Obinutuzumab (GA101) in relapsed/refractory chronic lymphocytic leukemia: final data from the phase 1/2 GAUGUIN study

被引：125

作者：

Cartron, Guillaume ^{[1
]}

de Guibert, Sophie ^{[2
]}

Dilhuydy, Marie-Sarah ^{[3
]}

Morschhauser, Franck ^{[4
]}

Leblond, Veronique ^{[5
]}

Dupuis, Jehan ^{[6
]}

Mahe, Beatrice ^{[7
]}

Bouabdallah, Reda ^{[8
]}

Lei, Guiyuan ^{[9
]}

Wenger, Michael ^{[10
]}

Wassner-Fritsch, Elisabeth ^{[11
]}

Hallek, Michael ^{[12
]}

机构：

[1] CHU Montpellier, CNRS, UMR 5235, Dept Hematol, F-34295 Montpellier, France

[2] Ctr Hosp Univ Pontchaillou, Inst Natl Sante & Rech Med 1414, Unite Invest Clin, Serv Hematol Clin, Rennes, France

[3] Ctr Hosp Univ Bordeaux, Hop Haut Leveque, Serv Hematol Clin & Therapie Cellulaire, Bordeaux, France

[4] CHU Lille, Serv Hematol, F-59037 Lille, France

[5] Grp Hosp Pitie Salpetriere, Serv Hematol, F-75634 Paris, France

[6] CHU Henri Mondor, Unite Hemopathies Lymphoides, F-94010 Creteil, France

[7] CHU Nantes, Dept Hematol, F-44035 Nantes 01, France

[8] Ctr Lutte Canc Paoli Calmettes, Marseille, France

[9] Roche Prod, Pharma Dev Biostat, Welwyn Garden City, Herts, England

[10] F Hoffmann La Roche, Dept Med Oncol, Basel, Switzerland

[11] F Hoffmann La Roche, Pharma Dev Oncol, Basel, Switzerland

[12] Univ Cologne, Dept Internal Med 1, D-50931 Cologne, Germany

来源：

BLOOD | 2014年 / 124卷 / 14期

关键词：

B-CELL LYMPHOMA; MONOCLONAL-ANTIBODIES; COMPLEMENT ACTIVATION; ANTI-CD20; ANTIBODY; II GAUGUIN; HUMAN CD20; RITUXIMAB; TRIAL; FLUDARABINE; MAINTENANCE;

D O I：

10.1182/blood-2014-07-586610

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

GAUGUIN evaluated the safety and efficacy of obinutuzumab (GA101) monotherapy in patients with relapsed/refractory chronic lymphocytic leukemia (CLL). In phase 1 (dose escalation), 13 patients received obinutuzumab 400 to 1200 mg (days 1 and 8 of cycle 1; day 1 of cycles 2-8). In phase 2, 20 patients received a fixed dose of 1000 mg (days 1, 8, and 15 of cycle 1; day 1 of cycles 2-8). Infusion-related reactions occurred in nearly all patients, but few were grade 3/4. Grade 3/4 neutropenia occurred in 7 patients in phase 1 (but was not dose-related) and in 4 patients in phase 2. Overall end-of-treatment response (all partial responses) was 62% (phase 1) and 15% (phase 2); best overall response was 62% and 30%, respectively. Phase 2 median progression-free survival was 10.7 months and median duration of response was 8.9 months. In summary, obinutuzumab monotherapy is active in patients with heavily pretreated relapsed/refractory CLL. GAUGUIN was registered at www.clinicaltrials.gov as #NCT00517530.

引用

页码：2196 / 2202

页数：7

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