Decitabine Combining Dexamethasone Versus Dexamethasone in Management of ITP

Immune Thrombocytopenia Clinical Trial

Official title:

A Multicenter Prospective Randomized Study of Dexamethasone Combined With Decitabine Versus Dexamethasone in the Treatment of Newly Diagnosed Primary Immune Thrombocytopenia (ITP)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03252457
• Other study ID #: DAC in ITP
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: September 1, 2018
• Est. completion date: December 1, 2021

Study information

• Verified date: August 2018
• Source: Shandong University
• Contact: Ming Hou, Dr
• Phone: +86-531-82169114
• Email: houming[@]medmail.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Immune Thrombocytopenia
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Intervention

Drug:
• Decitabine
given intravenously at a dose of 3.5mg/m2/d for 4 consecutive days as a cycle and repeated every 2 weeks for 3cycles
• 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.

Locations

Country	Name	City	State
China	Qilu hospital, Shandong University	Jinan	Shandong

Sponsors (5)

Lead Sponsor	Collaborator
Shandong University	Chinese Academy of Medical Sciences, Qingdao Central Hospital, Second Affiliated Hospital of Medical College Shandong University, Shandong Provincial Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

Din B, Wang X, Shi Y, Li Y. Long-term effect of high-dose dexamethasone with or without low-dose dexamethasone maintenance in untreated immune thrombocytopenia. Acta Haematol. 2015;133(1):124-8. doi: 10.1159/000362529. Epub 2014 Sep 20. — View Citation

Rodeghiero F, Stasi R, Gernsheimer T, Michel M, Provan D, Arnold DM, Bussel JB, Cines DB, Chong BH, Cooper N, Godeau B, Lechner K, Mazzucconi MG, McMillan R, Sanz MA, Imbach P, Blanchette V, Kühne T, Ruggeri M, George JN. Standardization of terminology, d — View Citation

Wei Y, Ji XB, Wang YW, Wang JX, Yang EQ, Wang ZC, Sang YQ, Bi ZM, Ren CA, Zhou F, Liu GQ, Peng J, Hou M. High-dose dexamethasone vs prednisone for treatment of adult immune thrombocytopenia: a prospective multicenter randomized trial. Blood. 2016 Jan 21;1 — View Citation

Zhou H, Hou Y, Liu X, Qiu J, Feng Q, Wang Y, Zhang X, Min Y, Shao L, Liu X, Li G, Li L, Yang L, Xu S, Ni H, Peng J, Hou M. Low-dose decitabine promotes megakaryocyte maturation and platelet production in healthy controls and immune thrombocytopenia. Throm — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of platelet response(continuous response rate)	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.	up to 1 year per subject
Secondary	therapy associated adverse events	The number and frequency of therapy associated adverse events	up to 1 year per subject