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Glasdegib in Refractory Patients With Sclerotic Chronic Graft-Versus-Host Disease

NCT03415867 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2022-03-17

No results posted yet for this study

Summary

This is a phase 1b/2a, open label, multi-centre, safety and efficacy study of glasdegib in patients with sclerotic cGVHD refractory to second-line treatment. The design for the current study is a standard 3+3 dose-finding scheme. A dose escalation/de-escalation design will be applied in successive patient cohorts until identification of MTD. Glasdegib will be self-administered orally once daily in the morning as monotherapy in continuous 28-day treatment cycles for a maximum of 24 cycles. Those patients enrolled in the trial that obtain objective clinical benefit under treatment with glasdegib (defined as the achievement of at least a partial response at one or more target organs), will be allowed to proceed to a slow dose withdrawal phase over a period of 6 months after the end of Cycle 24.

Conditions

  • Sclerodermoid Chronic Graft-Versus-Host Disease (Disorder)

Interventions

DRUG

Glasdegib

A dose escalation/de-escalation design will be applied in successive patient cohorts until identification of MTD (dose range: 25-200 mg OD).

Sponsors & Collaborators

  • Grupo Espanol de trasplantes hematopoyeticos y terapia celular

    lead OTHER

Principal Investigators

  • José Antonio Pérez-Simón, M.D. Ph.D. · Department of Hematology, Hospital Universitario Virgen del Rocío. Spain

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-09
Primary Completion
2022-01-09
Completion
2022-06-09

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03415867 on ClinicalTrials.gov