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

NCT00225875 | Terminated Phase 2

• 1 other identifier: PTAI
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autoimmune Thrombocytopenic Purpura

Keywords

Autoimmune thrombocytopenic purpura; Rituximab

Outcome Measures

Primary Outcomes (1)

• Satisfactory response to one year, platelets >=50x109/L and at least 2 times superior in the initial, and persistent figure without treatment during one year after the stop of the treatment.

Secondary Outcomes (2)

• Incomplete response to one year,platelets >= 30x109/L and < 50x109/L and at least twice the figure initial or > 50x109/L but lower than twice the persistent initial figure without treatment during one year after the end of the treatment.

• Splenectomy at one year satisfactory Response to 2 years Incomplete Response to 2 years Splenectomy at 2 years Tolerance of the treatment.

Interventions

Mabthéra DRUG

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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)
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Etablissement Français du Sang: collaborator

Study Sites (1)

Hôpital Henri Mondor

Créteil, 94000, France

Location

Related Publications (2)

• Michel M, Chanet V, Galicier L, Ruivard M, Levy Y, Hermine O, Oksenhendler E, Schaeffer A, Bierling P, Godeau B. Autoimmune thrombocytopenic purpura and common variable immunodeficiency: analysis of 21 cases and review of the literature. Medicine (Baltimore). 2004 Jul;83(4):254-263. doi: 10.1097/01.md.0000133624.65946.40.

  PMID: 15232313 BACKGROUND

• Godeau B, Porcher R, Fain O, Lefrere F, Fenaux P, Cheze S, Vekhoff A, Chauveheid MP, Stirnemann J, Galicier L, Bourgeois E, Haiat S, Varet B, Leporrier M, Papo T, Khellaf M, Michel M, Bierling P. Rituximab efficacy and safety in adult splenectomy candidates with chronic immune thrombocytopenic purpura: results of a prospective multicenter phase 2 study. Blood. 2008 Aug 15;112(4):999-1004. doi: 10.1182/blood-2008-01-131029. Epub 2008 May 7.

  PMID: 18463354 DERIVED

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

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

Study Officials

• Bertrand Godeau, Professor

  Henri Mondor University Hospital

  PRINCIPAL INVESTIGATOR

• Philippe Bierling, Professor

  EFS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 20, 2005
• First Posted: September 26, 2005
• Study Start: September 1, 2003
• Study Completion: July 1, 2007
• Last Updated: October 27, 2005

Record last verified: 2005-03

Locations

FR (1)