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
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
- Leukemia, Myeloid, Acute
- Myelodysplastic Syndromes
- Chronic Myelomonocytic Leukemia
- IDH2 Gene Mutation
- IDH2 R172
- IDH2 R140
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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