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Small Molecule Inhibitor

Pelabresib + Ruxolitinib for Myelofibrosis

Phase 1 & 2
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
- No prior treatment with a BET inhibitor
- Patients with confirmed diagnosis of MF who meet all of the following criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up average number of rbc units per subject-month, up to 24 weeks and beyond
Awards & highlights

Study Summary

This trial is studying the effects of CPI-0610 in patients with leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasms, and myelofibrosis.

Eligible Conditions
  • Leukemia
  • Bone Marrow Disease
  • Essential Thrombocythemia
  • Myelofibrosis
  • Blood Diseases
  • Tumors
  • Cancer
  • Preleukemia
  • Primary Myelofibrosis
  • Precancerous Conditions
  • Acute Myelocytic Leukemia
  • Myelodysplastic Syndrome
  • Myelodysplastic/Myeloproliferative Neoplasms
  • Myeloproliferative Disorder

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have not been treated with a medication called a BET inhibitor before.
Select...
You have been diagnosed with myelofibrosis and meet all of the following conditions.
Select...
You have a serious or advanced form of the disease, which is determined by meeting at least one of the following criteria:
Select...
You have at least two symptoms that can be measured using a form called the Myelofibrosis Symptom Assessment Form Version 4.0 (MFSAF v4.0).
Select...
You have been diagnosed with MF (myelofibrosis) and you meet all of the following requirements.
Select...
Your doctor has determined that you have a high risk of complications or disease progression based on a scoring system called DIPSS.
Select...
Your doctor has determined that your condition is at a high risk level according to the DIPSS scoring system.
Select...
You have a history of blood clotting, a condition called erythromelalgia, or frequent migraines.
Select...
You have at least two noticeable symptoms or a total score of 10 or higher on a form that measures symptoms related to myelofibrosis.
Select...
For Arm 4 (ET Expansion), you should meet the following criteria:
Select...
You have had a previous episode of bleeding related to a blood disorder called essential thrombocythemia (ET).
Select...
You have had diabetes or high blood pressure for more than 6 months and you take medication to manage it.
Select...
You have tried hydroxyurea (HU) before but it did not work well for you or you had bad side effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~average number of rbc units per subject-month, up to 24 weeks and beyond
This trial's timeline: 3 weeks for screening, Varies for treatment, and average number of rbc units per subject-month, up to 24 weeks and beyond for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 2 (Arm 4): Evaluate the complete hematological response rate
Phase 2 (Cohorts 1A and 2A): Evaluate the RBC (Red Blood Cell) transfusion independence rate
Phase 2 (Cohorts 1B and 2B and Arm 3): Evaluate the spleenic response
Secondary outcome measures
Phase 2 (Arms 1, 2, and 3): Evaluate the duration of the spleenic response by imaging
Phase 2 (all arms): Evaluate the change in patient reported outcomes
Phase 2 (all arms): area under the curve (AUC)
+1 more
Other outcome measures
Phase 2 (Arms 1, 2, and 3): Evaluate response category rate
Phase 2 (Arms 1, 2, and 3): Evaluate the rate of RBC transfusion and the RBC transfusion dependence rate

Trial Design

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)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib
2018
Completed Phase 3
~1140

Find a Location

Who is running the clinical trial?

Constellation PharmaceuticalsLead Sponsor
8 Previous Clinical Trials
1,076 Total Patients Enrolled
The Leukemia and Lymphoma SocietyOTHER
80 Previous Clinical Trials
16,633 Total Patients Enrolled
41 Trials studying Leukemia
3,650 Patients Enrolled for Leukemia
Debbie JohnsonStudy DirectorConstellation Pharmaceuticals
5 Previous Clinical Trials
401 Total Patients Enrolled

Media Library

CPI-0610 (Small Molecule Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02158858 — Phase 1 & 2
Leukemia Research Study Groups: Arm 3: JAKi Naïve Combination Arm, Arm 1: Prior JAKi (JAK inhibitor) Monotherapy Arm (MF patients treated with pelabresib alone), Arm 4: Essential Thrombocythemia (ET) Monotherapy Arm, Arm 2: Prior JAKi Combination Arm
Leukemia Clinical Trial 2023: CPI-0610 Highlights & Side Effects. Trial Name: NCT02158858 — Phase 1 & 2
CPI-0610 (Small Molecule Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02158858 — Phase 1 & 2

Frequently Asked Questions

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

How many health care facilities are participating in the trial's execution?

"Currently, 20 sites are enrolling participants for this research endeavour - notable centres include St. Paul's Hospital in Vancouver, the Juravinski Cancer Centre in Hamilton and the Icahn School of Medicine at Mount Sinai in New york City; an additional 17 locations can also be found on our website."

Answered by AI

What therapeutic purpose is CPI-0610 typically used for?

"CPI-0610 is a therapeutic agent designed to treat polycythemia vera, conditions unresponsive or hostile towards hydroxyurea, and primary myelofibrosis."

Answered by AI

What is the current count of participants in this clinical trial?

"Affirmative, according to the details found on clinicaltrials.gov this trial is actively enlisting participants. It was created on July 29th 2014 and recently updated on May 16th 2022. This medical experiment targets 341 patients at 20 sites of research."

Answered by AI

Are there still opportunities for patients to join this research endeavor?

"As declared on clinicaltrials.gov, the recruitment process for this medical trial is ongoing. It was first announced in late July 2014 and last updated on May 16th 2022."

Answered by AI

Is there a precedent for using CPI-0610 in clinical research?

"In 2002, the NIH Clinical Center on Rockville Pike initiated research into CPI-0610. Now 95 studies have been finished and there are 97 trials in progress, many of which are centered around Vancouver Canada."

Answered by AI
~32 spots leftby Mar 2025