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Ponatinib for Chronic Myeloid Leukemia
Study Summary
This trial tests ponatinib hydrochloride as second line therapy for CML patients who didn't respond to initial treatment with imatinib mesylate, dasatinib, or nilotinib, or can't tolerate those treatments. Ponatinib hydrochloride may work by blocking a protein needed for cell growth.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 2 trial • 12 Patients • NCT02265341Trial Design
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Who is running the clinical trial?
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- I can care for myself and perform daily activities.My high blood pressure is not under control.My chronic myeloid leukemia is in an advanced stage.I have had pancreatitis in the last year.My CML is in the accelerated phase.My condition has worsened but not reached an advanced stage.I have taken more than one approved or experimental drug for my leukemia.My leukemia is in the early stage and tests positive for specific genetic markers.My organs are functioning well.I am using effective birth control methods.I have been treated with a BCR-ABL inhibitor other than bosutinib, dasatinib, or nilotinib.I have severe heart disease that limits my daily activities.I have had a heart attack, unstable chest pain, stroke, or mini-stroke.I have had severe heart failure in the last 6 months.I am using effective birth control methods.My cancer did not respond to a specific approved cancer drug.I stopped taking bosutinib, dasatinib, or nilotinib at least 2 days ago.I do not have any serious or uncontrolled heart conditions.My diabetes is not well-managed.I have a history of serious heart rhythm problems.I have had a blood clot in a vein within the last 6 months.I am older than 18 years.
- Group 1: Ponatinib hydrochloride
- 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
Why did researchers design this clinical trial?
"The purpose of this study is to assess the rate of MCyR at 6 months post-treatment (MCyR6) and will secondary measure duration of MCyR, MMR, and time to transformation to accelerated phase CML."
Are there any other precedents for this type of treatment?
"Ponatinib Hydrochloride is being trialed in 29 active studies, 3 of which are Phase 3 clinical trials. The highest concentration of these research centres for this medication are based in Roma and Gyeongsangbuk-do; however, there are 796 total locations running tests for Ponatinib Hydrochloride."
What indications does Ponatinib Hydrochloride usually treat?
"Ponatinib Hydrochloride is an effective treatment against acute lymphoblastic leukemia (all), myeloid leukemia, chronic, chronic phase, and leukemia, myeloid, accelerated phase."
How many people have been selected to participate in this clinical research?
"That is correct. Based on the information available on clinicaltrials.gov, it seems that this study is still open to recruiting patients. The trial was first posted on 1/17/2013 and edited for the last time on 6/15/2022. They are looking for 50 patients from a single site."
Are we still enrolling individuals in this experiment?
"That is correct. The clinical trial is currently underway and recruiting 50 patients from a single site, as stated on the website clinicaltrials.gov. This information was originally posted on 1/17/2013 and was last updated on 6/15/2022."
Has Ponatinib Hydrochloride been cleared for use by the FDA?
"Ponatinib Hydrochloride is considered to be a level 2 medication in terms of safety. While there is some evidence that it is safe, none of the clinical trials thus far have been able to confirm its efficacy."
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