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Clinical Trial
. 2010 Feb;95(2):329-32.
doi: 10.3324/haematol.2009.012484. Epub 2009 Aug 13.

Fractionated subcutaneous rituximab is well-tolerated and preserves CD20 expression on tumor cells in patients with chronic lymphocytic leukemia

Affiliations
Clinical Trial

Fractionated subcutaneous rituximab is well-tolerated and preserves CD20 expression on tumor cells in patients with chronic lymphocytic leukemia

Georg Aue et al. Haematologica. 2010 Feb.

Abstract

A pilot study previously demonstrated that thrice-weekly, fractionated-dose intravenous rituximab (RTX) limits CD20 loss from chronic lymphocytic leukemia (CLL) B cells, thereby enhancing immunotherapeutic targeting. Here, we investigated the feasibility of giving 20 mg rituximab subcutaneously thrice weekly for up to 12 weeks in 4 previously treated CLL patients. Subcutaneous rituximab was well-tolerated with minimal injection site reactions; a variable degree of efficacy was observed, likely influenced by the size of the patients' B cell/CD20 burden. Subcutaneous RTX largely preserved CD20 expression on leukemic cells but the most effective therapeutic dosing regimen needs to be established (ClinicalTrials.gov Identifier: NCT00366418).

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Figures

Figure 1.
Figure 1.
Absolute lymphocyte counts, CD20 expression and complement deposition on leukemic cells during the first 72 hours of treatment in chronic lymphocytic leukemia. The first 20 mg intravenous dose of RTX on day 1 was followed by a subcutaneous 20 mg dose of RTX on day 3. (A) Absolute lymphocyte counts (ALC) pre-treatment, and 2, 4, 6, 24 hours after the first 20 mg intravenous infusion of RTX. The dashed line at the 48 hour timepoint indicates the first subcutaneous injection of 20 mg RTX. Measurements are taken 2, 4, 6, and 24 hours after the subcutaneous RTX administration. (B) Quantitative levels of CD20 on patient’s B cells by flow cytometry (molecules of equivalent soluble fluorochome, MESF). (C) Cells were stained with an mAb specific for C3dg to measure deposition of complement fragments on cells after RTX treatment.
Figure 2.
Figure 2.
A single 20 mg intravenous dose of RTX on day 1 followed by thrice weekly subcutaneous 20 mg doses of RTX over 6–12 weeks. (A) ALC, and (B) quantitative levels of CD20 on patient’s B cells are shown for the period of treatment. The last RTX injection for patient 1 was on day 84, and final measurements on day 92 are shown.

References

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