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Treatment of ITP With Rituximab and / or Accutane

Primary Purpose

Immune Thrombocytopenia

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Rituximab plus methylprednisolone
methylprednisolone
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immune Thrombocytopenia focused on measuring Immune Thrombocytopenia, Rituximab, methylprednisolone

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Rituximab plus methylprednisolone

    Methylprednisolone

    Arm Description

    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).

    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).

    Outcomes

    Primary Outcome Measures

    Relapse free survival
    Relapse was defined as a drop in platelet count to <30 ×109/L following an initial best response (partial or complete response).

    Secondary Outcome Measures

    Cumulative response rate
    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.
    Cumulative complete response rate
    platelet count >100 x 10^9/L, confirmed on at least 2 separate occasions at least 7 days apart, and absence of bleeding
    Cumulative relapse rate
    Time to response (from randomization to the achievement of response)Duration of response (from the initial response to the first relapse)
    adverse event/serious adverse event and cumulative rate of bleeding events
    adverse event/serious adverse event associated with study drugs and bleeding events

    Full Information

    First Posted
    April 17, 2016
    Last Updated
    May 11, 2016
    Sponsor
    Peking University People's Hospital
    Collaborators
    Beijing Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02757196
    Brief Title
    Treatment of ITP With Rituximab and / or Accutane
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2016 (undefined)
    Primary Completion Date
    December 2017 (Anticipated)
    Study Completion Date
    December 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Peking University People's Hospital
    Collaborators
    Beijing Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    a prospective, multicenter, randomized, open-label, Phase II, two arms interventional trial performed in 5 departments of hematology in China
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Immune Thrombocytopenia
    Keywords
    Immune Thrombocytopenia, Rituximab, methylprednisolone

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    112 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Rituximab plus methylprednisolone
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Methylprednisolone
    Arm Type
    Active Comparator
    Arm Description
    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).
    Intervention Type
    Drug
    Intervention Name(s)
    Rituximab plus methylprednisolone
    Other Intervention Name(s)
    monoclone antibody of cluster of differentiation antigen 20
    Intervention Description
    rituximab （1000mg IV day1, week 3, week 17 , and week 19）
    Intervention Type
    Drug
    Intervention Name(s)
    methylprednisolone
    Other Intervention Name(s)
    intravenous methylprednisolone
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Relapse free survival
    Description
    Relapse was defined as a drop in platelet count to <30 ×109/L following an initial best response (partial or complete response).
    Time Frame
    From date of randomization until the date of relapse or death from any cause, whichever came first, assessed up to 1 year
    Secondary Outcome Measure Information:
    Title
    Cumulative response rate
    Description
    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.
    Time Frame
    1 year
    Title
    Cumulative complete response rate
    Description
    platelet count >100 x 10^9/L, confirmed on at least 2 separate occasions at least 7 days apart, and absence of bleeding
    Time Frame
    1 year
    Title
    Cumulative relapse rate
    Description
    Time to response (from randomization to the achievement of response)Duration of response (from the initial response to the first relapse)
    Time Frame
    1 year
    Title
    adverse event/serious adverse event and cumulative rate of bleeding events
    Description
    adverse event/serious adverse event associated with study drugs and bleeding events
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xiao-Hui Zhang, Doctor
    Phone
    861088324577
    Email
    zhangxh100@sina.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ru Feng, Doctor
    Phone
    861085136381
    Email
    frbld@sina.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xiao-jun Huang, Dr
    Organizational Affiliation
    Peking University People's Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Treatment of ITP With Rituximab and / or Accutane

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