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Tyrosine Kinase Inhibitor

Ponatinib for Chronic Myeloid Leukemia (OPTIC Trial)

Phase 2
Waitlist Available
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have chronic phase-chronic myelogenous leukemia/chronic myeloid leukemia (CP-CML) and have received at least two prior tyrosine kinase inhibitor (TKI) therapies and have demonstrated resistance to treatment OR have documented history of presence of T315I mutation after receiving any number of prior TKI.
Diagnosis of chronic myeloid leukemia (CML) will be made using standard hematopathologic and cytogenetic criteria; CP-CML will be defined by specific criteria.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to data cut-off: 31 may 2020 (approximately 5 years)
Awards & highlights

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.

Who is the study for?
This trial is for adults with chronic phase chronic myeloid leukemia (CP-CML) who have tried at least two tyrosine kinase inhibitors without success or have a specific mutation (T315I). Participants must be in good health otherwise, with proper liver, kidney, and pancreatic function, no major heart issues, and not pregnant. They should also agree to use effective contraception.Check my eligibility
What is being tested?
The study tests three different starting doses of ponatinib (45 mg, 30 mg, and 15 mg daily) to see how well they work in patients resistant to previous treatments or those with the T315I mutation. The goal is to achieve a very low level of cancer cells after one year as measured by a specific lab test.See study design
What are the potential side effects?
Ponatinib may cause side effects such as liver problems, pancreatitis, high blood pressure, rash or dry skin. It can also affect the heart's rhythm and increase the risk of blood clots or bleeding.

OPTIC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have chronic myeloid leukemia and my previous treatments haven't worked or I have a specific mutation.
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I have been diagnosed with chronic myeloid leukemia in the chronic phase.
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My tests show I have the Philadelphia chromosome in my cancer cells.
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My previous treatment with a TKI drug did not work.
Select...
My kidney function is within normal ranges.
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My pancreas is functioning normally.
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My liver is working well.
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I am able to care for myself and perform daily activities.

OPTIC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to data cut-off: 31 may 2020 (up to approximately 5 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to data cut-off: 31 may 2020 (up to approximately 5 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Molecular Response (MR2: <=1% Breakpoint Cluster Region-Abelson Transcript Level) as Measured by the International Scale (BCR-ABL1IS) at Month 12
Secondary outcome measures
Duration of Major Molecular Response (MMR/MR3)
Duration of Response in Responders
Kaplan-Meier Estimate of Duration of Response (DOR) of <=1% BCR-ABL1 IS (MR2) at Months 12 and 24
+13 more

OPTIC Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort C: Ponatinib 15 mgExperimental Treatment1 Intervention
Participants received ponatinib 15 mg orally once daily up to data cut-off: 31 May 2020 in each 28 day Cycle.
Group II: Cohort B: Ponatinib 30 mgExperimental Treatment1 Intervention
Ponatinib 30 mg orally once daily in each 28 day Cycle until achievement of ≤1% BCR-ABL1IS. Once ≤1% BCR-ABL1IS up to data cut-off: 31 May 2020. Once ≤1% BCR-ABL1IS was achieved, participants received reduced dose of ponatinib 15 mg orally once daily.
Group III: Cohort A: Ponatinib 45 mgExperimental Treatment1 Intervention
Ponatinib 45 mg orally once daily in each 28-day cycle until achievement of ≤1% BCR-ABL1IS up to data cut-off: 31 May 2020. Once ≤1% BCR-ABL1IS was achieved, participants received reduced dose of ponatinib 15 mg orally once daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ponatinib
2015
Completed Phase 2
~820

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor
1,198 Previous Clinical Trials
4,178,070 Total Patients Enrolled
Ariad PharmaceuticalsLead Sponsor
36 Previous Clinical Trials
3,606 Total Patients Enrolled
Study Director Clinical ScienceStudy DirectorTakeda
5 Previous Clinical Trials
1,184 Total Patients Enrolled

Media Library

Ponatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02467270 — Phase 2
Chronic Myeloid Leukemia Research Study Groups: Cohort A: Ponatinib 45 mg, Cohort C: Ponatinib 15 mg, Cohort B: Ponatinib 30 mg
Chronic Myeloid Leukemia Clinical Trial 2023: Ponatinib Highlights & Side Effects. Trial Name: NCT02467270 — Phase 2
Ponatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02467270 — Phase 2

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~29 spots leftby Mar 2025