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

Phase 3

Not yet recruiting

• Conditions: Cyclophosphamide Adverse Reaction; Graft Versus Host Disease; Hematologic Malignancy
• Interventions: Drug: Post-transplantation Cyclophosphamide at dose 50 mg/kg/day; Drug: Post-transplantation Cyclophosphamide at dose 25 mg/kg/day

• Registration Number: NCT05158608
• Lead Sponsor: National Research Center for Hematology, Russia

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-12
• Study First Submitted: 2021-12-12
• Study First Submitted QC: 2021-12-12
• Study First Posted: 2021-12-15
• Last Update Submitted: 2021-12-17
• Study Start: 2022-01-01
• Last Update Posted: 2022-01-11
• Primary Completion: 2024-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cyclophosphamide on day +3,+4 at dose 50 mg/kg/day	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.
Cyclophosphamide on day +3,+4 at dose 25 mg/kg/day	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.

Primary Outcome Measures

Name	Time	Method
Incidence of acute graft-versus-host disease, grades II-IV	180 days	MAGIC criteria
Incidence of chronic GVHD, moderate and severe (NIH criteria)	365 days	NIH criteria

Secondary Outcome Measures

Name	Time	Method
Non-relapse mortality analysis	365 days	Kaplan-Meier survival analysis, competing risk analysis
Event-free survival analysis	365 days	Kaplan-Meier survival analysis
Incidence of graft failure and poor graft function	365 days	Kaplan-Meier survival analysis, competing risk analysis
Overall survival analysis	365 days	Kaplan-Meier survival analysis
Incidence of 30-Day Readmission	365 days	Kaplan-Meier survival analysis, competing risk analysis