Short treatment with a drug for patients affected by a type of a treatment-resistant anaemia, where the red cells are destroyed by some cold cells (autoantibodies).

Phase 1

• Conditions: Anaemia with refractory cold agglutinin disease; MedDRA version: 14.1Level: PTClassification code 10009868Term: Cold type haemolytic anaemiaSystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2011-006329-42-IT
• Lead Sponsor: G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-30
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

- Patients with chronic cold agglutinin disorder requiring transfusion or with a hemoglobin concentration below 10g/L determined at least monthly during the two months before entering the trial; - Failure of at least one previous treatment attempt; - Hemoglobin level assessment; - Cold agglutinin (CA) titer at 4°C of 64 or higher; - Written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- Presence of a concomitant lymphoproliferative disorder requiring specific treatment for reasons other than cold agglutinin related hemolytic anemia. - Preexisting peripheral neuropathy. - Known hypersensitivity to Bortezomib. - Non-cooperative behaviour or non-compliance. - Psychiatric diseases or conditions that might impair the ability to give informed consent. - Patients who are pregnant (women of childbearing potential must have a negative serum pregnancy test). Post-menopausal women must be amenorrhoic for at least 24 months to be considered of non-childbearing potential. Male and female patients must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified