A Phase Ⅲa Study of Genetically Modified Recombinant Human Interleukin-11
NCT ID: NCT01663441
Last Updated: 2020-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
62 participants
INTERVENTIONAL
2015-03-31
2017-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
SINGLE
Study Groups
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A1
Patients in this treatment group will receive NL201(5μg/kg) in the first Chemotherapy cycle.Then，in the second Chemotherapy cycle，receive NL201(7.5μg/kg).
Only for Dose-finding in Phase Ⅲa.
NL201
mIL-11:5μg/kg，subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy；
NL201
mIL-11:7.5μg/kg，subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy；
A2
Patients in this treatment group will receive NL201(7.5μg/kg) in the first Chemotherapy cycle.Then，in the second Chemotherapy cycle，receive NL201(5μg/kg).
Only for Dose-finding in Phase Ⅲa.
NL201
mIL-11:5μg/kg，subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy；
NL201
mIL-11:7.5μg/kg，subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy；
A
Patients in this treatment group will receive NL201（optimal dosing dose）in the first Chemotherapy cycle.Then，in the second Chemotherapy cycle，receive rhIL-11(25μg/kg).
Only in Phase Ⅲb.
NL201
The optimal dosing dose NL201，subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy.
rhIL-11
rhIL-11(25μg/kg)，subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy.
B
Patients in this treatment group will receive rhIL-11(25μg/kg) in the first Chemotherapy cycle.Then，in the second Chemotherapy cycle，receive NL201（optimal dosing dose）.
Only in Phase Ⅲb.
NL201
The optimal dosing dose NL201，subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy.
rhIL-11
rhIL-11(25μg/kg)，subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy.
Interventions
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NL201
mIL-11:5μg/kg，subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy；
NL201
mIL-11:7.5μg/kg，subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy；
NL201
The optimal dosing dose NL201，subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy.
rhIL-11
rhIL-11(25μg/kg)，subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients (age,18-75 years) receiving chemotherapy, who had experienced platelet counts below 75×10\^9/L；
* patients were required to have adequate bone marrow,hepatic, and renal functions at the time of study entry；
* ECOG ≤2；
* patients to have normal laboratory findings:while white blood count \>3.0×10\^9/L,platelet count ≥100×10\^9/L, and AST and/or ALT lesser than 2.5 times the upper limit of the normal value；
* The estimated life expectancy of the patient was more than 3 months.
Exclusion Criteria
* patients with childbearing potential；
* patients who were breast-feeding or pregnant
18 Years
75 Years
ALL
No
Sponsors
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Beijing Northland Biotech. Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Beijing Cancer Hospital
Beijing, Beijing Municipality, China
The Third Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The First Hospital of Jilin University
Changchun, Jilin, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Countries
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Related Links
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Related Info
Other Identifiers
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NL201-Ⅲ-2012
Identifier Type: -
Identifier Source: org_study_id
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