Study of the Effectiveness of Rituximab in Adults With Chronic and Severe Immune Thrombocytopenic Purpura and Candidate for a Splenectomy

• Status: Terminated
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this study is to evaluate the clinical effectiveness of the rituximab at the adults with a chronic immune thrombocytopenic purpura (>=6 months of evolution) and severe (platelets <= 30x109/L) and candidate to a splenectomy. The objective is to obtain after a treatment by the rituximab a satisfactory response to one year, defined by a number of platelets higher than 50x109/L and at least 2 times superior with the persistent initial figure without treatment during one year after the end of the treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Etablissement Français du Sang
• Treatments: Rituximab

Criteria

Inclusion Criteria:

• Platelets <= 30x109/L in the absence of agglutinat

• Evolution of the PTAI >= 6 months starting from the date of the diagnosis

• Myélogramme normal and rich in mégacaryocytes

• Age >=18 years

• Among patients at which the treatments prescribed before (and in particular corticoids or intravenous immunoglobulins) did not have any effectiveness, even transitory, the diagnosis of ITP will have to be confirmed by an isotopic study of the 1/2 life of the plates.

Exclusion Criteria:

• Refusal of informed and enlightened assent written.

• Intermittent ITP defined by which has occurred of transitory periods of remissions variable length of the thrombocytopenia.

• Sick splenectomized whatever is the reason

• Splénomégalie

• Absence of vaccination against the pneumococcus

• Absence of vaccination against Haemophilus influenzae

• Previous of treatment by the rituximab

• Administration of a treatment known as active during the ITP other than corticoids in the 30 days which precede inclusion

• CIVD and/or weakens haemolytic with schizocytes

• Serology VIH or positive VHC, Ag positive HBs

• Rate of ALAT or ASAT higher than twice the higher limit of the normal of the laboratory

• Associated autoimmune anomalies:

• Anti DNA and/or anti ECT (ENA) and/or anti Ro (SSA)

• The presence isolated from antibody anti cores (nuclear anti factors) is not a criterion of exclusion.

• Anticoagulant circulating of lupic type and/or antibody anticardiolipines with antecedent of thrombosis or spontaneous miscarriages with repetition (their isolated presence is not a criterion of exclusion)

• Other autoimmune diseases: lupus (with at least 4 criteria of the ACR), polyarthrite chronic evolutionary, disease of Biermer, affected thyroid, weakens haemolytic autoimmune.

• Pregnant woman, breast feeding, woman in genital working life in the effective absence of contraception throughout treatment and 12 month after stop of the treatment.

• Evolutionary or previous cancer of malignant hemopathy

• Over-sensitiveness with murine proteins