Health TrialsbyHealthPanel

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

ConditionMDS
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorTreebough Therapies

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Decitabine

    Drug

    Oral tetrahydrouridine and oral decitabine capsule

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: ActiveExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

White blood cell measurement

Measure neutrophils count

Time frame
every 4 weeks
2

Platelet count

Measure platelets in the blood

Time frame
every 4 week

Secondary outcomes

1

Response for high-risk MDS

Measure using International Working Group (IWG) 2023 response criteria

Time frame
every 4 weeks
2

Hospitalization

Record the number of days of hospitalization

Time frame
every 4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Treebough Therapies

Lead sponsor

EpiDestiny, Inc.

Collaborator

Source ClinicalTrials.gov
Apply now