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Report for Clinical Trial NCT03883087

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase II Multi-center, Open Label Study of HQP1351 in Chinese Patients of Chronic Myeloid Leukemia With T315I Mutation in Chronic Phase

The purpose of this study is to evaluate the efficacy of HQP1351 in patients with chronic myeloid leukemia in chronic phase (CML-CP) harboring T315I mutation. The efficacy of HQP1351 was determined by evaluating the subjects' major cytogenetic response (MCyR).

NCT03883087 Chronic Myeloid Leukemia, Chronic Phase
MeSH:Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive
HPO:Chronic myelogenous leukemia Leukemia Myeloid leukemia

1 Interventions

Name: HQP1351

Description: 40 mg tablet, taken orally once every other day of a 28-day cycle
Type: Drug
Group Labels: 1

HQP1351


Primary Outcomes

Description: MCyR is the proportion of patients achieving Complete cytogenetic response (CCyR: defined as 0% Philadelphia chromosome-positive [Ph+] metaphases by cytogenetic analysis of bone marrow) or Partial Cytogenetic Response (PCyR: defined as >0% to 35% Ph+ metaphases by cytogenetic analysis of bone marrow). It is defined as the best response obtained by the subjects during the whole treatment process of the study. And MCyR can only be considered as CCyR if the subject meets PCyR at baseline.

Measure: Major cytogenetic response (MCyR)

Time: By the end of Cycle 24 (each cycle is 28 days)

Secondary Outcomes

Description: CCyR is the proportion of patients achieving CCyR after being treated with HQP1351. It is defined as the best response obtained by the subjects during the whole treatment process of the study.

Measure: Complete cytogenetic response (CCyR)

Time: By the end of Cycle 24 (each cycle is 28 days)

Description: CHR requires that all of the following are present: white blood cell<10×10E9/ liter; blood platelet count<450×10E9/ liter; no medullary immature granulocytes in the peripheral blood (such as protocell, promyelocyte and myelocyte); basophils in peripheral blood are less than 5%; no disease symptoms, signs and palpable splenomegaly has disappeared; the duration of the above criteria is no less than 4 weeks. We will calculate the proportion of patients achieving CHR after being treated with HQP1351. It is defined as the best response obtained by the subjects during the whole treatment process of the study.

Measure: Complete hematologic response (CHR)

Time: By the end of Cycle 24 (each cycle is 28 days)

Description: MMR is the proportion of patients achieving a ratio of ≤0.1% breakpoint cluster region (BCR) abelson leukemia (ABL) to ABL transcripts on the international scale (≤0.1% BCR-ABL/ABL[IS]) after being treated with HQP1351. It is defined as the best response obtained by the subjects during the whole treatment process of the study.

Measure: Major molecular response (MMR)

Time: By the end of Cycle 24 (each cycle is 28 days)

Description: BCR-ABL1(IS) ≤1% is the proportion of patients achieving BCR-ABL1(IS) ≤1% by quantitative polymerase chain reaction detection. It is defined as the best response obtained by the subjects during the whole treatment process of the study.

Measure: BCR-ABL1(IS) transcript ≤1%

Time: By the end of Cycle 24 (each cycle is 28 days)

Description: The time to response is defined as the interval between the first use of HQP1351 and the first date at which the criteria for response are met. The subject who isn't met the response criteria will be censored at the last assessment time.

Measure: Time to response

Time: By the end of Cycle 24 (each cycle is 28 days)

Description: Duration of response is defined as the interval between the first assessment at which the criteria for response are met until the earliest date at which the criteria for progression are met, and the subject who isn't met the progression criteria will be censored at the last assessment time. The duration of response is calculated only for subjects who achieved response.

Measure: Duration of response

Time: By the end of Cycle 24 (each cycle is 28 days)

Description: PFS is defined as the interval between the first dose date of HQP1351 treatment and the first date at which the criteria for progression are met, or death. The subject who isn't progression or death will be censored at the last response assessment.

Measure: Progression free survival (PFS)

Time: By the end of Cycle 24 (each cycle is 28 days)

Description: OS is defined as the interval between the first dose date of HQP1351 treatment and date of death, censored at the last contact date to be alive.

Measure: Overall survive (OS)

Time: By the end of Cycle 24 (each cycle is 28 days)

Description: Patients with HQP1351 treatment related AE, SAE will be assessed according NCI CTCAE Version 5.0.

Measure: Safety: adverse events (AEs), and serious AEs (SAEs)

Time: By the end of Cycle 24 (each cycle is 28 days)

Other Outcomes

Description: During the course of HQP1351 therapy, the relationship between BCR-ABL1 kinase region/other mutations and drug resistance/disease progression will be measured.

Measure: The relationship between mutation and efficacy.

Time: By the end of Cycle 24 (each cycle is 28 days)

Description: Objects' quality of life will be measured during the course of HQP1351 therapy by European Organization for Research and Treatment quality of life questionnaire core-30 version3.

Measure: Quality of life (QOL)

Time: By the end of Cycle 24 (each cycle is 28 days)

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 T315I

A Phase II Multi-center, Open Label Study of HQP1351 in Chinese Patients of Chronic Myeloid Leukemia With T315I Mutation in Chronic Phase. --- T315I ---

A Pivotal Study of HQP1351 in Patients of Chronic Myeloid Leukemia in Chronic Phase With T315I Mutation The purpose of this study is to evaluate the efficacy of HQP1351 in patients with chronic myeloid leukemia in chronic phase (CML-CP) harboring T315I mutation. --- T315I ---

A Pivotal Study of HQP1351 in Patients of Chronic Myeloid Leukemia in Chronic Phase With T315I Mutation The purpose of this study is to evaluate the efficacy of HQP1351 in patients with chronic myeloid leukemia in chronic phase (CML-CP) harboring T315I mutation. --- T315I --- --- T315I ---

After any targeted BCR-ABL1 tyrosine kinase inhibitors (TKI) treatment, CML-CP patients with T315I mutation. --- T315I ---

Chronic Myeloid Leukemia, Chronic Phase Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive This is an open, single-arm, multi-center phase 2 clinical study to evaluate the efficacy and safety of oral administrated HQP1351(40mg, QOD) in CML-CP patients with T315I mutation in China. --- T315I ---



HPO Nodes


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