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Clinical Trial Summary

The main purpose of this study is to determine the safe and efficacy of APR-246 in combination with azacitidine as well as to see complete remission of this patients


Clinical Trial Description

Patients will be treated for a total of 6 cycles.For patients responding or who have stable disease following cycle 6, treatment may continue until one of the following criteria applies:

- Inter-current illness that prevent further administration of treatment

- Unacceptable adverse event(s)

- Participant decides to withdraw from the study,

- general or specific changes in the participant's condition render the participant unacceptable for further treatment in the judgment of the investigator.

- Evidence of disease progression by international working Group (IWG) 2006 criteria.

- participants who wish not to continue treatment at time of disease assessment at end of cycle 6 will complete their end of treatment visit upon completion of cycle 6 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03588078
Study type Interventional
Source Groupe Francophone des Myelodysplasies
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date September 15, 2018
Completion date May 15, 2021

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