MedTrace Logo

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

NCT07006025 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-01-15

No results posted yet for this study

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

Conditions

Interventions

DRUG

Decitabine

Oral tetrahydrouridine and oral decitabine capsule

Sponsors & Collaborators

  • EpiDestiny, Inc.

    collaborator INDUSTRY

  • Treebough Therapies

    lead INDUSTRY

Principal Investigators

  • Mendel Goldfinger, MD · Montefiore/Einstein Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-03
Primary Completion
2026-12-30
Completion
2027-03-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07006025 on ClinicalTrials.gov