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This multicenter, prospective, open-label, randomized, superiority phase 3 study is designed to demonstrate that treatment with a triple combination of acalabrutinib, obinutuzumab and venetoclax (GAVe) prolong the progression-free survival (PFS) as compared to treatment with the combination of obinutuzumab and venetoclax (GVe) in pa-tients with high risk CLL (defined as having at least one of the follow-ing risk factors: 17p-deletion, TP53-mutation or complex karyotype).
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This phase II trial investigates the how well acalabrutinib and obinutuzumab work in treating patients with chronic lymphocytic leukemia (CLL). Acalabrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with obinutuzumab may induce changes in body\'s immune system and may interfere with the ability of tumor cells to grow and spread. Giving acalabrutinib and obinutuzumab may help to control disease progression in CLL patients who have not received treatment for CLL.
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This research study is studying a combination of drugs as a possible treatment for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
The names of the study drugs involved in this study are:
* obinutuzumab
* venetoclax
* acalabrutinib
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Background: Early results from ELEVATE‐TN (NCT02475681) at a median follow‐up of 28.3 months demonstrated superior efficacy of acalabrutinib (A) � obinutuzumab (O) compared with O + chlorambucil (Clb) in patients with treatment‐na.ve (TN) chronic lymphocytic leukemia (CLL) (Sharman et al. Lancet 2020;395:1278‐91). Aims: To report the updated efficacy and safety results from the ELEVATE‐TN study after a median follow‐up duration of 4 years. Methods: Patients received A�O or O+Clb. Crossover to A monotherapy was permitted in patients who progressed on O+Clb. Investigator‐assessed (INV) progression‐free survival (PFS), INV overall response rate (ORR), overall survival (OS), and safety were evaluated. Informed consent was obtained from all patients prior to trial enrollment. Results: A total of 535 patients (A+O, n=179; A, n=179; O+Clb, n=177) were randomized. The median patient age was 70 years; 63% of patients had unmutated IGHV and 9% had del(17p). At a median follow‐up of 46.9 months (range, 0.0‐59.4; data cutoff: Sept 11, 2020), the median PFS was not reached (NR) for A+O and A patients versus 27.8 months for O+Clb patients (both P<0.0001). In patients with unmutated IGHV, the median PFS was NR (A+O and A) versus 22.2 months among O+Clb patients (both P<0.0001). In patients with del(17p), the median PFS was NR (A+O and A) versus 17.7 months for O+Clb (P<0.005). Estimated 48‐month PFS rates were 87% for A+O, 78% for A, and 25% for O+Clb. Median OS was NR in any treatment arm with a trend towards significance in the A+O group (A+O vs O+Clb, P=0.0604); estimated 48‐month OS rates were 93% (A+O), 88% (A), and 88% (O+Clb). ORR was significantly higher with A+O (96.1%; 95% CI 92.1‐98.1) versus O+Clb (82.5%; 95% CI 76.2‐87.4; P<0.0001); ORR with A was 89.9% (95% CI 84.7‐ 93.5; P=0.035 vs O+Clb). Complete response/complete response with incomplete hematologic recovery (CR/CRi) rates were higher with A+O (26.8%/3.9%) versus O+Clb (12.4%/0.6%); 10.6%/0.6% had CR/CRi with A. Common adverse events (AEs) and AEs of interest are shown in the Table. Overall treatment discontinuation rates were 25.1% (A+O), 30.7% (A), and 22.6% (O+Clb); the most common reasons were AEs (12.8%, 12.3%, 14.7%, respectively) and progressive disease (4.5%, 7.8%, 1.7%). Most patients (77.4%) completed O+Clb treatment. Summary/Conclusion: With a median follow‐up of 46.9 months (~4 years) in the ELEVATE‐TN study, the efficacy and safety of A+O and A monotherapy was maintained, with an increase in CR since the interim analysis (from 21% to 27% [A+O] and from 7% to 11% [A]) and low rates of discontinuation.
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This Primary objective is evaluating the efficacy of obinutuzumab in combination with chlorambucil (Arm A) compared with acalabrutinib in combination with obinutuzumab (Arm B) for the treatment of previously untreated chronic lymphocytic leukemia (CLL). Secondary objectives: 1) To evaluate the efficacy of obinutuzumab in combination with chlorambucil (Arm A) versus acalabrutinib monotherapy (Arm C) based on IRC assessment of PFS per IWCLL 2008 criteria.
2)To compare obinutuzumab plus chlorambucil (Arm A) versus acalabrutinib plus obinutuzumab (Arm B) and obinutuzumab plus chlorambucil (Arm A) versus acalabrutinib monotherapy (Arm C) in terms of: IRC-assessed objective response rate (ORR); Tine to next treatment (TTNT); Overall Survival (OS)