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

NCT05311943 | Unknown Phase 3

• 1 other identifier: OLV20220331
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

olverembatinib, CML-CP

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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.

  3, 6, 9, 12 months.

• Proportion of patients with MR 4.5 at 3, 6, 9, 12 months.

  3, 6, 9, 12 months.

• Progression free survival (PFS)

  12 months

• Overall survive (OS)

  12 months

Study Arms (1)

olverembatinib

EXPERIMENTAL

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

Drug: olverembatinib

Interventions

olverembatinib DRUG

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

Also known as: HQP1351

olverembatinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenzhen Second People's Hospital: lead

Study Sites (1)

Shenzhen Second People's Hospital

Shenzhen, Guangdong, 518035, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Chronic-Phase

Interventions

olverembatinib

Condition Hierarchy (Ancestors)

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xin Du, Phd

  Shenzhen Second People's Hospital

  STUDY CHAIR

Central Study Contacts

Xin Du, Phd

CONTACT

075583366388; duxingz@medmail.com.cn

Xin Du, Phd

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 5, 2022
• Study Start: July 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2025
• Last Updated: July 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)