Pelabresib + Ruxolitinib for Myelofibrosis
Recruiting in Palo Alto (17 mi)
+44 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Waitlist Available
Sponsor: Constellation Pharmaceuticals
No Placebo Group
Trial Summary
What is the purpose of this trial?Phase 1 Part (Complete): Open-label, sequential dose escalation study of pelabresib in patients with previously treated Acute Leukemia, Myelodysplastic Syndrome, Myelodysplastic/Myeloproliferative Neoplasms, and Myelofibrosis.
Phase 2 Part: Open-label study of CPI-0610 with and without Ruxolitinib in patients with Myelofibrosis.
CPI-0610 is a small molecule inhibitor of bromodomain and extra-terminal (BET) proteins.
Eligibility Criteria
Participant Groups
4Treatment groups
Experimental Treatment
Group I: Arm 4: Essential Thrombocythemia (ET) Monotherapy ArmExperimental Treatment1 Intervention
Open to high-risk patients with ET who are resistant or intolerant to hydroxyurea (HU)
Group II: Arm 3: JAKi Naïve Combination ArmExperimental Treatment2 Interventions
Open to patients with MF who have not previously received a JAKi (pelabresib + Ruxolitinib) and have DIPSS risk category Intermediate-2 or higher
Group III: Arm 2: Prior JAKi Combination ArmExperimental Treatment2 Interventions
* Cohort 2A: Open to patients with MF who are Transfusion Dependent (TD) and are currently taking ruxolitinib but have disease that is not being adequately controlled by ruxolitinib (pelabresib + Ruxolitinib)
* Cohort 2B: Open to patients with MF who are not TD and are currently taking ruxolitinib but have disease that is not being adequately controlled by ruxolitinib. (CPI-0610 + Ruxolitinib)
Group IV: Arm 1: Prior JAKi (JAK inhibitor) Monotherapy Arm (MF patients treated with pelabresib alone)Experimental Treatment1 Intervention
* Cohort 1A: Open to patients with MF who are Transfusion Dependent (TD) and who have previously been treated with a JAKi and are intolerant, resistant, refractory or lost response to the JAKi, or are ineligible to be treated with a JAKi (pelabresib alone)
* Cohort 1B: Open to patients with MF who are not TD and who have previously been treated with a JAKi and are intolerant, resistant, refractory or lost response to the JAKi, or are ineligible to be treated with a JAKi. (CPI-0610 alone)
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
St. Paul's HospitalVancouver, Canada
Juravinski Cancer CentreHamilton, Canada
Princess Margaret Cancer CentreToronto, Canada
Jewish General HospitalMontreal, Canada
More Trial Locations
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Who is running the clinical trial?
Constellation PharmaceuticalsLead Sponsor
The Leukemia and Lymphoma SocietyCollaborator