Actively Recruiting
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
Led by M.D. Anderson Cancer Center · Updated on 2026-03-09
50
Participants Needed
1
Research Sites
936 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Philadelphia chromosome-positive or BCR-ABL-positive chronic phase chronic myeloid leukemia confirmed by cytogenetics, FISH, or PCR
- Failure to therapy with one FDA-approved second-generation tyrosine kinase inhibitor (bosutinib, dasatinib, or nilotinib) as defined by European LeukemiaNet or NCCN guidelines
- Loss of complete cytogenetic response or development of mutations during prior TKI treatment
- Age over 18 years
- ECOG performance status of 0 to 2
- Adequate organ function including total bilirubin ≤1.5x upper limit of normal (or ≤3.0x if Gilbert syndrome), SGPT ≤2.5x upper limit, and creatinine clearance ≥30 mL/min
- Ability to provide informed consent
- Women of childbearing potential must practice effective birth control and have a negative pregnancy test before starting treatment
- Men must use effective birth control during the trial and for 3 months after last dose
- Discontinued prior second-generation TKI therapy or other anti-leukemia therapy (except hydroxyurea) at least 48 hours before study start and recovered from toxicity to grade 1 or better
You will not qualify if you...
- Prior therapy with BCR-ABL-targeted TKIs other than bosutinib, dasatinib, or nilotinib
- Active NYHA class 3-4 heart disease or uncontrolled cardiovascular disease including recent heart attack, unstable angina, stroke, TIA, peripheral vascular infarction, revascularization procedures, or severe heart failure
- History of significant atrial or ventricular arrhythmias
- Venous thromboembolism within 6 months prior to enrollment
- Active, uncontrolled psychiatric disorders including psychosis, major depression, or bipolar disorder
- Uncontrolled hypertension (blood pressure >150/90 mmHg) despite treatment or requiring 3 or more antihypertensive medications
- Poorly controlled diabetes with HbA1c >7.5%
- Pregnant or breastfeeding women
- History of pancreatitis within 1 year or chronic pancreatitis
- Accelerated or blast phase CML or history of blast phase
- More than one FDA-approved TKI or investigational non-FDA approved TKI for CML previously received except for specified second-generation TKIs
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
E
Elias Jabbour, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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