Status:
COMPLETED
Rituximab in Auto-Immune Hemolytic Anemia
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Warm Autoimmune Hemolytic Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The hypothesis based on retrospective data is that, the rate of overall response-rate (PR + CR) at 1 year will be much higher in the rituximab arm (80%) than in the placebo arm (20%).Thirty four patie...
Detailed Description
The primary aim of the study is to assess the efficacy (overall response rate at 1 year) of rituximab (an anti-CD20 monoclonal antibody) in AIHA due to warm autoantibody when administered at the initi...
Eligibility Criteria
Inclusion
- Age \> 18 years
- AIHA defined at time of diagnosis by a Hgb level £ 10 g/dL, with a reticulocytes count \> 120 109/L, signs of hemolysis (at least a haptoglobin level \< 4 mg/L), and a positive direct antiglobulin test (DAT) ( IgG or IgG + complement pattern).
- Disease duration equal or less than 6 weeks at time of inclusion --\> removed by amendment n°4 and substituted by :First episode of AIHA to "hot" antibody previously untreated or treated corticosteroids for less than 6 weeks.
- Patients with an associated autoimmune thrombocytopenia (Evans' syndrome) will be eligible for the study if the platelet count is over 30 x 109/L at inclusion.
- Normal level gammaglobulins in the serum (i.e. \>5g/L) at inclusion.
- Absence of detectable lymph nodes on a total body CT-scan (to be performed before inclusion if not performed at diagnosis).
- Effective means of contraception during treatment and for six months after completion of treatment for all women of child bearing age
- Negative serum pregnancy test within 14 days prior to study entry.
- Written informed consent
Exclusion
- Previous treatment with rituximab
- AIHA diagnosed and treated more than 6 weeks prior to inclusion removed by amendment n°4 and substituted by AIHA relapsed or newly diagnosed but treated with corticosteroids for more than 6 weeks
- Ongoing immunosuppressive therapy (other than corticosteroids) or previous treatment administered within 2 weeks prior to the beginning of the study treatment
- Non-Hodgkin Lymphoma (NHL) other than stage A chronic lymphoid leukemia
- Previous or concomitant malignancy other than basal cell or squamous cell carcinoma of the skin, carcinoma-in-situ of the cervix, or other malignancy for which the patient had not been disease-free for at least 5 years.
- Autoimmune disorder such as SLE with at least one extra-hematological manifestation requiring a treatment with steroids and/or immunosuppressive drugs.
- Any other associated cause congenital or acquired hemolytic anemia (except thalassemia trait or heterozygous sickle cell anemia).
- Negative DAT or DAT positive with isolated anti-C3d pattern related to the presence of a monoclonal IgM with cold agglutinin properties.
- Positive HIV test and/or hepatitis virus C infection and/or positive hepatitis B virus surface antigen (HbsAg).
- Neutrophils count \< 1,000/mm 3 at inclusion.
- Impaired renal function as indicated by a serum creatinine level \> 2 mg/d
- Inadequate liver function as indicated by a total bilirubin level \> 2.0 mg/dL and/or an AST or ALT level \> 2x upper limit of normal.
- New York Heart Classification III or IV heart disease.
- Previous history of severe psychiatric disorder or are unable to comply with study and follow-up procedures
- Pregnant or lactating women, or woman planning to become pregnant within 12 months of receiving study drug
- Absence of written informed consent.
Key Trial Info
Start Date :
March 3 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 8 2016
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01181154
Start Date
March 3 2011
End Date
January 8 2016
Last Update
October 19 2017
Active Locations (1)
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1
Henri Mondor University Hospital
Créteil, France, 94000