Recombinant Human Interleukin-11 Combination Low-dose Rituximab in Immune Thrombocytopenia (Incritop)
This study is currently recruiting participants.
Verified November 2011 by Shandong University
Sponsor:
Ming Hou
Collaborators:
Peking Union Medical College Hospital
Chinese Academy of Medical Sciences
First Affiliated Hospital, Sun Yat-Sen University
West China Hospital
Shandong Provincial Hospital
Wuhan Union Hospital, China
Zhejiang University
Information provided by (Responsible Party):
Ming Hou, Shandong University
ClinicalTrials.gov Identifier:
NCT01317966
First received: March 17, 2011
Last updated: November 1, 2011
Last verified: November 2011
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Purpura, Thrombocytopenic, Idiopathic |
Drug: rhIL-11 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Multicentre Investigation of Recombinant Human Interleukin-11 (rhIL-11) Combination Low-dose Rituximab in Management of Steroid-Resistant/Relapsed Immune Thrombocytopenia (ITP) |
Resource links provided by NLM:
Further study details as provided by Shandong University:
Primary Outcome Measures:
- Evaluation of platelet response (Complete Response) [ Time Frame: The time frame is up to 14 days per subject ] [ Designated as safety issue: Yes ]CR. A complete response (CR) was defined as a sustained (≥ 4 months) platelet count ≥ 100×109/L without recurrence of thrombocytopenia
Secondary Outcome Measures:
- Evaluation of platelet response (R) [ Time Frame: The time frame is up to 14 days per subject ] [ Designated as safety issue: Yes ]R. A response (R) was defined as a sustained (≥ 4 months) platelet count ≥ 30×109/L without recurrence of thrombocytopenia
- The time of rhIL-11 onset. [ Time Frame: The time frame is up to 28 days per subject. ] [ Designated as safety issue: Yes ]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)
- DFS [ Time Frame: The time frame is up to 90 days per subject. ] [ Designated as safety issue: Yes ]The median disease-free survival periods
- The number and frequency of IL-11 associated adverse events. [ Time Frame: up to 14 days per subject ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 199 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
rhIL-11Combinating Low-dose Rituximab
rhIL-11 (interleukin-11, Juheli) 50 mcg/kg subcutaneously daily for 14 days Rituximab 100mcg weekly for 4 weeks |
Drug: rhIL-11
Recombinant Human Interleukin-11 (rhIL-11) Combinating Low-dose Rituximab
Other Names:
|
Eligibility| Ages Eligible for Study: | 16 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
100
Criteria
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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01317966
Locations
| China, Shandong | |
| Qilu Hospital, Shandong University | Recruiting |
| Jinan, Shandong, China, 250012 | |
| Contact: Jun Peng, MD 86-531-82169867 junpeng88@sina.com.cn | |
Sponsors and Collaborators
Ming Hou
Peking Union Medical College Hospital
Chinese Academy of Medical Sciences
First Affiliated Hospital, Sun Yat-Sen University
West China Hospital
Shandong Provincial Hospital
Wuhan Union Hospital, China
Zhejiang University
Investigators
| Principal Investigator: | Ming Hou, Dr. | Shandong University |
More Information
Publications:
| Responsible Party: | Ming Hou, Director of Hematology Department, Shandong University |
| ClinicalTrials.gov Identifier: | NCT01317966 History of Changes |
| Other Study ID Numbers: | ITP-001 |
| Study First Received: | March 17, 2011 |
| Last Updated: | November 1, 2011 |
| Health Authority: | China: Food and Drug Administration |
Additional relevant MeSH terms:
|
Purpura Thrombocytopenia Purpura, Thrombocytopenic, Idiopathic Purpura, Thrombocytopenic Blood Coagulation Disorders Hematologic Diseases Hemorrhage Pathologic Processes Skin Manifestations Signs and Symptoms Blood Platelet Disorders Thrombotic Microangiopathies |
Hemorrhagic Disorders Autoimmune Diseases Immune System Diseases Oprelvekin Rituximab Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 19, 2013