A Randomized, Open-label, Phase 2 Trial of Ponatinib in Patients with Resistant Chronic Phase Chronic Myeloid Leukemia to Characterize the Efficacy and Safety of a Range of Doses

Conditions

Chronic Phase Chronic Myeloid Leukemia

Brief summary

01. ≤ 1% BCR-ABL1IS at 12 months for each starting dose cohort.

Detailed description

01. Molecular response rates: MMR at 12 and 24 months, 02. Cytogenetic response rates: MCyR by 12 months, 03. Duration of MMR, 04. Safety a.Rate of AOEs and VTEs in each dose cohort b.Rate of AEs in each dose cohort c.Rate of SAEs in each dose cohort, 05. Cytogenetic response rates: CCyR at 12 months, 06. Molecular response rates: MR4, and MR4.5 by and at 3-month intervals and MR1 (≤ 10% BCR-ABL1IS) at 3 months, 07. Hematologic response rate: Complete hematologic response (CHR) at 3 months, 08. Tolerability: a.Rate of discontinuation due to AEs in each dose cohort b.Dose reductions due to AE in each dose cohort c.Dose interruptions in each dose cohort, 09. Duration of response: a.Rate of ≤1% BCR-ABL1IS by 12 months and at and by 6, 18, and 24 months b.MMR at and by 6 and 18 months; and by 12 and 24 months, 10. Duration of response in responders, 11. Time to response, 12. Rate of progression to accelerated phase (AP-) or blast phase (BP-) CML, 13. PFS, 14. OS

Related papers

No related papers found yet.

Interventions

DRUGIclusig 30 mg film-coated tablets

DRUGIclusig 45 mg film-coated tablets

DRUGIclusig 15 mg film-coated tablets

DRUGPonatinib

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
01. ≤ 1% BCR-ABL1IS at 12 months for each starting dose cohort.	—

Secondary

Measure	Time frame
01. Molecular response rates: MMR at 12 and 24 months, 02. Cytogenetic response rates: MCyR by 12 months, 03. Duration of MMR, 04. Safety a.Rate of AOEs and VTEs in each dose cohort b.Rate of AEs in each dose cohort c.Rate of SAEs in each dose cohort, 05. Cytogenetic response rates: CCyR at 12 months, 06. Molecular response rates: MR4, and MR4.5 by and at 3-month intervals and MR1 (≤ 10% BCR-ABL1IS) at 3 months, 07. Hematologic response rate: Complete hematologic response (CHR) at 3 months, 08. Tolerability: a.Rate of discontinuation due to AEs in each dose cohort b.Dose reductions due to AE in each dose cohort c.Dose interruptions in each dose cohort, 09. Duration of response: a.Rate of ≤1% BCR-ABL1IS by 12 months and at and by 6, 18, and 24 months b.MMR at and by 6 and 18 months; and by 12 and 24 months, 10. Duration of response in responders, 11. Time to response, 12. Rate of progression to accelerated phase (AP-) or blast phase (BP-) CML, 13. PFS, 14. OS	—

Measure

Time frame

01. Molecular response rates: MMR at 12 and 24 months, 02. Cytogenetic response rates: MCyR by 12 months, 03. Duration of MMR, 04. Safety a.Rate of AOEs and VTEs in each dose cohort b.Rate of AEs in each dose cohort c.Rate of SAEs in each dose cohort, 05. Cytogenetic response rates: CCyR at 12 months, 06. Molecular response rates: MR4, and MR4.5 by and at 3-month intervals and MR1 (≤ 10% BCR-ABL1IS) at 3 months, 07. Hematologic response rate: Complete hematologic response (CHR) at 3 months, 08. Tolerability: a.Rate of discontinuation due to AEs in each dose cohort b.Dose reductions due to AE in each dose cohort c.Dose interruptions in each dose cohort, 09. Duration of response: a.Rate of ≤1% BCR-ABL1IS by 12 months and at and by 6, 18, and 24 months b.MMR at and by 6 and 18 months; and by 12 and 24 months, 10. Duration of response in responders, 11. Time to response, 12. Rate of progression to accelerated phase (AP-) or blast phase (BP-) CML, 13. PFS, 14. OS

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Countries

France, Poland

Outcome results

None listed