Study of Lenalidomide to Evaluate Safety and Efficacy in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
NCT ID: NCT00963105
Last Updated: 2018-10-31
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
104 participants
INTERVENTIONAL
2009-10-19
2017-09-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Lenalidomide in Pediatric Subjects With Relapsed or Refractory Acute Myeloid Leukemia
NCT02538965
Lenalidomide in Previously Treated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
NCT00439231
A Study of Lenalidomide Maintenance for High-risk Patients With CLL Following First-line Therapy
NCT01556776
Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia
NCT00352365
Revlimid in Patients With Acute Myelogenous Leukemia and Myelodysplastic Syndrome
NCT00360672
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Lenalidomide 5 mg
Participants received a starting dose of 5 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability.
Participants continued receiving study drug until disease progression or unacceptable toxicity, unless they withdrew consent or had other reasons to discontinue from study drug
lenalidomide
Depending on the starting dose, subjects will be allocated in a double-blind fashion to three different regimens and will escalate every 28 days, based on individual subject tolerability, as follows:
* Treatment Arm 1: 5 mg →10 mg →15 mg →20 mg →25 mg/daily
* Treatment Arm 2: 10 mg →15 mg →20 mg →25 mg/daily
* Treatment Arm 3: 15 mg →20 mg →25 mg/daily Subjects will continue treatment until disease progression or unacceptable toxicity
Lenalidomide 10 mg
Participants received a starting dose of 10 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability.
Participants continued receiving study drug until disease progression or unacceptable toxicity, unless they withdrew consent or had other reasons to discontinue from study drug
lenalidomide
Depending on the starting dose, subjects will be allocated in a double-blind fashion to three different regimens and will escalate every 28 days, based on individual subject tolerability, as follows:
* Treatment Arm 1: 5 mg →10 mg →15 mg →20 mg →25 mg/daily
* Treatment Arm 2: 10 mg →15 mg →20 mg →25 mg/daily
* Treatment Arm 3: 15 mg →20 mg →25 mg/daily Subjects will continue treatment until disease progression or unacceptable toxicity
Lenalidomide 15 mg
Participants received a starting dose of 15 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability.
Participants continued receiving study drug until disease progression or unacceptable toxicity, unless they withdrew consent or had other reasons to discontinue from study drug
lenalidomide
Depending on the starting dose, subjects will be allocated in a double-blind fashion to three different regimens and will escalate every 28 days, based on individual subject tolerability, as follows:
* Treatment Arm 1: 5 mg →10 mg →15 mg →20 mg →25 mg/daily
* Treatment Arm 2: 10 mg →15 mg →20 mg →25 mg/daily
* Treatment Arm 3: 15 mg →20 mg →25 mg/daily Subjects will continue treatment until disease progression or unacceptable toxicity
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
lenalidomide
Depending on the starting dose, subjects will be allocated in a double-blind fashion to three different regimens and will escalate every 28 days, based on individual subject tolerability, as follows:
* Treatment Arm 1: 5 mg →10 mg →15 mg →20 mg →25 mg/daily
* Treatment Arm 2: 10 mg →15 mg →20 mg →25 mg/daily
* Treatment Arm 3: 15 mg →20 mg →25 mg/daily Subjects will continue treatment until disease progression or unacceptable toxicity
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Must be able to adhere to the study visit schedule and other protocol requirements
* Must have a documented diagnosis of B-cell CLL
* Must be relapsed or refractory to at least 1 regimen for treatment of CLL. At least one of the prior treatments must have included a purine analog-based or bendamustine-based regimen
* Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2.
Exclusion Criteria
* Active infections requiring systemic antibiotics
* Systemic treatment for B-cell CLL within 28 days of initiation of lenalidomide treatment
* Alemtuzumab therapy within 120 days of initiating lenalidomide treatment
* Prior therapy with lenalidomide
* History of grade 4 rash due to prior thalidomide treatment
* Planned autologous or allogeneic bone marrow transplantation
* Central nervous system (CNS) involvement as documented by spinal fluid cytology or imaging.
* Uncontrolled hyperthyroidism or hypothyroidism
* Venous thromboembolism within 12 months
* ≥ Grade 2 neuropathy
* Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
* Disease transformation \[i.e. Richter's Syndrome (lymphomas) or prolymphocytic leukemia\]
* Participation in any clinical study or having taken any investigational therapy within 28 days prior to initiating lenalidomide therapy
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Celgene
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jeffery Jones, M.D., MPH
Role: STUDY_DIRECTOR
Celgene Corporation
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UCSD Moores Cancer Center
La Jolla, California, United States
Desert Hematology Oncology Medical Group, Inc.
Rancho Mirage, California, United States
Stanford University School of Medicine
Stanford, California, United States
Cancer Center of Central Connecticut
Southington, Connecticut, United States
Cancer and Blood Disease Center
Lecanto, Florida, United States
Northwestern University Medical Center Division of Hematology Oncology
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Long Island Jewish Medical Center CLL Research and Treatment Program
New Hyde Park, New York, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
Gabrail Cancer Center Research
Canton, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Drexel University, College of Medicine, Clinical Research Group
Philadelphia, Pennsylvania, United States
Cross Cancer Institute
Edmonton, Alberta, Canada
Juravinski Cancer Centre
Hamilton, Ontario, Canada
CHU Sud
Amiens, , France
Hopital Avicenne
Bobigny, , France
CHU Grenoble
Grenoble, , France
Clinique Victor Hugo
Le Mans, , France
Institut Paoli Calmettes
Marseille, , France
CHU Montpellier - Hôpital Saint Eloi
Montpellier, , France
Hopital Emile Muller
Mulhouse, , France
Hopital Pitie Salpetriere
Paris, , France
CH Perpignan - Hopital Saint-Jean
Perpignan, , France
CHRU - Hopital du Haut Leveque
Pessac, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Hopital Robert Debre
Reims, , France
CHU Rennes Hematology
Rennes, , France
CHRU Hopital Brabois
Vandœuvre-lès-Nancy, , France
Charite -Universitätsmedizin Berlin
Berlin, , Germany
Klinikum der Universitat zu Koln
Cologne, , Germany
Universitatsklinikum Essen
Essen, , Germany
Ernst-Moritz-Arndt-Universität Greifswald
Greifswald, , Germany
Universitatsklinikum Schleswig Holstein
Kiel, , Germany
University of Ulm Abteilung Innere Medizin III
Ulm, , Germany
Azienda Ospedaliera Universitaria San Martino
Genova, , Italy
Ematologia ed Immunologia, Azienda Ospedaliera "Vito Fazzi" di Lecce
Lecce, , Italy
I.R.C.C.S. Ospedale San Raffaele
Milan, , Italy
Istituto Europeo di Oncologia - IEO
Milan, , Italy
Universita degli Studi di Padova
Padua, , Italy
Universita' Degli Studi Di Perugia
Perugia, , Italy
Hospital Clinic Provincial de Barcelona
Barcelona, , Spain
Hospital Universitari Germans Trias i Pujol
Barcelona, , Spain
Karolinska Universitetssjukhuset
Stockholm, , Sweden
St James's Institute of Oncology
Leeds, , United Kingdom
St.Bartholomew's Hospital
London, , United Kingdom
King's College Hospital
London, , United Kingdom
The Royal Marsden Hospital
London, , United Kingdom
Christie Hospital NHS Foundation Trust
Manchester, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Wendtner CM, Hallek M, Fraser GA, Michallet AS, Hillmen P, Durig J, Kalaycio M, Gribben JG, Stilgenbauer S, Buhler A, Kipps TJ, Purse B, Zhang J, De Bedout S, Mei J, Chanan-Khan A. Safety and efficacy of different lenalidomide starting doses in patients with relapsed or refractory chronic lymphocytic leukemia: results of an international multicenter double-blinded randomized phase II trial. Leuk Lymphoma. 2016;57(6):1291-9. doi: 10.3109/10428194.2015.1128540. Epub 2016 Jan 14.
Buhler A, Wendtner CM, Kipps TJ, Rassenti L, Fraser GA, Michallet AS, Hillmen P, Durig J, Gregory SA, Kalaycio M, Aurran-Schleinitz T, Trentin L, Gribben JG, Chanan-Khan A, Purse B, Zhang J, De Bedout S, Mei J, Hallek M, Stilgenbauer S. Lenalidomide treatment and prognostic markers in relapsed or refractory chronic lymphocytic leukemia: data from the prospective, multicenter phase-II CLL-009 trial. Blood Cancer J. 2016 Mar 11;6(3):e404. doi: 10.1038/bcj.2016.9.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2009-009836-54
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CC-5013-CLL-009
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.