Open Label Phase 1/2 Study of Tasquinimod in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), or Post-Essential Thrombocytosis Myelofibrosis (Post-ET MF)

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06327100
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Post-Essential Thrombocytosis Myelofibrosis
  • Post-polycythemia Vera Myelofibrosis
  • Primary Myelofibrosis

Eligibility Criteria

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

Interventions

Study Details

To learn if tasquinimod either alone or in combination with ruxolitinib can help to control PMF, post-PV MF, or post-ET MF.

Key Dates

Start date
Aug 1, 2024
Status verified
May 2026
Primary completion
May 1, 2029
Completion
May 1, 2031

Study Design

Enrollment
33 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1
    Participants have already been receiving ruxolitinib for at least 3 months and are not responding well to ruxolitinib or have low blood cell counts, participants will be assigned to Group 1. In Group 1, participants will receive tasquinimod alone daily each 28 day cycle.
  • Experimental: Group 2
    Participants who are already on a stable dose of ruxolitinib for at least 8 weeks who have achieved a sub-optimal response will be assigned to Group 2. In Group 2, participants will receive tasquinimod daily on days 1-28 and ruxolitinib dose will be continued.

Primary Outcome Measure

Safety and adverse events (AEs) [ Time Frame: Through study completion; an average of 1 year. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Lucia Masarova, MD
[email protected]
832-750-4211
Lucia Masarova, MD (PRINCIPAL_INVESTIGATOR)

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By research site
MD Anderson Cancer Center· Houston, TX

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