Treatment With Olverembatinib in CML-CP Patients Who Failed to at Least Two Previously Administered Second-generation TKIs.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2025-06-30

Brief Summary

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The purpose of this trial is to evaluate the efficacy and safety of olverembatinib(HQP1351) in patients with chronic myeloid leukemia in chronic phase (CML-CP) who are resistant and/or intolerant to at least two second-generation tyrosine kinase inhibitors. The efficacy of olverembatinib is determined by evaluating the major molecular responses(MMR) at the and of 12 months.

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Detailed Description

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Conditions

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Olverembatinib Chronic Myeloid Leukemia, Chronic Phase Tyrosine Kinase Inhibitors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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olverembatinib

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

Group Type EXPERIMENTAL

olverembatinib

Intervention Type DRUG

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

Interventions

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olverembatinib

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

Intervention Type DRUG

Other Intervention Names

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HQP1351

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years and ≤75 years.
* Diagnosis of CML-CP.
* ECOG performance of 0-2.
* Adequate end organ function defined as the following: total bilirubin \<1.5xULN, SGPT \<2.5x ULN, creatinine \<1.5x ULN.
* Resistance and/or intolerance of at least two second-generation TKIs.
* Patients must sign an informed consent form (ICF) indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.

Exclusion Criteria

* Known to be allergic to study drug ingredients or their analogues.
* History of undergone major surgery within 4 weeks.
* Patients unwilling or unable to comply with the protocol.
* Pregnant or breast-feeding patients.
* patients with other malignant tumor.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No