Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT04603495
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Myelofibrosis
  • Post-essential Thrombocythemia Myelofibrosis
  • Post-polycythemia Vera Myelofibrosis
  • Primary Myelofibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pelabresib — DRUG
    Double-blind treatment (pelabresib or matching placebo) will be administered daily for 14 consecutive days followed by a 7-day break, which is considered 1 cycle of treatment (1 cycle = 21 days). Pelabresib is a small molecule inhibitor of BET proteins with a novel mechanism of action and potential for disease-modifying effects in MF.
  • Ruxolitinib — DRUG
    Ruxolitinib is a JAK inhibitor and a current, approved treatment option for MF.
  • Placebo — DRUG
    Placebo tablets are designed to match pelabresib tablets. Each placebo tablet contains no active pharmaceutical ingredient and is visibly identical to experimental drug in size, shape, and packaging. Placebo dosing follows the same dosing conventions as pelabresib.

Study Details

A Phase 3, randomized, blinded study comparing pelabresib (CPI-0610) and ruxolitinib with placebo and ruxolitinib in myelofibrosis (MF) patients that have not been previously treated with Janus kinase inhibitors (JAKi). Pelabresib is a small molecule inhibitor of bromodomain and extra-terminal (BET) proteins.

Key Dates

Start date
Apr 9, 2021
Status verified
Nov 2025
Primary completion
Aug 23, 2023
Completion
Jun 30, 2027

Study Design

Enrollment
430 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pelabresib + ruxolitinib
    Pelabresib monohydrate tablets + ruxolitinib phosphate tablets
  • Active Comparator: Placebo + ruxolitinib
    Matching placebo tablets + ruxolitinib phosphate tablets

Primary Outcome Measure

Number of Participants With Splenic Response by Central Radiology Reads at Week 24 [ Time Frame: Week 24 ]

Locations (20)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-3300-
Ironwood Physicians P.C. dba Ironwood Cancer and Research CentersChandlerArizona85224-
UC San Diego Moores Cancer CenterLa JollaCalifornia92093-
UCLA Medical CenterLos AngelesCalifornia90095-
USC/Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
Yale University School of MedicineNew HavenConnecticut06510-
Mayo ClinicJacksonvilleFlorida32224-
Moffitt Cancer CenterTampaFlorida33612-
Decatur Memorial Hospital Cancer Care Center of Decatur/Cancer Care Specialists of ILDecaturIllinois62526-
Franciscan Health/Indiana blood and Marrow TransplantationIndianapolisIndiana46237-
Norton Cancer Institute, St. Matthews CampusLouisvilleKentucky40207-
University of Michigan Medical CenterAnn ArborMichigan48109-
Washington UniversitySt LouisMissouri63110-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Weill Cornell Medical College- New York Presbyterian HospitalNew YorkNew York10065-
Cleveland Clinic Taussig Cancer CenterClevelandOhio44195-
MD Anderson Cancer CenterHoustonTexas77030-
University of Texas Health Science Center - San AntonioSan AntonioTexas78229-
Center for Blood Disorders and Cellular Therapy, Swedish Cancer InstituteSeattleWashington98104-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALIronwood Physicians P.C. dba Ironwood Cancer and Research Centers· Chandler, AZUC San Diego Moores Cancer Center· La Jolla, CAUCLA Medical Center· Los Angeles, CAUSC/Norris Comprehensive Cancer Center· Los Angeles, CAYale University School of Medicine· New Haven, CT

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