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

Chronic Myeloid Leukemia, Chronic Phase Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05311943
• Other study ID #: OLV20220331
• Status: Recruiting
• Phase: Phase 3
• Start date: July 1, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: March 2022
• Source: Shenzhen Second People's Hospital
• Contact: Xin Du, Phd
• Phone: 075583366388
• Email: duxingz[@]medmail.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia, Chronic Phase
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

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

Locations

Country	Name	City	State
China	Shenzhen Second People's Hospital	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen Second People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients who achieve and maintain major molecular response(MMR) at 12 months using RQ-PCR test.	Major molecular response (MMR) is defined as BCR-ABL1 = 0.1 percent.	12 months
Secondary	The proportion of patients with MMR at 3, 6, 9 months.		3, 6, 9 months.
Secondary	The proportion of patients with MR 4.0 at 3, 6, 9, 12 months.	Molecular response (MR) 4.0 is defined as BCR-ABL transcripts = 0.01 percent.	3, 6, 9, 12 months.
Secondary	Proportion of patients with MR 4.5 at 3, 6, 9, 12 months.	Molecular response (MR) 4.5 is defined as BCR-ABL transcripts = 0.0032 percent.	3, 6, 9, 12 months.
Secondary	Progression free survival (PFS)	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.	12 months
Secondary	Overall survive (OS)	OS is defined as the interval between the first dose date and date of death, censored at the last contact date to be alive.	12 months
Secondary	Incidence of adverse events (AEs) and serious adverse events (SAEs) to Olverembatinib.	Evaluation of adverse events (AEs), serious AEs (SAEs)	12 months.