A Multicentre Investigation of 2 Cycles Rituximab Compared With Standard Regimen in Management of Steroid-Resistant/Relapsed Immune Thrombocytopenia (ITP)

2 Cycles Rituximab Compared With Standard Regimen in Management of ITP

Sponsors

Lead Sponsor: Shandong University

Source Shandong University
Brief Summary

The project was undertaking by Qilu Hospital, Shandong University and other several well-known hospitals in China. In order to report the efficacy and safety of Rituximab in different frequencies for the treatment of adults with steroid-resistant/relapsed immune thrombocytopenia (ITP).

Detailed Description

The investigators are undertaking a parallel group, multicentre, randomised controlled trial of 60 refractory ITP adult patients from medical centers in China. One part of the participants are randomly selected to receive rituximab (given intravenously at a dose of 375mg/m(2) weekly for 2 weeks, i.e. Day 1, 8; the others are selected to receive standard rituximab treatment (given intravenously at a dose of 375 mg/m(2) weekly for 4 cycles, i.e. Day 1, 8, 15, 22). Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. In order to report the efficacy and safety of the combination therapy compared to conventional rituximab therapy for the treatment of adults with steroid-resistant/relapsed immune thrombocytopenia (ITP).

Overall Status Withdrawn
Start Date May 2014
Completion Date January 2016
Primary Completion Date January 2015
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Early Response 3 months
Duration Response 12 months
Secondary Outcome
Measure Time Frame
Safety 1 months
Condition
Intervention

Intervention Type: Drug

Intervention Name: Rituximab

Description: Rituximab was given intravenously at a dose of 375mg/m(2) weekly for 2 consecutive weeks (Day 1, 8) in 2 cycles arm; or 4 consecutive weeks (Day 1, 8, 15, 22) in standard 4 cycles arm

Eligibility

Criteria:

Inclusion Criteria:

1. Meet the diagnostic criteria for immune thrombocytopenia.

2. Untreated hospitalized patients, may be male or female, between the ages of 18 ~ 80 years.

3. To show a platelet count <30×10^9/L, and with bleeding manifestations.

4. Willing and able to sign 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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Ming Hou, Dr. Principal Investigator Shandong University
Location
Facility: Qilu Hospital, Shandong University
Location Countries

China

Verification Date

May 2014

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Shandong University

Investigator Full Name: Ming Hou

Investigator Title: Professor and Director

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: 2 cycles

Type: Experimental

Description: 2 cycles RTX

Label: standard 4 cycles

Type: Active Comparator

Description: standard 4 cycles RTX

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov