Open Label Phase 1/2 Study of Tasquinimod in Patients With Primary Myelofibrosis (PMF), Post-Poly… (NCT06327100) | Clinical Trial Compass
RecruitingPhase 1/2
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)
United States33 participantsStarted 2024-08-01
Plain-language summary
To learn if tasquinimod either alone or in combination with ruxolitinib can help to control PMF, post-PV MF, or post-ET MF.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
Participants eligible for inclusion in this study have to meet the following criteria:
Myelofibrosis MF Monotherapy:
Participants who are not candidates for, intolerant of, or relapsed/refractory to approved JAKi (ruxolitinib and / or fedratinib / pacritinib) or when further benefit from therapy is not anticipated per investigator. Participants not eligible for JAKi therapy irrespectively of previous treatments. Prior JAKi therapy is not required.
Myelofibrosis Ruxolitinib Combination MF participants treated with Ruxolitinib for at least 3 months on a stable, uninterrupted dose for at least 2 months prior to study enrollment AND have suboptimal response (palpable spleen of ≥5 cm, or total symptoms score of ≥10) or progressive anemia/thrombocytopenia/neutropenia.
AND all the below criteria in both cohorts:
* Must be diagnosed with treatment requiring PMF or post ET/PV MF diagnosed according to the 2016 World Health Organization with intermediate -1, intermediate -2 or high-risk disease according to the DIPSS prognostic scoring system, or if with low risk disease then with symptomatic splenomegaly that is ≥ 5 cm below left costal margin by physical exam.
* Peripheral or bone marrow blasts must be \< 10%
* Participants must provide written informed consent.
* Age 18 years or older. Because no dosing or adverse event data are currently available on the use of tasquinimod as monotherapy or in combination with ruxolitinib in patients \<18 years of age, chi…
What they're measuring
1
Safety and adverse events (AEs)
Timeframe: Through study completion; an average of 1 year.