Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-Randomized, Multi-Center Study Demonstrating the Efficacy of Terminal Complement Inhibition in Patients with Cold Agglutinin Disease Using Eculizumab - DECADE Trial

• Register: EUCTR
• Last refreshed on: 19 January 2015
• Main ID: EUCTR2009-016966-97-DE
• Date of registration: 08/02/2010
• Prospective Registration: Yes
• Primary sponsor: Universitätsklinikum Essen
• Public title: Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-Randomized, Multi-Center Study Demonstrating the Efficacy of Terminal Complement Inhibition in Patients with Cold Agglutinin Disease Using Eculizumab - DECADE Trial
• Scientific title: Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-Randomized, Multi-Center Study Demonstrating the Efficacy of Terminal Complement Inhibition in Patients with Cold Agglutinin Disease Using Eculizumab - DECADE Trial
• Date of first enrolment: 08/06/2010
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-016966-97
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Germany

Key inclusion & exclusion criteria

Inclusion criteria:
Diagnosis of CAD defined by the combination of chronic hemolysis, cold agglutinin titer (IgM or IgA) >64 at 4°C, positive direct antiglobulin test (DAT) when performed with polyspecific antiserum, negative (or only weakly positive) anti-IgG, and strongly positive with anti-C3d.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
An active aggressive lymphoma requiring therapy or an active non-lymphatic malignant disease other than basal cell carcinoma or CIS of the cervix.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Cold agglutinin disease
MedDRA version: 12.1 Level: LLT Classification code 10009868 Term: Cold type haemolytic anaemia

Intervention(s)

Trade Name: Soliris (R)
Pharmaceutical Form: Concentrate for solution for infusion

Primary Outcome(s)

Main Objective: Evaluation of the efficacy and safety of eculizumab in symptomatic or transfusion-dependent patients with untreated or refractory hemolytic cold agglutinin disease (CAD)

Primary end point(s): Primary endpoint for this study is lactate dehydrogenase (LDH) change from baseline to 26 weeks.

Secondary Objective: Effect of eculizumab in hemolytic cold agglutinin disease on lactate dehydrogenase (LDH) change, transfusion avoidance, PRBC units transfused, change in hemoglobin levels, haptoglobin, hemopexin, free hemoglobin, reticulocytes, SF-36V2 QLQ, FACIT-F SCALE version 4, Six-Minute Walk Test, circulatory symptoms and thrombosis record from baseline to 26 weeks. Exploratory endpoints include: direct agglutination test (DAT), serum monoclonal immunoglobulin level, cold agglutinin (IgM or IgA) titer and thermal amplitude measures from randomization to 26 weeks, presence of a clonal B-cell lymphoproliferative disorder defined by monoclonal IgM? or IgA? band by serum electrophoresis and immunofixation, immunophenotyping of bone marrow, immunophenotyping of peripheral blood and blood pressure.

Secondary ID(s)

CAD01