Hetrombopag in Secondary Prevention of XPO-1 Inhibitor-induced Thrombocytopenia in Lymphoma

Phase 2

Not yet recruiting

• Conditions: Chemotherapy-Induced Thrombocytopenia
• Interventions: Drug: Hetrombopag

• Registration Number: NCT05969158
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-07-24
• Study First Submitted QC: 2023-07-24
• Study First Posted: 2023-08-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-01
• Study Start: 2023-09-04
• Last Update Posted: 2023-09-06
• Primary Completion: 2025-05-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

1. Thrombocytopenia caused by non-tumor chemotherapy drugs, including but not limited to hypersplenism, infection, and bleeding (including severe visceral or intracranial bleeding), occurred within 6 months before screening;
2. A history of blood other than lymphoma and chemotherapy-induced thrombocytopenia (CIT), such as acute lymphoblastic leukemia, acute myeloid leukemia, any myeloid malignancy, myelodysplastic syndrome, myeloproliferative diseases, and multiple myeloma;
3. Any history of arterial or venous thrombosis in the 3 months prior to screening;
4. Patients had clinical manifestations of severe bleeding (such as gastrointestinal bleeding, craniocerebral hemorrhage, etc.) 2 weeks before screening, or previous PLT > 400×109/L;
5. The subject has an allergic reaction to hetrombopag or any of its excipients;
6. Serious cardiovascular disease (such as NYHA heart function) in the 6 months prior to screening Score Ⅲ-Ⅳ), arrhythmias known to increase the risk of thromboembolism, such as atrial fibrillation, after coronary stenting, angioplasty, and coronary artery bypass grafting;
7. The subjects participated in other clinical studies of similar platelet enhancing drugs within 30 days prior to screening;
8. As assessed by the investigator, the subject has any concomitant medical history that could impair the subject's safe completion of the study, such as unstable angina pectoris, renal failure on hemodialysis, or active infection requiring intravenous antibiotics;
9. Subjects who are pregnant or breastfeeding, or who cannot use contraception during the trial;
10. Other circumstances in which the investigator considers the subject unsuitable for participation in the study;
11. HIV infected persons;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hetrombopag	Hetrombopag	Hetrombopag 5mg/d

Primary Outcome Measures

Name	Time	Method
The incidence of grade 3/4 thrombocytopenia during chemotherapy cycles before and after enrollment.	Five days before and five days after chemotherapy	The incidence of grade 3/4 thrombocytopenia during chemotherapy cycles before and after enrollment.

Secondary Outcome Measures

Name	Time	Method
The minimum and maximum values of median platelets before and after secondary prevention.	2-3 months	The minimum and maximum values of median platelets before and after secondary prevention.
The duration of PLT < 75×109 /L, PLT < 50×109 /L and PLT < 25×109 /L before and after chemotherapy;	2-3 months	The duration of PLT \< 75×109 /L, PLT \< 50×109 /L and PLT \< 25×109 /L before and after chemotherapy;
The time required for platelet recovery to 100×109/L and 75×109/L;	2-3 months	The time required for platelet recovery to 100×109/L and 75×109/L;
The proportion of patients receiving platelet transfusion, the number and amount of transfusion;	2-3 months	The proportion of patients receiving platelet transfusion, the number and amount of transfusion;
The proportion of reduced or delayed chemotherapy doses in the next cycle due to thrombocytopenia.	2-3 months	The proportion of reduced or delayed chemotherapy doses in the next cycle due to thrombocytopenia.