Treatment of ITP With Rituximab and / or Accutane

NCT02757196 | Unknown Phase 2 DMC

• 1 other identifier: ITP Treatment--100
• Study Type: interventional
• Target: 112
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Immune Thrombocytopenia

Keywords

Immune Thrombocytopenia; Rituximab; methylprednisolone

Outcome Measures

Primary Outcomes (1)

• 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).

  From date of randomization until the date of relapse or death from any cause, whichever came first, assessed up to 1 year

Secondary Outcomes (4)

• Cumulative response rate

  1 year

• Cumulative complete response rate

  1 year

• Cumulative relapse rate

  1 year

• adverse event/serious adverse event and cumulative rate of bleeding events

  1 year

Study Arms (2)

Rituximab plus methylprednisolone

EXPERIMENTAL

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

Methylprednisolone

ACTIVE COMPARATOR

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

Interventions

Rituximab plus methylprednisolone DRUG

rituximab （1000mg IV day1, week 3, week 17 , and week 19）

Also known as: monoclone antibody of cluster of differentiation antigen 20

Rituximab plus methylprednisolone

methylprednisolone DRUG

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

Also known as: intravenous methylprednisolone

Methylprednisolone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Beijing Hospital: collaborator

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

Rituximab; Methylprednisolone

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Xiao-jun Huang, Dr

  Peking University People's Hospital

  STUDY CHAIR

Central Study Contacts

Xiao-Hui Zhang, Doctor

CONTACT

861088324577; zhangxh100@sina.com

Ru Feng, Doctor

CONTACT

861085136381; frbld@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2016
• First Posted: May 2, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: May 13, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share