At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 33 enrolled
Drug / intervention
APR-246drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Trial of APR-246 in Combination With Azacitidine as Maintenance Therapy for TP53 Mutated AML or MDS Following Allogeneic Stem Cell Transplant
In Brief
A Phase 2 clinical trial evaluating APR-246 for Acute Myeloid Leukemia or Myelodysplastic Syndromes. Completed, enrolled 33 participants across 7 sites.
Detailed Summary
A multi-center, open label, Phase II clinical trial to assess the safety and efficacy of APR-246 in combination with azacitidine as maintenance therapy after allogeneic HSCT (hematopoietic stem cell transplant) for patients with TP53 mutant AML or MDS.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedApr 2019
Enrollment StartSep 2019
Primary CompletionAug 2021
Study CompletionJan 2022
TodayJul 2026
First PostedApr 30, 2019
Enrollment StartSep 16, 2019
Primary CompletionAug 27, 2021
Study CompletionJan 14, 2022
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 7.2 years ago
Interventions
APR-246drug
APR-246 will be administered on Days 1-4, with azacitidine on Days 1-5, of every 28 day cycle. Patients may receive a maximum of 12 cycles.