Your session is about to expire
← Back to Search
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)
Prognostic risk-factor score of Intermediate-1 or higher per Dynamic International Prognostic Scoring System (DIPSS) scoring system
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 belowSelect...
I have been diagnosed with myelofibrosis.
Select...
My condition is rated Intermediate-1 or higher on the DIPSS scale.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I've had symptoms scoring 3 or more on average, or a total score of 10 or more, in the last week.
Select...
My spleen is enlarged, measuring 450 cm^3 or more.
Select...
I am 18 years old or older.
MANIFEST-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks of treatment
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
9 Previous Clinical Trials
1,037 Total Patients Enrolled
1 Trials studying Primary Myelofibrosis
341 Patients Enrolled for Primary Myelofibrosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with myelofibrosis.My blood, kidney, and liver functions are all within normal ranges.My condition is rated Intermediate-1 or higher on the DIPSS scale.I can take care of myself and am up and about more than half of my waking hours.I have had my spleen removed or treated with radiation in the last 6 months.I've had symptoms scoring 3 or more on average, or a total score of 10 or more, in the last week.I don't have any health conditions or take medications that would stop me from receiving treatment.I have been treated with JAKi or BET inhibitors for a blood disorder.My spleen is enlarged, measuring 450 cm^3 or more.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Pelabresib + ruxolitinib
- Group 2: Placebo + ruxolitinib
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Primary Myelofibrosis Patient Testimony for trial: Trial Name: NCT04603495 — Phase 3
Share this study with friends
Copy Link
Messenger