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

Primary Purpose

Chemotherapy-induced Thrombocytopenia

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
QL0911
Sponsored by
Qilu Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chemotherapy-induced Thrombocytopenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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; Received bone marrow transplantation or stem cell infusion within one year before screening; Patients with chronic hepatitis B or hepatitis C in active period, and patients with positive antibodies to human immunodeficiency virus; The absolute value of neutrophils in the screening period is less than 1.5× 109/L, and hemoglobin is less than 90g/L; The total bilirubin in the screening period is more than 3 times the upper limit of the normal range; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were higher than the upper limit of normal range by 3 times. For patients with liver metastasis, alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≥ 5 times the upper limit of the normal range; Blood creatinine concentration ≥1.5ULN or EGFR ≤ 60 ml/min; patients with severe drug allergic reaction; Patients who have used any research drugs (excluding vitamins and minerals) within 3 months before the first administration; Patients who plan pregnancy, pregnancy or lactation; The researcher judges the patients who are not suitable for this experiment.

Sites / Locations

  • Shanghai East Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

QL0911 Group 1

QL0911 Group 2

QL0911 Group 3

Arm Description

Starting dose 1μg/kg;PLT 100~200×10^9/L

Starting dose 2μg/kg;PLT 100~200×10^9/L

Starting dose 2μg/kg;PLT <100×10^9/L

Outcomes

Primary Outcome Measures

The effective response rate of QL0911 on the 21st day (21-days chemotherapy cycle) after administration.
The effective response rate of QL0911 on the 28th day (28-days chemotherapy cycle) after administration.

Secondary Outcome Measures

Changes of platelet count from baseline in each visit(21-days chemotherapy cycle)
Changes of platelet count from baseline in each visit(28-days chemotherapy cycle)

Full Information

First Posted
April 23, 2023
Last Updated
May 5, 2023
Sponsor
Qilu Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05851027
Brief Title
Evaluating the Efficacy and Safety of QL0911 in Chemotherapy- Induced Thrombocytopenia
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
September 10, 2021 (Actual)
Study Completion Date
September 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qilu Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Thrombocytopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
QL0911 Group 1
Arm Type
Experimental
Arm Description
Starting dose 1μg/kg;PLT 100~200×10^9/L
Arm Title
QL0911 Group 2
Arm Type
Experimental
Arm Description
Starting dose 2μg/kg;PLT 100~200×10^9/L
Arm Title
QL0911 Group 3
Arm Type
Experimental
Arm Description
Starting dose 2μg/kg;PLT <100×10^9/L
Intervention Type
Drug
Intervention Name(s)
QL0911
Intervention Description
Qilu investigational product (QL0911 or placebo) will be administered in the clinic by a qualified healthcare provider as a subcutaneous injection.
Primary Outcome Measure Information:
Title
The effective response rate of QL0911 on the 21st day (21-days chemotherapy cycle) after administration.
Time Frame
21 days
Title
The effective response rate of QL0911 on the 28th day (28-days chemotherapy cycle) after administration.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Changes of platelet count from baseline in each visit(21-days chemotherapy cycle)
Time Frame
21 days
Title
Changes of platelet count from baseline in each visit(28-days chemotherapy cycle)
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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; Received bone marrow transplantation or stem cell infusion within one year before screening; Patients with chronic hepatitis B or hepatitis C in active period, and patients with positive antibodies to human immunodeficiency virus; The absolute value of neutrophils in the screening period is less than 1.5× 109/L, and hemoglobin is less than 90g/L; The total bilirubin in the screening period is more than 3 times the upper limit of the normal range; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were higher than the upper limit of normal range by 3 times. For patients with liver metastasis, alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≥ 5 times the upper limit of the normal range; Blood creatinine concentration ≥1.5ULN or EGFR ≤ 60 ml/min; patients with severe drug allergic reaction; Patients who have used any research drugs (excluding vitamins and minerals) within 3 months before the first administration; Patients who plan pregnancy, pregnancy or lactation; The researcher judges the patients who are not suitable for this experiment.
Facility Information:
Facility Name
Shanghai East Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200120
Country
China

12. IPD Sharing Statement

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

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