Back to resultsAll-Trans Retinoic Acid (ATRA) Combining Dexamethasone Versus High-dose Dexamethasone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)
Primary Purpose
Purpura, Idiopathic Thrombocytopenic Purpura
Status
Withdrawn
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
All-Trans Retinoid Acid(ATRA)
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Purpura focused on measuring Purpura, Idiopathic Thrombocytopenic Purpura
Eligibility Criteria
Inclusion Criteria:
- Meet the diagnostic criteria for immune thrombocytopenia.
- Untreated hospitalized 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.
- Willing and able to sign written informed consent
Exclusion Criteria:
- Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
- Received high-dose steroids or [2] 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. 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.
Sites / Locations
- Qilu Hospital, Shandong University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
High dose-DEX
ATRA & High dose-DEX
Arm Description
40 patients are enrolled to take dexamethasone orally at a dose of 40 mg daily for 4 days
40 patients are enrolled to take Dexamethasone orally at 40mg a day for 4 days and all-trans retinoic acid at 10mg tablet every 8 hours a day for 12 consecutive weeks.
Outcomes
Primary Outcome Measures
Platelet count
The outcome should be classified into one of the following descriptions accordingly :
CR. A complete response (CR) was defined as a sustained (≥ 3 months) platelet count ≥ 100×10^9/L.
R. A response (R) was defined as a sustained (≥ 3 months) platelet count ≥ 30×10^9/L without recurrence of thrombocytopenia.
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.
Relapse.A relapse was defined as platelet count falls below 30×10^9/L or bleeding accrues after achieving R or CR.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01882127
Brief Title
All-Trans Retinoic Acid (ATRA) Combining Dexamethasone Versus High-dose Dexamethasone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)
Official Title
Clinical Study on All-Trans Retinoic Acid (ATRA) Combining High-dose Dexamethasone Versus High-dose Dexamethasone Alone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Withdrawn
Why Stopped
No eligible patient was enrolled.
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The project was undertaking by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of All-Trans Retinoic Acid (ATRA) combining with High-dose Dexamethasone for the treatment of adults with primary immune thrombocytopenia (ITP), compared to conventional high-dose dexamethasone therapy.
Detailed Description
The investigators are undertaking a parallel group, randomised controlled trial of 80 primary ITP adult patients from Qilu Hospital of Shandong University in China. One part of the participants are randomly selected to receive All-Trans Retinoic Acid(10mg tablet by mouth every 8 hours a day for 12 consecutive weeks, combining with dexamethasone (given orally at a dose of 40 mg per day for 4 days, the others are selected to receive high-dose of dexamethasone treatment (given orally at a dose of 40 mg daily for 4 days). Patients were monitored every 1 to 3 days at the first two weeks and every 1 to 4 weeks afterwards for platelet counts, and were monitored every 1 month for transaminitis and other side effects
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Purpura, Idiopathic Thrombocytopenic Purpura
Keywords
Purpura, Idiopathic Thrombocytopenic Purpura
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High dose-DEX
Arm Type
Active Comparator
Arm Description
40 patients are enrolled to take dexamethasone orally at a dose of 40 mg daily for 4 days
Arm Title
ATRA & High dose-DEX
Arm Type
Experimental
Arm Description
40 patients are enrolled to take Dexamethasone orally at 40mg a day for 4 days and all-trans retinoic acid at 10mg tablet every 8 hours a day for 12 consecutive weeks.
Intervention Type
Drug
Intervention Name(s)
All-Trans Retinoid Acid(ATRA)
Other Intervention Name(s)
Acid, trans-Retinoic, trans Retinoic Acid, all-trans-Retinoic Acid, Acid, all-trans-Retinoic, all trans Retinoic Acid
Intervention Description
patients in ATRA&High dose-DEX group take All-Trans Retinoic Acid(orally,10mg every 8 hours a day for 12 consecutive weeks) in combination with dexamethasone(intravenously , 40mg/d for 4 consecutive days).
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Patients in High dose-DEX treatment group take dexamethasone( orally , 40mg daily for 4 days),patients in ATRA&High dose-DEX group take All-Trans Retinoic Acid(orally,10mg every 8 hours a day for 12 consecutive weeks) in combination with dexamethasone(intravenously , 40mg/d for 4 consecutive days).
Primary Outcome Measure Information:
Title
Platelet count
Description
The outcome should be classified into one of the following descriptions accordingly :
CR. A complete response (CR) was defined as a sustained (≥ 3 months) platelet count ≥ 100×10^9/L.
R. A response (R) was defined as a sustained (≥ 3 months) platelet count ≥ 30×10^9/L without recurrence of thrombocytopenia.
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.
Relapse.A relapse was defined as platelet count falls below 30×10^9/L or bleeding accrues after achieving R or CR.
Time Frame
up to six months per subject
Other Pre-specified Outcome Measures:
Title
Bleeding episodes
Time Frame
up to six months per subject
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Meet the diagnostic criteria for immune thrombocytopenia.
Untreated hospitalized 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.
Willing and able to sign written informed consent
Exclusion Criteria:
Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
Received high-dose steroids or [2] 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming Hou, Dr
Organizational Affiliation
Shandong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Qilu Hospital, Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250000
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
21072052
Citation
Toth K, Sarang Z, Scholtz B, Brazda P, Ghyselinck N, Chambon P, Fesus L, Szondy Z. Retinoids enhance glucocorticoid-induced apoptosis of T cells by facilitating glucocorticoid receptor-mediated transcription. Cell Death Differ. 2011 May;18(5):783-92. doi: 10.1038/cdd.2010.136. Epub 2010 Nov 12.
Results Reference
background
PubMed Identifier
1020044
Citation
Tancini G, Marchini S. Adriamycin plus cyclophosphamide in advanced bronchial carcinoma. Tumori. 1976 Jul-Aug;62(4):373-5. doi: 10.1177/030089167606200403.
Results Reference
background
PubMed Identifier
10089890
Citation
Tosi P, Pellacani A, Visani G, Ottaviani E, Ronconi S, Zamagni E, Benni M, Cavo M, Tura S. In vitro treatment with retinoids decreases bcl-2 protein expression and enhances dexamethasone-induced cytotoxicity and apoptosis in multiple myeloma cells. Eur J Haematol. 1999 Mar;62(3):143-8. doi: 10.1111/j.1600-0609.1999.tb01736.x.
Results Reference
background
PubMed Identifier
8547658
Citation
Chen YH, Desai P, Shiao RT, Lavelle D, Haleem A, Chen J. Inhibition of myeloma cell growth by dexamethasone and all-trans retinoic acid: synergy through modulation of interleukin-6 autocrine loop at multiple sites. Blood. 1996 Jan 1;87(1):314-23.
Results Reference
background
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All-Trans Retinoic Acid (ATRA) Combining Dexamethasone Versus High-dose Dexamethasone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)
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