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

Therapy for chronic cold agglutinin disease: A prospective, non-randomized international multicenter trial on the safety and efficacy of bendamustine and rituximab combination therapy. - CAD5

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004835-30-NO

Enrollment

Registered

2012-08-29

Start date

2012-10-23

Completion date

Unknown

Last updated

2022-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary chronic cold agglutinin disease requiring treatment

Interventions

Trade Name: Levact Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: BENDAMUSTINE HYDROCHLORIDE CAS Number: 3543-75-7 Concentration unit: mg/ml milligram(s)/millilitre Co

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Weekly during treatment, monthly during six months after treatment and every third month after that up to three years after end of therapy.;Main Objective: Rate of complete and partial responses, respectively.;Secondary Objective: Time to response; time to best response; hematological toxicity grade 4; frequency of dose reduction; response duration.;Primary end point(s): Rate of complete and partial responses	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Weekly during treatment, monthly during six months after treatment and every third month after that up to three years after end of therapy.;Main Objective: Rate of complete and partial responses, respectively.;Secondary Objective: Time to response; time to best response; hematological toxicity grade 4; frequency of dose reduction; response duration.;Primary end point(s): Rate of complete and partial responses

—

Secondary

Measure	Time frame
Secondary end point(s): Time to response; time to best response; hematological toxicity grade 4; frequency of dose reduction; response duration.;Timepoint(s) of evaluation of this end point: Weekly during treatment, monthly during six months after treatment and every third month after that up to three years after end of therapy.	—

Countries

Denmark, Finland, Norway

Contacts

Public ContactSigbjorn Berentsen

Department of Medicine

sigbjorn.berentsen@haugnett.no

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026