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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05158608

Acronym

CY25

Enrollment

100

Registered

2021-12-15

Start date

2022-01-01

Completion date

2025-01-01

Last updated

2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cyclophosphamide Adverse Reaction, Graft Versus Host Disease, Hematologic Malignancy

Keywords

Allogeneic transplantation, Graft-versus-host-disease prophylaxis, Post-transplant cyclophosphamide

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.

Interventions

DRUGPost-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.

DRUGPost-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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Contacts

Primary ContactMikhail Drokov, MD, Ph.D

mdrokov@gmail.com+74956149042

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026