RecruitingPhase 2NCT01746836

Ponatinib Hydrochloride as Second Line Therapy in Treating Patients With Chronic Myeloid Leukemia in Chronic Phase Resistant or Intolerant to Imatinib Mesylate, Dasatinib, or Nilotinib

Ponatinib as Second Line Therapy for Patients With Chronic Myeloid Leukemia in Chronic Phase Resistant or Intolerant to Imatinib, Dasatinib or Nilotinib


Sponsor

M.D. Anderson Cancer Center

Enrollment

50 participants

Start Date

Jan 17, 2013

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial studies how well ponatinib hydrochloride works as second line therapy in treating patients with chronic myeloid leukemia in chronic phase that has not responded to initial treatment (first line) with imatinib mesylate, dasatinib, or nilotinib or cannot tolerate imatinib mesylate, dasatinib, or nilotinib. Ponatinib hydrochloride may stop or control the growth of cancer cells by blocking a protein needed for cell growth.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether ponatinib (a targeted cancer drug) can help people with chronic myeloid leukemia (CML — a type of blood cancer) who have not responded to or cannot tolerate other standard targeted therapies. **You may be eligible if...** - You have CML in its early (chronic) phase confirmed by specific genetic tests - Your cancer has not responded well to at least one standard targeted therapy (such as dasatinib, nilotinib, or bosutinib) - You are older than 18 and in reasonably good health - Your liver and kidney function tests are within acceptable limits - You are willing to use effective contraception during the study **You may NOT be eligible if...** - You have received more than one approved targeted therapy for CML, or any non-approved targeted therapy - You have serious heart or blood vessel disease (history of heart attack, stroke, blood clots, severe heart failure) - You have uncontrolled high blood pressure, poorly controlled diabetes (HbA1c over 7.5%), or active serious psychiatric illness - You are pregnant or breastfeeding - You have a history of pancreatitis (inflamed pancreas) within the past year - Your CML has advanced to a blast or accelerated phase Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERLaboratory Biomarker Analysis

Blood draws.

DRUGPonatinib Hydrochloride

Starting dose: 30 mg by mouth once a day.

OTHERQuality-of-Life Assessment

Surveys completed.


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT01746836


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