The Study of Different Dose Rituximab in the Treatment of ITP

August 22, 2017 updated by: Ming Hou, Shandong University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 68 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Current HIV infection or hepatitis B virus or hepatitis C virus infections.
  2. 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)
  3. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
  4. 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.
  5. Patients who are deemed unsuitable for the study by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
Drug: Rituximab
given with a single dose of 375mg/m2
Other Names:
  • Mabthera
Experimental: group B
In group B, Rituximab was given with a single dose of 375mg/m2
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
Drug: Rituximab
given with a single dose of 375mg/m2
Other Names:
  • Mabthera

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of platelet response(continuous response rate)
Time Frame: 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.
up to 1 year per subject

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
therapy associated adverse events
Time Frame: up to 1 year per subject
The number and frequency of therapy associated adverse events
up to 1 year per subject

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Investigators

  • Principal Investigator: Ming Hou, Dr, Shandong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2010

Primary Completion (Actual)

December 31, 2015

Study Completion (Actual)

December 31, 2016

Study Registration Dates

First Submitted

August 18, 2017

First Submitted That Met QC Criteria

August 22, 2017

First Posted (Actual)

August 23, 2017

Study Record Updates

Last Update Posted (Actual)

August 23, 2017

Last Update Submitted That Met QC Criteria

August 22, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RTX 4v1 in ITP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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