This protocol will allow ponatinib with refractory Chronic Myeloid Leukemia or Ph+ Acute Lymphoblastic Leukemia
Name: Ponatinib
Description: 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
Measure: MCyR(Major Cytogenetic Response) of CP-CML patients Time: 12 monthsDescription: 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
Measure: MaHR(Major Hematologic Response) of AP-CML, BP-CML and Ph+ ALL patients by 6 months Time: 6 monthsDescription: Assessment in the total patient population
Measure: Duration of response Time: Up to 5 yearsDescription: Assessment in the total patient population
Measure: Progression-free survival (PFS) Time: Up to 5 yearsDescription: Assessment in the total patient population
Measure: Overall survival (OS) Time: Up to 5 yearsDescription: Assessment in the total patient population
Measure: Time to response (TTR) Time: Up to 5 yearsDescription: Number of participants with adverse events as assessed by CTCAE v5.0
Measure: Adverse events Time: Up to 5 yearsDescription: 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.
Measure: EORTC QLQ-C30 (version 3) Time: Up to 5 yearsDescription: Plasma concentration-time data for the population PK study
Measure: Maximum Plasma Concentration [Cmax] Time: Up to 3 monthsAllocation: N/A
Single Group Assignment
There is one SNP
A Phase II Multi-center, Randomized, Open-label Study of Ponatinib in Chinese Patients With Chronic Myeloid Leukemia Who Have Failed Prior TKIs or With T315I Mutation, or Ph+ALL Who Have Failed Prior TKIs or With T315I Mutation. --- T315I ---
A Phase II Multi-center, Randomized, Open-label Study of Ponatinib in Chinese Patients With Chronic Myeloid Leukemia Who Have Failed Prior TKIs or With T315I Mutation, or Ph+ALL Who Have Failed Prior TKIs or With T315I Mutation. --- T315I --- --- T315I ---
The Study for CML Who Failed Prior TKIs or With T315I Mutation or Ph+ ALL Who Failed Prior TKIs or With T315I Mutation This protocol will allow ponatinib with refractory Chronic Myeloid Leukemia or Ph+ Acute Lymphoblastic Leukemia MCyR(Major Cytogenetic Response) of CP-CML patients. --- T315I ---
The Study for CML Who Failed Prior TKIs or With T315I Mutation or Ph+ ALL Who Failed Prior TKIs or With T315I Mutation This protocol will allow ponatinib with refractory Chronic Myeloid Leukemia or Ph+ Acute Lymphoblastic Leukemia MCyR(Major Cytogenetic Response) of CP-CML patients. --- T315I --- --- T315I ---
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. --- T315I ---
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. --- T315I --- --- T315I ---
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. --- T315I ---
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. --- T315I --- --- T315I ---
Inclusion Criteria: For CP-CML patients: 1. Patients with CP-CML Patients must either meet criterion 2 or 3: 2. Be previously treated with and resistant or intolerant to either Dasatinib or Nilotinib: 3. Develop the T315I mutation after any TKI therapy; 4. Must be ≥18 years old. 5. Provide written informed consent. --- T315I ---
Chronic Myeloid Leukemia Acute Lymphoblastic Leukemia Leukemia Leukemia, Myeloid Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Myelogenous, Chronic, BCR-ABL Positive 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. --- T315I ---