GVHD Prophylaxis With Methotrexate in Haploidentical HCT Using Posttransplant Cyclophosphamide

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

47

Participants

Timeline

Start Date

October 7, 2020

Primary Completion Date

December 31, 2023

Study Completion Date

December 31, 2025

Conditions
Graft Vs Host DiseaseHematopoietic Neoplasm
Interventions
DRUG

Methotrexate Injectable Solution

"Phase 1:~* Level -1: Methotrexate 7.5 mg/m2 on D+6 and D+9\*. Level -1 will be explored only if the starting dose is too toxic (reduced dose).~* Level 0 \[Starting Dose\]: Methotrexate 10 mg/m2 on D+6 and 7.5 mg/m2 on D+9~* Level +1: Methotrexate 10 mg/m2 on D+6 and D+9~* Level +2: Methotrexate 15 mg/m2 on D+6 and 10 mg/m2 on D+9~Phase 2: dose determined in the phase 1 trial"

Trial Locations (4)

Unknown

RECRUITING

Instituto Nacional de Câncer José Alencar Gomes Da Silva - Inca, Rio de Janeiro

RECRUITING

Centro de Hematologia e Hemoterapia - HEMOCENTRO, Campinas

RECRUITING

Hospital Amaral Carvalho / Fundação Dr. Amaral Carvalho, Jaú

05403-000

RECRUITING

Hospital das Clinicas da Universidade de Sao Paulo, São Paulo

All Listed Sponsors
collaborator

Libbs Farmacêutica LTDA

INDUSTRY

lead

University of Sao Paulo General Hospital

OTHER