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- Title
Alemtuzumab consolidation in chronic lymphocytic leukaemia: a phase I/II multicentre trial.
- Authors
Al‐Sawaf, Othman; Fischer, Kirsten; Herling, Carmen D.; Ritgen, Matthias; Böttcher, Sebastian; Bahlo, Jasmin; Elter, Thomas; Stilgenbauer, Stephan; Eichhorst, Barbara F.; Busch, Raymonde; Elberskirch, Ute; Abenhardt, Wolfgang; Kneba, Michael; Hallek, Michael; Wendtner, Clemens‐Martin
- Abstract
Objective Despite high rates of long-lasting remissions in patients with chronic lymphocytic leukaemia ( CLL) treated with chemoimmunotherapy, none of the current therapeutic approaches is curative with the exception of allogeneic transplantation. One strategy to extend progression-free survival and long-term survival might be the establishment of consolidation therapies. Methods In this trial, patients with complete or partial second remission after fludarabine-based treatment received consolidation therapy with alemtuzumab. The aim of this phase I/ II trial was to determine the maximal tolerable dose ( MTD) of alemtuzumab consolidation and to evaluate safety and efficacy in patients who responded to second-line fludarabine-based treatment. Thirteen patients in complete ( CR) or partial remission ( PR) received alemtuzumab dose escalation starting with 10 mg intravenously (iv) once weekly for 8 wk and increasing in 10-mg intervals per dose level. Results The main dose-limiting toxicities ( DLTs) were infectious complications, and the MTD was determined at 10 mg. After alemtuzumab consolidation, seven of 13 patients (53%) were in CR, and four of these patients (30.7%) achieved minimal residual disease ( MRD) negativity (<1 × 10E-4). At a median follow-up of 71.5 months, four patients were progression-free, with a median progression-free survival ( PFS) of 28.5 months after the end of second-line treatment. Conclusion The results provide a safe and efficient schedule with weekly intravenous application of 10 mg of alemtuzumab as a consolidation regime in patients with CLL.
- Subjects
ALEMTUZUMAB; CHRONIC lymphocytic leukemia; IMMUNOTHERAPY; FLUDARABINE; TREATMENT effectiveness; DRUG dosage
- Publication
European Journal of Haematology, 2017, Vol 98, Issue 3, p254
- ISSN
0902-4441
- Publication type
Article
- DOI
10.1111/ejh.12825