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

ConditionsChronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive Philadelphia Chromosome Positive, BCR-ABL1 Positive Chronic Myelogenous Leukemia Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorM.D. Anderson Cancer Center

About this trial

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 criteria

Qualifiers

Diagnosis of Philadelphia chromosome (Ph)-positive (by cytogenetics or fluorescent in situ hybridization [FISH]) or breakpoint cluster region (BCR)-ABL-positive (by polymerase chain reaction [PCR]) CML in chronic phase.

Less than complete hematologic response (CHR) at or beyond 3 months

No partial cytogenetic response at or beyond 3 months

BCR-ABL1 ≥ 10% at or beyond 3 months

Disqualifiers

Prior therapy with other BCR-ABL-targeted TKIs except bosutinib, dasatinib or nilotinib. Participants with T315I mutations are eligible and will be analyzed separately.

Active NYHA cardiac class 3-4 heart disease

Any history of MI, unstable angina, cerebrovascular accident, or TIA

Any history of peripheral vascular infarction, including visceral infarction

Trial design

Treatments tested in this trial

Laboratory Biomarker Analysis
Ponatinib Hydrochloride
Quality-of-Life Assessment

Treatment groups

50 Participants

are divided into 1 treatment group

Sponsors and collaborators

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov