For more information regarding these studies, contact Cancer Research at (601) 984-1095
Bayer CHRONOS-4: A Phase III, randomized, double-blind, controlled, multicenter study of intravenous PI3K inhibitor copanlisib in combination with standard immunochemotherapy versus standard immunochemotherapy in patients with relapsed indolent non-Hodgkin’s lymphoma (iNHL)
The purpose of the 17833 study is to assess whether the drug being tested (copanlisib) in combination with standard immunochemotherapy (rituximab in combination with bendamustine [R-B] and rituximab in combination with a 4 drug combination of cyclophosphamide, doxorubicin, vincristine and prednisone/prednisolone [R-CHOP]) is effective and safe compared with placebo (simulated treatment) in combination with standard immunochemotherapy (R-B or R-CHOP) in participants with relapsed indolent B-cell non-Hodgkin’s lymphoma (iNHL) who have received one but no more than 3 lines of treatment and have been previously exposed to rituximab and alkylating agent.
Participants should be in need of, and fit for, immunochemotherapy and should not be resistant to rituximab (resistance defined as lack of response, or progression within 6 months of the last course of treatment with a rituximab containing regimen). The study is composed of 2 parts: a safety run-in, where the recommended phase III dose of copanlisib in combination with R-CHOP will be determined and a phase III part for the copanlisib R-B combination From the RB safety run-in part of the study that has already completed, the recommended dose of copanlisib was determined at 60 mg. This dose was reviewed and agreed by an independent Data Monitoring Committee, who also reviews the safety data that is collected during the study.
Principal Investigator: Stephanie Elkins, MD
MOR208C204:A Phase II/III, Randomised, Multicentre Study of MOR00208 with Bendamustine versus Rituximab with Bendamustine in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL) Who Are Not Eligible for High-Dose Chemotherapy (HDC) and Autologous Stem-Cell Transplantation (ASCT) – B-MIND
The purpose of this research study is to compare the effects and safety of the study drug, MOR00208, given with bendamustine (BEN) to another treatment combination, rituximab (RTX) in combination with BEN to find out which combination is better for treating DLBCL. MOR00208 is an investigational drug. An investigational drug is one that is not approved by the U.S. Food and Drug Administration (FDA) for sale and use in the United States. RTX and BEN are both approved in many countries for the treatment of lymphomas. The combination of both is considered and recommended by some medical authorities in some other countries as an option to treat DLBCL.
The reasoning behind this study is to investigate the efficacy of MOR00208 in combination with BEN in comparison with the combination of RTX and BEN in shrinking the cancer or stopping it from growing for some time. Furthermore, the sponsor will compare the toxicity of the combination of MOR00208 and BEN with the toxicity and side effect profile of the combination of RTX and BEN.
The knowledge about the treatment combination of MOR00208 and BEN is limited as it has not been systematically studied in a research study before. A safety evaluation of the study drug combination was performed in this study when three participants had received MOR00208 and BEN treatment, and when three participants had received RTX and BEN treatment. There was another safety review when 10 participants had received the treatments and the safety data was analysed by independent researchers. The study staff will monitor your treatment closely and evaluate any negative side effects you may experience and you may be asked to stay at the clinic for observation after the treatment, if medically required.