The Study of Different Dose Rituximab in the Treatment of ITP

Sponsor

Shandong University (Other)

Overall Status

Completed

CT.gov ID

NCT03258866

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The project was undertaking by Qilu Hospital of Shandong University in China. In order to compare the efficacy, safety and response duration of different dose of rituximab in patients primary immune thrombocytopenia(pITP).

Condition or Disease	Intervention/Treatment	Phase
Purpura, Thrombocytopenic, Idiopathic Immune Thrombocytopenia	Drug: Rituximab Drug: Rituximab	Phase 4

Detailed Description

62 patients with pITP who had failed to respond to glucocorticosteroids were randomly divided into 2 groups: group A(n = 32) and group B(n = 30). In group A, Rituximab was given with a fixed dose of 100 mg administered as an intravenous infusion weekly (on day 1, 8, 15 and 22). In group B, Rituximab was given with a single dose of 375mg/m2. The clinical effect, onset time, duration of efficacy and adverse reactions were observed to compare the efficacy and safety of two different plans.

Study Design

Study Type:

Interventional

Actual Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Clinical Randomized Controlled Study of Different Dose Rituximab in the Treatment of Primary Immune Thrombocytopenia

Actual Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Dec 31, 2015

Actual Study Completion Date :

Dec 31, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: group A In group A, Rituximab was given with a fixed dose of 100 mg administered as an intravenous infusion weekly (on day 1, 8, 15 and 22).	Drug: Rituximab given with a fixed dose of 100 mg administered as an intravenous infusion weekly (on day 1, 8, 15 and 22) Other Names: Mabthera
Experimental: group B In group B, Rituximab was given with a single dose of 375mg/m2	Drug: Rituximab given with a single dose of 375mg/m2 Other Names: Mabthera

Arm

Intervention/Treatment

Experimental: group A

In group A, Rituximab was given with a fixed dose of 100 mg administered as an intravenous infusion weekly (on day 1, 8, 15 and 22).

Drug: Rituximab

given with a fixed dose of 100 mg administered as an intravenous infusion weekly (on day 1, 8, 15 and 22)

Other Names:

Mabthera

Experimental: group B

In group B, Rituximab was given with a single dose of 375mg/m2

Drug: Rituximab

given with a single dose of 375mg/m2

Other Names:

Mabthera

Outcome Measures

Primary Outcome Measures

Evaluation of platelet response(continuous response rate) [up to 1 year per subject]
Complete Response:a sustained (≥ 3 months) platelet count≥100×10^9/L;response: a sustained (≥ 3 months) platelet count ≥ 30×10^9/L without recurrence of thrombocytopenia;No response (NR): platelet count < 30 × 10^9/L or a less than two fold increase in platelet count from baseline or the presence of bleeding. Platelet count must be measured on two occasions more than a day apart.

Secondary Outcome Measures

therapy associated adverse events [up to 1 year per subject]
The number and frequency of therapy associated adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Meet the diagnostic criteria for immune thrombocytopenia.
Male or female, between the ages of 10 ~ 70 years.
Normal glucocorticoid therapy is ineffective or effective but the maintenance dose is large, without immunosuppressive therapy or immunosuppressive treatment ineffective
To show a platelet count < 30×10^9/L, or with bleeding manifestations.
Eastern Cooperative Oncology Group（ECOG）performance status ≤ 2

Exclusion Criteria:

Current HIV infection or hepatitis B virus or hepatitis C virus infections.
Severe medical condition (lung, hepatic or renal disorder) other than 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.