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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Acthar SLE (Systemic Lupus Erythematosus)

NCT02779153

Systemic Lupus Erythematosus (SLE) Repository Corticotropin Injection

WITHDRAWN PHASE4

The RITAI Cohort: An Observational Study on Rituximab Off-label Use for Auto-immune Disorders

NCT00960713

Pemphigus Auto-immune Thrombocytopenic Purpura Hemolytic Auto-immune Anaemia +2 more

COMPLETED

A Phase 1/2a Study of DB-2304 in Healthy Adults and SLE Participants

NCT06625671

Systemic Lupus Erythematosus (SLE)

RECRUITING PHASE1/PHASE2

Preliminary Clinical Study of UTAA09 Injection in the Treatment of Relapsed/Refractory Autoimmune Diseases

NCT06417398

Systemic Lupus Erythematosus Idiopathic Inflammatory Myopathies Systemic Sclerosis +4 more

NOT_YET_RECRUITING EARLY_PHASE1

Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus Erythematosus

NCT01408576

Systemic Lupus Erythematosus

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Autoimmune Hemolytic Disease (Cold Type) (Warm Type)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

prednisone, low dose rituximab

Patients with "warm" AIHA will receive:

Rituximab 100 mg i.v.weekly (fixed dose irrespective of body surface area) for 4 consecutive weeks (days +7, +14, +21, +28), and prednisone 1 mg/kg/die p.o. days from day +1 to day +30, followed by tapering (10 mg/week until 0.5/mg/kg/die, then 5 mg/week until stop)

Patients with CHD will receive:

Rituximab 100 mg i.v.weekly (fixed dose irrespective of body surface area) for 4 consecutive weeks (days +7, +14, +21, +28)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No