A SINGLE-ARM PILOT STUDY WITH LOW-DOSE RITUXIMAB PLUS STANDARD ORAL PREDNISONE IN IDIOPATHIC AUTOIMMUNE HEMOLYTIC ANEMIA - ND

• Conditions: ANEMIE EMOLITICHE AUTOIMMUNI IDIOPATICHE

• Registration Number: EUCTR2008-006713-25-IT
• Lead Sponsor: OSPEDALE MAGGIORE DI MILANO (IRCCS)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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who have provided written informed consent prior to study participation, with the understanding that the consent may be withdrawn by the patient at any time without prejudice
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified