Jennifer Woyach, MD
A prospective, open-label, multicenter randomized phase III trial to compare the efficacy and safety of a combined regimen of obinutuzumab and venetoclax (GDC-0199/ABT-199) versus obinutuzumab and chlorambucil in previously untreated patients with CLL and coexisting medical conditions. NCT02242942
A randomized phase III study of bendamustine plus rituximab versus ibrutinib plus rituximab versus ibrutinib alone in untreated older patients (≥65 years of age) with chronic lymphocytic leukemia (CLL). NCT01886872
A randomized, multi-center, open-label, phase 3 study of the Bruton’s tyrosine kinase inhibitor ibrutinib in combination with obinutuzumab versus chlorambucil in combination with obinutuzumab in subjects with treatment-naïve chronic lymphocytic leukemia or small lymphocytic lymphoma. NCT02264574
Fischer K et al. Effect of fixed-duration venetoclax plus obinutuzumab (VenG) on progression-free survival (PFS), and rates and duration of minimal residual disease negativity (MRD–) in previously untreated patients (pts) with chronic lymphocytic leukemia (CLL) and comorbidities. ASCO 2019;Abstract 7502.
Moreno C et al. Ibrutinib plus obinutuzumab versus chlorambucil plus obinutuzumab in first-line treatment of chronic lymphocytic leukemia (iLLUMINATE): A multicentre, randomised, open-label, phase 3 trial. Lancet Oncol 2019;20(1):43-56. Abstract
Shanafelt T et al. A randomized phase III study of ibrutinib (PCI-32765)-based therapy vs standard fludarabine, cyclophosphamide, and rituximab (FCR) chemoimmunotherapy in untreated younger patients with chronic lymphocytic leukemia (CLL): A trial of the ECOG-ACRIN Cancer Research Group (E1912). Proc ASH 2018;Abstract LBA-4.
Woyach JA et al. Ibrutinib alone or in combination with rituximab produces superior progression free survival (PFS) compared with bendamustine plus rituximab in untreated older patients with chronic lymphocytic leukemia (CLL): Results of Alliance North American Intergroup study A041202. Proc ASH 2018;Abstract 6.
Jennifer R Brown, MD, PhD
Advani RH et al. Bruton tyrosine kinase inhibitor ibrutinib (PCI-32765) has significant activity in patients with relapsed/refractory B-cell malignancies. J Clin Oncol 2013;31(1):88-94. Abstract
Burris H et al. Clinical activity and safety profile of TGR-1202, a novel once daily PI3Kδ inhibitor, in patients with CLL and B-cell lymphoma. ASCO 2015;Abstract 7069.
Byrd JC et al. Acalabrutinib in treatment-naïve (TN) chronic lymphocytic leukemia (CLL): Updated results from the phase 1/2 ACE-CL-001 study. Proc ASH 2018;Abstract 692.
Byrd JC et al. Acalabrutinib (ACP-196) in relapsed chronic lymphocytic leukemia. N Engl J Med 2016;374(4):323-32. Abstract
Cheson BD et al. Novel targeted agents and the need to refine clinical end points in chronic lymphocytic leukemia. J Clin Oncol 2012(23);30:2820-2. Abstract
Fowler NH et al. Safety and activity of the chemotherapy-free triplet of ublituximab, TGR-1202, and ibrutinib in relapsed B-cell malignancies. ASCO 2015;Abstract 8501.
Gauthier J et al. Immunotherapy with T-cells engineered with a chimeric antigen receptor bearing a human CD19-binding single chain variable fragment for relapsed or refractory acute lymphoblastic leukemia and B-cell non-Hodgkin lymphoma. Proc ASH 2018;Abstract 1415.
Ghia P et al. ASCEND phase 3 study of acalabrutinib vs investigator’s choice of rituximab plus idelalisib (IDR) OR bendamustine (BR) in patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL). EHA 2019;Abstract LB2606.
Gill SI et al. Prospective clinical trial of anti-CD19 CAR T-cells in combination with ibrutinib for the treatment of chronic lymphocytic leukemia shows a high response rate. Proc ASH 2018;Abstract 298.
Hallek M et al. Guidelines for the diagnosis and treatment of chronic lymphocytic leukemia: A report from the International Workshop on Chronic Lymphocytic Leukemia updating the National Cancer Institute-Working Group 1996 guidelines. Blood 2008;111(12):5446-56. Abstract
Jones JA et al. Updated results of a phase III randomized, controlled study of idelalisib in combination with ofatumumab for previously treated chronic lymphocytic leukemia (CLL). ASCO 2016;Abstract 7515.
Kochenderfer JN et al. Chemotherapy-refractory diffuse large B-cell lymphoma and indolent B-cell malignancies can be effectively treated with autologous T cells expressing an anti-CD19 chimeric antigen receptor. J Clin Oncol 2015;33(6):540-9. Abstract
Kochenderfer JN et al. B-cell depletion and remissions of malignancy along with cytokine-associated toxicity in a clinical trial of anti-CD19 chimeric-antigen-receptor–transduced T cells. Blood 2012;119:2709-20. Abstract
Porter DL et al. Randomized, phase II dose optimization study of chimeric antigen receptor (CAR) modified T cells directed against CD19 in patients (pts) with relapsed, refractory (R/R) CLL. Proc ASCO 2016;Abstract 3009.
Siddiqi T et al. TRANSCEND CLL 004: Minimal residual disease (MRD) negative responses after lisocabtagene maraleucel (Liso-Cel; JCAR017), a CD19-directed CAR T cell product, in patients (pts) with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). ASCO 2019;Abstract 7501.
Tam C et al. Favorable patient survival after failure of venetoclax (ABT-199/GDC-0199) therapy for relapsed or refractory chronic lymphocytic leukemia (CLL). Blood 2015;126(23):2939. Abstract
Turtle CJ et al. Durable molecular remissions in chronic lymphocytic leukemia treated with CD19-specific chimeric antigen receptor-modified T cells after failure of ibrutinib. J Clin Oncol 2017;35(26):3010-20. Abstract
Christopher R Flowers, MD, MS
Flinn IW et al. The phase 3 DUO trial: Duvelisib vs ofatumumab in relapsed and refractory CLL/SLL. Blood 2018;132(23):2446-55. Abstract
Kater AP et al. Fixed duration of venetoclax-rituximab in relapsed/refractory chronic lymphocytic leukemia eradicates minimal residual disease and prolongs survival: Post-treatment follow-up of the MURANO phase III study. J Clin Oncol 2019;37(4):269-77. Abstract
Seymour JF et al. MURANO trial establishes feasibility of time-limited venetoclax-rituximab (VenR) combination therapy in relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL). Proc ASH 2018;Abstract 184.
Seymour JF et al. Venetoclax-rituximab in relapsed or refractory chronic lymphocytic leukemia. N Engl J Med 2018;378(12):1107-20. Abstract
William G Wierda, MD, PhD
A phase 3, multicenter, randomized, prospective, open-label trial of standard chemoimmunotherapy (FCR/BR) versus rituximab plus venetoclax (RVe) versus obinutuzumab (GA101) plus venetoclax (GVe) versus obinutuzumab plus ibrutinib plus venetoclax (GIVe) in fit patients with previously untreated chronic lymphocytic leukemia (CLL) without del(17p) or TP53 mutation. NCT02950051
A phase 3, randomized study to assess the efficacy and safety of ublituximab in combination with TGR-1202 compared to obinutuzumab in combination with chlorambucil in patients with chronic lymphocytic leukemia (CLL). NCT02612311
A randomized, multicenter, open-label, 3 arm phase 3 study of obinutuzumab in combination with chlorambucil, acalabrutinib (ACP-196) in combination with obinutuzumab, and acalabrutinib monotherapy in subjects with previously untreated CLL. NCT02475681
A randomized, multicenter, open-label, phase 3 study to compare the efficacy and safety of acalabrutinib (ACP-196) in combination with venetoclax with and without obinutuzumab compared to investigator’s choice of chemoimmunotherapy in subjects with previously untreated chronic lymphocytic leukemia without del(17p) or TP53 mutation. NCT03836261
A randomized, multicenter, open-label, phase 3 study to evaluate the efficacy and safety of acalabrutinib versus chlorambucil plus rituximab in subjects with previously untreated chronic lymphocytic leukemia. NCT04075292
A randomized phase III study of ibrutinib plus obinutuzumab versus ibrutinib plus venetoclax and obinutuzumab in untreated older patients (≥70 years of age) with chronic lymphocytic leukemia (CLL). NCT03737981
A randomized phase III study of the addition of venetoclax to ibrutinib and obinutuzumab versus ibrutinib and obinutuzumab in untreated younger patients with chronic lymphocytic leukemia (CLL). NCT03701282
An international, phase 3, open-label, randomized study of BGB-3111 compared with bendamustine plus rituximab in patients with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). NCT03336333
Hillmen P et al. Ibrutinib plus venetoclax in relapsed/refractory CLL: Results of the Bloodwise TAP Clarity study. Proc ASH 2018;Abstract 182.
Jain N et al. Combined ibrutinib and venetoclax in patients with treatment-naïve high-risk chronic lymphocytic leukemia (CLL). Proc ASH 2018;Abstract 696.
Jain N et al. Combined venetoclax and ibrutinib for patients with previously untreated high-risk CLL, and relapsed/refractory CLL: A phase II trial. Proc ASH 2017;Abstract 429.
Phase I/II study of immunotherapy for advanced CD19+ chronic lymphocytic leukemia, acute lymphoblastic leukemia/lymphoma and non-Hodgkin lymphoma with defined subsets of autologous T cells engineered to express a CD19-specific chimeric antigen receptor. NCT01865617
Rogers KA et al. Phase 1b study of obinutuzumab, ibrutinib, and venetoclax in relapsed and refractory chronic lymphocytic leukemia. Blood 2018;132(15):1568-72. Abstract
Wierda WG et al. Phase 2 CAPTIVATE results of ibrutinib (ibr) plus venetoclax (ven) in first-line chronic lymphocytic leukemia (CLL). ASCO 2018;Abstract 7502.