Decitabine Combining Dexamethasone Versus Dexamethasone in Management of ITP

NCT03252457 | Unknown Phase 3 DMC

• 1 other identifier: DAC in ITP
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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 .

Conditions

Purpura, Thrombocytopenic, Idiopathic; Immune Thrombocytopenia

Keywords

Purpura; Thrombocytopenia; immune throbocytopenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• therapy associated adverse events

  up to 1 year per subject

Study Arms (2)

combination treatment group

EXPERIMENTAL

100 enrolled patients are randomly picked up to take decitabine in combination with dexamethasone at the indicated dose

Drug: Decitabine; Drug: Dexamethasone

single treatment group

ACTIVE COMPARATOR

100 enrolled patients are randomly picked up to take dexamethasone at the indicated dose

Drug: Dexamethasone

Interventions

Decitabine DRUG

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

Also known as: pharmachemie

combination treatment group

Dexamethasone DRUG

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.

Also known as: Hydrocortisone

combination treatment group; single treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet the diagnostic criteria for immune thrombocytopenia.
• within 3 months fromdiagnosis,untreated patients, may be male or female, between the ages of 18 \~ 80 years.
• To show a platelet count \< 30×10\^9/L, and with bleeding manifestations.
• Eastern Cooperative Oncology Group（ECOG）performance status ≤ 2.

You may not qualify if:

• Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
• Received high-dose steroids or intravenous immunoglobulin transfusion(IVIG) in the 3 weeks prior to the start of the study.
• Current HIV infection or hepatitis B virus or hepatitis C virus infections.
• 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)
• Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
• 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.
• Patients who are deemed unsuitable for the study by the investigator.

Sponsors & Collaborators

• Shandong University: lead
• Second Affiliated Hospital of Medical College Shandong University: collaborator
• Shandong Provincial Hospital: collaborator
• Qingdao Central Hospital: collaborator
• Chinese Academy of Medical Sciences: collaborator

Study Sites (1)

Qilu hospital, Shandong University

Jinan, Shandong, 250012, China

Location

Related Publications (4)

• 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, Kuhne T, Ruggeri M, George JN. Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group. Blood. 2009 Mar 12;113(11):2386-93. doi: 10.1182/blood-2008-07-162503. Epub 2008 Nov 12.

  PMID: 19005182 RESULT

• 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. Thromb Haemost. 2015 May;113(5):1021-34. doi: 10.1160/TH14-04-0342. Epub 2015 Jan 8.

  PMID: 25566808 RESULT

• 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;127(3):296-302; quiz 370. doi: 10.1182/blood-2015-07-659656. Epub 2015 Oct 19.

  PMID: 26480931 RESULT

• 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.

  PMID: 25247485 RESULT

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic; Purpura; Thrombocytopenia

Interventions

Decitabine; Dexamethasone; Hydrocortisone

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Pregnenediones; Pregnenes; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Officials

• Ming Hou, Dr

  Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Hou, Dr

CONTACT

+86-531-82169114; houming@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: August 17, 2017
• Study Start: September 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: August 15, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)