Therapy for chronic cold agglutinin disease: A prospective,non-randomized international multicenter trial on the safetyand efficacy of bendamustine and rituximab combinationtherapy.

Phase 1

Conditions: Primary chronic cold agglutinin disease requiringtreatment
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2011-004835-30-DK

Lead Sponsor: Department of Medicine, Haugesund Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

1. CAD diagnosis defined by the combination of –
a. Chronic hemolysis
b. Cold agglutinin titer > 64
c. 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 –
a. Monoclonal band by serum electrophoresis with immunofixation, and/or
b. CD20 positive lymphocyte population with cellular ?/?-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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

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 > 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 < 18 years
10. Inability to cooperate