Oral Tetrahydrouridine-Decitabine in Patients With Advanced Myeloproliferative Neoplasms

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

Sponsor
John Mascarenhas
Study ID
NCT07872709
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Chric Phase MPN
  • MPN - Accelerated or Blast Phase
  • Myelofibrosis

Eligibility Criteria

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

Interventions

  • Oral THU-decitabine — DRUG
    Combination of Tetrahydrouridine and Decitabine oral treatment. Treatment is ingested weekly without interruption. For convenience of communication and planning, 4 weeks of treatment (28 days) is considered a treatment cycle. The first 2 cycles of therapy (week 1-8 of therapy) is considered an induction phase. After the induction phase (Cycle 3+): Treatment continues weekly.

Study Details

This is a phase II, multicenter, open-label study evaluating the feasibility, safety, and efficacy of oral tetrahydrouridine-decitabine (THU-decitabine) in patients with advanced myeloproliferative neoplasms (MPN).

Key Dates

First listed
Oct 14, 2026
Start date
Jan 31, 2027
Status verified
Oct 2026
Primary completion
Jul 31, 2029
Completion
Jan 31, 2033

Study Design

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

Arms

  • Experimental: Oral THU-decitabine
    Study participants will receive oral THU-decitabine once weekly (on the same day each week ±1 day). Oral THU-Dec 8-12/0.16-0.24 mg/kg (\~10/0.2 mg/kg) (THU ingested 1 hour before decitabine). THU and decitabine are supplied as capsules: each THU capsule contains THU 250 mg; each decitabine capsule contains decitabine 5 mg. Since this trial utilizes capsules, there has to be rounding of dosages.

Primary Outcome Measure

Treatment Completion Rate [ Time Frame: 6 Cycles (24 Weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Gillian Sanchez
[email protected]
Gabriela Bello
[email protected]
John Mascarenhas (PRINCIPAL_INVESTIGATOR)

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By research site
Icahn School of Medicine at Mount Sinai· New York, NY

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