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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04522895
Other study ID # AG-221CL-AML-PI13299
Secondary ID 2019-001416-30
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date August 27, 2020
Est. completion date August 30, 2024

Study information

Verified date December 2023
Source Heinrich-Heine University, Duesseldorf
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Enasidenib
Participants receive up to 12 cycles of Enasidenib.

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Sponsors (3)

Lead Sponsor Collaborator
Heinrich-Heine University, Duesseldorf Celgene Corporation, Koordinierungszentrum für Klinische Studien Düsseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Type, incidence and severity of adverse events specifying seriousness and expectedness (AE, SAE, SUSAR) Number of participants with Adverse Events as assessed by CTCAE v5.0 through study completion, an average of 2 years
Secondary Number of participants who maintain remission (molecular/hematological) after allo-SCT Number of participants who maintain Remission (molecular/hematological) as a measure of efficacy through study completion, an average of 2 years
Secondary Overall Survival Days from start of Treatment and from date of allo-SCT until death or last follow up as a measure of efficacy through study completion, an average of 2 years
Secondary Relapse-free Survival Days from evaluation of remission at screening and from date of allo-SCT until relapse, death, or last follow up as a measure of efficacy through study completion, an average of 2 years
Secondary Non-relapse mortality Days from evaluation of remission at screening and from date of allo-SCT until death without relapse or last follow up as a measure of efficacy through study completion, an average of 2 years
Secondary Relapse incidence number of participants that relapse during the study as a measure of efficacy through study completion, an average of 2 years
Secondary Numbers of Participants Meeting Criteria of Treatment Failure Number of participants who require any cellular or pharmacological intervention due to pending or frank relapse (defined as treatment-failure) as a measure of efficacy through study completion, an average of 2 years
Secondary Correlation of cytogenetics/molecular alterations and relapse-free survival Comparison of relapse-free survival between different cytogenetics/molecular subtypes as a measure of efficacy using time to event curves and log-rank test through study completion, an average of 2 years
Secondary Incidence, course and severity of aGvHD and cGvHD Incidence, course and severity of aGvHD and cGvHD as a measure of safety through study completion, an average of 2 years
Secondary Number of hospitalizations Number of hospitalizations per participant as a measure of safety through treatment completion, an average of 1 year
Secondary Number of participants who require dose reductions for toxicity reasons Number of participants who require dose reductions for toxicity reasons as a measure of safety through treatment completion, an average of 1 year
Secondary Number of participants who have to stop consolidation therapy due to toxicity (Consolidation Arm) Number of participants who have to stop consolidation therapy due to toxicity as a measure of safety (Consolidation Arm) through treatment completion, an average of 1 year
Secondary Number of participants who can receive all 12 cycles of consolidation therapy(Consolidation Arm) Number of participants who can receive all 12 cycles of consolidation therapy as a measure of Safety (Consolidation Arm) through treatment completion, an average of 1 year
Secondary Number of screened participants that can start consolidation therapy within the envisaged time frame (Consolidation Arm) Number of screened participants that can start consolidation therapy within the envisaged time Frame as a measure of safety (Consolidation Arm) up to 65 days
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