Back to resultsTreatment With Olverembatinib in CML-CP Patients Who Failed to at Least Two Previously Administered Second-generation TKIs.
Primary Purpose
Olverembatinib, Chronic Myeloid Leukemia, Chronic Phase, Tyrosine Kinase Inhibitors
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
olverembatinib
Sponsored by
About this trial
This is an interventional treatment trial for Olverembatinib focused on measuring olverembatinib, CML-CP
Eligibility Criteria
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.
Sites / Locations
- Shenzhen Second People's HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
olverembatinib
Arm Description
40mg, taken orally once every other day of a 28-day cycle
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
The proportion of patients with MMR at 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.
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.
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.
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.
Incidence of adverse events (AEs) and serious adverse events (SAEs) to Olverembatinib.
Evaluation of adverse events (AEs), serious AEs (SAEs)
Full Information
NCT ID
NCT05311943
First Posted
March 28, 2022
Last Updated
July 26, 2022
Sponsor
Shenzhen Second People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05311943
Brief Title
Treatment With Olverembatinib in CML-CP Patients Who Failed to at Least Two Previously Administered Second-generation TKIs.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen Second People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Olverembatinib, Chronic Myeloid Leukemia, Chronic Phase, Tyrosine Kinase Inhibitors
Keywords
olverembatinib, CML-CP
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
olverembatinib, 40mg, taken orally once every other day of a 28-day cycle
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
olverembatinib
Arm Type
Experimental
Arm Description
40mg, taken orally once every other day of a 28-day cycle
Intervention Type
Drug
Intervention Name(s)
olverembatinib
Other Intervention Name(s)
HQP1351
Intervention Description
olverembatinib, 40mg, taken orally once every other day of a 28-day cycle
Primary Outcome Measure Information:
Title
The proportion of patients who achieve and maintain major molecular response(MMR) at 12 months using RQ-PCR test.
Description
Major molecular response (MMR) is defined as BCR-ABL1 ≤ 0.1 percent.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
The proportion of patients with MMR at 3, 6, 9 months.
Time Frame
3, 6, 9 months.
Title
The proportion of patients with MR 4.0 at 3, 6, 9, 12 months.
Description
Molecular response (MR) 4.0 is defined as BCR-ABL transcripts ≤ 0.01 percent.
Time Frame
3, 6, 9, 12 months.
Title
Proportion of patients with MR 4.5 at 3, 6, 9, 12 months.
Description
Molecular response (MR) 4.5 is defined as BCR-ABL transcripts ≤ 0.0032 percent.
Time Frame
3, 6, 9, 12 months.
Title
Progression free survival (PFS)
Description
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.
Time Frame
12 months
Title
Overall survive (OS)
Description
OS is defined as the interval between the first dose date and date of death, censored at the last contact date to be alive.
Time Frame
12 months
Title
Incidence of adverse events (AEs) and serious adverse events (SAEs) to Olverembatinib.
Description
Evaluation of adverse events (AEs), serious AEs (SAEs)
Time Frame
12 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Du, Phd
Phone
075583366388
Email
duxingz@medmail.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Du, Phd
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xin Du, Phd
Organizational Affiliation
Shenzhen Second People's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Shenzhen Second People's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518035
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Du, Phd
Phone
075583366388
Ext
8196
Email
duxingz@medmail.com.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment With Olverembatinib in CML-CP Patients Who Failed to at Least Two Previously Administered Second-generation TKIs.
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