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

Part of paid clinical trials in The Bronx, New York.

Sponsor
Treebough Therapies
Study ID
NCT07006025
Phase
PHASE1
Status
Recruiting
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Conditions

  • MDS

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Decitabine — DRUG
    Oral tetrahydrouridine and oral decitabine capsule

Study Details

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

Key Dates

Start date
Jun 3, 2025
Status verified
Jan 2026
Primary completion
Dec 30, 2026
Completion
Mar 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Active
    Oral capsules of THU followed 1 hour later by decitabine

Primary Outcome Measure

White blood cell measurement [ Time Frame: every 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Montefiore Einstein Medical CenterThe BronxNew York10467
Davina Hoban
[email protected]
201-618-4725
Mendel Goldfinger, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Montefiore Einstein Medical Center· The Bronx, NY

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