Reparixin in Patients With Myelofibrosis Myeloproliferative Neoplasms Research Consortium (MPN-RC… (NCT05835466) | Clinical Trial Compass
RecruitingPhase 2
Reparixin in Patients With Myelofibrosis Myeloproliferative Neoplasms Research Consortium (MPN-RC 120)
United States10 participantsStarted 2023-07-24
Plain-language summary
This is an open label, phase II study to assess the efficacy, safety, and tolerability of Reparixin in patients with DIPSS intermediate-2, or high-risk primary myelofibrosis (PMF), post essential thrombocythemia/polycythemia vera related MF (Post ET/PV MF) after prior treatment, and those who are ineligible or refuse treatment, with a Janus kinase inhibitor (JAKi). 26 patients will be enrolled. Eligible patients will receive oral reparixin three times daily on a 4-week cycle for a core study period of 6 cycles (24 weeks). After cycle 6, patients may continue receiving reparixin once daily on a 4-week cycle if at least stable disease (SD) is met by IWG-MRT criteria until loss of response, disease progression, unacceptable toxicity, patient/physician withdrawal, or termination of study by sponsor.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Be ≥ 18 years of age at time of signing the informed consent form (ICF)
* Willing to voluntarily sign the ICF
* Have a pathologically confirmed diagnosis of PMF, post-ET-MF, or post-PV-MF as per the World Health Organization (WHO) diagnostic criteria with intermediate-2 or higher risk disease by DIPSS
* Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Willing to undergo a bone marrow biopsy at screening
o A bone marrow biopsy obtained within 90 days of screening without intervening treatments and approved by the study chair may suffice.
* Be refractory/resistant to or intolerant of/inappropriate for JAKi therapy as defined by at least one of the following:
* Treatment for ≥ 3 months with inadequate efficacy as demonstrated by persistent palpable splenomegaly ≥ 5cm or symptoms related to splenomegaly,
* Treatment for ≥ 28 days complicated by either:
* Development of a red blood cell transfusion requirement (at least 2 units/month for 2 months)
* CTCAE grade ≥ 3 AEs of thrombocytopenia, anemia, hematoma, or hemorrhage while being treated with a JAKi
* Development of non-hematological toxicity that makes patient intolerant of JAKi therapy
* In the Investigator's judgment, are not candidates for available approved JAKi
* Recovery to ≤ Grade 1 or baseline of any toxicities due to prior systemic treatments, excluding alopecia
* At least two weeks must have elapsed between the last dose of any MF-directed drug treatmen…
What they're measuring
1
Efficacy of reparixin treatment per IWG/ELN criteria
Timeframe: Cycle 6 (each cycle is 4 weeks) Response Assessment