Clinical trial NCT02137681: A Multicentre Investigation of 2 Cycles Rituximab Compared With Standard Regimen in Management of Steroid-Resistant/Relapsed Immune Thrombocytopenia （ITP）
Official title: 2 Cycles Rituximab Compared With Standard Regimen in Management of ITP
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Immune Thrombocytopenia
Keywords: immune thrombocytopenia
rituximab
efficacy
safety
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2014-05-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Early Response
timeFrame: 3 months
measure: Duration Response
timeFrame: 12 months
Secondary outcomes:
measure: Safety
timeFrame: 1 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Shandong University
name: Ming Hou, Dr.
role: PRINCIPAL_INVESTIGATOR
References: