Health TrialsbyHealthPanel

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 PositivePhiladelphia Chromosome Positive, BCR-ABL1 Positive Chronic Myelogenous LeukemiaRecurrent 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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Laboratory Biomarker Analysis

    Other intervention

    Blood draws.

  • Ponatinib Hydrochloride

    Drug

    Starting dose: 30 mg by mouth once a day.

  • Quality-of-Life Assessment

    Other intervention

    Surveys completed.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Ponatinib hydrochlorideExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

MCyR at 6 months (MCyR6)

The method of Kaplan and Meier will be used to estimate the unadjusted distribution of duration of MCyR. An appropriate time-to-event regression model will be fit to the event time data to assess the effects of patient covariates on the event time variable, with the particular model determined by preliminary goodness-of-fit analyses. The distribution of MCyR6 will be tabulated and effects of baseline patient covariates on this variable will be assessed by logistic regression.

Time frame
At 6 months
2

Time-to-toxicity defined as any grade 3 or 4 drug-related adverse event that is not responsive to standard therapeutic management and requires permanent treatment discontinuation

Time-to-toxicity will be monitored using the Bayesian method of Thall, et al. The method of Kaplan and Meier will be used to estimate the unadjusted distribution of time to toxicity. An appropriate time-to-event regression model will be fit to the event time data to assess the effects of patient covariates on the event time variable, with the particular model determined by preliminary goodness-of-fit analyses.

Time frame
Up to 30 days post-treatment

Secondary outcomes

1

Duration of MCyR

The method of Kaplan and Meier will be used to estimate the unadjusted distribution of the duration of MCyR. An appropriate time-to-event regression model will be fit to the event time data to assess the effects of patient covariates on the event time variable, with the particular model determined by preliminary goodness-of-fit analyses.

Time frame
Up to 24 months
2

Time to transformation to accelerated phase CML

The method of Kaplan and Meier will be used to estimate the unadjusted distribution of the time to transformation to accelerated phase CML. An appropriate time-to-event regression model will be fit to the event time data to assess the effects of patient covariates on the event time variable, with the particular model determined by preliminary goodness-of-fit analyses.

Time frame
Up to 5 years
3

Time to transformation to blastic phase CML

The method of Kaplan and Meier will be used to estimate the unadjusted distribution of the time to transformation to blastic phase CML. An appropriate time-to-event regression model will be fit to the event time data to assess the effects of patient covariates on the event time variable, with the particular model determined by preliminary goodness-of-fit analyses.

Time frame
Up to 5 years
4

MMR

An appropriate time-to-event regression model will be fit to the event time data to assess the effects of patient covariates on the event time variable, with the particular model determined by preliminary goodness-of-fit analyses. The distribution of MMR will be tabulated and effects of baseline patient covariates on this variable will be assessed by logistic regression.

Time frame
Up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
Apply now