Evaluate Ofirnoflast in Adults With Very Low- to Intermediate-risk Myelodysplastic Syndromes Requiring Transfusions
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHalia Therapeutics, Inc.
About this trial
The primary objective of this study is to evaluate the efficacy and safety of ofirnoflast administered orally once daily in adults with very low- to intermediate-risk myelodysplastic syndromes (MDS) who are transfusion-dependent and have failed one to three prior therapies, in order to identify the optimal dose for continuation into a Phase 3 study.
The secondary objectives of this study are to evaluate the extended hematologic response to ofirnoflast, to assess the safety and tolerability of ofirnoflast during the dose-selection phase, and to evaluate hematologic improvement with ofirnoflast treatment.
Eligibility criteria
Qualifiers
At least 18 years of age at the time of signing informed consent.
Capable of giving signed informed consent
Documented diagnosis of very low-, low-, or intermediate-risk MDS
Documented diagnosis of anemia
Disqualifiers
Anemia due to other causes (e.g., iron deficiency).
Known clinically significant anemia due to iron, vitamin B12, or folate deficiency; autoimmune or hereditary hemolytic anemia; or gastrointestinal bleeding.
History of hemoglobinopathies, intrinsic RBC membrane/enzyme defects, or hemolytic anemia.
Prior history of AML, secondary MDS, or other malignancy (except non-melanoma skin cancer or in situ cervical/breast carcinoma) unless disease-free for >1 year.
Trial design
Treatments tested in this trial
- Ofirnoflast
Treatment groups
50 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Halia Therapeutics, Inc.
Lead sponsor
Parexel
Collaborator
Source ClinicalTrials.gov