A Single-Arm Pilot Study With Low-Dose Rituximab Plus Standard Oral Prednisone In Idiopathic Autoimmune Hemolytic Anemia

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this prospective study was to evaluate the activity, safety and the duration of the response of low dose rituximab associated with standard oral prednisone as first line therapy in newly diagnosed warm autoimmune hemolytic anemia and cold hemagglutinin disease, and as second line therapy in warm autoimmune hemolytic anemia relapsed after standard oral prednisone. Further aim was to correlate the clinical response to biological parameters (cytokine and anti-erythrocyte antibody production in cultures).

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

Details

• Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Collaborator: University Hospital, Udine, Italy
• Treatments: Prednisone; Rituximab

Criteria

Inclusion Criteria:

• Newly diagnosed "warm" or "cold" AIHA, defined by symptomatic anemia and positive DAT, in the absence of underlying lymphoproliferative, infectious or neoplastic disease (according to the single Center diagnostic criteria).

• Idiopathic "warm" or "cold" AIHA relapsed after first line treatment with oral prednisone.

• Aged >18 years

• ECOG performance status grade 0, 1 or 2

• No psychiatric illness that precludes understanding concepts of the trial or signing informed consent

• Patients who have provided written informed consent prior to study participation, with the understanding that the consent may be withdrawn by the patient at any time without prejudice.

Exclusion Criteria:

• Cell or humoral immunologic deficit (congenital or acquired)

• Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent

• Active bacterial, viral, or fungal infection requiring systemic therapy HIV or HbsAg positive (with HBV-DNA+) or HCV-Ab positive (with HCV-RNA+) patients

• History of malignancies within 3 years prior to study entry

• Concomitant immunosuppressive or cytotoxic treatment

• Positive pregnancy test. Lactation.

• The presence of associated organ-specific autoimmune diseases do not constitute exclusion criteria. Previous splenectomy does not constitute exclusion criteria