Clinical trial NCT00963105: Study of Lenalidomide to Evaluate Safety and Efficacy in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Official title: A Phase 2, Multi-Center, Randomized, Double-Blinded, Parallel Group Study of the Safety and Efficacy of Different Lenalidomide (REVLIMID®) Dose Regimens in Subjects With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Relapsed or Refractory Chronic Lymphocytic Leukemia
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2009-08-21
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and effectiveness of different dose regimens of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia (CLL).


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years at the time of signing the informed consent form
* 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:

* Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
* 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

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events
timeFrame: From first dose of study drug to 30 days after the last dose; the maximum duration of treatment was 251, 265, and 267 weeks in the 5 mg, 10 mg, and 15 mg treatment groups respectively.
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Response was assessed after 3 cycles of therapy (Week 12) and every 4 weeks thereafter until disease progression. Maximum time on study was 91 months.
measure: Kaplan-Meier Estimate of Duration of Response
timeFrame: Response was assessed after 3 cycles of therapy (Week 12) and every 4 weeks thereafter until disease progression. Maximum time on study was 91 months.
measure: Time to Response
timeFrame: Response was assessed after 3 cycles of therapy (Week 12) and every 4 weeks thereafter until disease progression. Maximum time on study was 91 months.
measure: Kaplan-Meier Estimate of Time to Progression
timeFrame: From randomization until the end of the study; maximum time on study was 91 months.
measure: Kaplan-Meier Estimate of Event-Free Survival
timeFrame: From randomization until the end of the study; maximum time on study was 91 months.
measure: Kaplan-Meier Estimate of Progression Free Survival
timeFrame: From randomization until the end of the study; maximum time on study was 91 months.
measure: Kaplan-Meier Estimate of Overall Survival
timeFrame: From randomization until the end of the study; maximum time on study was 91 months.
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD Moores Cancer Center
state: California
city: Rancho Mirage
country: United States
facility: Desert Hematology Oncology Medical Group, Inc.
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Southington
country: United States
facility: Cancer Center of Central Connecticut
state: Connecticut
city: Lecanto
country: United States
facility: Cancer and Blood Disease Center
state: Florida
city: Chicago
country: United States
facility: Northwestern University Medical Center Division of Hematology Oncology
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Cancer Center
state: Indiana
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center CLL Research and Treatment Program
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center Research
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Philadelphia
country: United States
facility: Drexel University, College of Medicine, Clinical Research Group
state: Pennsylvania
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: Amiens
country: France
facility: CHU Sud
city: Bobigny Cedex
country: France
facility: Hopital Avicenne
city: Grenoble Cedex 09
country: France
facility: CHU Grenoble
city: Le Mans
country: France
facility: Clinique Victor Hugo
city: Marseille Cedex 9
country: France
facility: Institut Paoli Calmettes
city: Montpellier Cedex 5
country: France
facility: CHU Montpellier - Hôpital Saint Eloi
city: Mulhouse
country: France
facility: Hopital Emile Muller
city: Paris
country: France
facility: Hopital Pitie Salpetriere
city: Perpignan
country: France
facility: CH Perpignan - Hopital Saint-Jean
city: Pessac
country: France
facility: CHRU - Hopital du Haut Leveque
city: Pierre Bénite
country: France
facility: Centre Hospitalier Lyon Sud
city: REIMS cedex
country: France
facility: Hopital Robert Debre
city: Rennes cedex
country: France
facility: CHU Rennes Hematology
city: Vandoeuvre les Nancy
country: France
facility: CHRU Hopital Brabois
city: Berlin
country: Germany
facility: Charite -Universitätsmedizin Berlin
city: Essen
country: Germany
facility: Universitatsklinikum Essen
city: Greifswald
country: Germany
facility: Ernst-Moritz-Arndt-Universität Greifswald
city: Kiel
country: Germany
facility: Universitatsklinikum Schleswig Holstein
city: Köln
country: Germany
facility: Klinikum der Universitat zu Koln
city: Ulm
country: Germany
facility: University of Ulm Abteilung Innere Medizin III
city: Genova
country: Italy
facility: Azienda Ospedaliera Universitaria San Martino
city: Lecce
country: Italy
facility: Ematologia ed Immunologia, Azienda Ospedaliera "Vito Fazzi" di Lecce
city: Milano
country: Italy
facility: I.R.C.C.S. Ospedale San Raffaele
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia - IEO
city: Padova
country: Italy
facility: Universita degli Studi di Padova
city: Perugia
country: Italy
facility: Universita' Degli Studi Di Perugia
city: Barcelona
country: Spain
facility: Hospital Clinic Provincial de Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset
city: Leeds
country: United Kingdom
facility: St James's Institute of Oncology
city: London
country: United Kingdom
facility: St.Bartholomew's Hospital
city: London
country: United Kingdom
facility: King's College Hospital
city: London
country: United Kingdom
facility: The Royal Marsden Hospital
city: Manchester
country: United Kingdom
facility: Christie Hospital NHS Foundation Trust
Study officials:
affiliation: Celgene Corporation
name: Jeffery Jones, M.D., MPH
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.