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Navitoclax + Ruxolitinib for Myeloproliferative Disorders
Study Summary
This trial has 4 parts to evaluate the safety and how well the drug navitoclax works when given alone or with another drug, ruxolitinib. The trial will also look at how navitoclax affects QTc prolongation and how it affects the PK, safety, and tolerability of celecoxib in people with MPN or CMML.
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?
Media Library
- I am Japanese and considering Navitoclax treatment (Part 1 only).I have been on ruxolitinib for at least 12 weeks and my dose hasn't changed recently.I haven't taken strong CYP3A inducers in the last 10 days.My myelofibrosis is classified as intermediate-2 or high-risk.I have been treated with a BH3 mimetic or BET inhibitor before.I need treatment and have either not responded to or cannot tolerate at least one prior therapy, or I refuse standard therapy.I may have had specific treatments for my blood disorder before starting the study drug, but not certain ones right before.I am able to get out of my bed or chair and move around.I am eligible for both initial and follow-up phases of the study.My blood or bone marrow has more than 10% blast cells.My spleen is enlarged, either felt below my ribs or confirmed by a scan.I have been diagnosed with a specific type of blood cancer.I haven't taken strong or moderate CYP3A inhibitors recently.My blood, kidney, liver, and bone marrow are functioning well.I have been diagnosed with a type of myelofibrosis according to WHO standards.I have been diagnosed with myelofibrosis according to WHO standards.I haven't taken strong CYP3A or CYP2C9 inhibitors recently.I need treatment to reduce blood cells and have not responded well to or cannot tolerate previous treatments.I have been diagnosed with myelofibrosis, polycythemia vera, or essential thrombocythemia.My blood, kidney, liver, and bone marrow are functioning well.I can take care of myself but might not be able to do heavy physical work.I am taking blood thinners other than low-dose aspirin or LMWH.My blood tests show a high number of immature blood cells.I haven't taken strong CYP3A or CYP2C9 inducers in the last 10 days.I am fully active and can carry on all pre-disease activities without restriction.I haven't taken strong medications like ketoconazole within the last 2 weeks.I am eligible for a specific drug combination therapy.I have taken a BH3 mimetic drug before.My blood or bone marrow shows signs of turning into leukemia.I am taking medication that affects blood clotting, except for low dose aspirin or LMWH.My blood, kidney, liver, and bone marrow are functioning well.I have not taken CYP2C9 inhibitors in the last 28 days or within their half-life period.I have other serious health conditions that are not under control.I have taken drugs that affect liver enzyme CYP2C9 within the last 10 days.I am receiving treatment for chronic active hepatitis B or C.I am eligible for a stem cell transplant.I cannot or do not want to have a stem cell transplant.I need treatment for myelofibrosis and have either not been treated with a JAK2 inhibitor or have only been treated with ruxolitinib.I haven't had any cancer other than myeloproliferative neoplasm in the last 2 years.I have been treated with a BH3 mimetic before.I am taking blood thinners other than low-dose aspirin or LMWH.I have tried ruxolitinib for myelofibrosis and it didn't work or caused side effects.
- Group 1: Part 5: Navitoclax + Ruxolitinib Combination Therapy
- Group 2: Part 1: Navitoclax Monotherapy
- Group 3: Part 4: Navitoclax + Celecoxib
- Group 4: Part 3: Navitoclax Monotherapy
- Group 5: Part 2: Navitoclax + Ruxolitinib Combination Therapy
- 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
What potential risks can be attributed to Navitoclax consumption?
"Limited clinical data for both safety and efficacy of Navitoclax resulted in a score of 1 on our scale."
Are there any vacancies available for those wishing to participate in this clinical trial?
"Per the data found on clinicaltrials.gov, this research is actively seeking participants. The trial was first posted in November of 2019 and has been recently updated as of October 2022."
What is the participant count of this research project?
"For this research to be successful, 72 patients that meet the eligibility requirements must participate. Such participants can join from two separate locations: St. Joseph Heritage Healthcare /ID# 242558 in Fullerton, California and Pennsylvania Cancer Specialists Research Institute - Gettysburg /ID# 242550 in Gettysburg, Pennsylvania."
What clinical conditions has Navitoclax been approved to address?
"The pharmaceutical Navitoclax has demonstrated efficacy in treating polycythemia vera, polycythemia and those that are resistant or intolerant to hydroxyurea."
Have any prior investigations explored the potential of Navitoclax as a therapeutic option?
"Presently, there are 141 clinical trials analysing the efficacy of Navitoclax, 18 of which are in the late stages. Though Beijing is home to a significant proportion of these experiments, 4398 sites around the world conduct investigations into this medication."
How many venues are conducting this experiment?
"Patients can obtain this intervention at St. Joseph Heritage Healthcare/ID# 242558 in Fullerton, California, Pennsylvania Cancer Specialists Research Institute - Gettysburg / ID# 242550 in Gettysburg, Pennsylvania and City of Hope/ ID# 239769in Duarte, Illinois as well as a further 15 clinical trial sites."
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