Spots Global Cancer Trial Database for A Study to Determine Dose, Safety, and Efficacy of Durvalumab as Monotherapy and in Combination Therapy in Subjects With Lymphoma or Chronic Lymphocytic Leukemia
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: A Study to Determine Dose, Safety, and Efficacy of Durvalumab as Monotherapy and in Combination Therapy in Subjects With Lymphoma or Chronic Lymphocytic Leukemia
Official Title: A Phase 1/2, Open-label, Multi-center Study to Assess the Safety and Tolerability of Durvalumab (Anti-PDL1 Antibody) as Monotherapy and in Combination Therapy in Subjects With Lymphoma or Chronic Lymphocitic Leukemia
Study ID: NCT02733042
Study Description
Brief Summary: This study is designed to determine the recommended phase 2 dose (RP2D), and the safety, and efficacy of durvalumab as monotherapy and when given in combination with lenalidomide and rituximab; ibrutinib; or bendamustine and rituximab at the RP2D in adults with lymphoma or chronic lymphocytic leukemia (CLL).
Detailed Description: The study was to consist of 3 parts: dose-finding, dose-confirmation, and dose-expansion. In this study, 4 treatment arms were to be investigated: * Arm A: durvalumab and lenalidomide ± rituximab * Arm B: durvalumab and ibrutinib * Arm C: durvalumab and rituximab ± bendamustine * Arm D: durvalumab (monotherapy) The study was to start with 3 dose-finding cohorts (Arms A, B, and C) and 1 dose-confirmation cohort (Arm D) in parallel. All treatment arms were to be open for enrollment at study start except in the US, where Arm D was to enroll depending on the availability of treatment slots and following the completion of assessment of responses from the combination therapy arms. For Arms A and C, prior to enrolling participants to receive all 3 drugs, the doublet combinations were to be evaluated. Once the doublet combinations were deemed tolerable, the eventual triplet combinations were to be tested. On 05 September 2017, the US FDA issued a Partial Clinical Hold on the study Arm A. Following this Partial Clinical Hold no more participants were enrolled into study Arm A. Participants already enrolled and treated in Arm A who were receiving clinical benefit, based on the discretion of the investigator, could continue study treatment after being reconsented. Arm B and C completed dose confirmation. The dose expansion part of the study was not opened.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
Pinnacle Oncology Hematology, Scottsdale, Arizona, United States
University of Colorado Cancer Center, Aurora, Colorado, United States
Shands Cancer Center University of Florida, Gainesville, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Emory University, Atlanta, Georgia, United States
Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States
Mayo Clinic, Rochester, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
Weill Cornell Medical College, New York, New York, United States
Local Institution - 005, Rochester, New York, United States
University of Rochester, Rochester, New York, United States
The Ohio State University, Columbus, Ohio, United States
University of Oklahoma Peggy and Charles Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Jefferson Medical Oncology Associates, Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center, Houston, Texas, United States
Houston Methodist Cancer Center, Houston, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
Centre Hospitalier Universitaire d'Avicennes, Bobigny Cedex, , France
Hopital Henri Mondor, Creteil, , France
Centre Hospitalier, Dijon Cedex, , France
Institut Paoli Calmettes, Marseille Cedex 9, , France
CHU Montpellier, Montpellier Cedex 5, , France
Local Institution - 102, Montpellier Cedex 5, , France
Centre Hospitalier Universitaire de Nantes, Nantes, , France
Local Institution - 105, Nantes, , France
Hopital Haut Leveque, Pessac Cedex, , France
Centre Hospitalier Lyon-Sud, Pierre-Benite CEDEX, , France
Local Institution - 103, Pierre-Benite CEDEX, , France
CHRU Rennes, Rennes, , France
Centre Henri Becquerel, Rouen Cedex, , France
Universitatsklinikum Essen, Essen, , Germany
UKG Universitatsklinikum Gottingen, Göttingen, , Germany
Universitatsklinikum des Saarlandes, Homburg-Saar, , Germany
Universitatsklinik Koln, Köln, , Germany
Medizinische Klinik III Klinikum der Universität München-Großhadern, München, , Germany
University of Bologna, Bologna, , Italy
Local Institution - 306, Brescia, , Italy
Spedali Civili Di Brescia, Brescia, , Italy
IEO- Istituto Europeo di Oncologia, Milano, , Italy
A.O. Ospedale Ca Granda - Niguarda, Milano, , Italy
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale, Napoli, Campania, , Italy
Local Institution - 304, Napoli, Campania, , Italy
I.R.C.C.S. Policlinico San Matteo, Pavia, , Italy
IRCCS Humanitas Clinical Institute, Rozzano (milano), , Italy
Local Institution - 602, Chuo-ku, Tokyo, Japan
National Cancer Center Hospital, Chuo-ku, , Japan
Tokai University Hospital, Isehara City, Kanagawa, , Japan
Aichi Cancer Center, Nagoya, , Japan
VU Academic Medical Center, Amsterdam, Amsterdam, , Netherlands
UMC Groningen, Groningen, , Netherlands
Leids Universitair Medisch Centrum, Leiden, , Netherlands
Erasmus Medical Center, Rotterdam, , Netherlands
Local Institution - 501, Rotterdam, , Netherlands
Local Institution - 402, Plymouth, Devon, United Kingdom
Local Institution - 407, Nottingham, Nottinghamshire, United Kingdom
St James University Hospital, Leeds, , United Kingdom
UCL Cancer Institute, London, , United Kingdom
Christie Hospital NHS Trust, Manchester, , United Kingdom
Local Institution - 404, Manchester, , United Kingdom
Nottingham University Hospitals NHS Trust, Nottingham, , United Kingdom
Local Institution - 406, Oxford, , United Kingdom
Oxford University Hospitals NHS Trust- Churchill Hospital-Oxford Centre for Respiratory Medicine, Oxford, , United Kingdom
Derriford Hospital, Plymouth, , United Kingdom
Southampton University Hospitals NHS Trust, Southampton, , United Kingdom
Contact Details
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
