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

NCT01317966 | Withdrawn

• 1 other identifier: ITP-001
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Purpura, Thrombocytopenic, Idiopathic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Evaluation of platelet response (R)

  The time frame is up to 14 days per subject

• The time of rhIL-11 onset.

  The time frame is up to 28 days per subject.

• DFS

  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

Study Arms (1)

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

Interventions

rhIL-11 DRUG

Recombinant Human Interleukin-11 (rhIL-11) Combinating Low-dose Rituximab

Also known as: Rituximab, ITP

rhIL-11Combinating Low-dose Rituximab

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

100

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ming Hou: lead
• Peking Union Medical College Hospital: collaborator
• Chinese Academy of Medical Sciences: collaborator
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• West China Hospital: collaborator
• Shandong Provincial Hospital: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Zhejiang University: collaborator

Study Sites (1)

Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

Location

Related Publications (1)

• 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.

  PMID: 20546023 RESULT

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

oprelvekin; Rituximab; Inosine Triphosphate

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Inosine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Ming Hou, Dr.

  Shandong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Hematology Department

Study Record Dates

• First Submitted: March 17, 2011
• First Posted: March 18, 2011
• Study Start: March 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: March 1, 2012
• Last Updated: April 20, 2016

Record last verified: 2011-11

Locations

CN (1)