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To explore the efficacy and safety of hetrombopag for secondary prevention of thrombocytopenia caused by XPO-1 inhibitor Selinexor combined with chemotherapy in patients with lymphoma.
To investigate the efficacy and safety of hetrombopag for secondary prevention of thrombocytopenia in patients with lymphoma treated with XPO-1 inhibitor Selinexor combined with chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hetrombopag | Experimental | Hetrombopag 5mg/d |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hetrombopag | Drug | After screening, patients who were treated with XPO-1 inhibitor Selinexor combined with chemotherapy and developed chemotherapy-related thrombocytopenia (CIT) after treatment and met the secondary prevention criteria were eligible for inclusion criteria. The platelet reduction after the previous chemotherapy was used as the control group: The patients did not routinely receive prophylactic platelet elevation therapy after the previous Selinexor combined chemotherapy, and when PLT < 50×109/L. Platelet reduction after chemotherapy in secondary prevention unit was used as the experimental group: The subjects will initiate treatment with 5 mg hetrombopag once a day, starting orally 5 days before chemotherapy, take it for 5 days (D-5-D-1), and continue taking it orally for 5 days after chemotherapy (D1-D5). |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of grade 3/4 thrombocytopenia during chemotherapy cycles before and after enrollment. | The incidence of grade 3/4 thrombocytopenia during chemotherapy cycles before and after enrollment. | Five days before and five days after chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| The minimum and maximum values of median platelets before and after secondary prevention. | The minimum and maximum values of median platelets before and after secondary prevention. | 2-3 months |
| The duration of PLT < 75×109 /L, PLT < 50×109 /L and PLT < 25×109 /L before and after chemotherapy; |
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Inclusion criteria:
(1) Adequate bone marrow function at Screening: absolute count of blood neutrophils (ANC) ≥1.5×109/L; Platelet (PLT) ≥100×109/L; Hemoglobin (HB) ≥90g/L; (2) Liver function: Without liver metastasis, serum total bilirubin (TBIL) ≤ upper limit of normal (ULN) ×1.5, alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ULN×3; With liver metastasis, TBIL≤ upper limit of normal (ULN) ×3, ALT, AST≤ULN×5; (3) Kidney function: creatinine (Cr) ≤1.5×ULN; (4) Coagulation function: International standardized ratio (INR) of prothrombin time (PT) ≤ULN×1.5;
7. Able to take oral medications;
8. Patients voluntarily sign informed consent;
9. Survival is expected to be ≥12 weeks at the time of screening, and can be treated with the current chemotherapy regimen for at least 2 cycles;
10. Subjects of reproductive age who agree to use reliable contraceptive methods throughout the study period (including male or female condoms, contraceptive foam, contraceptive gel, contraceptive film, contraceptive paste, contraceptive support, abstinence from sex, and insertion of an IUD); Excluding female subjects who have undergone hysterectomy, bilateral salpingectomy, bilateral tubal ligation, or more than 1 year postmenopausal, and male subjects who have undergone bilateral vasectomy or ligation.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhiming Li, MD. | Contact | +86-13719189172 | lizhm@sysucc.org.cn | |
| Yu Wang, MD. | Contact | +86-20-87343765 | wangyu@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zhiming Li, MD. | Sun Yat-sen University | Principal Investigator |
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| ID | Term |
|---|---|
| C000614661 | hetrombopag |
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The duration of PLT < 75×109 /L, PLT < 50×109 /L and PLT < 25×109 /L before and after chemotherapy; |
| 2-3 months |
| The time required for platelet recovery to 100×109/L and 75×109/L; | The time required for platelet recovery to 100×109/L and 75×109/L; | 2-3 months |
| The proportion of patients receiving platelet transfusion, the number and amount of transfusion; | The proportion of patients receiving platelet transfusion, the number and amount of transfusion; | 2-3 months |
| The proportion of reduced or delayed chemotherapy doses in the next cycle due to thrombocytopenia. | The proportion of reduced or delayed chemotherapy doses in the next cycle due to thrombocytopenia. | 2-3 months |