Immune Thrombocytopenia
Conditions
Keywords
immune thrombocytopenia, rituximab, efficacy, safety
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).
Interventions
DRUGRituximab
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
Sponsors
Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early Response | 3 months | response rate (CR+R) at the 3rd month from the initial injection of RTX. CR is defined as platelet count ≥ 100×10\^9/L, and R is defined as platelet count of \>30 × 10\^9/L with a least a doubling of the baseline value. |
| Duration Response | 12 months | response rate (CR+R) at the 12st month from the initial injection of RTX. CR is defined as platelet count ≥ 100×10\^9/L, and R is defined as platelet count of \>30 × 10\^9/L with a least a doubling of the baseline value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 1 months | The type and frequency of therapy associated adverse events |
Countries
China
Outcome results
None listed