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:

  1. Clinically confirmed immune thrombocytopenic purpura (ITP) newly diagnosed
  2. Platelet count less than 30×109/L on two occasions or Platelets above 30×109/L combined with bleeding manifestation
  3. Subject is ≥ 18 years and ≤80years
  4. Subject has signed and dated written informed consent.
  5. Fertile patients must use effective contraception during treatment and observational period
  6. Negative pregnancy test

Exclusion Criteria:

  1. Have an impaired renal function as indicated by a serum creatinine level > 2.0 mg/dL
  2. 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
  3. Have a New York Heart Classification III or IV heart disease
  4. Have a history of severe psychiatric disorder or are unable to comply with study and follow-up procedures
  5. Have active hepatitis B or hepatitis C infection
  6. Have a HIV infection
  7. Have active infection requiring antibiotic therapy within 7 days prior to study entry
  8. Are pregnant or lactating women, or plan to become pregnant or impregnated within 12 months of receiving study drug
  9. Previous treatment with rituximab
  10. Previous splenectomy
  11. Had previous or concomitant malignant disease
  12. Not willing to participate in the study.
  13. Expected survival of < 2 years
  14. Intolerant to murine antibodies
  15. Immunosuppressive treatment within the last month
  16. Connective tissue disease
  17. Autoimmune hemolytic anemia
  18. 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).
Drug: Rituximab plus methylprednisolone
rituximab （1000mg IV day1, week 3, week 17 , and week 19）
Other Names:
  • monoclone antibody of cluster of differentiation antigen 20
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).
Drug: methylprednisolone
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:
  • intravenous methylprednisolone

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.

Sponsor

Peking University People's Hospital

Collaborators

Beijing Hospital

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

Keywords

Additional Relevant MeSH Terms

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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