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Pelabresib + Ruxolitinib for Myelofibrosis
Study Summary
This trial is studying the effects of CPI-0610 in patients with leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasms, and myelofibrosis.
- 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 belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You have not been treated with a medication called a BET inhibitor before.You have been diagnosed with myelofibrosis and meet all of the following conditions.You have at least two noticeable symptoms or a total score of 10 or higher on a form that measures symptoms related to myelofibrosis.You have had a previous episode of bleeding related to a blood disorder called essential thrombocythemia (ET).You have had diabetes or high blood pressure for more than 6 months and you take medication to manage it.For Arm 4 (ET Expansion), you should meet the following criteria:You have tried hydroxyurea (HU) before but it did not work well for you or you had bad side effects.You have a serious or advanced form of the disease, which is determined by meeting at least one of the following criteria:Your doctor has determined that your condition is at a high risk level according to the DIPSS scoring system.You have a history of blood clotting, a condition called erythromelalgia, or frequent migraines.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).You have been diagnosed with MF (myelofibrosis) and you meet all of the following requirements.Your doctor has determined that you have a high risk of complications or disease progression based on a scoring system called DIPSS.
- Group 1: Arm 3: JAKi Naïve Combination Arm
- Group 2: Arm 1: Prior JAKi (JAK inhibitor) Monotherapy Arm (MF patients treated with pelabresib alone)
- Group 3: Arm 4: Essential Thrombocythemia (ET) Monotherapy Arm
- Group 4: Arm 2: Prior JAKi Combination Arm
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
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