Rituximab in Auto-Immune Hemolytic Anemia (NCT01181154) | Clinical Trial Compass
CompletedPhase 3
Rituximab in Auto-Immune Hemolytic Anemia
France32 participantsStarted 2011-03-03
Plain-language 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 patients (17 in each arm) will be include (amendment n°6 - 15/10/2013) over a 3 year period (amendment n°3 - 11/12/2012).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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
What they're measuring
1
Overall response rate (complete and partial response) in both arms
✕. 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).