CLL: Therapy, excluding Transplantation: Cellular Therapy and Immunomodulation in CLL

295  Combination of Lenalidomide and Rituximab in Patients with Treatment-NaïVe and Relapsed Chronic Lymphocytic Leukemia: Treatment Results and Predictive Factors of Response

Paolo Strati, MD, et al.

The Abstract concludes: The combination of lenalidomide and rituximab is an effective and safe regimen for the treatment of pts with TN and/or R CLL. B2M is the only predictive factor of response to this regimen in both in TN and R pts. Gene mutations inducing increased NOTCH1 signaling, such as SPEN and FBXW7 mutations, predicted shorter PFS after treatment with lenalidomide and rituximab.


296  A Phase II Trial of Nivolumab Combined with Ibrutinib for Patients with Richter Transformation

Nitin Jain, MD, et al.

The Abstract concludes: The combination of nivolumab and ibrutinib has clinical activity in pts with RT with a 43% response rate.


297  Phase I/II Study of Umbralisib (TGR-1202) in Combination with Ublituximab (TG-1101) and Pembrolizumab in Patients with Relapsed/Refractory CLL and Richter’s Transformation

Anthony R. Mato, et al.

The Abstract concludes: The triplet combination of umbralisib + ublituximab + pembro was well-tolerated. Responses were durable in BTK refractory, high risk pts, including two CR’s in RT pts. In contrast to pembro monotherapy, data suggest that CLL/RT pts who achieve ≥ PR with this checkpoint inhibitor-containing regimen can achieve durable responses. Correlative studies suggest that maintenance of Tregs may limit autoimmune sequelae. Enrollment is ongoing in both the CLL (BTK refractory only) and RT cohorts.


298  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

Saar I. Gill, et al.

The Abstract concludes: In patients not achieving CR despite at least 6 months of ibrutinib who were treated with humanized CART19, we found an iwCLL CR rate of 43% and a bone marrow remission rate of 94% including a 78% MRD negative response by deep sequencing. This compares favorably to prior CART19 cell studies in patients with progressive CLL (iwCLL CR rates of 21-29%). CRS was frequent but mild-moderate and did not commonly require anti-cytokine therapy. These results suggest that the combination of CTL119 with ibrutinib results in a high rate of sustained responses and high rates of MRD-ve marrow response in patients with CLL. This combination will be further tested in larger studies.


299 Comparison of Efficacy and Toxicity of CD19-Specific Chimeric Antigen Receptor T-Cells Alone or in Combination with Ibrutinib for Relapsed and/or Refractory CLL

Jordan Gauthier, et al.

The Abstract concludes: Administration of ibrutinib from 2 weeks before leukapheresis until 3 months after JCAR014 was well tolerated in most pts. This approach might decrease the incidence of severe CRS and improve responses in pts with R/R CLL.


300  Rapid MRD-Negative Responses in Patients with Relapsed/Refractory CLL Treated with Liso-Cel, a CD19-Directed CAR T-Cell Product: Preliminary Results from Transcend CLL 004, a Phase 1/2 Study Including Patients with High-Risk Disease Previously Treated with Ibrutinib

Tanya Siddiqi, et al.

The Abstract concludes: Liso-cel toxicities were manageable, including events of CRS and NE, in these heavily pretreated pts with CLL. CRs and undetectable MRD were rapidly achieved in pts with both high-risk and standard-risk CLL who previously received ibrutinib, with the majority also having had received venetoclax. These preliminary data support continued development of single-dose liso-cel treatment in CLL.