BI 695500 (rituximab biosimilar) / Boehringer Ingelheim - LARVOL DELTA

Bortezomib and Vorinostat as Maintenance Therapy After Autologous Stem Cell Transplant in Treating Patients With Non-Hodgkin Lymphoma (clinicaltrials.gov) - P2; N=20; Recruiting; Sponsor: Fred Hutchinson Cancer Research Center; Trial primary completion date: Oct 2015 ➔ Apr 2016

Trial primary completion date • Biosimilar

Combination Chemotherapy, Rituximab, and Ixazomib Citrate in Treating Patients With Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1/2; N=55; Not yet recruiting; Sponsor: Northwestern University

New P1/2 trial • Biosimilar • Hematological Malignancies • Leukemia • Non-Hodgkin’s Lymphoma • Oncology

Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin in Treating Patients With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma (clinicaltrials.gov) - P2; N=28; Recruiting; Sponsor: University of Washington; Not yet recruiting ➔ Recruiting

Enrollment open • Acute Lymphocytic Leukemia • Biosimilar • Hematological Malignancies • Leukemia • Lymphoma • Oncology

Rituximab and LMP-Specific T-Cells in Treating Pediatric Solid Organ Recipients With EBV-Positive Cluster of Differentiation(CD) 20-Positive Post-Transplant Lymphoproliferative Disorder (clinicaltrials.gov) - P2; N=90; Not yet recruiting; Sponsor: Children's Oncology Group; N=50 ➔ 90; Initiation date: Oct 2016 ➔ Feb 2017; Trial primary completion date: Aug 2019 ➔ Dec 2019

Enrollment change • Trial initiation date • Trial primary completion date • Biosimilar • Oncology

Vorinostat, Cladribine, and Rituximab in Treating Patients With Mantle Cell Lymphoma, Relapsed Chronic Lymphocytic Leukemia, or Relapsed B Cell Non-Hodgkin's Lymphoma (clinicaltrials.gov) - P2; N=66; Active, not recruiting; Sponsor: OHSU Knight Cancer Institute; Trial primary completion date: Aug 2015 ➔ Dec 2015

Trial primary completion date • Biosimilar

Rituximab and LMP-Specific T-Cells in Treating Pediatric Solid Organ Recipients With EBV-Positive Cluster of Differentiation(CD) 20-Positive Post-Transplant Lymphoproliferative Disorder (clinicaltrials.gov) - P2; N=90; Recruiting; Sponsor: Children's Oncology Group; Trial primary completion date: Dec 2019 ➔ Dec 2021

Trial primary completion date • Biosimilar • Oncology

Akt Inhibitor MK2206, Bendamustine Hydrochloride, and Rituximab in Treating Patients With Relapsed Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (clinicaltrials.gov) - P1/2; N=15; Completed; Sponsor: National Cancer Institute (NCI); Active, not recruiting ➔ Completed

Trial completion • Biosimilar • Chronic Lymphocytic Leukemia • Non-Hodgkin’s Lymphoma

Efficacy, Pharmacokinetics, and Safety of BI 695500 in Patients With Rheumatoid Arthritis (clinicaltrials.gov) - P3; N=293; Terminated; Sponsor: Boehringer Ingelheim; N=237 ➔ 293; Completed ➔ Terminated; Lack of efficacy

Enrollment change • Trial termination • Biosimilar • Immunology • Inflammation • Rheumatoid Arthritis

Pharmacokinetics and pharmacodynamics of BI 695500 vs. rituximab as first line-treatment in patients with low tumor burden lymphoma (clinicaltrials.gov) - P1, N=90; Sponsor: Boehringer Ingelheim; Not yet recruiting; New P1 trial.

New P1 trial • Biosimilar