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.

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Myeloid Leukemia, Chronic Phase; Olverembatinib; Tyrosine Kinase Inhibitors
• Intervention / Treatment: Drug: olverembatinib

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518035
      • Recruiting
      • Shenzhen Second People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: olverembatinib; 40mg, taken orally once every other day of a 28-day cycle	Drug: olverembatinib; olverembatinib, 40mg, taken orally once every other day of a 28-day cycle; Other Names: HQP1351

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shenzhen Second People's Hospital
• Investigators: Study Chair: Xin Du, Phd, Shenzhen Second People's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2022
• Primary Completion (ANTICIPATED): June 30, 2024
• Study Completion (ANTICIPATED): June 30, 2025

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: April 4, 2022
• First Posted (ACTUAL): April 5, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 29, 2022
• Last Update Submitted That Met QC Criteria: July 26, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: olverembatinib, CML-CP
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Myeloproliferative Disorders; Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Other Study ID Numbers: OLV20220331

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No