Overview

Bendamustine and Rituximab Combination Therapy for Cold Agglutinin Disease

Status:
Completed
Trial end date:
2016-12-01
Target enrollment:
0
Participant gender:
All
Summary
Prospective, non-randomized multicenter study on the safety and efficacy of combination therapy with bendamustine and rituximab for chronic cold agglutinin disease.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Helse Fonna
Treatments:
Agglutinins
Bendamustine Hydrochloride
Cold agglutinins
Rituximab
Criteria
Inclusion Criteria:

1. CAD diagnosis defined by the combination of -

1. Chronic hemolysis

2. Cold agglutinin titer 64 or higher

3. Positive direct antiglobulin test when performed with polyspecific antiserum,
negative (or only weakly positive) with anti-IgG, and strongly positive with
anti-C3d

2. The presence of a clonal B-cell lymphoproliferative disorder defined by -

1. Monoclonal band by serum electrophoresis with immunofixation, and/or

2. 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

3. Indication for therapy, i.e. significant anemia and/or considerable cold-induced
circulatory symptoms

4. Written informed consent

Exclusion Criteria:

1. An aggressive lymphoma

2. Non-lymphatic malignant disease other than basal cell carcinoma of the skin. A history
of probably cured cancer is not an exclusion criterion.

3. Known HIV infection

4. Acute or chronic hepatitis B or C

5. 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.

6. Pregnancy or breast-feeding

7. Patients of childbearing age who are not willing to use safe contraception during the
entire study period and 6 months following its cessation

8. All contraindications to the study drugs will be regarded as exclusion criteria.

9. Age below 18 years

10. Inability to cooperate