Rituximab in Auto-Immune Hemolytic Anemia

NCT01181154 | Completed Phase 3

• 2 other identifiers: P0807042008-008255-42
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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 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).

Conditions

Warm Autoimmune Hemolytic Anemia

Keywords

Auto-Immune; Hemolytic; Anemia; AHA; AIHA; Rituximab

Outcome Measures

Primary Outcomes (1)

• Overall response rate (complete and partial response) in both arms

  at 1 year

Secondary Outcomes (7)

• Comparison in both arms of the mean cumulative doses of prednisone

  at 1 year

• Comparison in both arms of the number of transfusions of packed red blood cells in both arms

  at 1 year

• Comparison in both arms of the number of days in hospital

  within the first year of follow-up

• Comparison in both arms of the number of patients requiring a splenectomy and/or an immunosuppressor

  during the first 12 months of follow-up

• Comparison in both arm of the mortality

  at 1 year

Study Arms (2)

equivalent volume total (=1000 ml)

PLACEBO COMPARATOR

Placebo : equivalent volume total (=1000 ml)

Drug: Placebo

rituximab (Mabthera®)

EXPERIMENTAL

rituximab (Mabthera®), 1000 mg at day 1 and day 15

Drug: rituximab (Mabthera®)

Interventions

rituximab (Mabthera®) DRUG

1000 mg at day 1 and day 15

Also known as: rituximab (Mabthera®)1000 mg at day 1 and day 15

rituximab (Mabthera®)

Placebo DRUG

equivalent volume total

Also known as: Placebo equivalent volume total

equivalent volume total (=1000 ml)

Eligibility Criteria

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

You may qualify if:

• 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).
• 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

You may not qualify if:

• Previous treatment with rituximab
• 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).
• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Hoffmann-La Roche: collaborator

Study Sites (1)

Henri Mondor University Hospital

Créteil, 94000, France

Location

MeSH Terms

Conditions

Hemolysis; Anemia

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Marc MICHEL, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2010
• First Posted: August 13, 2010
• Study Start: March 3, 2011
• Primary Completion: January 8, 2015
• Study Completion: January 8, 2016
• Last Updated: October 19, 2017

Record last verified: 2017-10

Locations

FR (1)