OncoMatch/Clinical Trials/NCT01746836
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
Is NCT01746836 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Ponatinib Hydrochloride for chronic phase chronic myelogenous leukemia, bcr-abl1 positive.
Treatment: Ponatinib Hydrochloride — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Chronic Myeloid Leukemia
Biomarker criteria
Required: ABL1 fusion
Required: BCR fusion
Allowed: ABL1 t315i
Disease stage
Required: Stage CHRONIC PHASE
Excluded: Stage ACCELERATED PHASE, BLAST PHASE
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: BCR-ABL inhibitor (bosutinib, dasatinib, nilotinib) — second-generation TKI
failure to therapy to one FDA-approved second-generation TKI (currently bosutinib, dasatinib, and nilotinib are approved as frontline therapy), defined as per European leukemiaNet (ELN)35 or National Comprehensive Cancer Network (NCCN) recommendations
Cannot have received: BCR-ABL inhibitor
Exception: bosutinib, dasatinib, or nilotinib allowed
Prior therapy with other BCR-ABL-targeted TKIs except bosutinib, dasatinib or nilotinib
Cannot have received: BCR-ABL inhibitor
Exception: no more than one FDA-approved TKI for CML
Participants who have received more than one FDA-approved TKI for CML, or any investigational, non-FDA approved TKI
Lab requirements
Kidney function
creatinine clearance (CrCL) ≥ 30 mL/min (Cockcroft-Gault formula)
Liver function
total bilirubin ≤1.5x ULN (unless due to Gilbert syndrome, in which case it should be ≤3.0x ULN), SGPT ≤2.5x ULN
Adequate end organ function, defined as the following: total bilirubin ≤1.5x ULN (unless due to Gilbert syndrome, in which case it should be ≤3.0x ULN), SGPT ≤2.5x ULN, creatinine clearance (CrCL) ≥ 30 mL/min (Cockcroft-Gault formula).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- M D Anderson Cancer Center · Houston, Texas
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