CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 1 enrolled
Drug / intervention
Azacitidine +1 moredrug
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.

Search/NCT03701295
NCT03701295Phase 2Completed
CompareCT.gov

A Phase Ib/II Study of the Histone Methyltransferase Inhibitor Pinometostat in Combination With Azacitidine in Patients With 11q23-Rearranged Acute Myeloid Leukemia

National Cancer Institute (NCI)·interventional·Posted Oct 10, 2018·Updated Oct 18, 2023

In Brief

A Phase 2 clinical trial evaluating Azacitidine and Pinometostat for Acute Myeloid Leukemia With t(9;11)(p21.3;q23.3); MLLT3-MLL and 3 related conditions. Completed, enrolled 1 participant across 1 site.

Detailed Summary

This phase Ib/II trial studies the side effects and best dose of pinometostat when given together with azacitidine and to see how well it works in treating patients with acute myeloid leukemia that has come back (relapsed), does not respond to treatment (refractory), or is newly diagnosed, with an 11q23 rearrangement. Pinometostat and azacitidine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia With t(9;11)(p21.3;q23.3); MLLT3-MLL, Leukemia Cutis, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedOct 10, 2018
Enrollment StartMar 6, 2020
Primary CompletionDec 8, 2020
Study CompletionJan 12, 2021
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 7.7 years ago

Interventions

Azacitidinedrug

Given IV or SC

Pinometostatdrug

Given IV