Loading clinical trials...

UNKNOWNPHASE2

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

NCT05969158•Sun Yat-sen University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age between 18 and 70 years old, gender is not limited;
•2. Lymphoma was confirmed by histopathological or cytological examination;
•3. The patient needs to receive Selinexor combined chemotherapy containing XPO-1 inhibitor, which may include R-CHOP, R-gemox, DICE, DHAP, SMILE, etc., but is not limited to the above schemes;
•4. Patients who do not routinely undergo preventive platelet elevation therapy after the above treatment can receive salvage therapeutic platelet elevation therapy only when the PLT is \< 50×109/L;
•5. Patients with the lowest platelet value \< 50×109/L after the previous course of treatment.
•6. The patient's laboratory examination meets the following 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;
+1 more criteria

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;
+1 more criteria

Key Dates

Start Date

September 4, 2023

Primary Completion Date

May 1, 2025

Completion Date

August 1, 2025

Last Updated

September 6, 2023

Enrollment

ESTIMATED participants

Conditions

Chemotherapy-Induced Thrombocytopenia

Interventions

Hetrombopag

DRUG

Contacts

Zhiming Li, MD.

CONTACT

+86-13719189172 lizhm@sysucc.org.cn

Yu Wang, MD.

CONTACT

+86-20-87343765 wangyu@sysucc.org.cn

Romiplostim N01 for Chemotherapy-induced Thrombocytopenia

NCT07063225

Chemotherapy-induced ThrombocytopeniaRomiplostim N01

View study

ACTIVE_NOT_RECRUITINGPHASE3

Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Solid Tumors.

NCT05864014

Chemotherapy-Induced Thrombocytopenia

View study

UNKNOWN

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 6, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Romiplostim N01 for Chemotherapy-induced Thrombocytopenia

Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Solid Tumors.

Romiplostim in Chemotherapy-Induced Thrombocytopenia

The Efficacy and Safety of Hetrombopag as Secondary Prevention to Chemotherapy-induced Thrombocytopenia in Patients With Gynecologic Malignancies

Evaluating the Efficacy and Safety of QL0911 in Chemotherapy- Induced Thrombocytopenia

A Phase Ⅲa Study of Genetically Modified Recombinant Human Interleukin-11