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Bromodomain and Extra-Terminal Protein Inhibitor

Pelabresib for Myelofibrosis (MANIFEST-2 Trial)

Phase 3
Waitlist Available
Research Sponsored by Constellation Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Confirmed diagnosis of myelofibrosis (primary, post-polycythemia vera, or post essential thrombocythemia)
Confirmed diagnosis of myelofibrosis (primary, post-polycythemia vera, or post essential thrombocythemia)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks of treatment
Awards & highlights

MANIFEST-2 Trial Summary

This trial is testing a new drug, pelabresib, to see if it is better than the current best drug, ruxolitinib, for myelofibrosis patients who have not yet been treated with Janus kinase inhibitors.

Who is the study for?
This trial is for adults with myelofibrosis, including those who developed it from polycythemia vera or essential thrombocythemia. Participants must have certain symptoms and spleen enlargement, be in a specific risk category, and have good organ function. They can't join if they've had their spleen removed recently or used JAKi/BET inhibitors before.Check my eligibility
What is being tested?
The study tests Pelabresib (a BET protein inhibitor) combined with Ruxolitinib versus a placebo with Ruxolitinib in patients new to JAK inhibitor treatments. It's randomized and blinded, meaning participants are assigned by chance to either the test drug or placebo without knowing which one they receive.See study design
What are the potential side effects?
Potential side effects of Pelabresib include gastrointestinal issues like nausea and vomiting, fatigue, muscle pain, anemia (low red blood cell count), potential liver enzyme changes indicating liver stress, and possible respiratory problems.

MANIFEST-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with myelofibrosis.
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I have been diagnosed with myelofibrosis.
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My condition is rated Intermediate-1 or higher on the DIPSS scale.
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I have had symptoms scoring 3 or more on average, or a total score of 10 or more, in the last week.
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I can take care of myself and am up and about more than half of my waking hours.
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I am 18 years old or older.
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My condition is rated Intermediate-1 or higher on the DIPSS scale.
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My spleen is enlarged, measuring 450 cm^3 or more.
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I can take care of myself but might not be able to do heavy physical work.
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I've had symptoms scoring 3 or more on average, or a total score of 10 or more, in the last week.
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My spleen is enlarged, measuring 450 cm^3 or more.
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My condition is rated Intermediate-1 or higher on the DIPSS scale.
Select...
I have been diagnosed with myelofibrosis.
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My blood, kidney, and liver functions are all within normal ranges.
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I am 18 years old or older.
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I've had symptoms scoring 3 or more on average, or a total score of 10 or more, in the last week.
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My spleen is enlarged, measuring 450 cm^3 or more.
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I am 18 years old or older.

MANIFEST-2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Splenic response at Week 24
Secondary outcome measures
Total Symptom Score absolute change from baseline to Week 24
Total Symptom Score response at Week 24

MANIFEST-2 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Pelabresib + ruxolitinibExperimental Treatment2 Interventions
Pelabresib monohydrate tablets + ruxolitinib phosphate tablets
Group II: Placebo + ruxolitinibActive Control2 Interventions
Matching placebo tablets + ruxolitinib phosphate tablets
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pelabresib
2021
Completed Phase 1
~40
Ruxolitinib
2018
Completed Phase 3
~1140

Find a Location

Who is running the clinical trial?

Constellation PharmaceuticalsLead Sponsor
8 Previous Clinical Trials
987 Total Patients Enrolled
1 Trials studying Primary Myelofibrosis
341 Patients Enrolled for Primary Myelofibrosis

Media Library

Pelabresib (CPI-0610) (Bromodomain and Extra-Terminal Protein Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04603495 — Phase 3
Primary Myelofibrosis Research Study Groups: Pelabresib + ruxolitinib, Placebo + ruxolitinib
Primary Myelofibrosis Clinical Trial 2023: Pelabresib (CPI-0610) Highlights & Side Effects. Trial Name: NCT04603495 — Phase 3
Pelabresib (CPI-0610) (Bromodomain and Extra-Terminal Protein Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04603495 — Phase 3
Primary Myelofibrosis Patient Testimony for trial: Trial Name: NCT04603495 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What have been the recorded side effects of CPI-0610?

"Given that this is a Phase 3 trial with supporting efficacy data as well as multiple rounds of safety data, our team has rated CPI-0610's safety at a 3."

Answered by AI

How many people fit the requirements to participate in this clinical trial?

"In order to carry out this clinical trial, 400 individuals that meet the inclusion criteria will be needed. The sponsor, Constellation Pharmaceuticals, plans to execute the study at different locations including Franciscan Health/Indiana blood and Marrow Transplantation in Indianapolis, Indiana and Moffitt Cancer Center in Tampa, Florida."

Answered by AI

Are there a lot of hospitals running this trial?

"This trial has 36 different active locations, some of which include Franciscan Health/Indiana blood and Marrow Transplantation in Indianapolis, Moffitt Cancer Center in Tampa, and The Ottawa Hospital General Campus in Ottawa."

Answered by AI

Could you tell me if there has been prior research involving CPI-0610?

"CPI-0610 was first studied in 2002 at the National Institutes of Health Clinical Center. To date, there have been a total of 18378 completed studies with 99 ongoing trials. Many of these live studies are taking place in Indianapolis, Indiana."

Answered by AI

What conditions does CPI-0610 show the most promise in treating?

"CPI-0610 is an effective treatment for polycythemia vera, polycythemia, and patients who cannot tolerate or have developed resistance to hydroxyurea."

Answered by AI

Are there still places available for people who want to participate in this trial?

"Yes, the information on clinicaltrials.gov point out that this clinical trial is currently searching for candidates. The clinical trial was initially posted on 11/19/2020 and was most recently edited on 10/10/2022. The trial is admitting 400 patients across 36 sites."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
What site did they apply to?
Summit Medical Group - Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

Hydrea 1986-2013; Jakafi 2014 to present; Navitoclax 10/22 to present.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Summit Medical Group - Cancer Center: < 48 hours
Average response time
  • < 2 Days
~110 spots leftby Mar 2025