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

Primary Purpose

Anemia, Hemolytic, Autoimmune

Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
prednisolone + mabthera
Prednisolone
Sponsored by
Copenhagen University Hospital at Herlev
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia, Hemolytic, Autoimmune focused on measuring autoimmune hemolytic anemia, hemolytic anemia, Rituximab, Treatment of autoimmune hemolytic anemia, warm antibody dependant autoimmune hemolytic anemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aalborg Hospital
  • Rigshospitalet - Copenhagen University Hospital
  • Esbjerg Sygehus
  • Haderslev Sygehus
  • Department of Haematology, Herlev Hospital
  • Holstebro Sygehus
  • Naestved Sygehus
  • Odense University Hospital
  • Roskilde Hospital
  • Vejle Hospital
  • Viborg Sygehus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prednisolone + Rituximab

Prednisolone

Arm Description

Outcomes

Primary Outcome Measures

Number of patients in each group in complete or partial remission

Secondary Outcome Measures

Side effects

Full Information

First Posted
May 28, 2010
Last Updated
September 9, 2013
Sponsor
Copenhagen University Hospital at Herlev
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1. Study Identification

Unique Protocol Identification Number
NCT01134432
Brief Title
Prednisolone +/- Addition of Anti-CD20 Antibody, Rituximab, in Patients With Immune Hemolytic Anemia
Official Title
Anti-CD20 Antibody Rituximab in Addition to Prednisolone in Treatment of Warm Antibody Related Autoimmune Hemolytic Anemia. A Randomised Danish Multicenter Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Copenhagen University Hospital at Herlev

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Hemolytic, Autoimmune
Keywords
autoimmune hemolytic anemia, hemolytic anemia, Rituximab, Treatment of autoimmune hemolytic anemia, warm antibody dependant autoimmune hemolytic anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prednisolone + Rituximab
Arm Type
Experimental
Arm Title
Prednisolone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
prednisolone + mabthera
Other Intervention Name(s)
mabthera equals Rituximab
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Intervention Description
Prednisolone: 1,5 mg/kg for two weeks and then gradually reduced dosis over two months
Primary Outcome Measure Information:
Title
Number of patients in each group in complete or partial remission
Time Frame
End of treatment and follow-up for 12 months
Secondary Outcome Measure Information:
Title
Side effects
Time Frame
End of treatment plus follow-up for 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henrik S Birgens, MD
Organizational Affiliation
Department of Haematology (L121), Copenhagen University Hospital Herlev
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg Hospital
City
Aalborg
ZIP/Postal Code
DK-9000
Country
Denmark
Facility Name
Rigshospitalet - Copenhagen University Hospital
City
Copenhagen
ZIP/Postal Code
DK-2100
Country
Denmark
Facility Name
Esbjerg Sygehus
City
Esbjerg
ZIP/Postal Code
DK-6700
Country
Denmark
Facility Name
Haderslev Sygehus
City
Haderslev
ZIP/Postal Code
DK-6100
Country
Denmark
Facility Name
Department of Haematology, Herlev Hospital
City
Herlev
ZIP/Postal Code
DK-2730
Country
Denmark
Facility Name
Holstebro Sygehus
City
Holstebro
ZIP/Postal Code
DK-7500
Country
Denmark
Facility Name
Naestved Sygehus
City
Naestved
ZIP/Postal Code
DK-4700
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
DK-5000
Country
Denmark
Facility Name
Roskilde Hospital
City
Roskilde
ZIP/Postal Code
DK-4000
Country
Denmark
Facility Name
Vejle Hospital
City
Vejle
ZIP/Postal Code
DK-7100
Country
Denmark
Facility Name
Viborg Sygehus
City
Viborg
ZIP/Postal Code
DK-8800
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

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

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