ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02834468
Recruitment Status : Unknown
Verified June 2016 by Ming Hou, Shandong University.
Recruitment status was:  Recruiting
First Posted : July 15, 2016
Last Update Posted : July 15, 2016
Sponsor:
Collaborators:
Linyi People's Hospital
Liaocheng People's Hospital
Qingdao University
Information provided by (Responsible Party):
Ming Hou, 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.

Condition or disease Intervention/treatment Phase
Immune Thrombocytopenia Drug: DEX Combined With RTX, CSA and IVIG Phase 3

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Randomized Study of Dexamethasone Combined With Rituximab, Cyclosporin and Intravenous Immunoglobulin in the Management of Newly Diagnosed ITP Patients
Study Start Date : June 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: Treatment group
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.
Drug: DEX Combined With RTX, CSA and IVIG
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.
Other Name: The combined therapy for ITP




Primary Outcome Measures :
  1. Evaluation of platelet response (Complete Response) [ Time Frame: 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

  2. Evaluation of platelet response (Response) [ Time Frame: 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.

  3. Evaluation of platelet response (No Response) [ Time Frame: 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.

  4. Evaluation of platelet response (relapses) [ Time Frame: 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 :
  1. The number and frequency of therapy associated adverse events [ Time Frame: up to 9 months per subject ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02834468


Contacts
Contact: Ming Hou 86-531-82169879 qlhouming@sina.com.cn

Locations
China
Qilu Hospital, Shandong University Recruiting
Jinan, China
Contact: Yun Xiao Yang    86-531-82169114    qlyykyc@163.com   
Sponsors and Collaborators
Shandong University
Linyi People's Hospital
Liaocheng People's Hospital
Qingdao University
Investigators
Study Chair: Ming Hou Qilu Hospital, Shandong University

Publications:
Responsible Party: Ming Hou, Prof., Shandong University
ClinicalTrials.gov Identifier: NCT02834468     History of Changes
Other Study ID Numbers: ITP-2016-Combined Therapy
First Posted: July 15, 2016    Key Record Dates
Last Update Posted: July 15, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ming Hou, Shandong University:
Dexamethasone
Rituximab
Cyclosporin
Intravenous Immunoglobulin

Additional relevant MeSH terms:
Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Dexamethasone acetate
Dexamethasone
Rituximab
BB 1101
Cyclosporins
Cyclosporine
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
gamma-Globulins
Rho(D) Immune Globulin
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents