OlverembatinibPhase 3NCT05311943
Treatment With Olverembatinib in CML-CP Patients Who Failed to at Least Two Previously Administered Second-generation TKIs.
A Phase 3 study testing olverembatinib in people with Olverembatinib and Chronic Myeloid Leukemia, Chronic Phase, run by Shenzhen Second People's Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Olverembatinib, Chronic Myeloid Leukemia, Chronic Phase, Tyrosine Kinase Inhibitors
- What is being tested?
- olverembatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 30 Jun 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Xin Du, Phd contact
China1 site, 1 recruiting
- Recruiting
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518035
Xin Du, Phd, 075583366388 ext. 8196, duxingz@medmail.com.cn
About this study
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.
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.
- Being tested
- olverembatinib
- Keywords
- olverembatinib, CML-CP
- Medical subject headings
- Leukemia, Myeloid, Chronic-Phase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olverembatinibDrug
Also called HQP1351
olverembatinib, 40mg, taken orally once every other day of a 28-day cycle
| Study group | Role | What they receive |
|---|---|---|
| olverembatinib | Experimental | 40mg, taken orally once every other day of a 28-day cycle Receives: Drug: olverembatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (6)
The proportion of patients with MMR at 3, 6, 9 months.
Measured: 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.
Measured: 3, 6, 9, 12 months.
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.
Measured: 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.
Measured: 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.
Measured: 12 months
Incidence of adverse events (AEs) and serious adverse events (SAEs) to Olverembatinib.
Evaluation of adverse events (AEs), serious AEs (SAEs)
Measured: 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start1 Jul 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OlverembatinibStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- olverembatinib, 40mg, taken orally once every other day of a 28-day cycle
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Second People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xin Du, Phd, Study chair, Shenzhen Second People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05311943
- Sponsor's protocol ID
- OLV20220331
- Status last verified
- Mar 2022
- First submitted
- 28 Mar 2022
- Last updated
- 29 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05311943
- Acronym / sponsor ID
- OLV20220331
- Keywords
- olverembatinib, CML-CP
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shenzhen Second People's HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 5 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- olverembatinib, 40mg, taken orally once every other day of a 28-day cycle
| Arm | Type | Receives |
|---|---|---|
| olverembatinib | Experimental | Drug: olverembatinib40mg, taken orally once every other day of a 28-day cycle |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| olverembatinibAlso: HQP1351olverembatinib, 40mg, taken orally once every other day of a 28-day cycle | Drug | olverembatinib |
Primary outcome
The proportion of patients who achieve and maintain major molecular response(MMR) at 12 months using RQ-PCR test.
Time frame: 12 months
Major molecular response (MMR) is defined as BCR-ABL1 ≤ 0.1 percent.
6 secondary outcomes
The proportion of patients with MMR at 3, 6, 9 months.
Time frame: 3, 6, 9 months.
The proportion of patients with MR 4.0 at 3, 6, 9, 12 months.
Time frame: 3, 6, 9, 12 months.
Proportion of patients with MR 4.5 at 3, 6, 9, 12 months.
Time frame: 3, 6, 9, 12 months.
Progression free survival (PFS)
Time frame: 12 months
Overall survive (OS)
Time frame: 12 months
Incidence of adverse events (AEs) and serious adverse events (SAEs) to Olverembatinib.
Time frame: 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Olverembatinib
Not yet recruitingPhase 2
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Phase II Clinical Trial, Blinatumomab
RecruitingPhase 2
Phase II Study Assessing the Efficacy and Toxicity of Olverembatinib Monotherapy in Patients With Chronic Myeloid Leukemia in Chronic Phase After Failing One Prior Therapy With a Second Generation Tyrosine Kinase Inhibitor or Asciminib
Chronic Myeloid Leukemia
RecruitingPhase 1
A Phase I Study of Decitabine, Lisaftoclax, and Olverembatinib in Patients With Advanced Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Myeloid Leukemia
Advanced Chronic Myeloid Leukemia, Philadelphia Chromosome-Positive Acute Myeloid Leukemia
RecruitingPhase 3
Study of Olverembatinib (HQP1351) in Patients With CML-CP
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RecruitingPhase 1
Study for Safety and Efficacy of Olverembatinib Combined With APG-2575 in Children With Relapsed/Refractory Ph + ALL
Lymphoblastic Leukemia, Acute, Childhood, Leukemia, Lymphoblastic, Acute, Philadelphia-Positive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xin Du, Phd contact
Xin Du, Phd study chair
Shenzhen Second People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing olverembatinib in people with Olverembatinib and Chronic Myeloid Leukemia, Chronic Phase, run by Shenzhen Second People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xin Du, Phd (075583366388, duxingz@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients who achieve and maintain major molecular response(MMR) at 12 months using RQ-PCR test. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2022.