A5053787554- Chronic Lymphocytic Leukemia Research
- Lymphoma Diagnosis and Treatment
- Chronic Myeloid Leukemia Treatments
- Acute Lymphoblastic Leukemia research
- Immunodeficiency and Autoimmune Disorders
- Galectins and Cancer Biology
- Gastrointestinal Tumor Research and Treatment
- Advanced Breast Cancer Therapies
- Methemoglobinemia and Tumor Lysis Syndrome
- Blood Coagulation and Thrombosis Mechanisms
- Phagocytosis and Immune Regulation
- Hemophilia Treatment and Research
AbbVie (United States)
2016-2025
Pharmacyclics (United States)
2014-2023
We report long-term follow-up from the RESONATE-2 phase 3 study of once-daily Bruton's tyrosine kinase inhibitor ibrutinib, which is only targeted therapy with significant progression-free survival (PFS) and overall (OS) benefit in multiple randomized chronic lymphocytic leukemia (CLL) studies. Patients (≥65 years) previously untreated CLL, without del(17p), were randomly assigned 1:1 to ibrutinib 420 mg until disease progression/unacceptable toxicity (n = 136) or chlorambucil 0.5-0.8 mg/kg...
CAPTIVATE (NCT02910583), a randomized phase II study, evaluates minimal residual disease (MRD)-guided treatment discontinuation following completion of first-line ibrutinib plus venetoclax in patients with chronic lymphocytic leukemia (CLL).Previously untreated CLL age < 70 years received three cycles and then 12 combined venetoclax. Patients the MRD cohort who met stringent random assignment criteria for confirmed undetectable (Confirmed uMRD) were randomly assigned 1:1 to double-blind...
CAPTIVATE (NCT02910583) is an international phase 2 study in patients aged ≤70 years with previously untreated chronic lymphocytic leukemia (CLL). Results from the cohort investigating fixed-duration (FD) treatment ibrutinib plus venetoclax are reported. Patients received 3 cycles of lead-in then 12 (oral [420 mg/d]; oral [5-week ramp-up to 400 mg/d]). The primary endpoint was complete response (CR) rate. Hypothesis testing performed for without del(17p) prespecified analyses all treated...
Results of RESONATE-2 (PCYC-1115/1116) supported approval ibrutinib for first-line treatment chronic lymphocytic leukemia. Extended analysis was conducted to determine long-term efficacy and safety in older patients with A total 269 aged ≥65 years previously untreated leukemia without del(17p) were randomized 1:1 (n=136) or chlorambucil (n=133) on days 1 15 a 28-day cycle 12 cycles. Median duration 28.5 months. Ibrutinib significantly prolonged progression-free survival versus (median, not...
Abstract Purpose: Ibrutinib, a first-in-class, once-daily, oral inhibitor of Bruton tyrosine kinase, promotes apoptosis, and inhibits B-cell proliferation, adhesion, migration. Ibrutinib has demonstrated single-agent efficacy acceptable tolerability at doses 420 840 mg in patients with chronic lymphocytic leukemia/small lymphoma (CLL/SLL) who were treatment-naïve (TN) or had relapsed/refractory (R/R) CLL after ≥1 prior therapy phase Ib/II study (PCYC-1102). Subsequently, the ibrutinib dose...
Summary Patients with chronic lymphocytic leukaemia/small lymphoma ( CLL / SLL ) deletion 17p [del(17p)] have poor outcomes chemoimmunotherapy. Ibrutinib is indicated for the treatment of , including del(17p) and allows without chemotherapy. This integrated analysis was performed to evaluate in 230 patients relapsed/refractory from three ibrutinib studies. With a median 2 prior therapies (range, 1–12), 18% 79% evaluable had del(11q) or unmutated IGHV respectively. follow‐up 28 months,...
We evaluated immune cell subsets in patients with chronic lymphocytic leukemia (CLL) who received first-line therapy 3 cycles of ibrutinib then 13 plus venetoclax the minimal residual disease (MRD) cohort CAPTIVATE study (NCT02910583). Patients Confirmed undetectable MRD (uMRD) were randomly assigned to placebo or groups; without uMRD groups. compared samples collected at 7 time points age-matched healthy donors. CLL cells decreased within after initiation; from cycle 16 onward, levels...
7009 Background: The phase 2 CAPTIVATE study evaluated first-line ibrutinib (Ibr) + venetoclax (Ven) for CLL/SLL in cohorts: minimal residual disease (MRD)-guided randomized discontinuation (MRD cohort) and Fixed Duration (FD cohort). Ibr±Ven retreatment was allowed patients (pts) who had progressive (PD). Here, we report outcomes pts with high-risk genomic features from the FD cohort MRD placebo arm. Methods: Pts aged ≤70 y previously untreated without restriction on risk factors received 3...
7501 Background: CAPTIVATE (PCYC-1142) is a multicenter phase 2 study of first-line I+V in CLL. We previously reported results from the Minimal Residual Disease (MRD) cohort wherein undetectable MRD (uMRD) was achieved over two-thirds patients (pts) with 12 cycles I+V, and 30-mo PFS rates were ≥95% irrespective subsequent randomized treatment (Wierda, ASH 2020). now present FD cohort, evaluating fixed-duration tx I+V. Methods: Pts aged ≤70 y untreated CLL/SLL received 3 I then (I 420 mg/d...
TPS4618 Background: Urothelial carcinoma (UC) has a high mortality rate in patients (pts) with metastatic disease. While immune checkpoint inhibitors (CPI), including programmed cell death protein 1 (PD-1) combined chemotherapy (CTx) or enfortumab vedotin (EV), have been approved for first-line treatment of (m)UC, many pts de novo develop acquired resistance. For without response to frontline whose disease progressed on prior CPI combinations, optimal is unclear and new therapies are...
7036 Background: First-line ibrutinib (Ibr) + venetoclax (Ven) treatment for CLL/SLL was tested in the phase 2 CAPTIVATE study, including minimal residual disease (MRD)–guided randomized discontinuation (MRD cohort) and Fixed Duration (FD) cohorts. We report final analysis results patients (pts) treated with FD Ibr+Ven cohort MRD placebo arm. Methods: Pts ≤70 y previously untreated received 3 cycles of Ibr, then 12 (Ibr, 420 mg/d orally; Ven, 5-wk ramp up to 400 orally), 13 On-study...
7502 Background: Ibr, a first-in-class, once-daily BTK inhibitor, is approved in the US and EU for CLL treatment, including del17p. Early studies support synergistic antitumor activity with combined ibr ven, BCL-2 inhibitor by FDA relapsed del17p CLL. Single-agent lead-in may lower tumor lysis syndrome (TLS) risk debulking prior to adding ven. PCYC-1142 (CAPTIVATE) multicenter, phase 2 study of + ven (I+V) first-line (NCT02910583) evaluating if remission undetectable minimal residual disease...
Increased absolute lymphocyte count (ALC) is a key feature of chronic lymphocytic leukemia (CLL) but also observed during treatment with B-cell receptor pathway inhibitors including ibrutinib, first-in-class inhibitor Bruton's tyrosine kinase. In patients CLL treated single-agent ibrutinib in two multicenter, open-label, randomized, phase 3 studies (RESONATE-2, NCT01722487; RESONATE, NCT01578707), lymphocytosis was 77 136 (57%) first-line and 133 195 (69%) relapsed/refractory patients. On...
7535 Background: CAPTIVATE (PCYC-1142) is a multicenter phase 2 study of first-line ibrutinib (I) + venetoclax (V) in CLL/SLL. Follow-up results from the fixed duration (FD) cohort showed 3-y PFS rate 88% overall and rates ≥80% patients (pts) with high-risk features (Wierda, ASCO 2022). Here we present updated FD 4-y follow-up. Methods: Pts aged ≤70 y previously untreated CLL/SLL received 3 cycles I then 12 I+V (I 420 mg/d orally; V ramp-up to 400 orally). Responses were investigator...