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

Shenzhen University

Status and phase: Enrolling; Phase 3

Conditions: Olverembatinib; Tyrosine Kinase Inhibitors; Chronic Myeloid Leukemia, Chronic Phase

Treatments: Drug: olverembatinib

Study type: Interventional

Funder types: Other

Identifiers

NCT05311943

OLV20220331

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

olverembatinib

Experimental group

Description:

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

Treatment:

Drug: olverembatinib