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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Shandong University.
Recruitment status was  Recruiting
Sponsor:
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
  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:
  • Rituximab
  • ITP

  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:

  1. Patients may be male or female, between the ages of 16 ~ 75 years old.
  2. 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.
  3. 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.
  4. ECOG performance status ≤ 2.
  5. Patients failed to respond to acceptable dose of steroids for 4 weeks, or relapsed. Some patients were also refractory to splenectomy.
  6. Patients must be willing and able to give written informed consent.

Exclusion Criteria:

  1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
  2. Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit.
  3. Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study.
  4. Current HIV infection or hepatitis B virus or hepatitis C virus infections.
  5. 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).
  6. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
  7. 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.
  8. Patients who are deemed unsuitable for the study by the investigator (or coinvestigator).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Thrombocytopenia
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
Immune System Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Hemorrhagic Disorders
Autoimmune Diseases
Rituximab
Oprelvekin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on October 01, 2014