Clinical trial NCT01317966: Recombinant Human Interleukin-11 Combination Low-dose Rituximab in Immune Thrombocytopenia
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)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Purpura, Thrombocytopenic, Idiopathic
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College Hospital
name: Chinese Academy of Medical Sciences
name: First Affiliated Hospital, Sun Yat-Sen University
name: West China Hospital
name: Shandong Provincial Hospital
name: Wuhan Union Hospital, China
name: Zhejiang University
First posted: 2011-03-18
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100

Brief summary: 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).


Eligibility 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).

Primary outcomes:
measure: Evaluation of platelet response (Complete Response)
timeFrame: The time frame is up to 14 days per subject
Secondary outcomes:
measure: Evaluation of platelet response (R)
timeFrame: The time frame is up to 14 days per subject
measure: The time of rhIL-11 onset.
timeFrame: The time frame is up to 28 days per subject.
measure: DFS
timeFrame: The time frame is up to 90 days per subject.
measure: The number and frequency of IL-11 associated adverse events.
timeFrame: up to 14 days per subject
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Shandong University
name: Ming Hou, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zaja F, Vianelli N, Volpetti S, Battista ML, Defina M, Palmieri S, Bocchia M, Medeot M, De Luca S, Ferrara F, Isola M, Baccarani M, Fanin R. Low-dose rituximab in adult patients with primary immune thrombocytopenia. Eur J Haematol. 2010 Oct;85(4):329-34. doi: 10.1111/j.1600-0609.2010.01486.x. Epub 2010 Jul 28.