Ivosidenib and Ruxolitinib in Patients With Advanced Myeloproliferative Neoplasms (MPNs) That Hav… (NCT06291987) | Clinical Trial Compass
RecruitingPhase 1
Ivosidenib and Ruxolitinib in Patients With Advanced Myeloproliferative Neoplasms (MPNs) That Have an IDH1 Gene Mutation
United States18 participantsStarted 2024-09-19
Plain-language summary
The purpose of this research is to gather information on the safety and effectiveness determining maximum tolerated dose (MTD) of ruxolitinib in combination with ivosidenib in IDH1-mutated advanced-phase Ph-negative MPNs while evaluate the efficacy of ruxolitinib in combination with ivosidenib in IDH1-mutated advanced-phase Ph-negative MPNs.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Advanced-Phase IDH1-mutated Ph-negative MPNs (both untreated and relapsed/refractory) including any of the following:
* polycythemia vera with (PV) ≥ 5% peripheral or bone marrow blasts at time of screening
* essential thrombocythemia (ET) with ≥ 5% peripheral or bone marrow blasts at time of screening
* primary myelofibrosis (PMF) with ≥ 5% peripheral or bone marrow blasts at time of screening
* Atypical CML with ≥ 5% peripheral or bone marrow blasts at time of screening
* MPN-NOS with ≥ 5% peripheral or bone marrow blasts at time of screening
* MDS/MPN Overlap Syndromes including CMML with ≥ 5% peripheral or bone marrow blasts at time of screening
* post-PV myelofibrosis with ≥ 5% blasts peripheral or bone marrow blasts at time of screening
* post-ET myelofibrosis with ≥ 5% blasts peripheral or bone marrow blasts at time of screening
* primary and secondary myelofibrosis with inadequate response to JAK inhibitor regardless of blast percentage. Inadequate response to JAK inhibitor will be defined as lack of achieving any clinical improvement criteria within 12 weeks of of JAK inhibitor initiation.
* Patients can be on cytoreduction at time of study enrollment with hydroxyurea or steroids.
* Age ≥18 years.
* ECOG performance status ≤2
* Patients must have normal organ and marrow function as defined below:
* Creatinine clearance ≥60 mL/min, determined by the Cockroft-Gault formula, OR serum creatinine ≤ 1.5 x ULN
* AST and ALT ≤3 …
What they're measuring
1
Maximum tolerated dose
Timeframe: At the end of Cycle 1 (each cycle is 28 days)