Chemotherapy-induced Thrombocytopenia
Conditions
Keywords
Chemotherapy, Thrombocytopenia, Interleukin-11, Platelet
Brief summary
This phases Ⅲ trials is divided into two stages,Ⅲa and Ⅲb.The aim of Ⅲa is to evaluate the optimal dosing dose of genetically modified recombinant human IL-11 (mIL-11) in a multicenter randomized self-control trial involving 60 cancer patients undergoing chemotherapy.The aim of Ⅲb is to evaluate the efficacy and safety of genetically modified recombinant human IL-11 (mIL-11), using rhIL-11 as an active control, in a multicenter randomized trial involving 240 cancer patients undergoing chemotherapy.
Detailed description
The investigators recently developed a mutant form of rhIL-11 with improved stability. In in vitro experimental systems, mIL-11 was shown to endure chemical and proteolytic stresses more effectively, while retaining the biological activity of the original rhIL-11. The improved stability of mIL-11 was also demonstrated in the comparative pharmacokinetic study of subcutaneously delivered mIL-11 and rhIL-11 in the rodent and primate models. Based on its improved pharmacokinetic and pharmacodynamic features. In Phase II study shows that mIL-11 is well tolerated and has thrombopoietic activity equivalent to one third of the clinical dose of rhIL-11, indicating the potential of mIL-11 for use in the treatment of CIT. This study is a phase III, single-blinded, randomized,multicenter,cross-over study designed to evaluate optimal dosing dose and efficacy and safety of mIL-11 on CIT patients receiving suitable chemotherapeutic regimen for treating cancer.
Interventions
DRUGNL201
mIL-11:5μg/kg，subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy；
DRUGrhIL-11
rhIL-11(25μg/kg)，subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy.
Sponsors
Beijing Northland Biotech. Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* histological verification of malignancy at the time of initial diagnosis； * 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 who received total body irradiation； * patients with childbearing potential； * patients who were breast-feeding or pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recovery time of platelet counts from below 100x10^9/L raise to more than 100 x10^9/L. | During 21 days of chemotherapy cycles |
Secondary
| Measure | Time frame |
|---|---|
| Nadir platelet counts | During 21 days of chemotherapy cycles |
| Platelet counts at day 21 after the initiation of chemotherapy. | Day 21 after the initiation of chemotherapy. |
| Average platelet counts | During 21 days of chemotherapy cycles |
| Incidence of thrombocytopenia | During 21 days of chemotherapy cycles |
Countries
China
Outcome results
None listed