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Status unknownNCT05311943Updated Jul 29, 2022

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

A Phase 3 interventional study of olverembatinib in Olverembatinib, Chronic Myeloid Leukemia, Chronic Phase and Tyrosine Kinase Inhibitors, sponsored by Shenzhen Second People's Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-07-29.

Sponsored by Shenzhen Second People's Hospital · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • olverembatinib, CML-CP
03

In context

Leukemia, Myeloid, Chronic-Phase

192 studies on the registry are indexed under Leukemia, Myeloid, Chronic-Phase; 27 are open to participants now.

This study's planned enrollment of 40 is below the median of 50 across 152 interventional studies indexed under Leukemia, Myeloid, Chronic-Phase.

Browse Leukemia, Myeloid, Chronic-Phase studies →

Lead sponsor

Shenzhen Second People's Hospital is the lead sponsor of 51 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    olverembatinib

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

    Drug: olverembatinib

Interventions

  • Drugolverembatinib

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

    Also known as: HQP1351

06

What researchers measure

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.

    Time frame: 12 months

Secondary outcomes

  1. The proportion of patients with MMR at 3, 6, 9 months.

    Time frame: 3, 6, 9 months.

  2. 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.

    Time frame: 3, 6, 9, 12 months.

  3. 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.

    Time frame: 3, 6, 9, 12 months.

  4. 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.

    Time frame: 12 months

  5. 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.

    Time frame: 12 months

  6. Incidence of adverse events (AEs) and serious adverse events (SAEs) to Olverembatinib.

    Evaluation of adverse events (AEs), serious AEs (SAEs)

    Time frame: 12 months.

07

Study locations

1 of 1 sites recruiting
  • Shenzhen Second People's Hospital
    Shenzhen, Guangdong 518035, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2022 (actual). Primary completion is estimated for Jun 2024, 23 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 28, 2022
First posted
Apr 5, 2022
StartActual
Jul 1, 2022
Primary completionEst.
Jun 30, 2024
CompletionEst.
Jun 30, 2025
Last update
Jul 29, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05311943
Lead sponsor
Shenzhen Second People's Hospital
Responsible party
Sponsor
First posted
Apr 5, 2022
Start date
Jul 1, 2022
Primary completion
Jun 30, 2024 (estimated)
Completion
Jun 30, 2025 (estimated)
Last update
Jul 29, 2022

Study contacts

Xin Du, Phd
Contact
duxingz@medmail.com.cn
075583366388
Xin Du, Phd
Contact
Xin Du, Phd
study chair · Shenzhen Second People's Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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