Pacritinib Versus Best Available Therapy to Treat Patients With Myelofibrosis and Thrombocytopenia (NCT02055781) | Clinical Trial Compass
TerminatedPhase 3
Pacritinib Versus Best Available Therapy to Treat Patients With Myelofibrosis and Thrombocytopenia
United States311 participantsStarted 2014-02
Plain-language summary
Phase 3, randomized, controlled study to evaluate the safety and efficacy of oral pacritinib compared to Best Available Therapy (BAT) in patients with thrombocytopenia and primary or secondary myelofibrosis.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Intermediate -1 or -2 or high-risk Myelofibrosis (per Passamonti et al 2010)
* Thrombocytopenia (platelet count ≤ 100,000/µL) at any time after signing informed consent
* Palpable splenomegaly ≥ 5 cm on physical examination
* Total Symptom Score ≥ 13 on the MPN-SAF TSS 2.0, not including the inactivity question
* Patients who are platelet or red blood cell transfusion-dependent are eligible
* Adequate white blood cell counts (with low blast counts), liver function, and renal function
* At least 6 months from prior splenic irradiation
* At least 1-4 weeks since prior myelofibrosis therapy, including any erythropoietic or thrombopoietic agent
* Not pregnant, not lactating, and agree to use effective birth control
* Able and willing to undergo frequent MRI or CT assessments and complete symptom assessments using a patient-reported outcome instrument
Exclusion Criteria:
* Prior treatment with more than 2 JAK2 inhibitors or with pacritinib
* There is no maximum cumulative prior JAK2 inhibitor treatment
* History of (or plans to undergo) spleen removal surgery or allogeneic stem cell transplant
* Ongoing gastrointestinal medical condition such as Crohn's disease, Inflammatory bowel disease, chronic diarrhea, or constipation
* Active bleeding that requires hospitalization during the screening period
* Cardiovascular disease, including recent history or currently clinically symptomatic and uncontrolled: congestive heart failure, arrhythmia, angina, QTc prolon…