Who is sponsoring NCT05158608?

NCT05158608 is sponsored by National Research Center for Hematology, Russia.

What drugs are being tested in NCT05158608?

Interventions in NCT05158608: Post-transplantation Cyclophosphamide at dose 25 mg/kg/day, Post-transplantation Cyclophosphamide at dose 50 mg/kg/day.

What condition does NCT05158608 study?

NCT05158608 studies Graft Versus Host Disease, Hematologic Malignancy, Cyclophosphamide Adverse Reaction.

Is NCT05158608 still recruiting?

NCT05158608 is currently status unknown. Last updated 11 January 2022.

Last reviewed 2022-01-11 · How we verify

NCT05158608: CY25

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Status unknown Phase 3 Last updated 11 January 2022

What this trial tests

Phase 3 trial testing Post-transplantation Cyclophosphamide at dose 25 mg/kg/day in Graft Versus Host Disease in 100 participants. Status unknown.

Timeline

1 January 2022

Primary endpoint
1 January 2024

1 January 2025

Quick facts

Lead sponsor	National Research Center for Hematology, Russia
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	100
Start date	1 January 2022
Primary completion	1 January 2024
Estimated completion	1 January 2025

Drugs / interventions tested

Post-transplantation Cyclophosphamide at dose 25 mg/kg/day — full drug profile →
Post-transplantation Cyclophosphamide at dose 50 mg/kg/day

Conditions studied

Graft Versus Host Disease — all drugs for Graft Versus Host Disease →
Hematologic Malignancy — all drugs for Hematologic Malignancy →
Cyclophosphamide Adverse Reaction — all drugs for Cyclophosphamide Adverse Reaction →

Sponsor

National Research Center for Hematology, Russia — full company profile →

Who can join

18 and older, any sex, with Graft Versus Host Disease or Hematologic Malignancy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Graft-versus-tumor effect of post-transplant cyclophosphamide-based allogeneic hematopoietic cell transplantation.
Nakamae H. · · 2024 · cited 5× · PMID 38903503 · DOI 10.3389/fimmu.2024.1403936
Immunopathogenic mechanisms and modulatory approaches to graft-versus-host disease prevention in acute myeloid leukaemia.
Pang Y, Holtzman NG. · · 2023 · cited 3× · PMID 37353287 · DOI 10.1016/j.beha.2023.101475

Verify or expand the search:

Other recruiting trials for Graft Versus Host Disease

Currently open trials in the same condition.

NCT07356245 — Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant T-Cell Lymphoma · Phase 2 · recruiting
NCT07006506 — A Study of Belumosudil in People at Risk of Developing Graft-Versus-Host Disease After a Stem Cell Transplant · Phase 2 · recruiting
NCT06815003 — Vedolizumab Plus Post-transplant Cyclophosphamide and Short Course Tacrolimus for the Prevention of Graft Versus Host Di · Phase 2 · recruiting
NCT06705062 — Study Comparing Reduced Versus Standard Dose Post-transplantation Cyclophosphamide in Combination With Post-engraftment · Phase 3 · recruiting
NCT06252870 — Study Testing Two Conditioning Regimen With a Single Prophylaxis of GVHD by Cyclophosphamide and Methotrexate Post-trans · Phase 2 · recruiting

Other National Research Center for Hematology, Russia trials

Trials by the same sponsor.

NCT06721598 — An Extension Study to Evaluate the Safety and Efficacy of an Anti-CD19 CAR-T Product in Patients with B-cell Lymphoproli · not yet recruiting
NCT06705530 — A Study to Evaluate the Tolerability, Safety, and Efficacy of an Anti-CD19 CAR-T Product in Patients With B-cell Lymphop · Phase 1, PHASE2 · completed
NCT06237192 — MRD-associated Non-intensive But Non-interruptive Treatment of Ph-negative Acute Lymphoblastic Leukemia Adult Patients · NA · recruiting
NCT06188676 — Multicenter Study of Safety and Efficacy Nivolumab at the Fixed Dose 40 mg (Nivo40) in Combination With Chemo-Immunother · Phase 3 · recruiting
NCT05165719 — Validation of 'Corona-T-test' for Assessment of SARS-COV-2-specific T-cell Response After COVID-19 or Vaccination · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05158608 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Research Center for Hematology, Russia
Last refreshed: 11 January 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05158608.

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