Clinical trial · Interventional
A Phase Ⅲa Study of Genetically Modified Recombinant Human Interleukin-11
Multicenter, Randomized Phase Ⅲa Study of Genetically Modified Recombinant Human Interleukin-11 to Prevent Chemotherapy-induced Thrombocytopenia in Cancer Patients Receiving Chemotherapy.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy-induced Thrombocytopenia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NL201 | Drug | — | UNRESOLVED |
| rhIL-11 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- A1
- description
- 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.
- interventionNames
- Drug: NL201
- type
- EXPERIMENTAL
- label
- A2
- description
- 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.
- interventionNames
- Drug: NL201
- type
- ACTIVE_COMPARATOR
- label
- A
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available