ANEMIE EMOLITICHE AUTOIMMUNI IDIOPATICHE
Conditions
Interventions
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Rituximab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Sponsors
OSPEDALE MAGGIORE DI MILANO (IRCCS)
Eligibility
Sex/Gender
All
Inclusion 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who have provided written informed consent prior to study participation, with the understanding that the consent may be withdrawn by the patient at any time without prejudice Are the trial subjects under 18?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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the activity (in terms of overall clinical response, complete response and partial response) of low-dose (LD) rituximab associated with standard oral prednisone as first line therapy in newly diagnosed idiopathic autoimmune hemolytic anemia (AIHA), and as second line therapy in AIHA relapsed after standard oral prednisone To evaluate the efficacy (in terms of overall clinical response, complete response and partial response) of LD rituximab as first line therapy in newly diagnosed idiopathic cold hemagglutinin disease (CHD), alone or in association with oral prednisone, in the judgment of the doctor.;Secondary Objective: To assess the duration of the response (sustained response) To evaluate the response according to the type of the hemolytic anemia (?warm? or ?cold?) In relapsed patients, to compare the amount of past steroid therapy with the steroid administration associated with LD rituximab To correlate the clinical response with biological parameters [direct antiglobulin test (DAT) and mitogen stimulated-DAT positivity, in vitro cytokine production, T-lymphocyte activation markers, B-lymphocyte oligoclonality, FCgRIII polymorphism];Primary end point(s): To evaluate the activity (in terms of overall clinical response, complete response and partial response) of low-dose (LD) rituximab associated with standard oral prednisone as first line therapy in newly diagnosed idiopathic autoimmune hemolytic anemia (AIHA), and as second line therapy in AIHA relapsed after standard oral prednisone To evaluate the efficacy (in terms of overall clinical response, complete response and partial response) of LD rituximab as first line therapy in newly diagnosed idiopathic cold hemagglutinin disease (CHD), alone or in association with oral prednisone, in the judgment of the doctor. | — |
Countries
Italy
Outcome results
None listed