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Oral Tetrahydrouridine-Decitabine for Relapsed or Refractory Myelodysplastic Syndromes (MDS)

This study is testing an oral combination of tetrahydrouridine and decitabine for people with myelodysplastic syndromes (MDS) that has returned or not responded to previous treatments. The main goals are to see if the drug is safe and how well it works. You may be able to join if you are 18 or older, have MDS that has relapsed or is refractory, and meet other health requirements. The study hopes to find out if this combination drug causes side effects and if it can improve your health and reduce hospital stays. The study plans to enroll 20 participants, but its current status is unclear.

Study design
This is a single-arm, open-label Phase 1 study, meaning all participants will receive the study drug and both you and the study team will know what treatment you are receiving. It plans to enroll 20 participants.
What's involved
You would take tetrahydrouridine and decitabine once a week for 24 weeks. You would also visit the clinic once every 4 weeks for checkups and tests, and keep a diary of your symptoms.
Compensation
Not stated in the trial record.
Follow-up
White blood cell and platelet counts will be measured every 4 weeks during the 24-week treatment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07006025

A Study of Oral Tetrahydrouridine-Decitabine in Relapsed or Refractory Myelodysplastic Syndromes (MDS)

Recruiting
PHASE1Ages 18+InterventionalTreatment
Treebough Therapies
~20 participants
Updated 2026-01-15 on ClinicalTrials.gov
What's tested:Decitabine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
White blood cell measurement
Measured over every 4 weeks
+1 more outcome measured

Conditions

MDS

Explore related trials

Myelodysplastic Syndrome

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Mendel Goldfinger, MD · PRINCIPAL_INVESTIGATOR · Montefiore/Einstein Cancer Center

Who to contact

Davina Hoban
[email protected]
201-618-4725
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • White blood cell measurementevery 4 weeks

    Measure neutrophils count

  • Platelet countevery 4 week

    Measure platelets in the blood