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In a Letter to the Editor of Leukemia, Manuela A. Hoechstetter from Klinikum Schwabing, Munich, Germany, et al. reported findings from the CLL1 trial conducted by the German CLL study group (NCT00262782).
The CLL1 trial aimed to investigate risk-adapted therapy in patients with early stage (0–II) Chronic Lymphocytic Leukemia (CLL). The trial’s protocol was designed in 1997 and identified High-Risk (HR) patients who may progress and receive subsequent treatment ≤2 years after diagnosis either by Lymphocyte Doubling Time (LDT) of less than 12 months or Bone Marrow Infiltration Pattern (BMIP). HR patients were randomly assigned, at a ratio of 1:1, to either early fludarabine (HR-F: 25mg/m2 IV, days 1–5, q28 x 6 cycles) or watch and wait (HR-W&W).
CLL1 was carried out in 123 centers in Germany and Austria and the primary endpoint was PFS. Secondary measures included OS and Time-To-First-Treatment (TTFT).
The authors stated that their findings support watch and wait as the current standard of care for early stage CLL. The group, based on their results, also caution not to treat too early. Lastly, they emphasize that novel agents require “rigorous testing in randomized trials before being approved or generally used in early stage CLL.”
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