NCT05969158

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

An Open, Single-center, Phase II Clinical Study of Hetrombopag in Secondary Prevention of XPO-1 Inhibitor Selinexor Combined With Chemotherapy Induced Thrombocytopenia in Lymphoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chemotherapy-Induced Thrombocytopenia

Interventions

Type	Name	Description
DRUG	Hetrombopag	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).

Timeline

• Start date: 2023-09-04
• Primary completion: 2025-05-01
• Completion: 2025-08-01
• First posted: 2023-08-01
• Last updated: 2023-09-06