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Report for Clinical Trial NCT04233346

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

This protocol will allow ponatinib with refractory Chronic Myeloid Leukemia or Ph+ Acute Lymphoblastic Leukemia

NCT04233346 Chronic Myeloid Leukemia Acute Lymphoblastic Leukemia
MeSH:Leukemia Leukemia, Myeloid Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Myelogenous, Chronic, BCR-ABL Positive
HPO:Chronic myelogenous leukemia Leukemia Myeloid leukemia

1 Interventions

Name: Ponatinib

Description: CP-CML patients will be randomized into 30 mg and 45 mg dose groups at the ratio of 1:1,each group taken orally once daily. Other patients taken 45mg orally once daily.
Type: Drug
Group Labels: 1

Ponatinib


Primary Outcomes

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 months

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 hematology responses

Measure: MaHR(Major Hematologic Response) of AP-CML, BP-CML and Ph+ ALL patients by 6 months

Time: 6 months

Secondary Outcomes

Description: Assessment in the total patient population

Measure: Duration of response

Time: Up to 5 years

Description: Assessment in the total patient population

Measure: Progression-free survival (PFS)

Time: Up to 5 years

Description: Assessment in the total patient population

Measure: Overall survival (OS)

Time: Up to 5 years

Description: Assessment in the total patient population

Measure: Time to response (TTR)

Time: Up to 5 years

Description: Number of participants with adverse events as assessed by CTCAE v5.0

Measure: Adverse events

Time: Up to 5 years

Description: 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 years

Description: Plasma concentration-time data for the population PK study

Measure: Maximum Plasma Concentration [Cmax]

Time: Up to 3 months

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 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 ---

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 ---



HPO Nodes


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