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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| olverembatinib | Experimental | 40mg, taken orally once every other day of a 28-day cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| olverembatinib | Drug | olverembatinib, 40mg, taken orally once every other day of a 28-day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Molecular response (MR) 4.0 is defined as BCR-ABL transcripts ≤ 0.01 percent. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Du, Phd | Contact | 075583366388 | duxingz@medmail.com.cn | |
| Xin Du, Phd | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Xin Du, Phd | Shenzhen Second People's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenzhen Second People's Hospital | Recruiting | Shenzhen | Guangdong | 518035 | China |
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olverembatinib, 40mg, taken orally once every other day of a 28-day cycle
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| 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. | 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. | 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. | 12 months |
| Incidence of adverse events (AEs) and serious adverse events (SAEs) to Olverembatinib. | Evaluation of adverse events (AEs), serious AEs (SAEs) | 12 months. |
| ID | Term |
|---|---|
| D015466 | Leukemia, Myeloid, Chronic-Phase |
| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C579813 | olverembatinib |
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