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

Treatment With Olverembatinib in Chronic Phase Chronic Myeloid Leukemia Patients Who Failed to at Least Two Previously Administered Second-generation Tyrosine Kinase Inhibitors: a Prospective, Single-arm Clinical Trial.

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05311943

Enrollment

Registered

2022-04-05

Start date

2022-07-01

Completion date

2025-06-30

Last updated

2022-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Myeloid Leukemia, Chronic Phase, Olverembatinib, Tyrosine Kinase Inhibitors

Keywords

olverembatinib, CML-CP

Brief summary

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.

Interventions

DRUGolverembatinib

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
The proportion of patients who achieve and maintain major molecular response(MMR) at 12 months using RQ-PCR test.	12 months	Major molecular response (MMR) is defined as BCR-ABL1 ≤ 0.1 percent.

Secondary

Measure	Time frame	Description
The proportion of patients with MR 4.0 at 3, 6, 9, 12 months.	3, 6, 9, 12 months.	Molecular response (MR) 4.0 is defined as BCR-ABL transcripts ≤ 0.01 percent.
Proportion of patients with MR 4.5 at 3, 6, 9, 12 months.	3, 6, 9, 12 months.	Molecular response (MR) 4.5 is defined as BCR-ABL transcripts ≤ 0.0032 percent.
The proportion of patients with MMR at 3, 6, 9 months.	3, 6, 9 months.	—
Overall survive (OS)	12 months	OS is defined as the interval between the first dose date and date of death, censored at the last contact date to be alive.
Incidence of adverse events (AEs) and serious adverse events (SAEs) to Olverembatinib.	12 months.	Evaluation of adverse events (AEs), serious AEs (SAEs)
Progression free survival (PFS)	12 months	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.

Countries

China

Contacts

Primary ContactXin Du, Phd

duxingz@medmail.com.cn075583366388

Backup ContactXin Du, Phd

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026