Non Hodgkin Lymphoma Clinical Trial

A Study to Determine Dose, Safety, and Efficacy of Durvalumab as Monotherapy and in Combination Therapy in Subjects With Lymphoma or Chronic Lymphocytic Leukemia

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).

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Subject who has histologically confirmed and documented B-cell lymphoma (eg, follicular, diffuse large B-cell, mantle cell, small lymphocytic, or Hodgkin lymphoma) and chronic lymphocytic leukemia.
Subject who has high-risk chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
Subject who was previously treated with at least one prior systemic chemotherapy, immunotherapy, or chemoimmunotherapy.
Subject who has the Eastern Cooperative Oncology Group performance status of 0, 1, or 2.
Subject who is willing and able to undergo biopsy.
Subject who has documented active relapsed or refractory disease requiring therapeutic intervention.
Subject with lymphoma who has measurable disease (≥ 2.0 cm in its longest dimension by computed tomography) or chronic lymphocytic leukemia in need of treatment.
Subject who fulfills the laboratory requirements as per protocol

Exclusion Criteria

Subject who has central nervous system (CNS) or meningeal involvement by lymphoma.
Subject who has any histopathologic finding consistent with myelodysplastic syndrome on bone marrow studies.

Subject who received any prior monoclonal antibodies against programmed cell death-1 (PD-1) or programmed cell death ligand-1 (PD-L1) and/or any prior:

Arm A only: drugs with immunomodulatory and other properties (eg, lenalidomide, thalidomide);
Arm B only: ibrutinib or other Bruton's tyrosine kinase (BTK) inhibitor;
Arms C only: bendamustine
Subject who has active auto-immune disease.
Subject who has history of organ transplant or allogeneic hematopoietic stem cell transplantation.
Subject who is seropositive for or active viral infection with hepatitis B virus (HBV) (hepatitis B surface antigen [HBsAg] positive and/or detectable viral DNA)
Subject who has known seropositivity for or active infection for human immunodeficiency virus (HIV) or hepatitis C virus (HCV).
Subject who has history of primary immunodeficiency or tuberculosis.
Subject who other invasive malignancy within 2 years (5 years for Arm A) except for noninvasive malignancies such as cervical carcinoma in situ, non-melanomatous carcinoma of the skin, ductal carcinoma in situ of the breast, or incidental histologic finding of prostate cancer (T1a or T1b using the TNM [tumor, nodes, metastasis] clinical staging system) that has/have been surgically cured.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

106

Study ID:

NCT02733042

Recruitment Status:

Completed

Sponsor:

Celgene

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There are 52 Locations for this study

See Locations Near You

Banner MD Anderson Cancer Center
Gilbert Arizona, 85234, United States
Pinnacle Oncology Hematology
Scottsdale Arizona, 85258, United States
University of Colorado Cancer Center
Aurora Colorado, 80045, United States
Shands Cancer Center University of Florida
Gainesville Florida, 32610, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
Emory University
Atlanta Georgia, 30322, United States
Northwestern University Feinberg School of Medicine
Chicago Illinois, 60611, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Weill Cornell Medical College
New York New York, 10065, United States
Local Institution - 005
Rochester New York, 14642, United States
University of Rochester
Rochester New York, 14642, United States
The Ohio State University
Columbus Ohio, 43210, United States
University of Oklahoma Peggy and Charles Stephenson Cancer Center
Oklahoma City Oklahoma, 73104, United States
Jefferson Medical Oncology Associates
Philadelphia Pennsylvania, 19107, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Houston Methodist Cancer Center
Houston Texas, 77030, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Centre Hospitalier Universitaire d'Avicennes
Bobigny Cedex , 93009, France
Hopital Henri Mondor
Creteil , 94010, France
Centre Hospitalier
Dijon Cedex , 21079, France
Institut Paoli Calmettes
Marseille Cedex 9 , 13273, France
CHU Montpellier
Montpellier Cedex 5 , 34295, France
Local Institution - 102
Montpellier Cedex 5 , 34295, France
Centre Hospitalier Universitaire de Nantes
Nantes , 44093, France
Local Institution - 105
Nantes , 44093, France
Hopital Haut Leveque
Pessac Cedex , 33604, France
Centre Hospitalier Lyon-Sud
Pierre-Benite CEDEX , 69495, France
Local Institution - 103
Pierre-Benite CEDEX , 69495, France
CHRU Rennes
Rennes , 35033, France
Centre Henri Becquerel
Rouen Cedex , 76038, France
Universitatsklinikum Essen
Essen , 45122, Germany
UKG Universitatsklinikum Gottingen
Göttingen , 37099, Germany
Universitatsklinikum des Saarlandes
Homburg-Saar , 66421, Germany
Universitatsklinik Koln
Köln , 50924, Germany
Medizinische Klinik III Klinikum der Universität München-Großhadern
München , 81377, Germany
University of Bologna
Bologna , 40138, Italy
Local Institution - 306
Brescia , 25123, Italy
Spedali Civili Di Brescia
Brescia , 25123, Italy
IEO- Istituto Europeo di Oncologia
Milano , 20144, Italy
A.O. Ospedale Ca Granda - Niguarda
Milano , 20162, Italy
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale
Napoli, Campania , 80131, Italy
Local Institution - 304
Napoli, Campania , 80131, Italy
I.R.C.C.S. Policlinico San Matteo
Pavia , 27100, Italy
IRCCS Humanitas Clinical Institute
Rozzano (milano) , 20089, Italy
Local Institution - 602
Chuo-ku Tokyo, 104-0, Japan
National Cancer Center Hospital
Chuo-ku , 104-0, Japan
Tokai University Hospital
Isehara City, Kanagawa , 259-1, Japan
Aichi Cancer Center
Nagoya , 464-8, Japan
VU Academic Medical Center, Amsterdam
Amsterdam , 1081 , Netherlands
UMC Groningen
Groningen , 9713 , Netherlands
Leids Universitair Medisch Centrum
Leiden , 2333 , Netherlands
Erasmus Medical Center
Rotterdam , 3015 , Netherlands
Local Institution - 501
Rotterdam , 3015 , Netherlands
Local Institution - 402
Plymouth Devon, PL6 8, United Kingdom
Local Institution - 407
Nottingham Nottinghamshire, NG5 1, United Kingdom
St James University Hospital
Leeds , LS9 7, United Kingdom
UCL Cancer Institute
London , WC1E , United Kingdom
Christie Hospital NHS Trust
Manchester , M20 4, United Kingdom
Local Institution - 404
Manchester , M20 4, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham , Ng5 1, United Kingdom
Local Institution - 406
Oxford , 0X3 7, United Kingdom
Oxford University Hospitals NHS Trust- Churchill Hospital-Oxford Centre for Respiratory Medicine
Oxford , 0X3 7, United Kingdom
Derriford Hospital
Plymouth , PL6 8, United Kingdom
Southampton University Hospitals NHS Trust
Southampton , SO16 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

106

Study ID:

NCT02733042

Recruitment Status:

Completed

Sponsor:


Celgene

How clear is this clinincal trial information?

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