Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloid Leukemia, Chronic Phase | Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Olverembatinib | — | UNRESOLVED | — |
| Tyrosine Kinase Inhibitors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| olverembatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- olverembatinib
- description
- 40mg, taken orally once every other day of a 28-day cycle
- interventionNames
- Drug: olverembatinib
Primary outcomes (1)
- measure
- The proportion of patients who achieve and maintain major molecular response(MMR) at 12 months using RQ-PCR test.
- timeFrame
- 12 months
- description
- Major molecular response (MMR) is defined as BCR-ABL1 ≤ 0.1 percent.
Secondary outcomes (6)
- measure
- The proportion of patients with MMR at 3, 6, 9 months.
- timeFrame
- 3, 6, 9 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available