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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01345708
• Date of registration: 28/04/2011
• Primary sponsor: Fondazione Ospedale
• Public title: A Single-Arm Pilot Study With Low-Dose Rituximab Plus Standard Oral Prednisone In Idiopathic Autoimmune Hemolytic Anemia
• Scientific title: A Single-Arm Pilot Study With Low-Dose Rituximab Plus Standard Oral Prednisone In Idiopathic Autoimmune Hemolytic Anemia
• Date of first enrolment: January 2009
• Target sample size: 23
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01345708
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Italy

Contacts

• Name: PierMannuccio Mannucci, MD
• Affiliation: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Via F. Sforza 28 20122, Milano.

Key inclusion & exclusion 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with the understanding that the consent may be withdrawn by the patient at any time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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Autoimmune Hemolytic Disease (Cold Type) (Warm Type)

Intervention(s)

Drug: prednisone, low dose rituximab

Primary Outcome(s)

overall response [Time Frame: month +2]

Secondary Outcome(s)

Sustained response (SR) [Time Frame: month +6, month +12]

Secondary ID(s)

Eudra CT 2008-006713-25

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University Hospital, Udine, Italy