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Ponatinib for Chronic Myeloid Leukemia (OPTIC Trial)
OPTIC Trial Summary
This trial is testing the effectiveness of a drug called ponatinib for people with a certain type of leukemia who haven't responded to other treatments.
OPTIC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowOPTIC Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.OPTIC Trial Design
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Who is running the clinical trial?
Media Library
- I have a bleeding disorder not caused by my leukemia.I had a stem cell transplant less than 60 days ago and am experiencing or being treated for graft-versus-host disease.I haven't had certain cancer treatments or recovered from their side effects recently.I have been treated with ponatinib before.My high blood pressure is not under control.I have had cancer before, but it's not one of the few exceptions.I have chronic myeloid leukemia and my previous treatments haven't worked or I have a specific mutation.I have been diagnosed with chronic myeloid leukemia in the chronic phase.My tests show I have the Philadelphia chromosome in my cancer cells.My previous treatment with a TKI drug did not work.My kidney function is within normal ranges.I have recovered from side effects of previous cancer treatments.I do not have any health conditions that would make the trial unsafe for me.I have not had major surgery in the last 2 weeks.I am currently on IV antibiotics for an infection.I have been diagnosed with HIV.My pancreas is functioning normally.I have a serious heart condition that is not under control.I am not on medications known to cause heart rhythm problems.My liver is working well.My diabetes is not well-managed.I do not have any stomach or bowel problems that affect how I absorb medicine taken by mouth.I am being considered for a stem cell transplant within the next 6-12 months.I haven't taken any targeted cancer drugs or experimental treatments recently.I am able to care for myself and perform daily activities.I have had pancreatitis before.
- Group 1: Cohort A: Ponatinib 45 mg
- Group 2: Cohort C: Ponatinib 15 mg
- Group 3: Cohort B: Ponatinib 30 mg
- 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 places are conducting this experiment?
"Currently, this clinical trial is being conducted at 19 different sites. Some of these locations include Durham, Minneapolis and Hackensack. There are also 16 other sites that are running this trial. If you are considering participating, it would be beneficial to choose a site that is close to your location to minimize travel."
What are the common conditions that Ponatinib is used to treat?
"Ponatinib is an effective treatment for acute lymphoblastic leukemia (all), myeloid leukemia, chronic, chronic phase, and leukemia, myeloid, accelerated phase."
How does this Ponatinib research compare to other published material?
"Currently, there are 29 different clinical trials involving ponatinib with 3 of them being in the final stage. Most of these trials are concentrated in Portland, Oregon; however, there are 795 research sites for ponatinib clinical trials in total."
Is Ponatinib really effective in treating patients or are there other potential side effects?
"Ponatinib is still being tested for efficacy in clinical trials, but the data collected thus far supports its safety."
Does this clinical trial have room for new participants?
"Although this trial is not currently recruiting, it was last updated on 1/4/2022. There are many other active clinical trials for myeloid leukemia, chronic, chronic phase and Ponatinib with 29 and 1501 trials respectively."
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