Efficacy and safety of ibrutinib in indian patients with relapsed or refractory chronic lymphocytic leukemia and mantle cell lymphoma: Cases from a named patient program

Abstract

Context:This named patient program evaluated the safety and efficacy of ibrutinib, a selective inhibitor of Bruton's tyrosine kinase in Indian patients with relapsed/refractory chronic lymphocytic leukemia (CLL, with/without chromosome 17 deletion [del17p]) and mantle cell lymphoma (MCL).Subjects and Methods:The eight enrolled patients (relapsed/refractory CLL: n = 6 [4/6 patients with del17p] and relapsed/refractory MCL: n = 2) had median age of 55 years (range, 52–60) and had received a median of 3 (CLL patients) and 4 (MCL patients) prior therapies. Patients received once-daily dose of ibrutinib (420 mg: CLL, 560 mg: MCL).Results:In CLL patients, the median time to response was 3 months (range, 0.5–7) and five of six patients had partial response (PR) whereas one achieved complete response (CR). Median time on treatment was 11.5 months (range, 8–14); five patients continued treatment and one was recommended stem cell transplantation (SCT). Of the two MCL patients, one achieved PR and one showed CR and advanced to SCT. In CLL patients, the median (range) hemoglobin level improved from 9.8 g/dL (7.2–11) at baseline to 12.0 g/dL (9.5–13.2) and median (range) platelet count improved from 150,000 cells/μL (21,000–195,000) at baseline to 190,350 cells/μL (130,000–394,000) at the time of analysis (July 2016). Most adverse events (AEs) reported were infections (n = 2). No Grade 3-4 or serious AEs, dose reductions, or treatment discontinuation due to AEs were reported.Conclusions:In this first real-world experience in Indian patients, ibrutinib demonstrated therapeutic efficacy in relapsed/refractory CLL (with/without del17p) and MCL. Safety results were consistent with the current known profile of ibrutinib.

Adverse drug events associated with ibrutinib for the treatment of elderly patients with chronic lymphocytic leukemia

“…Cases from a first named patient program in Indian CLL participants in a real-world setting also showed ibrutinib to be effective therapeutically [19] . The safety side of this drug was also not questionable.…”

The prognostic significance of XL DLEU/LAMP (13q14 deletion) in CCL patients: a cross section study

“…In the current study, the level of hemoglobin in CLL patients has been in the range of 6 to 15 g/dl and the mean was 10.80 ± 2.04 g/dl. In one study, the mean baseline hemoglobin level in patients with CLL was 9.8 g/dl and the range was form 7.2 to 11 g/dl (8) . In another study, the mean hemoglobin level of CLL patients was 9.5 g/dl and the range was from 3.9 to 15.2 g/dl (9) .…”

Mantle cell lymphoma: A clinical review of the changing treatment paradigms with the advent of novel therapies, and an insight into Indian data

“…The largest retrospective series of 51 patients, from a single centre, reported an earlier age at presentation (median = 57 years), frequent use of Cyclophosphamide, doxorubicin, vincristine, prednisolone (CHOP) based chemotherapy with or without Rituximab, 3‐year overall survival (OS) rate of 54%, 2‐year progression free survival (PFS) of 27%, and improved outcomes with the addition of rituximab to chemotherapy 113 . The smaller case series document the use of ibrutinib, 114 and lenalidomide, 115 in relapsed or refractory MCL. On perusal of the clinical trials registries of India (http://www.ctri.nic.in) and the national institutes of health (http://www.clinicaltrials.gov), we found only five clinical studies in various phases.…”