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# FDA Lifts Clinical Holds on Aprea Trials
- URL: https://www.fdaweb.com/fda-lifts-clinical-holds-on-aprea-trials/
- Published: 2022-03-16T12:00:00.000Z
- Updated: 2026-09-14T17:36:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151379

FDA has lifted clinical holds on Aprea Therapeutics’ clinical trials involving eprenetapopt in combination with azacitidine in myeloid malignancy programs. In 8/2021, FDA placed holds on the company’s Phase 3 frontline Myelodysplastic Syndrome (MDS) clinical trial, a Phase 2 MDS/*acute myeloid leukemia* post-transplant clinical trial, and a Phase 1/2 AML clinical trial.

Aprea says that in 12/2021 it discussed with FDA the requested data and analyses from the Phase 3 frontline MDS clinical trial and reached agreement on proposals for new clinical trials in myeloid malignancies. “In the first quarter of 2022 the company received clearance from FDA to proceed under its existing myeloid malignancy IND with a new clinical trial in relapsed/refractory MDS and AML,” it says.

At the time the clinical holds were first announced, the company said there were about 20 patients then receiving eprenetapopt in combination with azacitidine in its myeloid malignancy programs, which included the MDS, AML and post-transplant maintenance trials, all of which have completed enrollment. It said patients who are benefiting from treatment could continue to receive study treatment, but no new patients should be enrolled until the hold was resolved.