- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02757196
Treatment of ITP With Rituximab and / or Accutane
May 11, 2016 updated by: Peking University People's Hospital
Rituximab Plus Short-term Methylprednisolone Versus Standard Dose Methylprednisolone in Newly Diagnosed Participants With Immune Thrombocytopenia (ITP): A Multicenter, Randomized Phase II Study in China
a prospective, multicenter, randomized, open-label, Phase II, two arms interventional trial performed in 5 departments of hematology in China
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
This is a prospective, multicenter, randomized, open-label, Phase II, two arms interventional trial performed in 5 departments of hematology in China.
The investigators explore the efficacy and safety of Rituximab plus short-term methylprednisolone compare standard dose methylprednisolone in newly diagnosed ITP participants.
Study Type
Interventional
Enrollment (Anticipated)
112
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinically confirmed immune thrombocytopenic purpura (ITP) newly diagnosed
- Platelet count less than 30×109/L on two occasions or Platelets above 30×109/L combined with bleeding manifestation
- Subject is ≥ 18 years and ≤80years
- Subject has signed and dated written informed consent.
- Fertile patients must use effective contraception during treatment and observational period
- Negative pregnancy test
Exclusion Criteria:
- Have an impaired renal function as indicated by a serum creatinine level > 2.0 mg/dL
- Have an inadequate liver function as indicated by a total bilirubin level > 2.0 mg/dL and/or an aspartate aminotransaminase or alanine aminotransferase level > 3×upper limit of normal
- Have a New York Heart Classification III or IV heart disease
- Have a history of severe psychiatric disorder or are unable to comply with study and follow-up procedures
- Have active hepatitis B or hepatitis C infection
- Have a HIV infection
- Have active infection requiring antibiotic therapy within 7 days prior to study entry
- Are pregnant or lactating women, or plan to become pregnant or impregnated within 12 months of receiving study drug
- Previous treatment with rituximab
- Previous splenectomy
- Had previous or concomitant malignant disease
- Not willing to participate in the study.
- Expected survival of < 2 years
- Intolerant to murine antibodies
- Immunosuppressive treatment within the last month
- Connective tissue disease
- Autoimmune hemolytic anemia
- Patients currently involved in another clinical trial with evaluation of drug treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Rituximab plus methylprednisolone
Combination therapy with rituximab (1000mg IV day1, week 3, week 17 , and week 19)plus short-term methylprednisolone (1mg/kg, oral or IV; reduce to 50% of base dose at week 4, then reduce 8mg every 1 week until stopped).
|
rituximab (1000mg IV day1, week 3, week 17 , and week 19)
Other Names:
|
Active Comparator: Methylprednisolone
standard dose methylprednisolone alone (1mg/kg, oral or IV; begin to reduce at week 4, reduce 8mg every 2 weeks, then another 8 weeks later reduce 2-4mg every 2-4 weeks).
|
1mg/kg, oral or IV; begin to reduce at week 4, reduce 8mg every 2 weeks, then another 8 weeks later reduce 2-4mg every 2-4 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relapse free survival
Time Frame: From date of randomization until the date of relapse or death from any cause, whichever came first, assessed up to 1 year
|
Relapse was defined as a drop in platelet count to <30 ×109/L following an initial best response (partial or complete response).
|
From date of randomization until the date of relapse or death from any cause, whichever came first, assessed up to 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cumulative response rate
Time Frame: 1 year
|
platelet count ≥ 30 x 10^9/L and at least 2-fold increase of the baseline count, confirmed on at least 2 separate occasions at least 7 days apart, and absence of bleeding.
|
1 year
|
Cumulative complete response rate
Time Frame: 1 year
|
platelet count >100 x 10^9/L, confirmed on at least 2 separate occasions at least 7 days apart, and absence of bleeding
|
1 year
|
Cumulative relapse rate
Time Frame: 1 year
|
Time to response (from randomization to the achievement of response)Duration of response (from the initial response to the first relapse)
|
1 year
|
adverse event/serious adverse event and cumulative rate of bleeding events
Time Frame: 1 year
|
adverse event/serious adverse event associated with study drugs and bleeding events
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Xiao-jun Huang, Dr, Peking University People's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2016
Primary Completion (Anticipated)
December 1, 2017
Study Completion (Anticipated)
December 1, 2018
Study Registration Dates
First Submitted
April 17, 2016
First Submitted That Met QC Criteria
April 27, 2016
First Posted (Estimate)
May 2, 2016
Study Record Updates
Last Update Posted (Estimate)
May 13, 2016
Last Update Submitted That Met QC Criteria
May 11, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Autoimmune Diseases
- Hematologic Diseases
- Hemorrhage
- Hemorrhagic Disorders
- Blood Coagulation Disorders
- Skin Manifestations
- Blood Platelet Disorders
- Thrombotic Microangiopathies
- Purpura, Thrombocytopenic
- Purpura
- Purpura, Thrombocytopenic, Idiopathic
- Thrombocytopenia
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Neuroprotective Agents
- Protective Agents
- Antineoplastic Agents, Immunological
- Prednisolone
- Methylprednisolone Acetate
- Methylprednisolone
- Methylprednisolone Hemisuccinate
- Prednisolone acetate
- Prednisolone hemisuccinate
- Prednisolone phosphate
- Rituximab
Other Study ID Numbers
- ITP Treatment--100
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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