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

Purpura, Thrombocytopenic, Idiopathic Clinical Trial

— Incritop  

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01317966
• Other study ID #: ITP-001
• Status: Withdrawn
• Phase: N/A
• First received: March 17, 2011
• Last updated: April 18, 2016
• Start date: March 2011
• Est. completion date: March 2012

Study information

• Verified date: November 2011
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 75 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia
• Thrombocytosis

Intervention

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

Locations

Country	Name	City	State
China	Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (8)

Lead Sponsor	Collaborator
Ming Hou	Chinese Academy of Medical Sciences, First Affiliated Hospital, Sun Yat-Sen University, Peking Union Medical College Hospital, Shandong Provincial Hospital, West China Hospital, Wuhan Union Hospital, China, Zhejiang University

Country where clinical trial is conducted

China, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	The time of rhIL-11 onset.	The time to platelet recovery (de?ned as the number of days from the start of the study to the ?rst day with a platelet count of =30 × 109/L)	The time frame is up to 28 days per subject.	Yes
Secondary	DFS	The median disease-free survival periods	The time frame is up to 90 days per subject.	Yes
Secondary	The number and frequency of IL-11 associated adverse events.		up to 14 days per subject	Yes