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this is a single-arm, open, multicenter, phase 2 study to evaluate the efficacy, safety and pharmacokinetics of HYLM-122 monotherapy in Chinese subjects with FLT3 positive relapsed or refractory acute myeloid leukemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HYML-122 treatment | Experimental | HYML-122 tablets, 200mg spec, 28 days for each cycle. The first eligible three enrolled subjects will be administrated with 600mg bid dose regimen for 28 consecutive days ( 1 treatment cycle). The Data Monitoring Committee (DMC) will evaluate the safety, efficacy and PK data of these three subjects and make decision whether the regimen need to be adjusted (increasing/decreasing administration dosing or adjusting dosing frequency). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HYML-122 | Drug | each treatment cycle is comprised of 28-day consecutive dosing of HYML-122. Upon completion of each cycle, patients may continue to receive oral HYML-122 tablets if they are benefit from the treatment and the toxicity is tolerable. |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | overall remission rate, including complete remission without minimum residual disease (CRMRD-), complete remission (CR), complete remission with incomplete hematologic recovery (CRi), complete remission without platelet recovery (CRp), partial remission (PR). | up to 24 months |
| composite complete remission (CRc) rate | CRc rate is defined as the rate of all complete and incomplete remission (CRMRD-+CR+CRp+CRi). | up to 24 months. |
| Measure | Description | Time Frame |
|---|---|---|
| RFS | relapse-free survival, for patients achieving a complete remission, defined as the interval from the date of first documentation of a leukemia free state to date of recurrence, treatment failure, death due to any cause or last contact of the end-of-study follow up, which ever occurs first. | up to 24 months |
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Inclusion Criteria:
Refractory to at least 1 cycle of induction chemotherapy. Relapsed after achieving remission with a prior therapy.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Shu, MD. BS. | Contact | 86-13918983465 | shuyang@tarapeutics.com |
| Name | Affiliation | Role |
|---|---|---|
| Depei Wu, MD. PhD | The First Affiliated Hospital of Soochow University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215006 | China |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007951 | Leukemia, Myeloid |
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| EFS |
event-free survival, EFS is defined as the time from the date of enrollment until the date of documented relapse from CR, CRp or CRi, treatment failure, death from any cause or last contact of the end-of-study follow-up, whichever occurs first. |
| up to 24 months |
| OS | overall survival, OS is defined as time from the date of enrollment until the date of death from any cause. For a subject who is not known to have died buy the end-of-study follow-up, OS is censored at the date of last contact. | up to 24 months |
| duration of CR remission | DOR-CR is defined as the time from the date of first CR, CRp, CRi until the date of documented relapse. | up to 24 months |
| Incidence of Treatment-Emergent Adverse Events (Safety and tolerability) | safety and tolerability of investigational product assessed as the number of participants experience adverse events (AEs, CTCAE 5.0) or abnormalities in vital signs, laboratory tests, or electrocardiograms. | up to 24 months |
| Cmax,ss | Peak plasma concentration at steady state | at the end of Cycle 1 (each cycle is 28 days) |
| Cmin,ss | Minimum plasma concentration at steady state | at the end of Cycle 1 (each cycle is 28 days) |
| Cav,ss | The average steady-state plasma concentration | at the end of Cycle 1 (each cycle is 28 days) |
| AUCss | The area under the plasma concentration at steady state | at the end of Cycle 1 (each cycle is 28 days) |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |