Spots Global Cancer Trial Database for Study of the Safety and Efficacy of APR-246 in Combination With Azacitidine

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Trial Identification

Brief Title: Study of the Safety and Efficacy of APR-246 in Combination With Azacitidine

Official Title: A Phase 1b/2 Study to Evaluate the Safety and Efficacy of APR-246 in Combination With Azacitidine for the Treatment of Mutation TP53 (TP53) Mutant Myeloid Neoplasms

Study ID: NCT03588078

Conditions

Myelodysplastic Syndrome With Gene Mutation

Acute Myeloid Leukemia With Gene Mutations

Myeloproliferative Neoplasm

Chronic Myelomonocytic Leukemia

Interventions

APR-246

Azacitidine

Study Description

Brief 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

Detailed 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