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The trial is taking place at:
H

Hospital Sultanah Bahiyah | Clinical Research Centre

Veeva-enabled site

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

C

Constellation Pharmaceuticals

Status and phase

Active, not recruiting
Phase 3

Conditions

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

Treatments

Drug: Pelabresib
Drug: Placebo
Drug: Ruxolitinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT04603495
CPI 0610-04
2020-001989-10 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

430 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Aged ≥ 18 years
  • Confirmed diagnosis of myelofibrosis (primary, post-polycythemia vera, or post essential thrombocythemia)
  • Adequate hematologic, renal, and hepatic function
  • Have at least 2 symptoms with an average score ≥ 3 or an average total score of ≥ 10 over the 7-day period prior to randomization using the MFSAF v4.0
  • Prognostic risk-factor score of Intermediate-1 or higher per Dynamic International Prognostic Scoring System (DIPSS) scoring system
  • Spleen volume of ≥ 450 cm^3
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion criteria

  • Splenectomy or splenic irradiation in the previous 6 months
  • Chronic or active conditions and/or concomitant medication use that would prohibit treatment
  • Had prior treatment with any JAKi or BET inhibitor for treatment of a myeloproliferative neoplasm

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

430 participants in 2 patient groups

Pelabresib + ruxolitinib
Experimental group
Description:
Pelabresib monohydrate tablets + ruxolitinib phosphate tablets
Treatment:
Drug: Ruxolitinib
Drug: Pelabresib
Placebo + ruxolitinib
Active Comparator group
Description:
Matching placebo tablets + ruxolitinib phosphate tablets
Treatment:
Drug: Ruxolitinib
Drug: Placebo

Trial contacts and locations

159

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Data sourced from clinicaltrials.gov

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