Ponatinib - Frontline for Chronic Myeloid Leukemia (CML) in Accelerated Phase (AP)
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ClinicalTrials.gov Identifier: NCT01570868 |
Recruitment Status :
Terminated
(Closed due to slow accrual)
First Posted : April 4, 2012
Results First Posted : September 6, 2019
Last Update Posted : May 1, 2024
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Tracking Information | ||||
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First Submitted Date ICMJE | April 2, 2012 | |||
First Posted Date ICMJE | April 4, 2012 | |||
Results First Submitted Date ICMJE | May 26, 2017 | |||
Results First Posted Date ICMJE | September 6, 2019 | |||
Last Update Posted Date | May 1, 2024 | |||
Study Start Date ICMJE | April 2012 | |||
Actual Primary Completion Date | May 2016 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Complete Cytogenetic Response (CCyR) [ Time Frame: 6 months ] The binary indicator of complete cytogenetic remission measured from start of therapy to 6 months, denoted by CCR6. Method of Kaplan and Meier21 used to estimate the unadjusted distributions of time to toxicity, duration of CCR, and the times to transformation to accelerated phase or blastic phase chronic myeloid leukemia (CML).
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
Toxicity Profile: Most Common Grade 3-4 Non-Hematologic Adverse Events (AEs) Seen in More Than 1 Participant [ Time Frame: 3 months ] Time to toxicity monitoring defined as any grade 3 or 4 drug-related non-hematologic adverse event that has not resolved to grade 2 or less after 6 weeks of optimal therapeutic management, or drug-related toxicity of any grade that in the opinion of the investigator prevents further therapy with ponatinib. Time to toxicity monitored using the Bayesian method of Thall, et al.
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Original Secondary Outcome Measures ICMJE |
Time to Toxicity [ Time Frame: 3 months ] Time to toxicity (T) defined as any grade 3 or 4 drug-related non-hematologic adverse event that has not resolved to grade 2 or less after 6 weeks of optimal therapeutic management, or drug-related toxicity of any grade that in the opinion of the investigator prevents further therapy with ponatinib. Secondary outcomes include duration of complete cytogenic response (CCR), time to transformation to accelerated phase or blastic phase chronic myeloid leukemia (CML), and major molecular response (MMR). Time to toxicity monitored using the Bayesian method of Thall, et al.
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Ponatinib - Frontline for Chronic Myeloid Leukemia (CML) in Accelerated Phase (AP) | |||
Official Title ICMJE | Ponatinib as Initial Therapy for Patients With Chronic Myeloid Leukemia in Accelerated Phase | |||
Brief Summary | The goal of this clinical research study is to learn if ponatinib can help to control Chronic Myeloid Leukemia (CML) in accelerated phase. The safety of this drug will also be studied. Ponatinib is designed to block the function of BCR-ABL, which is the abnormal protein responsible for causing leukemia in certain cells. Ponatinib may cause a blood clot to form in an artery or in a vein. Depending on the location of the clot, this could cause a heart attack, a stroke, severe damage to other tissue, or death. A blood clot may occur within 2 weeks after you start taking the drug. About 25% (1 in 4) of patients taking the drug form an abnormal clot. Blood clots can occur in patients that do not have other known risk factors for forming clots. If you develop a blood clot, you will need to stop taking ponatinib. In some cases, emergency surgery could be needed to remove the clot and restore blood flow. |
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Detailed Description | Study Drug Administration: You will take ponatinib by mouth 1 time every day while you are on study with about a cup (8 ounces) of water. You should not eat within 2 hours before or after taking the drug. You will complete a study diary in which you will record the date and time that you take the study drug each time. If you miss any doses, you will also note this in the study diary. Bring this diary to every study visit, as described below. Study Visits: The tests and procedures for this study have a wide range of time in which they can be done. In general, your schedule of study visits will be as follows:
The study staff will help you schedule your study visits. The following tests and procedures will be performed:
Length of Participation: You may continue taking the study drug for up to 5 years. You will be taken off study early if intolerable side effects occur, if the disease gets worse, or if you are unable to follow study directions. Your participation on the study will be over when you have completed the follow-up visit/call. Follow-Up: If you leave the study, you will be called or you will come to the clinic within 30 days to learn about any side effects or symptoms you may be having. If you are called, this call will last about 2-3 minutes. This is an investigational study. Ponatinib is FDA approved to treat patients with certain types of leukemia. Its use in this study is investigational. Up to 80 patients will take part in this study. All will be enrolled at MD Anderson. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Intervention Model Description: Participants enrolled before July 25, 2013 were given a starting dose of 45 mg per day. The study was amended and the dose was lowered due to tolerability. Participants enrolled after this date were given a starting dose of 30 mg per day. Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | Leukemia | |||
Intervention ICMJE | Drug: Ponatinib
Starting dose: 45 mg by mouth once daily.
Other Name: AP24534
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
51 | |||
Original Estimated Enrollment ICMJE |
50 | |||
Actual Study Completion Date ICMJE | May 2016 | |||
Actual Primary Completion Date | May 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01570868 | |||
Other Study ID Numbers ICMJE | 2012-0074 NCI-2012-00572 ( Registry Identifier: NCI CTRP ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | M.D. Anderson Cancer Center | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | M.D. Anderson Cancer Center | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Ariad Pharmaceuticals | |||
Investigators ICMJE |
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PRS Account | M.D. Anderson Cancer Center | |||
Verification Date | April 2024 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |