Graft vs Host Disease Prophylaxis in unrelated donor transplantation: a randomized clinical trial comparing PTCY vs ATG

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-510441-24-00

Acronym

DKMS-21-01

Enrollment

640

Registered

2024-09-20

Start date

2022-01-28

Completion date

Unknown

Last updated

2024-09-20

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

Conditions

Graft Vs Host Disease Peripheral Blood Stem Cell Transplantation AML MDS MDS/MPN CMML

Brief summary

(1) overall survival (OS) from randomization, and (2) graft-versus-host disease-free and relapse-free survival (GRFS) from time of transplantation.

Detailed description

− Overall survival from HCT. − Relapse- and immunosuppression-free survival (RIFS) from HCT. − Event-free survival (EFS) from HCT. − Cumulative incidences of relapse from HCT. − Cumulative incidences of non-relapse mortality (NRM) from HCT, etc. (s.protocol section 10.2).

Interventions

DRUGMYCOPHENOLIC ACID

DRUGCYCLOPHOSPHAMIDE

DRUGTACROLIMUS

DRUGGrafalon 20 mg/ml Konzentrat zur Herstellung einer Infusionslösung

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
(1) overall survival (OS) from randomization, and (2) graft-versus-host disease-free and relapse-free survival (GRFS) from time of transplantation.	—

Secondary

Measure	Time frame
− Overall survival from HCT. − Relapse- and immunosuppression-free survival (RIFS) from HCT. − Event-free survival (EFS) from HCT. − Cumulative incidences of relapse from HCT. − Cumulative incidences of non-relapse mortality (NRM) from HCT, etc. (s.protocol section 10.2).	—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026