DEX Combined With RTX, CSA and IVIG in the Management of Newly Diagnosed ITP Patients

Phase 3

• Conditions: Immune Thrombocytopenia
• Interventions: Drug: DEX Combined With RTX, CSA and IVIG

• Registration Number: NCT02834468
• Lead Sponsor: Shandong University

Brief Summary

The project was undertaken by Qilu Hospital, Shandong University in China. In order to report the efficacy and safety of dexamethasone combined with rituximab, cyclosporin and intravenous immunoglobulin in the management of newly diagnosed ITP patients.

Detailed Description

The investigators are undertaking a multicenter trial of 100 primary ITP adult patients from 5 medical centers in China. All participants receive dexamethasone (given orally at a dose of 40 mg per day for 4 days), rituximab (given intravenously at a dose of 500mg once), cyclosporin (given orally at a dose of 2.5-3 mg/kg per day for 28 days) and intravenous immunoglobulin (given intravenously at a dose of 5g per month for 6 months) for the treatment of adults newly diagnosed ITP patients.

Study Timeline

• Status Verified: 2016-06
• Study Start: 2016-06
• Study First Submitted: 2016-07-13
• Study First Submitted QC: 2016-07-13
• Last Update Submitted: 2016-07-13
• Study First Posted: 2016-07-15
• Last Update Posted: 2016-07-15
• Primary Completion: 2018-07
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Meet the diagnostic criteria for immune thrombocytopenia.
2. Untreated hospitalized patients, may be male or female, between the ages of 18 -60 years.
3. To show a platelet count < 30×10^9/L, and with bleeding manifestations.
4. Eastern Cooperative Oncology Group（ECOG）performance status ≤ 2.
5. 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 high-dose steroids or [2] intravenous immunoglobulin transfusion(IVIG)in the 3 weeks prior to the start of the study.
3. Current HIV infection or hepatitis B virus or hepatitis C virus infections. Severe medical condition (lung, hepatic or renal disorder) other than ITP. 4.Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)

5.Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.

6.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.

7.Patients who are deemed unsuitable for the study by the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	DEX Combined With RTX, CSA and IVIG	DEX Combined With RTX, CSA and IVIG All patients are assigned to receive dexamethasone (given orally at a dose of 40 mg per day for 4 days), rituximab (given intravenously at a dose of 500mg once), cyclosporin (given orally at a dose of 2.5-3 mg/kg per day for 28 days) and intravenous immunoglobulin (given intravenously at a dose of 5g per month for 6 months) for the treatment of adults newly diagnosed ITP patients.

Primary Outcome Measures

Name	Time	Method
Evaluation of platelet response (Complete Response)	The time frame is up to 3 months per subject	CR. A complete response (CR) was defined as a sustained (≥ 3 months) platelet count ≥ 100×10\^9/L
Evaluation of platelet response (Response)	The time frame is up to 3 months per subject	R. A response (R) was defined as a sustained (≥ 3 months) platelet count ≥ 30×10\^9/L without recurrence of thrombocytopenia.
Evaluation of platelet response (No Response)	The time frame is up to 3 months per subject	NR.No response (NR) was defined as 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.
Evaluation of platelet response (relapses)	The time frame is up to 9 months per subject	A relapses was defined as platelet count falls below 30×10\^9/L or bleeding accrues after achieving R or CR.

Secondary Outcome Measures

Name	Time	Method
The number and frequency of therapy associated adverse events	up to 9 months per subject

Trial Locations

Locations (1)

Qilu Hospital, Shandong University; 🇨🇳 Jinan, China