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

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

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).

Study Overview

• Status: Withdrawn
• Conditions: Purpura, Thrombocytopenic, Idiopathic
• Intervention / Treatment: Drug: rhIL-11

• Study Type: Observational

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qilu Hospital, Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 75 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

100

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ming Hou
• Collaborators: Peking Union Medical College Hospital; Cancer Institute and 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (ANTICIPATED): December 1, 2011
• Study Completion (ANTICIPATED): March 1, 2012

Study Registration Dates

• First Submitted: March 17, 2011
• First Submitted That Met QC Criteria: March 17, 2011
• First Posted (ESTIMATE): March 18, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): April 20, 2016
• Last Update Submitted That Met QC Criteria: April 18, 2016
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Hematologic Diseases; Hemorrhage; Hemorrhagic Disorders; Blood Coagulation Disorders; Skin Manifestations; Blood Platelet Disorders; Thrombotic Microangiopathies; Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic; Thrombocytopenia; Physiological Effects of Drugs; Antirheumatic Agents; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Rituximab; Oprelvekin
• Other Study ID Numbers: ITP-001