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

NCT ID: NCT01134432

Last Updated: 2013-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anemia, Hemolytic, Autoimmune

Keywords

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autoimmune hemolytic anemia hemolytic anemia Rituximab Treatment of autoimmune hemolytic anemia warm antibody dependant autoimmune hemolytic anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prednisolone + Rituximab

Group Type EXPERIMENTAL

prednisolone + mabthera

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Prednisolone

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Prednisolone

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

Intervention Type DRUG

Other Intervention Names

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mabthera equals Rituximab

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Copenhagen University Hospital at Herlev

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Henrik S Birgens, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Haematology (L121), Copenhagen University Hospital Herlev

Locations

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Aalborg Hospital

Aalborg, , Denmark

Site Status

Rigshospitalet - Copenhagen University Hospital

Copenhagen, , Denmark

Site Status

Esbjerg Sygehus

Esbjerg, , Denmark

Site Status

Haderslev Sygehus

Haderslev, , Denmark

Site Status

Department of Haematology, Herlev Hospital

Herlev, , Denmark

Site Status

Holstebro Sygehus

Holstebro, , Denmark

Site Status

Naestved Sygehus

Næstved, , Denmark

Site Status

Odense University Hospital

Odense, , Denmark

Site Status

Roskilde Hospital

Roskilde, , Denmark

Site Status

Vejle Hospital

Vejle, , Denmark

Site Status

Viborg Sygehus

Viborg, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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AIHA-KA04062-gms

Identifier Type: -

Identifier Source: org_study_id