Prednisolone +/- Addition of Anti-CD20 Antibody, Rituximab, in Patients With Immune Hemolytic Anemia

September 9, 2013 updated by: Copenhagen University Hospital at Herlev

Anti-CD20 Antibody Rituximab in Addition to Prednisolone in Treatment of Warm Antibody Related Autoimmune Hemolytic Anemia. A Randomised Danish Multicenter Trial.

The conventional treatment in warm-antibody dependent autoimmune haemolytic anaemia (AIHA) is high-dose glucocorticoid, but in more than half of the patients, haemolytic activity will recur after end of treatment or during the gradual reduction in dose of the drug. As a result, many patients will finally be splenectomized or be treated with long-term glucocorticoids or other immunosuppressive drugs as azathioprine or cyclophosphamide. Recent studies have shown however, that some patients will respond to treatment with the chimeric anti-CD 20 antibody Rituximab and is some cases, the response is permanent. In most of the studies, Rituximab has been used in refractory disease or at least as second line treatment. In this study, patients with AIHA are randomized to receive either high-dose prednisolone with gradual reduction in dose over 2-3 months alone or in combination with Rituximab 375 mg/m2 once a week for 4 weeks. The efficacy of Rituximab will be evaluated by a comparison of the patients in the two treatment arms. The primary treatment goal is a reduction in the number of patients who obtain long-term complete or partial remission. The secondary treatment goal is a reduction in patients who will be splenectomised or receive other immunosuppressive drugs. Finally a comparison of side effects of the treatments will take place.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, DK-9000
        • Aalborg Hospital
      • Copenhagen, Denmark, DK-2100
        • Rigshospitalet - Copenhagen University Hospital
      • Esbjerg, Denmark, DK-6700
        • Esbjerg Sygehus
      • Haderslev, Denmark, DK-6100
        • Haderslev Sygehus
      • Herlev, Denmark, DK-2730
        • Department of Haematology, Herlev Hospital
      • Holstebro, Denmark, DK-7500
        • Holstebro Sygehus
      • Naestved, Denmark, DK-4700
        • Naestved Sygehus
      • Odense, Denmark, DK-5000
        • Odense University Hospital
      • Roskilde, Denmark, DK-4000
        • Roskilde Hospital
      • Vejle, Denmark, DK-7100
        • Vejle Hospital
      • Viborg, Denmark, DK-8800
        • Viborg Sygehus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 years or over
  • Clinical and biochemical signs of haemolytic anaemia
  • Positive Coombs test with anti-IgG on its own or with anti-CD3d
  • Adequate contraceptive measures (intrauterine device, contraceptive pill or gestagen deposit) for women of childbearing potential

Exclusion Criteria:

  • Performance status > 2
  • Previous treatment with Rituximab
  • Other immune suppressive or anti neoplastic treatment including prednisolone within 3 months
  • Auto immune haemolytic anaemia within 6 months
  • Other serious disease
  • Pregnant women and nursing mothers. Adequate contraceptive measures must be taken for the duration of the study.
  • Contraindication for treatment with Rituximab, i.e. patients that develop hypersensitivity/allergy to the contents of the drug or have antibodies against murine proteins.
  • Active infection which requires antibiotic treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prednisolone + Rituximab
Drug: prednisolone + mabthera

Prednisolone: 1,5 mg/kg for two weeks with gradually reduced dosis over two months.

Mabthera: 375 mg/m2 once a week for four weeks

Other Names:
  • mabthera equals Rituximab
Active Comparator: Prednisolone
Drug: Prednisolone
Prednisolone: 1,5 mg/kg for two weeks and then gradually reduced dosis over two months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients in each group in complete or partial remission
Time Frame: End of treatment and follow-up for 12 months
End of treatment and follow-up for 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Side effects
Time Frame: End of treatment plus follow-up for 12 months
End of treatment plus follow-up for 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Copenhagen University Hospital at Herlev

Investigators

  • Principal Investigator: Henrik S Birgens, MD, Department of Haematology (L121), Copenhagen University Hospital Herlev

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

May 28, 2010

First Submitted That Met QC Criteria

June 1, 2010

First Posted (Estimate)

June 2, 2010

Study Record Updates

Last Update Posted (Estimate)

September 10, 2013

Last Update Submitted That Met QC Criteria

September 9, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIHA-KA04062-gms

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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