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

Phase 3

Recruiting

• Conditions: Chronic Myeloid Leukemia, Chronic Phase; Olverembatinib; Tyrosine Kinase Inhibitors
• Interventions: Drug: olverembatinib

• Registration Number: NCT05311943
• Lead Sponsor: Shenzhen Second People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-28
• Study First Submitted QC: 2022-04-04
• Study First Posted: 2022-04-05
• Study Start: 2022-07-01
• Last Update Submitted: 2022-07-26
• Last Update Posted: 2022-07-29
• Primary Completion: 2024-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
The proportion of patients with MMR at 3, 6, 9 months.	3, 6, 9 months.
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.
Incidence of adverse events (AEs) and serious adverse events (SAEs) to Olverembatinib.	12 months.	Evaluation of adverse events (AEs), serious AEs (SAEs)
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.
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.

Trial Locations

Locations (1)

Shenzhen Second People's Hospital; 🇨🇳 Shenzhen, Guangdong, China