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CompletedNCT01345708Updated May 2, 2011

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

A Phase 2 interventional study of prednisone, low dose rituximab in Autoimmune Hemolytic Disease (Cold Type) (Warm Type), sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. Completed at 2 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-05-02.

Sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
23
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

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).

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Conditions studied

  • Autoimmune Hemolytic Disease (Cold Type) (Warm Type)

Keywords

  • Low dose rituximab
  • WAIHA
  • CHD
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In context

Anemia, Hemolytic

86 studies on the registry are indexed under Anemia, Hemolytic; 25 are open to participants now.

This study's enrollment of 23 is below the median of 31 across 58 interventional studies indexed under Anemia, Hemolytic.

Browse Anemia, Hemolytic studies →

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico is the lead sponsor of 214 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
23 participants (actual)

Interventions

  • Drugprednisone, 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)

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What researchers measure

Primary outcomes

  1. overall response

    Response will be evaluated at each clinic visit. Complete response (CR) will be defined as Hb increase \>2 g/dL and Hb \> 12 g/dL, normalization of all haemolytic markers and no transfusion requirement;Partial response (PR) will be defined as Hb increase \>2 g/dL and Hb 10-12 g/dL, and 50% reduction of transfusion. In the remaining cases there is no response.

    Time frame: month +2

Secondary outcomes

  1. Sustained response (SR)

    Sustained response (SR) was defined as Hb \> 10 g/dL at month +6 and +12, in the absence of any treatment.

    Time frame: month +6, month +12

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Study locations

2 sites
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
    MIlan, 20122, Italy
  • Wilma Barcellini MD, UO Ematologia 2, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
    Milan, 20122, Italy
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References and documents

Publications

  • Provan D, Butler T, Evangelista ML, Amadori S, Newland AC, Stasi R. Activity and safety profile of low-dose rituximab for the treatment of autoimmune cytopenias in adults. Haematologica. 2007 Dec;92(12):1695-8. doi: 10.3324/haematol.11709. PubMed 18055995 ↗
  • Zaja F, Vianelli N, Volpetti S, Battista ML, Defina M, Palmieri S, Bocchia M, Medeot M, De Luca S, Ferrara F, Isola M, Baccarani M, Fanin R. Low-dose rituximab in adult patients with primary immune thrombocytopenia. Eur J Haematol. 2010 Oct;85(4):329-34. doi: 10.1111/j.1600-0609.2010.01486.x. Epub 2010 Jul 28. PubMed 20546023 ↗
  • Gomez-Almaguer D, Solano-Genesta M, Tarin-Arzaga L, Herrera-Garza JL, Cantu-Rodriguez OG, Gutierrez-Aguirre CH, Jaime-Perez JC. Low-dose rituximab and alemtuzumab combination therapy for patients with steroid-refractory autoimmune cytopenias. Blood. 2010 Dec 2;116(23):4783-5. doi: 10.1182/blood-2010-06-291831. Epub 2010 Sep 14. PubMed 20841509 ↗
  • Barcellini W, Zaja F, Zaninoni A, Imperiali FG, Battista ML, Di Bona E, Fattizzo B, Consonni D, Cortelezzi A, Fanin R, Zanella A. Low-dose rituximab in adult patients with idiopathic autoimmune hemolytic anemia: clinical efficacy and biologic studies. Blood. 2012 Apr 19;119(16):3691-7. doi: 10.1182/blood-2011-06-363556. Epub 2012 Jan 20. PubMed 22267606 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01345708
Lead sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Collaborators
University Hospital, Udine, Italy
First posted
May 2, 2011
Start date
Jan 2009
Primary completion
Jan 2010
Completion
Jan 2011
Last update
May 2, 2011

Study contacts

PierMannuccio Mannucci, MD
study director · Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Via F. Sforza 28 20122, Milano.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.

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