A Study of Oral Tetrahydrouridine-Decitabine in Relapsed or Refractory Myelodysplastic Syndromes (MDS)
ConditionMDS
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorTreebough Therapies
About this trial
The goal of this clinical trial is to learn about the safety and effectiveness of the combination drug Tetrahydrouridine (THU) and decitabine (DEC) to treat patients with relapsed or refractory myelodysplastic syndrome. The main questions it aims to answer are:
* Does the combination drug exhibit hematological and nonhematological toxicity? * Does the combination drug improve health status and reduce the number of days of hospitalization?
Participants will:
* Take tetrahydrouridine and decitabine once a week for 24 weeks * Visit the clinic once every 4 weeks for checkups and tests * Keep a diary of their symptoms
Eligibility criteria
Qualifiers
Patients must have a diagnosis of MDS that has received one or more prior standard therapies and is relapsed or refractory
Patients must be 18 years of age or older
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 3
Patients must have adequate end-organ function
Disqualifiers
Diagnosis of acute promyelocytic leukemia (APL)
Prior treatment with ≥4 28-day cycles of parenteral or oral decitabine
No other disease-directed therapy, save for hydroxyurea, including experimental or investigational drug therapy for 14 days prior to study entry (hydroxyurea should be discontinued ≥24 hours prior to initiation of study drug)
Requiring concomitant treatment with drugs that are cytidine deaminase (CDA) substrates and/or inhibitors, e.g., cytarabine, 5-azacytidine, gemcitabine
Trial design
Treatments tested in this trial
- Decitabine
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Treebough Therapies
Lead sponsor
EpiDestiny, Inc.
Collaborator
Source ClinicalTrials.gov