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

Institute of Hospitalization and Scientific Care (IRCCS)

Status and phase

Completed

Phase 2

Conditions

Autoimmune Hemolytic Disease (Cold Type) (Warm Type)

Treatments

Drug: prednisone, low dose rituximab

Study type

Interventional

Funder types

Other

Identifiers

NCT01345708

Eudra CT 2008-006713-25

Details and patient eligibility

About

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).

Enrollment

23 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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have provided written informed consent prior to study participation, with the understanding that the consent may be withdrawn by the patient at any time without prejudice.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