Rituximab as Second Line Treatment for ITP

Last updated: March 25, 2014
Sponsor: Ostfold Hospital Trust
Overall Status: Completed

Phase

3

Condition

Immune Thrombocytopenia (Itp)

Dysfunctional Uterine Bleeding

Thrombosis

Treatment

N/A

Clinical Study ID

NCT00344149
3114
ITP001
  • Ages > 18
  • All Genders

Study Summary

Immune thrombocytopenic purpura (ITP) is an autoimmune disorder characterized thrombocytopenia.

Splenectomy is the standard treatment for patients who fails the first-line treatment: corticosteroid. Rituximab, has recently emerged as a promising treatment for ITP. The aim of the study is to determine whether early treatment with Rituximab can result in durable remissions, and consequently, lead to the avoidance of splenectomy in a significant number of patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. ITP with platelet count <30 x 109 /l after 2 weeks of treatment with prednisolon orduring prednisolon tapering period i.e. from week three of prednisolon initiation.Patients with platelet count between 30 -50 are eligible if a higher platelet count isconsidered necessary, because of : concomitant medical illness predisposing tobleeding (hypertension, GI bleeding, bleeding diathesis, previous history of bleeding)concomitant medical condition requiring platelet blocking agents/ anticoagulation,persistent bleeding despite platelets > 30 x 109 /l, prior to surgery, or because ofother patient related factors necessitating higher platelet count as occupation,hobby, psychological intolerability.

  2. Subject is >18 years

  3. Subject has signed and dated written informed consent.

  4. Subject is able to understand and comply with protocol requirements and instructions,and intends to complete the study as planned.

  5. Females in fertile age should express willingness for use of contraceptive means for 6months following the administration of the study drugs.

Exclusion

Exclusion criteria:

  1. Previous splenectomy, chemotherapy, treatment with anti-D Ig, rituximab, orimmune-suppressive treatments other than corticosteroids, Dapsone or Danazol

  2. Underlying malignancy or previous history of malignancy in the past 5 years (exceptskin carcinoma)

  3. Pregnancy and lactation

  4. Not willing to participate in the study

  5. Expected survival of < 2 years

  6. Known intolerance to murine antibodies

  7. Females in child-bearing age not willing to use contraception for 6 months

  8. HIV-positive/AIDS-, Hepatitis -B virus positive- or Hepatitis -C virus positive

  9. Patients with a definite Systemic Lupus Erythematosus (SLE) (> 4 of the AmericanCollege of Rheumatology Criteria)

  10. Patients currently involved in another clinical trial with evaluation of drugtreatment

  11. Bacterial infections, viral infections, fungal infections, myco-bacterial infections (excluding fungal infections) or other evolutive infections or any other infectionsepisode requiring hospitalisation or treatment with an antibiotics 4 weeks beforeselection for IV route or within 2 weeks before selection for oral route

  12. History of soft tissue, bone or joint infections (fascitis, abscess, osteomyelitis,septic arthritis) during the last year prior to inclusion in the study

  13. Medical history of relapsing or chronic severe infectious diseases or any otherunderlying pathology predisposing to serious infections

  14. Known Primary or secondary immune deficiency syndromes

  15. Administration of a living vaccine within 4 weeks preceding the inclusion in the study -16- Previous treatment with any lymphocytes depleting medication (e.g.: MabCampath®)

17- Previous treatment with inhibitors of leucocytes transmigration (e.g.: Tysabri®) 18-Known intolerance to human monoclonal antibodies 19- Known severe chronic pulmonaryobstructive Disease (FEV < 50% or functional dyspnoea grade 3) 20- Known congestive heartfailure NYHA (New York Heart Association classification of heart failure) class III and IV 21- Recent episode (<6 months) of acute coronary syndrome.

Study Design

Total Participants: 112
Study Start date:
June 01, 2006
Estimated Completion Date:
March 31, 2014

Study Description

ITP is an autoimmune disorder characterized by formation of autoantibodies against platelet antigens leading to premature platelet destruction and persistent thrombocytopenia often resulting in bleeding.

The goal of treatment is to raise the platelet count to a hemostatically safe level.

Treatment with corticosteroids rarely results in durable responses, and most of the patients will ultimately require a second-line treatment. Splenectomy results in a high rate of sustained remissions. However, the procedure is invasive and is associated with considerable short and long term morbidity and mortality. Rituximab, a chimeric anti-CD20 antibody with a B-cell depleting effect, has recently emerged as a promising treatment for ITP.

The study aims to determine whether early treatment with Rituximab can result in durable remissions, and consequently, avoidance of splenectomy in a clinical significant number of patients.

The main objective of this study is to assess the rate of treatment failure (splenectomy or meeting criteria for splenectomy after week 12) at 1.5-year in a prospective, randomized, placebo-controlled, double-blind, multi-centre

Connect with a study center

  • Østfold Hospital Trust in Fredrikstad and National hospital in Oslo

    Fredrikstad and Oslo, 1603
    Norway

    Site Not Available

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