Actively Recruiting
A Study of Oral Tetrahydrouridine-Decitabine in Relapsed or Refractory Myelodysplastic Syndromes (MDS)
Led by Treebough Therapies · Updated on 2026-01-15
20
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
Sponsors
T
Treebough Therapies
Lead Sponsor
E
EpiDestiny, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Study of Oral Tetrahydrouridine-Decitabine in Relapsed or Refractory Myelodysplastic Syndromes (MDS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of MDS that has relapsed or is refractory after one or more prior standard therapies
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 3 or less
- Adequate end-organ function
- Body weight of at least 41 kg
- Ability to understand and willing to sign informed consent and complete study procedures
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia (APL)
- Prior treatment with four or more 28-day cycles of parenteral or oral decitabine
- Use of other disease-directed therapies (except hydroxyurea) within 14 days before study entry; hydroxyurea must be stopped at least 24 hours before starting study drug
- Need for concurrent treatment with drugs that affect cytidine deaminase (CDA), such as cytarabine, 5-azacytidine, or gemcitabine
- Currently pregnant or breastfeeding; females of childbearing potential must have a negative pregnancy test within 72 hours before treatment start
- Uncontrolled illnesses that limit life expectancy or study participation
- Women of childbearing potential unwilling to use dual contraception during the study and for 6 months after last dose
- Sexually active males unwilling to use condoms during the study and for 6 months after last dose
- Uncontrolled active HIV infection; patients with controlled HIV on stable therapy without opportunistic infections are eligible
AI-Screening
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Trial Site Locations
Total: 1 location
1
Montefiore Einstein Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
Research Team
D
Davina Hoban
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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