Trials Sponsors Conditions Drugs Pricing

Conditions

Chronic Myeloid Leukemia - Accelerated Phase

Keywords

Chronic Myeloid Leukemia,CMLT315I mutationCML-APHQP1351Olverembatinib Tablets

Outcome Measures

Primary Outcomes (1)

Major hematologic response (MaHR)
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.
By the end of Cycle 24 (each cycle is 28 days)

Secondary Outcomes (9)

CHR
By the end of Cycle 24 (each cycle is 28 days)
Major cytogenetic response (MCyR)
By the end of Cycle 24 (each cycle is 28 days)
CCyR
By the end of Cycle 24 (each cycle is 28 days)
Major molecular response (MMR)
By the end of Cycle 24 (each cycle is 28 days)
Time to response
By the end of Cycle 24 (each cycle is 28 days)
+4 more secondary outcomes

Other Outcomes (2)

The relationship between mutation and efficacy.
By the end of Cycle 24 (each cycle is 28 days)
Quality of life (QOL)
By the end of Cycle 24 (each cycle is 28 days)

Study Arms (1)

HQP1351

EXPERIMENTAL

Drug: HQP1351

Interventions

HQP1351Drug

40 mg tablet, taken orally once every other day

HQP1351

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or non-pregnant, non-lactating female patients who are 18 years of age or older.
CML-AP patients with positive Ph chromosome or BCR-ABL fusion genes.

Sponsors & Collaborators

Ascentage Pharma Group Inc.
Industrylead

Study Sites (9)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Sun Yat-sen University Cancer Center

Guangzhou, Guandong, China

Nanfang hospital of southern medical university

Guangzhou, Guangdong, 510515, China

Shenzhen Second People's Hospital

Shenzhen, Guangdong, China

Henan Tumor Hospital

Zhengzhou, Henan, China

Tongji medical college Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Union Hospital medical college Huazhong University of Science and Technology

Related Publications (1)

Jiang Q, Li Z, Qin Y, Li W, Xu N, Liu B, Zhang Y, Meng L, Zhu H, Du X, Chen S, Liang Y, Hu Y, Liu X, Song Y, Men L, Chen Z, Niu Q, Wang H, Lu M, Yang D, Zhai Y, Huang X. Olverembatinib (HQP1351), a well-tolerated and effective tyrosine kinase inhibitor for patients with T315I-mutated chronic myeloid leukemia: results of an open-label, multicenter phase 1/2 trial. J Hematol Oncol. 2022 Aug 18;15(1):113. doi: 10.1186/s13045-022-01334-z.
PMID: 35982483DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Accelerated Phase

Interventions

olverembatinib

Condition Hierarchy (Ancestors)

Leukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic Processes

Study Officials

Xiaojun Huang, Professor
Peking University People's Hospital
PRINCIPAL INVESTIGATOR
Qian Jiang, Professor
Peking University People's Hospital
PRINCIPAL INVESTIGATOR

Enrollment

23 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 13, 2019

First Posted

March 20, 2019

Study Start

April 8, 2019

Actual (reported)

Primary Completion

You may not qualify if:

Received cytotoxic chemotherapy or radiotherapy within 28 days prior to the first administration, interferon or cytarabine or antitumor effect Chinese herbal medicine or Chinese patent medicine within 14 days prior to the first administration, or targeted BCR-ABL1 TKI within 7 days prior to the first administration, or hydroxyurea or anagrelide within 24 hours after the first administration, or adverse events (except alopecia) caused by previous treatment and have not recovered.
The patients who received any other investigating drugs within 14 days prior to first administration.
Patients who have progressed to blast phase (BP) in the past.
Patients who are currently receiving treatment with a medication that has the potential to interact with research drug.
Have previously been treated with ponatinib or HQP1351 (or drugs of similar composition).
Absorption disorder syndrome or other diseases affecting oral drug absorption.
Have any history of heart or vascular disease, such as hypertension (systolic blood pressure(HBP) \> 140mmHg and/or diastolic blood pressure \> 90mmHg), or take medications that are known to cause QT interval prolongation. The patients with well controlled HBP can be considered to be included.
Pulmonary systolic pressure (PSP) of echocardiography is more than 50 mmHg, or there is clinical symptom related to pulmonary hypertension.
Have a history of serious cardiovascular diseases during the previous treatment of chronic myeloid leukemia with TKI, including myocardial infarction, unstable angina pectoris, severe arrhythmia and congestive heart failure.
Underwent autologous or allogeneic stem cell transplant.
CML-AP patient currently diagnosed as major hematologic response (MaHR).
Have diseases with abnormal bleeding and coagulation function, or have a bleeding disorder unrelated to CML within 3 months before first dose of study drug.
Underwent major surgery (except minor surgical procedures, such as placement or bone marrow biopsy) with 14 days prior to the first dose of study drug.
Require concurrent treatment with immunosuppressive agents, other than corticosteroids prescribed for a short course of therapy (It is defined as a daily dose of corticosteroids less than 30 mg prednisone or the same amount of other corticosteroids within 7 days).
Have active nervous system (CNS) disease as evidence by cytology or pathology. In the absence of clinical CNS disease, lumbar puncture is not required.
+5 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Other Outcomes (2)

Study Arms (1)

HQP1351

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (9)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Other Outcomes (2)

Study Arms (1)

HQP1351

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (9)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations