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Open AccessArticle

Dose Intensive Rituximab and High-Dose Methylprednisolone in Elderly or Unfit Patients with Relapsed Chronic Lymphocytic Leukemia

1
Hematology, Oncology and Transfusion Medicine Center, Vilnius University Hospital Santaros Klinikos, 08661 Vilnius, Lithuania
2
Institute of Clinical Medicine, Vilnius University, 08661 Vilnius, Lithuania
3
Laboratory Diagnostics Centre, Vilnius University Hospital Santaros Klinikos, 08661 Vilnius, Lithuania
4
Radiology and Nuclear Medicine Center, Vilnius University Hospital Santaros Klinikos, 08661 Vilnius, Lithuania
*
Author to whom correspondence should be addressed.
Medicina 2019, 55(11), 719; https://doi.org/10.3390/medicina55110719
Received: 12 August 2019 / Revised: 18 October 2019 / Accepted: 25 October 2019 / Published: 29 October 2019
Background and Objectives: BTK and BCL2 inhibitors have changed the treatment paradigms of high-risk and elderly patients with chronic lymphocytic leukemia (CLL), but their long-term efficacy and toxicity are still unknown and the costs are considerable. Our previous data showed that Rituximab (Rtx) and high-dose methylprednisolone (HDMP) can be an effective and safe treatment option for relapsed high-risk CLL patients. Materials and Methods: We explored the efficacy and safety of a higher Rtx dose in combination with a shorter (3-day) schedule of HDMP in relapsed elderly or unfit CLL patients. Results: Twenty-five patients were included in the phase-two, single-arm trial. The median progression free survival (PFS) was 11 months (range 10–12). Median OS was 68 (range 47–89) months. Adverse events (AE) were mainly grade I–II° (77%) and no deaths occurred during the treatment period. Conclusions: 3-day HDMP and Rtx was associated with clinically meaningful improvement in most patients. The median PFS in 3-day and 5-day HDMP studies was similar and the toxicity of the 3-day HDMP schedule proved to be lower. The HDMP and Rtx combination can still be applied in some relapsed high-risk and elderly or unfit CLL patients if new targeted therapies are contraindicated or unavailable. (ClinicalTrials.gov identifier: NCT01576588). View Full-Text
Keywords: chronic lymphocytic leukemia; rituximab; high-dose methylprednisolone; elderly chronic lymphocytic leukemia; rituximab; high-dose methylprednisolone; elderly
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Pileckyte, R.; Valceckiene, V.; Stoskus, M.; Matuzeviciene, R.; Sejoniene, J.; Zvirblis, T.; Griskevicius, L. Dose Intensive Rituximab and High-Dose Methylprednisolone in Elderly or Unfit Patients with Relapsed Chronic Lymphocytic Leukemia. Medicina 2019, 55, 719.

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