RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Phase 1 Study of Oral Tetrahydrouridine-Decitabine to Treat Relapsed or Refractory Myelodysplastic Syndromes

Quick Facts

Study Start:2025-06-03

Study Completion:2027-03-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07006025

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

Davina Hoban

CONTACT

201-618-4725

dhoban@montefiore.org

Principal Investigator

Mendel Goldfinger, MD

PRINCIPAL_INVESTIGATOR

Montefiore/Einstein Cancer Center

Study Locations (Sites)

Montefiore Einstein Medical Center

Bronx, New York, 10467

United States

Collaborators and Investigators

Sponsor: EpiDestiny, Inc.

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-03

Study Completion Date2027-03-30

Study Record Updates