Ibrutinib in Combination With Lenalidomide and Rituximab in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
NCT ID: NCT02077166
Last Updated: 2022-02-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
138 participants
INTERVENTIONAL
2014-03-13
2020-12-17
Brief Summary
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Detailed Description
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Phase 2: This will be conducted as an international, multicenter, open-label study. Eligible subjects will receive ibrutinib, lenalidomide and rituximab.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1b: Enrolled at Lenalidomide Dose 15 mg (Dose Level 1)
Ibrutinib 560 mg administered orally (PO) once daily (QD) beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered intravenously (IV) on Day 1 of each 28-day cycle for 6 cycles.
Ibrutinib
Lenalidomide
Rituximab
Phase 1b: Enrolled at Lenalidomide Dose 10 mg (Dose Level -1)
De-escalation cohort: Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Ibrutinib
Lenalidomide
Rituximab
Phase 1b: Enrolled at Lenalidomide Dose 15 mg (Dose Level 1+)
Re-escalation cohort: Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Ibrutinib
Lenalidomide
Rituximab
Phase 1b: Enrolled at Lenalidomide Dose 20 mg (Dose Level 2)
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Ibrutinib
Lenalidomide
Rituximab
Phase 1b: Enrolled at Lenalidomide Dose 25 mg (Dose Level 3)
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Ibrutinib
Lenalidomide
Rituximab
Phase 2: Enrolled at Lenalidomide Dose 20 mg
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Ibrutinib
Lenalidomide
Rituximab
Phase 2: Enrolled at Lenalidomide Dose 25 mg
Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
Ibrutinib
Lenalidomide
Rituximab
Interventions
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Ibrutinib
Lenalidomide
Rituximab
Eligibility Criteria
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Inclusion Criteria
* Must have previously received first line treatment regimen
* Must be ineligible for high dose therapy/ stem cell transplantation
* Measurable disease sites on computed tomography (CT) scan (\>1.5 cm in longest dimension)
* prothrombin time/international normalized ratio (PT/INR) \< 1.5 x upper limit of normal (ULN) and partial thromboplastin time (PTT; activated partial thromboplastin time \[aPTT\]) \<1.5 x ULN
* Men and women ≥18 years of age
* Eastern Cooperative Oncology Group (ECOG) \< 2
* Adequate hepatic and renal function
* Adequate hematologic function
Exclusion Criteria
* History of allogeneic stem-cell (or other organ) transplantation
* Any chemotherapy, external beam radiation therapy, or anticancer antibodies within 2 weeks
* Radio- or toxin-immunoconjugates within 10 weeks
* Concurrent enrollment in another therapeutic investigational study or have previously taken ibrutinib and/or lenalidomide.
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Celgene Corporation
INDUSTRY
Pharmacyclics LLC.
INDUSTRY
Responsible Party
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Principal Investigators
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Jutta K. Neuenburg, MD, PhD
Role: STUDY_DIRECTOR
Pharmacyclics LLC.
Locations
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University of Alabama
Birmingham, Alabama, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Cedar Sinai Medical Center
Los Angeles, California, United States
UCLA Medical Center
Los Angeles, California, United States
University of Florida
Gainesville, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
Tulane Medical Center
New Orleans, Louisiana, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Comprehensive Cancer Center of Nevada
Las Vegas, Nevada, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Summit Medical Group
Morristown, New Jersey, United States
Weill Cornell Medical Center
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
University of Cincinnati Health Barrett Center
Cincinnati, Ohio, United States
Mid-Ohio Oncology/ Hematology
Columbus, Ohio, United States
University of TN Medical Center
Knoxville, Tennessee, United States
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States
Baylor Charles Sammons Cancer Center
Dallas, Texas, United States
The University of Texas, MD Anderson Cancer Center
Houston, Texas, United States
Medical Oncology Associates, PS
Spokane, Washington, United States
Northwest Medical Specialities, PLLC
Tacoma, Washington, United States
Ziekenhuis Netwerk Antwerpen - Campus Stuivenberg
Antwerp, , Belgium
CHU Brugmann
Brussels, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
UZ Leuven
Leuven, , Belgium
Universiaetsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany
Klinikum der Universitaet Muenchen - Campus Grosshadern
Munich, Bavaria, Germany
Klinikum rechts der Isar - Technische Universitaet Muenchen, III. Medizinische Klinik und Polyklinik
Munich, Bavaria, Germany
Universitaetsklinikum Wuerzburg, Medizinische Klinik und Poliklinik II
Würzburg, Bavaria, Germany
University Hospitals Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
University Hospital of Wales
Cardiff, , United Kingdom
Northwick Park Hospital
Harrow, , United Kingdom
The Leeds Teaching Hospitals
Leeds, , United Kingdom
Kings College Hospital
London, , United Kingdom
University College London Hospitals
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, , United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, , United Kingdom
Countries
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References
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Ramchandren R, Johnson P, Ghosh N, Ruan J, Ardeshna KM, Johnson R, Verhoef G, Cunningham D, de Vos S, Kassam S, Fayad L, Radford J, Bailly S, Offner F, Morgan D, Munoz J, Ping J, Szafer-Glusman E, Eckert K, Neuenburg JK, Goy A. The iR2 regimen (ibrutinib plus lenalidomide and rituximab) for relapsed/refractory DLBCL: A multicentre, non-randomised, open-label phase 2 study. EClinicalMedicine. 2022 Dec 26;56:101779. doi: 10.1016/j.eclinm.2022.101779. eCollection 2023 Feb.
Goy A, Ramchandren R, Ghosh N, Munoz J, Morgan DS, Dang NH, Knapp M, Delioukina M, Kingsley E, Ping J, Beaupre DM, Neuenburg JK, Ruan J. Ibrutinib plus lenalidomide and rituximab has promising activity in relapsed/refractory non-germinal center B-cell-like DLBCL. Blood. 2019 Sep 26;134(13):1024-1036. doi: 10.1182/blood.2018891598. Epub 2019 Jul 22.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2013-004341-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PCYC-1123-CA
Identifier Type: -
Identifier Source: org_study_id
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