Recombinant Human Interleukin-11 Combination Low-dose Rituximab in Immune Thrombocytopenia

Study Overview
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Brief Summary
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The purpose of this study is to determine whether Recombinant Human Interleukin-11 (rhIL-11) Combination Low-dose Rituximab prednisone are effective and safe in the management of Steroid-Resistant/Relapsed Immune Thrombocytopenia (ITP).

Official Title
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A Multicentre Investigation of Recombinant Human Interleukin-11 (rhIL-11) Combination Low-dose Rituximab in Management of Steroid-Resistant/Relapsed Immune Thrombocytopenia (ITP)

Conditions
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Purpura, Thrombocytopenic, Idiopathic

Intervention / Treatment
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* Drug: rhIL-11


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients may be male or female, between the ages of 16   75 years old. Isolated thrombocytopenia with an otherwise normal peripheral blood smear and no other causes of thrombocytopenia, morphologically normal bone marrow aspirate with normal to increased number of megakaryocytes, and absence of splenomegaly. To show a platelet count ≤ 30 × 109/L, or platelet count ≥ 30 × 109/L with bleeding manifestations at the moment of the first infusion with the study product. ＥＣＯＧ performance status ≤ 2. Patients failed to respond to acceptable dose of steroids for 4 weeks, or relapsed. Some patients were also refractory to splenectomy. Patients must be willing and able to give written informed consent. Exclusion Criteria: Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit. Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit. Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study. Current HIV infection or hepatitis B virus or hepatitis C virus infections. Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia). Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period. Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test. Patients who are deemed unsuitable for the study by the investigator (or coinvestigator).

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| rhIL-11Combinating Low-dose Rituximab<br>rhIL-11 (interleukin-11, Juheli) 50 mcg/kg subcutaneously daily for 14 days Rituximab 100mcg weekly for 4 weeks | Drug: rhIL-11<br>* Recombinant Human Interleukin-11 (rhIL-11) Combinating Low-dose Rituximab<br>* Other names: ITP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of platelet response (Complete Response) | CR. A complete response (CR) was defined as a sustained (≥ 4 months) platelet count ≥ 100×109/L without recurrence of thrombocytopenia | The time frame is up to 14 days per subject | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of platelet response (R) | R. A response (R) was defined as a sustained (≥ 4 months) platelet count ≥ 30×109/L without recurrence of thrombocytopenia | The time frame is up to 14 days per subject | 
| The time of rhIL-11 onset. | The time to platelet recovery (deﬁned as the number of days from the start of the study to the ﬁrst day with a platelet count of ≥30 × 109/L) | The time frame is up to 28 days per subject. | 
| DFS | The median disease-free survival periods | The time frame is up to 90 days per subject. | 
| The number and frequency of IL-11 associated adverse events. |  | up to 14 days per subject |