Decitabine Combining Dexamethasone Versus Dexamethasone in Management of ITP

Phase 3

• Conditions: Purpura, Thrombocytopenic, Idiopathic; Immune Thrombocytopenia
• Interventions: Drug: Decitabine; Drug: Dexamethasone

• Registration Number: NCT03252457
• Lead Sponsor: Shandong University

Brief Summary

The project was undertaking by Qilu Hospital of Shandong University and other 18 well-known hospitals in China. In order to report the efficacy and safety of decitabine combining with dexamethasone for the treatment of adults with immune thrombocytopenia (ITP), compared to dexamethasone alone .

Detailed Description

The investigators anticipate to undertaking a parallel group, multicentre, randomised controlled trial of 200 ITP adult patients from 19 medical centers in China. One part of the participants are randomly selected to receive dexamethasone (given 40mg/d for 4 consecutive days as a cycle , If platelet count remained below 30 × 109/L or there were bleeding symptoms by day 10, an additional cycle of dexamethasone was given) combining with decitabine (given intravenously at a dose of 3.5mg/m2/d for 4 consecutive days as a cycle and repeated every 2 weeks for 3 cycles), the others are selected to receive dexamethasone therapy(given 40mg/d for 4 consecutive days as a cycle, If platelet count remained below 30 × 109/L or there were bleeding symptoms by day 10, an additional cycle of dexamethasone was given). 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 dexemathasone alone therapy for the treatment of adults with ITP.

Study Timeline

• Study First Submitted: 2017-08-14
• Study First Submitted QC: 2017-08-15
• Study First Posted: 2017-08-17
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-13
• Last Update Posted: 2018-08-15
• Study Start: 2018-09-01
• Primary Completion: 2020-12-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Meet the diagnostic criteria for immune thrombocytopenia.
2. within 3 months fromdiagnosis,untreated 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. Eastern Cooperative Oncology Group（ECOG）performance status ≤ 2.

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 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.
4. 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)
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: PARALLEL

Arm && Interventions

Group	Intervention	Description
combination treatment group	Dexamethasone	100 enrolled patients are randomly picked up to take decitabine in combination with dexamethasone at the indicated dose
combination treatment group	Decitabine	100 enrolled patients are randomly picked up to take decitabine in combination with dexamethasone at the indicated dose
single treatment group	Dexamethasone	100 enrolled patients are randomly picked up to take dexamethasone at the indicated dose

Primary Outcome Measures

Name	Time	Method
Evaluation of platelet response(continuous response rate)	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.

Secondary Outcome Measures

Name	Time	Method
therapy associated adverse events	up to 1 year per subject	The number and frequency of therapy associated adverse events

Trial Locations

Locations (1)

Qilu hospital, Shandong University; 🇨🇳 Jinan, Shandong, China