IDH2-Post-Allo-Trial for Patients with IDH2-mut Myeloid Neoplasms After Allo-SCT

NCT04522895 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-09-19

No results posted yet for this study

Summary

This is a prospective, open label, single arm, multi-centre phase II trial aiming to evaluate the safety and efficacy of Enasidenib (investigational product) as prophylactic consolidation in patients with IDH2-mutated MDS, CMML and AML in remission after allo-SCT.

Conditions

Interventions

DRUG

Enasidenib

Participants receive up to 12 cycles of Enasidenib.

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY
  • Koordinierungszentrum für Klinische Studien Düsseldorf

    collaborator UNKNOWN
  • Heinrich-Heine University, Duesseldorf

    lead OTHER

Principal Investigators

  • Thomas Schroeder, PD Dr. · University Hospital Duesseldorf Dept. of Hematology, Oncology and Clinical Immunology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-27
Primary Completion
2024-07-24
Completion
2024-07-24

Countries

  • Germany

Study Locations

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Entities

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 NCT04522895 on ClinicalTrials.gov