Neoplasms

Blood and Lymph Conditions

All Conditions

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Neoplasms by Histologic Type

Hematologic Diseases

Myeloproliferative Disorders

Bone Marrow Diseases

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Myeloid Leukemia

Chronic Myeloid Leukemia

Chronic Myeloproliferative Disorders

All Drugs and Chemicals

Antineoplastic Agents

Anti-Infective Agents

Antisickling Agents

Amino Acids

Nilotinib

Dasatinib

Interferons

Homoharringtonine

Tyrosine Kinase Inhibitors

Hydroxyurea

Imatinib Mesylate

Antiviral Agents

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

HQP1351 40 mg, taken orally once every other day of a 28-day cycle

Best available therapy (BAT) will be selected by the investigator for each participant.

HQP1351 is a new, bioavailable inhibitor against BCRABLWT and a broad spectrum of BCR-ABL mutants including BCR-ABLT315I

HQP1351

Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines.

Hydroxyurea or Interferon-based therapy

Imatinib, Dasatinib or Nilotinib

Xiaojun Huang, Professor

The purpose of this study is to evaluate the efficacy of HQP1351 in patients with chronic myeloid leukemia in chronic phase (CML-CP) who are resistant and/or intolerant to first- and second-generation tyrosine kinase inhibitors. The efficacy of HQP1351 is determined by evaluating the subjects' event free survival (EFS).

This is a phase 2, randomized, open label, pivotal study to evaluate the efficacy and safety of HQP1351 in CML CP patients who are resistant and/or intolerant to first- and second-generation TKIs in China. A total of 141 CML CP patients will be included in this study. After screening, eligible subjects will be randomized by 2:1 ratio to enter HQP1351 therapy cohort and best available therapy (BAT) cohort. When the subjects in the two cohorts reach EFS assessment, they can crossover to contralateral cohort if the investigator and Sponsor think they could be clinically benefited. During treatment, each subject will be assessed regularly for hematological, cytogenetic and molecular responses. At the same time, safety information also will be evaluated.

A Pivotal Study of HQP1351 in Patients With Chronic Myeloid Leukemia in Chronic Phase

A Phase 2, Randomized, Open Label, Pivotal Study to Evaluate the Efficacy and Safety of HQP1351 in CML CP Patients Who Are Resistant and/or Intolerant to First- and Second-Generation Tyrosine Kinase Inhibitors

EFS is defined as any "event" occurred since randomization, such as disease progression.

CHR is the proportion of patients achieving CHR after being treated. It is defined as the best response obtained by the subjects during the whole treatment process of the study.

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.

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

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.

PFS is defined as the interval between the first dose date 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.

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

Adverse events (AEs), and serious AEs (SAEs): Patients treatment related AE, SAE will be assessed according NCI CTCAE Version 5.0.

HealthQuest Pharma Inc.

Ascentage Pharma Group Inc.

Leukemia, Myeloid, Accelerated Phase

40 mg tablet, taken orally once every other day

Qian Jiang, Professor

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

This is an open, single-arm, multi-center phase 2 clinical study to evaluate the efficacy and safety of oral administrated of HQP1351(40mg, QOD) in CML-AP patients with T315I mutation in China. A total of 20 CML-AP patients will be included in this pivotal study. After screening, eligible subjects will receive oral HQP1351 40mg on a continues once every other day dosing regimen, until disease progression, drug intolerance, or meet other treatment conditions to discontinue the study. During the course of treatment, each subject will be assessed regularly for hematological, cytogenetic and molecular responses. At the same time, safety information also will be evaluated.

A Pivotal Study of HQP1351 in Patients of Chronic Myeloid Leukemia in Accelerated Phase With T315I Mutation

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

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

Objects' quality of life will be measured during the course of HQP1351 therapy by European Organization for Research and Treatment (EORTC) quality of life questionnaire core-30 version3 \[QLQ-C30(V3) questionnaire\].

MaHR is the proportion of patients achieving Complete hematologic response (CHR) or no evidence of leukemia (NEL). It is defined as the best response obtained by the subjects during the whole treatment process of the study.

CHR is 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.

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.

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.

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.

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.

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.

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Pivotal Study of HQP1351 in Patients With Chronic Myeloid Leukemia in Chronic Phase	NCT04126681	Chronic Myeloid...	HQP1351 Hydroxyurea or ... Homoharringtoni... Imatinib, Dasat...	18 Years -	Ascentage Pharma Group Inc.
A Pivotal Study of HQP1351 in Patients With Chronic Myeloid Leukemia in Chronic Phase	NCT04126681	Chronic Myeloid...	HQP1351 Hydroxyurea or ... Homoharringtoni... Imatinib, Dasat...	18 Years -	Ascentage Pharma Group Inc.
A Pivotal Study of HQP1351 in Patients of Chronic Myeloid Leukemia in Accelerated Phase With T315I Mutation	NCT03883100	Chronic Myeloid...	HQP1351	18 Years -	Ascentage Pharma Group Inc.

Spots Global Cancer Trial Database for olverembatinib tablets