Spots Global Cancer Trial Database for Safety, PD & Efficacy of MT-3724 for the Treatment of Patients With Relapsed or Refractory DLBCL
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Trial Identification
Brief Title: Safety, PD & Efficacy of MT-3724 for the Treatment of Patients With Relapsed or Refractory DLBCL
Official Title: Safety, Pharmacodynamics and Efficacy of MT-3724 for the Treatment of Patients With Relapsed or Refractory DLBCL
Study ID: NCT02361346
Study Description
Brief Summary: The purpose of this study is to evaluate the safety and tolerability of MT-3724 in subjects with relapsed or refractory B-Cell NHL or relapsed and refractory CLL (Part 1 only) and relapsed and refractory DLBCL (Part 2 and Part 3). Part 3 evaluates the efficacy of MT-3724.
Detailed Description: This is a three-part Phase 2 study Part 1: (MT-3724 Dose Escalation) Define the maximum tolerated dose (MTD) of MT-3724 \[Completed\] Part 2: (MTD Expansion Cohort) Confirm the safety and tolerability of the MTD of MT-3724 in the MTD Expansion Cohort. Part 3: (Phase 2 MTD Expansion Cohort) Determine the efficacy of MT-3724 as monotherapy in subjects with relapsed or refractory DLBCL based on the overall response rate (ORR) by the revised Lugano Classification for Lymphoma adjusted according to LYRIC. It is anticipated that up to 100 patients will be enrolled in Part 3. Treatment will continue for up to six 21 days cycles. If the subject exhibits SD, CR or PR after the end of Cycle 6 and the investigator determines that the benefit-risk ratio is favorable, then the treatment with MT-3724 may be continued after discussion with the sponsor.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Arizona, Tucson, Arizona, United States
Innovative Clinical Research Institute, LLC, Whittier, California, United States
21st Century Oncology - Jacksonville, Jacksonville, Florida, United States
Orlando Health, Inc., Orlando, Florida, United States
Orlando Health, Inc., Orlando, Florida, United States
BRCR Medical Center, Plantation, Florida, United States
ASCLEPES Research Centers, Weeki Wachee, Florida, United States
Columbus Regional Research Institute, Columbus, Georgia, United States
University of Illinois, Cancer Center, Chicago, Illinois, United States
Healthcare Research Network III, LLC, Tinley Park, Illinois, United States
Carle Foundation Hospital, Urbana, Illinois, United States
Norton Healthcare, Inc, Louisville, Kentucky, United States
New York University Langone Medical Center, New York, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
University of North Carolina, Chapel Hill, North Carolina, United States
MD Anderson Cancer Center, Houston, Texas, United States
UT Health San Antonio Cancer, San Antonio, Texas, United States
Grodno University Hospital, Grodno, , Belarus
Minsk City Clinical Oncology Center, Minsk, , Belarus
Cross Cancer Institute, Edmonton, Alberta, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital, Kingston, Ontario, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Montreal Oncology Research, Quebec, , Canada
LLC ARENSIA Exploratory Medicine, Tbilisi, , Georgia
Rabin Medical Center, Davidoff Cancer Center, Hemato-Oncology Institute, Petah-Tikva, , Israel
Chaim Sheba Medical Center, Department of Hematology, Ramat Gan, , Israel
The Tel Aviv Sourasky Medical Center, Department of Hematology and Bone Marrow Transplantation, Tel-Aviv, , Israel
ARENSIA Exploratory Medicine,, Chisinau, , Moldova, Republic of
Maria Sklodowska-Curie National Institute of Oncology - National Research Institute, Gliwice, , Poland
University Hospital in Krakow, Teaching Unit of the Hematology Department, Kraków, , Poland
Frederic Chopin Provincial Teaching Hospital, Teaching Department of Hematology, Rzeszów, , Poland
Our Doctor Clinical Trials Center, Torun, , Poland
Institute of Hematology and Transfusion Medicine, Department of Hematology, Warsaw, , Poland
Jan Mikulicz Radecki University Hospital in Wroclaw, Department and Clinic of Hematology, Blood Neoplasms and Bone Marrow Transplantation, Wroclaw, , Poland
Clinical Center Kragujevac, Clinic of Hematology, Kragujevac, , Serbia
Clinical Center of Vojvodina, Clinic of Hematology, Novi Sad, , Serbia
Catalan Institute of Oncology (ICO) - Hospital Duran i Reynals, Department of Clinical Hematology, Barcelona, , Spain
University Hospital Vall d'Hebron (HUVH), Department of Hematology, Barcelona, , Spain
Hospital Universitario QuironSalud Madrid, Madrid, , Spain
University Hospital Virgen del Rocio (HUVR), Department of Hematology, Seville, , Spain
Medical Center of Limited Liability Company "Medical Centre Named by Academician Yurii Spizhenko, Kyiv, , Ukraine
Contact Details
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