With the introduction of novel agents for the treatment of chronic lymphocytic leukemia (CLL), treatment options and guidelines have evolved and expanded. The informCLL registry is the largest US-based prospective, observational registry of patients who received treatment for CLL/small lymphocytic lymphoma (SLL) in the era of novel agents. Researchers presented baseline characteristics, prognostic biomarker testing, and treatment patterns for patients enrolled in informCLL.1
The informCLL registry enrolled eligible adult patients with CLL/SLL who had initiated FDA-approved treatment within 45 days of enrollment. Patients were classified into 5 groups based on index treatment received: Imbruvica (ibrutinib; single agent or combination), chemoimmunotherapy, chemotherapy, immunotherapy, and other novel agents.
A total of 1461 patients were enrolled from October 2015 to June 2019. Of these, 855 patients (59%) were previously untreated, and 606 patients (41%) had relapsed or refractory CLL. Community-based practices enrolled 93% of patients. Enrolled patients had a median age of 71 years and 64% were male. For previously untreated patients, the median time from diagnosis to initial treatment was 18.6 months. Patients with relapsed or refractory CLL had a median time from diagnosis to index treatment of 84.27 months.
Prognostic biomarker testing rates were low, especially for TP53 and IGHV mutation status. Fluorescence in situ hybridization testing was performed in 28% of patients and was done more frequently in previously untreated patients compared with patients with relapsed or recurrent CLL (33% vs 21%). Testing for TP53 mutation was performed in 11% of patients and testing for IGHV mutation was performed in 12%. Of patients with prognostic biomarker testing, 24% had 17p deletion, 27% had TP53 mutation, and 71% had unmutated IGHV.
The most common treatment received by patients in the registry was Imbruvica, which was received by 46% of patients. For patients completing the most common chemoimmunotherapy regimens (Bendeka [bendamustine] plus Rituxan [rituximab], Fludara [fludarabine] plus Cytoxan [cyclophosphamide] plus Rituxan [rituximab]), at least 80% received fewer than 6 cycles per physician discretion. Only 6% of patients were treated with other novel agents as index treatment. Venclexta (venetoclax), either as a single agent or in combination, was the most commonly administered novel agent, and was primarily used in patients with relapsed or refractory CLL.
Of 100 patients with TP53 mutation, 67% received Imbruvica, 21% chemoimmunotherapy or chemotherapy, 5% immunotherapy, and 7% other novel agents. The proportion of patients with 17p deletion and/or TP53 mutation receiving chemoimmunotherapy decreased over the duration of the study, although the sample size was small. Of 121 patients with unmutated IGHV, 49% received Imbruvica, 39% chemoimmunotherapy or chemotherapy, 7% immunotherapy, and 5% other novel agents.
The informCLL registry provides an opportunity to assess CLL treatment patterns. Researchers conclude that data from informCLL indicate a knowledge gap in terms of prognostic marker testing and selection of therapies for high-risk disease. Continued follow-up will allow for the ongoing evaluation of real-world treatment decisions and identification of opportunities for improvement.
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