
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