CompletedPhase 2

Bendamustine and Rituximab Combination Therapy for Cold Agglutinin Disease

Denmark, Finland, Norway43 participantsStarted 2013-01

Plain-language summary

Prospective, non-randomized multicenter study on the safety and efficacy of combination therapy with bendamustine and rituximab for chronic cold agglutinin disease.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. CAD diagnosis defined by the combination of -
✓. Chronic hemolysis
✓. Cold agglutinin titer 64 or higher
✓. Positive direct antiglobulin test when performed with polyspecific antiserum, negative (or only weakly positive) with anti-IgG, and strongly positive with anti-C3d
✓. The presence of a clonal B-cell lymphoproliferative disorder defined by -
✓. Monoclonal band by serum electrophoresis with immunofixation, and/or
✓. CD20 positive lymphocyte population with cellular kappa/lamda-ratio higher than 3.5 or less than 0.9, using flowcytometric immunophenotyping of bone marrow aspirates
✓. Indication for therapy, i.e. significant anemia and/or considerable cold-induced circulatory symptoms

Exclusion criteria

✕. An aggressive lymphoma
✕. Non-lymphatic malignant disease other than basal cell carcinoma of the skin. A history of probably cured cancer is not an exclusion criterion.
✕. Known HIV infection
✕. Acute or chronic hepatitis B or C
✕. Liver failure or active parenchymal liver disease. Bilirubin levels higher than 51 mol/L (3.0 mg/dL) when due to hepatic impairment. Elevated serum bilirubin level due to hemolysis is not an exclusion criterion.
✕. Pregnancy or breast-feeding
✕. Patients of childbearing age who are not willing to use safe contraception during the entire study period and 6 months following its cessation
✕. All contraindications to the study drugs will be regarded as exclusion criteria.

What they're measuring

Frequency of complete and partial responses (CR/PR)

Timeframe: 6 months

Trial details

NCT IDNCT02689986

SponsorHelse Fonna

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-12

View on ClinicalTrials.gov More Cold Agglutinin Disease trials