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COMPLETEDPHASE2/PHASE3

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

A Multicenter, Randomized, Double Blind, Placebo Controlled Phase 3 Study Evaluating the Efficacy and Safety of Recombinant Human Thrombopoietin Mimetic Peptide-Fc Fusion Protein for Injection (QL0911) in Chemotherapy- Induced Thrombocytopenia

NCT05851027•Qilu Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

To evaluate the efficacy and safety of QL0911 in Chemotherapy- Induced Thrombocytopenia. Thrombocytopenia is a low number of platelets in the blood. Sometimes, thrombocytopenia is a side effect of chemotherapy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•At least 18 years old when signing the informed consent form;
•Histopathological or cytological examination, confirmed as solid tumor or lymphoma (including NSCLC, breast cancer, bladder cancer, pancreatic cancer, etc.), the chemotherapy cycle is 21 days or 28 days, and one or more of the following chemotherapy drugs are needed: anti-metabolic drugs, including gemcitabine, etc.; Platinum, including carboplatin, nedaplatin, cisplatin, lobaplatin, etc. Anthracyclines, including adriamycin, daunorubicin, epirubicin, etc. Alkylating agent, including cyclophosphamide, ifosfamide, etc. Other cytotoxic chemotherapy drugs that can cause thrombocytopenia;
•In the last regular chemotherapy cycle, the subject had a decrease in platelet count below 75× 109/L;
•Platelet count ≤ 200× 109/L one day before chemotherapy;
•The estimated survival time at screening is ≥12 weeks, and the current chemotherapy regimen can be accepted for at least 2 cycles (at least 1 cycle in PartA);
•According to the score standard of physical fitness of the Eastern Cancer Cooperative Group (ECOG), it is 0-2;
•Fully understand and abide by the requirements of this study, and sign the informed consent form voluntarily.

Exclusion Criteria

•Suffering from other hematopoietic diseases except lymphoma, including leukemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma and myelodysplastic syndrome;
•Thrombocytopenia caused by non-tumor chemotherapy drugs occurred within 6 months before screening, including but not limited to EDTA-dependent pseudothrombocytopenia, hypersplenism, infection and bleeding;
•Bone marrow invasion or bone marrow metastasis occurs;
•Being receiving radiotherapy or having received abdominal or pelvic radiotherapy within 3 months;
•There have been any arterial or venous thrombosis events within 6 months before screening;
•Screening patients with severe cardiovascular disease (NYHA cardiac function score III-IV) and arrhythmia that increases the risk of thrombosis, such as atrial fibrillation, after coronary stent implantation, angioplasty and coronary artery bypass grafting;
•Clinical manifestations of severe bleeding (such as gastrointestinal bleeding, etc.) within 2 weeks before screening;
•Received platelet transfusion within 2 days before randomization;
•Patients have been treated with thrombopoietin receptor agonists (such as romistine and itrapoppa) or human recombinant thrombopoietin (rhTPO) or rhIL-11 within 4 weeks before the first administration;
•Anticoagulant drugs such as heparin, warfarin and aspirin have been used within 7 days before the first administration;
+9 more criteria

Locations (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

January 15, 2021

Primary Completion Date

September 10, 2021

Completion Date

September 10, 2021

Last Updated

May 9, 2023

Enrollment

ACTUAL participants

Conditions

Chemotherapy-induced Thrombocytopenia

Interventions

QL0911

DRUG

Romiplostim N01 for Chemotherapy-induced Thrombocytopenia

NCT07063225

Chemotherapy-induced ThrombocytopeniaRomiplostim N01

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ACTIVE_NOT_RECRUITINGPHASE3

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

NCT05864014

Chemotherapy-Induced Thrombocytopenia

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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: May 9, 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.

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

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

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

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