May 2017

Dear Colleagues:

The lymphoid malignancies clinical trial portfolio at University Hospitals Seidman Cancer Center is centered around these new therapies:

Our frontline diffuse large B cell lymphoma studies are investigating improvements to the R-CHOP backbone. These trials include CASE 3413, investigating the addition of the proteasome inhibitor carfilzomib to R-CHOP, and the upcoming SEGE2416 study of the incorporation of the antibody - drug immunoconjugate denintuzumab mafodotin (targeting CD19) to R-CHOP or R-CHP.

Studies in relapsed lymphoma include a variety of different agents, including the nuclear transport inhibitor selinexor (KARY1414), signaling inhibitors against PI3K and JAK1 inhibitors (INCT1416), antibody-drug immunoconjugates targeting CD19 (ADCT1416) and CD30 (brentuximab) (CASE1415), the monoclonal antibody against PD-1 (REGE1416) as well as the bispecific antibody blinatumomab (AMGN1416).

The broad variety of current and upcoming studies reflects our goal of having a diverse portfolio of clinical trials, including different types of lymphoma and bringing to our patients multiple new agents. Our aim is to have studies and targeted therapies available for the majority of our patients.

Please feel free to contact us with questions or for more information regarding available clinical studies for your lymphoma patients.

Sincerely,

Paolo Caimi, MD
Hematologist/Oncologist
UH Seidman Cancer Center
Assistant Professor of Medicine
Case Western Reserve University School of Medicine
Paolo.Caimi@UHhospitals.org

Marcos de Lima, MD
Director, Bone Marrow Transplant
UH Cleveland Medical Center
Director, Hematologic Malignancies and Stem Cell Transplant Program
UH Seidman Cancer Center
Professor of Medicine
Case Western Reserve University School of Medicine
Marcos.delima@UHhhospitals.org

Open Lymphoma Clinical Trial Highlights

DIFFUSE LARGE B CELL LYMPHOMA

CASE 3413. A Phase I/II Study of Carfilzomib in Combination with R-CHOP (CR-CHOP) for Patients with Diffuse Large B -Cell Lymphoma. clinicaltrials.gov # NCT02073097

Local PI: Paolo Caimi, MD

SEGE 2416. An Open-Label Phase 2 Study of Denintuzumab Mafodotin (SGN-CD19A) in Combination with RCHOP or RCHP Compared with RCHOP Alone as Frontline Therapy in Patients with Diffuse Large B-Cell Lymphoma (DLBCL) or Follicular Lymphoma (FL) Grade 3b. clinicaltrials.gov # NCT02855359

Local PI: Paolo Caimi, MD

KARY1414. A Phase 2b Open-label, Randomized Two-arm Study Comparing High and Low Doses of Selinexor (KPT-330) in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL). clinicaltrials.gov #NCT02227251

Local PI: Paolo Caimi, MD

RELAPSED B CELL LYMPHOMA

REGE1416. A Phase 1 Study to Assess Safety and Tolerability of REGN1979, an Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody, and REGN2810, an Anti-Programmed Death-1 Monoclonal Antibody, in Patients with B-Cell Malignancies. clinicaltrials.gov #NCT02651662

Local PI: Paolo Caimi, MD

AMGN1416. A Phase 2/3 Multi-center Study to Evaluate the Safety and Efficacy of Blinatumomab in Subjects with Relapsed/Refractory Aggressive B-Cell Non Hodgkin Lymphoma (UPCOMING STUDY). clinicaltrials.gov #NCT02910063

Local PI: Paolo Caimi, MD

A051301. A Randomized Double-Blind Phase III Study of Ibrutinib During and Following Autologous Stem Cell Transplantation Versus Placebo in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma of the Activated B-cell Subtype. clinicaltrials.gov #NCT02443077

Local PI: Paolo Caimi, MD

RELAPSED T CELL LYMPHOMA

CASE1415. A Phase II Study of Single Agent Brentuximab Vedotin in Relapsed/Refractory CD30 Low (<10%) Mature T Cell Lymphoma (TCL). clinicaltrials.gov NCT02588651

Local PI: Paolo Caimi, MD

EBV-ASSOCIATED LYMPHOMAS

ATARA1416. Multicenter Expanded Access Protocol of Allogeneic Epstein-Barr Virus Cytotoxic T Lymphocytes (EBV-CTLs) for Patients with EBV-Associated Lymphomas and Lymphoproliferative Disorders in Immunocompromised Patients. clinicaltrials.gov NCT00002663

Local PI: Ben Tomlinson, MD