NCT07006025RecruitingPhase 1
A Study of Oral Tetrahydrouridine-Decitabine in Relapsed or Refractory Myelodysplastic Syndromes (MDS)
Phase 1 Study of Oral Tetrahydrouridine-Decitabine to Treat Relapsed or Refractory Myelodysplastic Syndromes
Source: ClinicalTrials.gov · Last updated 15 Jan 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 20 May 2025
- Start date
- 3 Jun 2025
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Treebough Therapies
- Diseases
- Myelodysplastic syndromes
- NCT number
- NCT07006025
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 20
- From 3 Jun 2025 to the primary completion date, 30 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Women of Childbearing Potential (WOCBP) who are unwilling to agree to use dual contraceptive measures (i.e., hormonal or barrier method of birth control; abstinence, condom) prior to study entry, for the duration of study participation, and until 6 months after taking the last dose of THU/decitabine
Other illness
- Uncontrolled intercurrent illness that could limit life expectancy or ability to complete study correlates
- 9\. Patients with uncontrolled active human retrovirus (HIV) infection, as this will further increase the risk for opportunistic infections. However, patients with HIV with undetectable viral load by polymerase chain reaction (PCR), without opportunistic infection, and on a stable regimen of antiretroviral therapy are eligible
Lab values
- Currently pregnant or breastfeeding. Females of childbearing potential must have a negative serum pregnancy test within 72 hours of treatment start.
Other
- Diagnosis of acute promyelocytic leukemia (APL)
- Sexually active male who is unwilling to use a condom when engaging in any sexual contact with a WOCBP, beginning at the screening visit and continuing until 6 months after taking the last dose of THU/decitabine
Who the study is looking for
- 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
- Patient's body weight must be ≥ 41 kg
- Subjects must be able to understand and willing to sign a written informed consent document and complete study-related procedures.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Montefiore Einstein Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.