Therapy of Chronic Cold Agglutinin Disease With Eculizumab
Cold Agglutinin DiseaseEvaluation of the efficacy and safety of eculizumab in symptomatic or transfusion-dependent patients with untreated or refractory hemolytic cold agglutinin disease(CAD)
A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold...
Agglutinin DiseaseColdThe purpose of Part A was to determine whether sutimlimab administration resulted in a greater than or equal to (>=) 2 grams per deciliter (g/dL) increase in hemoglobin (Hgb) levels or increased Hgb to >= 12 g/dL and obviated the need for blood transfusion during treatment in participants with primary cold agglutinin disease (CAD) who had a recent history of blood transfusion. The purpose of Part B was to evaluate the long-term safety and tolerability of sutimlimab in participants with CAD.
A Safety and Tolerability Study of BIVV020 in Adults With Cold Agglutinin Disease
Autoimmune Haemolytic AnaemiaPrimary Objective: To assess the safety and tolerability in participants with cold agglutinin disease (CAD), after a single dose of intravenous (IV) BIVV020 Secondary Objectives: To assess, in participants with cold agglutinin disease, after a single dose of intravenous (IV) BIVV020: The effect of BIVV020 on complement mediated hemolysis The pharmacodynamics (PD) of BIVV020 relating to complement inhibition The pharmacokinetics (PK) of BIVV020 The immunogenicity of BIVV020
Combination Chemotherapy and Rituximab in Treating Patients With Chronic Lymphocytic Leukemia (CLL)...
Chronic Lymphocytic LeukemiaRATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving more than one drug (combination chemotherapy) together with rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with rituximab works in treating patients with chronic lymphocytic leukemia (CLL) that has not responded to fludarabine (closed to entry as of 10/2006), CLL with autoimmune hemolytic anemia, or Richter transformation.
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ANX005 in Participants With Warm...
Warm Autoimmune Hemolytic Anemia (wAIHA)This study will evaluate the safety and tolerability of ANX005 in participants with Warm Autoimmune Hemolytic Anemia (wAIHA).
The Significance of Release of T-follicular Helper and T-follicular Regulatory Cells in Autoimmune...
Autoimmune Hemolytic Anemiawe study the circulating T-follicular regulatory and T-follicular regulatory cells in autoimmune hemolytic anemia.
Short Course of Bortezomib in Anemic Patients With Refractory Cold Agglutinin Disease
Refractory Cold Agglutinin DiseaseThis multicenter, phase II, open label study will enroll patients with chronic cold agglutinin disorder. A single course of Bortezomib will be given at the dose of 1,3 mg/sqm iv on days 1, 4, 8, 11.
Rituximab in Auto-Immune Hemolytic Anemia
Warm Autoimmune Hemolytic AnemiaThe hypothesis based on retrospective data is that, the rate of overall response-rate (PR + CR) at 1 year will be much higher in the rituximab arm (80%) than in the placebo arm (20%).Thirty four patients (17 in each arm) will be include (amendment n°6 - 15/10/2013) over a 3 year period (amendment n°3 - 11/12/2012).
A Safety and Efficacy Study of R935788 in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia...
Warm Antibody Autoimmune Hemolytic AnemiaThe purpose of this study is to evaluate whether fostamatinib is safe and effective in the treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA).
Safety, Tolerability and Activity of BIVV009 in Healthy Volunteers and Patients With Complement...
Bullous Pemphigoid (BP)Cold Agglutinin Disease (CAD)2 moreProspective, double-blind, randomized, placebo-controlled First-In-Human study with four sub-parts: Part A, a single ascending dose study (SAD) in normal human volunteers (NHVs), Part B, a multiple ascending dose study (MAD) in NHVs, Part C, a multiple dose (MD) study in patients with a complement-mediated disorder, and Part E, a multiple dose (MD) study in patients with cold agglutinin disease previously treated with BIVV009 within the scope of a BIVV009 clinical trial or named patient program use. Note: For parts A-C as well as at the start of part E, study drug was named TNT009. The study drug name is changed to BIVV009 with final version Final 15.0 of the clinical study protocol.