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

Graft Versus Host Disease Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05158608
• Other study ID #: CY25
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: January 1, 2022
• Est. completion date: January 1, 2025

Study information

• Verified date: December 2021
• Source: National Research Center for Hematology, Russia
• Contact: Mikhail Drokov, MD, Ph.D
• Phone: +74956149042
• Email: mdrokov[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Graft Versus Host Disease
• Graft vs Host Disease
• Hematologic Malignancy
• Hematologic Neoplasms

Intervention

Drug:
• Post-transplantation Cyclophosphamide at dose 25 mg/kg/day
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.
• Post-transplantation Cyclophosphamide at dose 50 mg/kg/day
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Research Center for Hematology, Russia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of acute graft-versus-host disease, grades II-IV	MAGIC criteria	180 days
Primary	Incidence of chronic GVHD, moderate and severe (NIH criteria)	NIH criteria	365 days
Secondary	Overall survival analysis	Kaplan-Meier survival analysis	365 days
Secondary	Event-free survival analysis	Kaplan-Meier survival analysis	365 days
Secondary	Non-relapse mortality analysis	Kaplan-Meier survival analysis, competing risk analysis	365 days
Secondary	Incidence of graft failure and poor graft function	Kaplan-Meier survival analysis, competing risk analysis	365 days
Secondary	Incidence of 30-Day Readmission	Kaplan-Meier survival analysis, competing risk analysis	365 days