Prednisolone +/- Addition of Anti-CD20 Antibody, Rituximab, in Patients With Immune Hemolytic Anemia
Anti-CD20 Antibody Rituximab in Addition to Prednisolone in Treatment of Warm Antibody Related Autoimmune Hemolytic Anemia. A Randomised Danish Multicenter Trial.
1 other identifier
interventional
65
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2005
Longer than P75 for phase_3
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 28, 2010
CompletedFirst Posted
Study publicly available on registry
June 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedSeptember 10, 2013
September 1, 2013
7.3 years
May 28, 2010
September 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients in each group in complete or partial remission
End of treatment and follow-up for 12 months
Secondary Outcomes (1)
Side effects
End of treatment plus follow-up for 12 months
Study Arms (2)
Prednisolone + Rituximab
EXPERIMENTALPrednisolone
ACTIVE COMPARATORInterventions
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
Prednisolone: 1,5 mg/kg for two weeks and then gradually reduced dosis over two months
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Aalborg Hospital
Aalborg, DK-9000, Denmark
Rigshospitalet - Copenhagen University Hospital
Copenhagen, DK-2100, Denmark
Esbjerg Sygehus
Esbjerg, DK-6700, Denmark
Haderslev Sygehus
Haderslev, DK-6100, Denmark
Department of Haematology, Herlev Hospital
Herlev, DK-2730, Denmark
Holstebro Sygehus
Holstebro, DK-7500, Denmark
Naestved Sygehus
Næstved, DK-4700, Denmark
Odense University Hospital
Odense, DK-5000, Denmark
Roskilde Hospital
Roskilde, DK-4000, Denmark
Vejle Hospital
Vejle, DK-7100, Denmark
Viborg Sygehus
Viborg, DK-8800, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Henrik S Birgens, MD
Department of Haematology (L121), Copenhagen University Hospital Herlev
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2010
First Posted
June 2, 2010
Study Start
March 1, 2005
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
September 10, 2013
Record last verified: 2013-09