Trial Profile
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
Status:
Active, no longer recruiting
Phase of Trial:
Phase I/II
Latest Information Update: 06 Jan 2022
Price :
$35
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At a glance
- Drugs Azacitidine (Primary) ; Azacitidine (Primary) ; Eprenetapopt (Primary)
- Indications Acute myeloid leukaemia; Chronic myelomonocytic leukaemia; Myelodysplastic syndromes; Myeloproliferative disorders
- Focus Therapeutic Use
Most Recent Events
- 14 Dec 2021 Results of long-term follow up analyses of two studies (NCT03072043/NCT03588078) presented at the 63rd American Society of Hematology Annual Meeting and Exposition.
- 05 Aug 2021 According to an Aprea media release, the company intends to work closely with the FDA to analyze the data, address the specific questions raised, and seek to resolve the partial clinical hold as soon as possible. The partial clinical hold does not apply to the Company's ongoing clinical trials in lymphoid malignancies and solid tumors.
- 05 Aug 2021 According to an Aprea media release, the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on clinical trials of eprenetapopt in combination with azacitidine in myeloid malignancy programs. Patients who are benefiting from treatment can continue to receive study treatment. As part of the clinical hold, no additional patients can be enrolled to these trials until the partial clinical hold is resolved.