NCT07006025 A Study of Oral Tetrahydrouridine-Decitabine in Relapsed or Refractory Myelodysplastic Syndromes (MDS)
| NCT ID | NCT07006025 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Treebough Therapies |
| Condition | MDS |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-06-03 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2025-06-03 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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. Exclusion Criteria: * 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 * Currently pregnant or breastfeeding. Females of childbearing potential must have a negative serum pregnancy test within 72 hours of treatment start. * Uncontrolled intercurrent illness that could limit life expectancy or ability to complete study correlates * 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 * 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 * 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
Contact & Investigator
Mendel Goldfinger, MD
PRINCIPAL INVESTIGATOR
Montefiore/Einstein Cancer Center
Frequently Asked Questions
Who can join the NCT07006025 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying MDS. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07006025 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07006025 currently recruiting?
Yes, NCT07006025 is actively recruiting participants. Contact the research team at dhoban@montefiore.org for enrollment information.
Where is the NCT07006025 trial being conducted?
This trial is being conducted at The Bronx, United States.
Who is sponsoring the NCT07006025 clinical trial?
NCT07006025 is sponsored by Treebough Therapies. The principal investigator is Mendel Goldfinger, MD at Montefiore/Einstein Cancer Center. The trial plans to enroll 20 participants.