A Phase 2 interventional study of Ponatinib 30mg OD and Ponatinib 45mg OD in Chronic Myeloid Leukemia and Acute Lymphoblastic Leukemia, sponsored by Otsuka Beijing Research Institute. Active, not recruiting at 14 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-04.
Sponsored by Otsuka Beijing Research Institute · Phase 2, Interventional, and Treatment
This protocol will allow ponatinib with refractory Chronic Myeloid Leukemia or Ph+ Acute Lymphoblastic Leukemia
The purpose of this study is to determine the safety and efficacy of ponatinib in patients with chronic myeloid leukemia (CML) in chronic phase (CP), accelerated phase (AP) or blast phase (BP) or with Ph positive (Ph+) acute lymphoblastic leukemia (ALL) who either are resistant or intolerant to either dasatinib or nilotinib, or have the T315I mutation.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 93 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Otsuka Beijing Research Institute is the lead sponsor of 36 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
For CP-CML patients:
Patients with CP-CML
Patients must either meet criterion 2 or 3:
For AP/BP-CML and ALL patients:
Exclusion Criteria:
For CP-CML patients:
Received other therapies (excluding hydroxyurea) as follows:
Received interferon, cytarabine, or immunotherapy within 14 days, or any other cytotoxic chemotherapy, radiotherapy, or investigational therapy within 28 days prior to receiving the first dose of Ponatinib.
For AP/BP-CML and ALL patients:
Received other therapies (excluding hydroxyurea) as follows:
For AP-CML patients, received interferon, cytarabine, or immunotherapy within 14 days, or any other cytotoxic chemotherapy, radiotherapy, or investigational therapy within 28 days prior to receiving the first dose of Ponatinib.
For BP-CML patients, received chemotherapy within 7 days prior to the first dose of Ponatinib. Otherwise, 2a applies.
For Ph+ ALL patients, received corticosteroids within 24 hours before the first dose of Ponatinib; otherwise, 2a applies.
50% CML patients will be treated with 30mg/day ponatinib,the treatment will up to 60 months
Drug: Ponatinib 30mg OD
50% CP-CML patients will be randomized 45 mg dose group . Other patients (with AP-CML, BP-CML, Ph+ ALL) will only be assigned to 45 mg dose group(30 patients). The treatment will up to 60 months.
Drug: Ponatinib 45mg OD
Ponatinib 30mg OD
Ponatinib 45mg OD
MCyR(Major Cytogenetic Response) of CP-CML patients
To confirm the efficacy of Ponatinib in Chinese patients with CML who have failed Dasatinib or Nilotinib or with T315I mutation, or Ph+ ALL who have failed prior TKIs or with T315I mutation as evidenced by cytogenetic responses
Time frame: 12 months
MaHR(Major Hematologic Response) of AP-CML, BP-CML and Ph+ ALL patients by 6 months
To confirm the efficacy of Ponatinib in Chinese patients with CML who have failed Dasatinib or Nilotinib or with T315I mutation, or Ph+ ALL who have failed prior TKIs or with T315I mutation as evidenced by hematology responses
Time frame: 6 months
Duration of response
Assessment in the total patient population
Time frame: Up to 5 years
Progression-free survival (PFS)
Assessment in the total patient population
Time frame: Up to 5 years
Overall survival (OS)
Assessment in the total patient population
Time frame: Up to 5 years
Time to response (TTR)
Assessment in the total patient population
Time frame: Up to 5 years
Adverse events
Number of participants with adverse events as assessed by CTCAE v5.0
Time frame: Up to 5 years
EORTC QLQ-C30 (version 3)
EORTC QLQ-C30 (version 3) score ranges from 1 to 4 or 1 to 7, A higher score represents a severer impressions or a best applies of patients.
Time frame: Up to 5 years
Maximum Plasma Concentration [Cmax]
Plasma concentration-time data for the population PK study
Time frame: Up to 3 months
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Otsuka Beijing Research Institute