Clinical trial NCT00875667: A Study to Determine the Efficacy of Lenalidomide Versus Investigator's Choice in Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL)
Official title: A Phase 2, Multicenter, Randomized Open-Label Study To Determine the Efficacy of Lenalidomide (Revlimid®) Versus Investigator's Choice in Patients With Relapsed or Refractory Mantle Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mantle Cell Lymphoma
Lymphoma, Mantle-Cell
Keywords: Mantle Cell Lymphoma
Relapsed Mantle Cell Lymphoma
Refractory Mantle Cell Lymphoma
Lymphoma
MCL
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2009-04-03
Enrollment: 254
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: To evaluate the safety and efficacy of lenalidomide versus investigator choice in patients with relapsed or refractory mantle cell lymphoma.

Detailed description: This research study is for patients who have relapsed or refractory mantle cell lymphoma following treatment such as radiotherapy, immunotherapy, chemotherapy, or radioimmunotherapy. Chemotherapy agents such as gemcitabine, cytarabine, chlorambucil, fludarabine, or the immunotherapeutic agent, rituximab, may be proposed. Thus, the aim is to search for new treatments that may improve the prognosis of patients with relapsed mantle cell lymphoma.

The present clinical study aims at determining if lenalidomide is safe and active in patients with mantle cell lymphoma who are refractory to their treatment or have relapsed once, twice or three times. Enrollment goal was met on March 7th 2013 and thus enrollment was stopped.

Eligibility criteria: Inclusion Criteria:

* Biopsy proven mantle cell lymphoma
* Patients who are refractory to their regimen or have relapsed once, twice or up to three times and who have documented progressive disease
* Eastern Cooperative Oncology Group (ECOG) performance score 0,1, or 2
* Willing to follow pregnancy precaution

Exclusion Criteria:

* Any of the following laboratory abnormalities
* Absolute neutrophil count (ANC) \< 1,500 cells/mm\^3 (1.5 x 10\^9/L)
* Platelet count \< 60,000/mm\^3 (60 x 10\^9/L)
* Serum aspartate transaminase/serum glutamic oxaloacetic transaminase(AST/SGOT) or alanine transaminase/serum glutamic pyruvic transaminase (ALT/SGPT) \>3.0 x upper limit or normal (ULN), except patients with documented liver involvement by lymphoma
* Serum total bilirubin \> 1.5 x ULN, except in case of Gilbert's Syndrome and documented liver involvement by lymphoma.
* Calculated creatinine clearance (Cockcroft-Gault formula) of \< 30 mL/min
* History of active central nervous system (CNS) lymphoma within the previous 3 months
* Subjects not willing to take deep venous thrombosis (DVT) prophylaxis
* Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are sero-positive because of hepatitis B virus vaccine are eligible

Primary outcomes:
measure: Kaplan Meier Estimate for Progression Free Survival (PFS) by Independent Review Committee (IRC) Central Review
timeFrame: From randomization to progression of disease or death; up to data cut off date of 07 March 2014; overall median follow-up time was 93.9 weeks
measure: Kaplan Meier Estimate for Progression Free Survival by Investigator's Assessment at the Final Analysis
timeFrame: From randomization to progression of disease or death; up to study discontinuation of 09 October 2018; overall median follow-up time was 285 weeks
Secondary outcomes:
measure: Percentage of Participants Who Achieved an Overall Response According to the IRC Central Review
timeFrame: From date of randomization to the data cut-off date of 07 March 2014; median treatment duration was 24.3 weeks for the lenalidomide arm and 13.1 weeks for the investigators choice arm
measure: Percentage of Participants Who Achieved an Overall Response as Assessed by the Investigator at the Final Analysis
timeFrame: From date of randomization to the study discontinuation date of 09 October 2018; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm
measure: Kaplan Meier Estimate for Duration of Response (DOR) According to the IRC Central Review
timeFrame: From date of randomization to the data cut-off date of 07 March 2014; median study duration was 70.7 weeks for the lenalidomide arm and 69.3 weeks for the investigators choice arm
measure: Kaplan Meier Estimate for Duration of Response as Assessed by the Investigator at the Final Analysis
timeFrame: From date of randomization to the study discontinuation date of 09 October 2018; median study duration was 103.9 weeks for lenalidomide and 87.0 weeks for the investigator choice arm
measure: Percentage of Participants With a Complete Response, Unconfirmed Complete Response, Partial Response and Stable Disease According to the IRC Central Review
timeFrame: From date of randomization to the data cut-off date of 07 March 2014; median treatment duration was 24.3 weeks for the lenalidomide arm and 13.1 weeks for the investigators choice arm
measure: Percentage of Participants With a Complete Response, Unconfirmed Complete Response, Partial Response and Stable Disease at the Final Analysis
timeFrame: From date of randomization to the discontinuation date of 09 October 2018; median treatment duration was 24.3 weeks for the lenalidomide arm and 13.1 weeks for the investigators choice arm
measure: Kaplan Meier Estimate of Time to Progression According to the IRC Central Review
timeFrame: From date of randomization to the data cut-off date of 07 March 2014; median study duration was 70.7 weeks for the lenalidomide arm and 69.3 weeks for the investigators choice arm
measure: Kaplan Meier Estimate of Time to Progression as Assessed by the Investigator at the Final Analysis
timeFrame: From date of randomization to the study discontinuation date of 09 October 2018; median study duration was 103.9 weeks for lenalidomide and 87.0 weeks for the investigator choice arm
measure: Kaplan Meier Estimate of Time to Treatment Failure (TTF) as Assessed by the Investigator
timeFrame: From the date of the first treatment to the data cut-off date of 07 March 2014; median treatment duration was 24.3 weeks for the lenalidomide arm and 13.1 weeks for the investigators choice arm
measure: Kaplan Meier Estimate of Time to Treatment Failure as Assessed by the Investigator at the Final Analysis
timeFrame: From date of first dose of treatment to the study discontinuation date of 09 October 2018; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm
measure: Kaplan Meier Estimate of Time to First Response (TTFR) According to the IRC Central Review
timeFrame: From randomization of study drug to time of first documented PR or better response; up to data cut-off date of 07 March 2014; median treatment duration was 24.3 weeks for the lenalidomide arm and 13.1 weeks for the investigators choice arm
measure: Kaplan Meier Estimate of Time to First Response as Assessed by the Investigator at the Final Analysis
timeFrame: From date of randomization to the study discontinuation date of 09 October 2018; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm
measure: Kaplan Meier Estimate for Overall Survival (OS) According to the IRC Central Review
timeFrame: From date of randomization to the data cut-off date of 07 March 2014; overall median follow-up was 93.9 weeks
measure: Kaplan Meier Estimate for Overall Survival as Assessed by the Investigator at the Final Analysis
timeFrame: From randomization to progression of disease or death; up to the study discontinuation date of 09 October 2018; overall median follow-up time was 285 weeks
measure: Number of Participants With Treatment Emergent Adverse Events
timeFrame: From the date of the first dose of study drug to 28 days after the last dose, up to the study discontinuation date of 09 October 2018; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigators choice arm
measure: Mean Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
timeFrame: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
measure: Maximum Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain to Treatment Discontinuation Visit
timeFrame: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
measure: Mean Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain
timeFrame: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
measure: Maximum Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain to Treatment Discontinuation Visit
timeFrame: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
measure: Mean Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain
timeFrame: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
measure: Maximum Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain to Treatment Discontinuation Visit
timeFrame: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
measure: Mean Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain
timeFrame: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
measure: Maximum Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain to Treatment Discontinuation Visit
timeFrame: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
measure: Mean Change From Baseline in the EORTC QLQ-C30 Fatigue Domain
timeFrame: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
measure: Maximum Change From Baseline in the EORTC QLQ-C30 Fatigue Domain to Treatment Discontinuation Visit
timeFrame: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
measure: Mean Change From Baseline in the EORTC QLQ-C30 Pain Domain
timeFrame: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
measure: Maximum Change From Baseline in the EORTC QLQ-C30 Pain Domain to Treatment Discontinuation Visit
timeFrame: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and time of discontinuation from treatment visit.Up to final data cut-0ff date of 07 March 2014
measure: Mean Change From Baseline in the EORTC QLQ-C30 Nausea / Vomiting Domain
timeFrame: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
measure: Maximum Change From Baseline in the EORTC QLQ-C30 Nausea and Vomiting Domain to Treatment Discontinuation Visit
timeFrame: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
measure: Mean Change From Baseline in the EORTC QLQ-C30 Constipation
timeFrame: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
measure: Maximum Change From Baseline in the EORTC QLQ-C30 Constipation Domain to Treatment Discontinuation Visit
timeFrame: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
measure: Mean Change From Baseline in the EORTC QLQ-C30 Diarhoea
timeFrame: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
measure: Maximum Change From Baseline in the EORTC QLQ-C30 Diarhoea Domain to Treatment Discontinuation Visit
timeFrame: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and time of discontinuation from treatment visit.Up to final data cut-0ff date of 07 March 2014
measure: Mean Change From Baseline in the EORTC QLQ-C30 Insomnia Domain
timeFrame: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
measure: Maximum Change From Baseline in the EORTC QLQ-C30 Insomnia Domain to Treatment Discontinuation Visit
timeFrame: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
measure: Mean Change From Baseline in the EORTC QLQ-C30 Dyspnoea Domain to Treatment Discontinuation Visit
timeFrame: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
measure: Maximum Change From Baseline in the EORTC QLQ-C30 Dyspnoea Domain to Treatment Discontinuation Visit
timeFrame: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
measure: Mean Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain to Treatment Discontinuation Visit
timeFrame: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
measure: Maximum Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain to Treatment Discontinuation Visit
timeFrame: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
measure: Mean Change From Baseline in the EORTC QLQ-C30 Financial Problems Domain to Treatment Discontinuation Visit
timeFrame: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
measure: Maximum Change From Baseline in the EORTC QLQ-C30 Financial Problems Domain to Treatment Discontinuation Visit
timeFrame: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
measure: Mean Change From Baseline in the EORTC QLQ-C30 Global Health Status / QoL Domain
timeFrame: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
measure: Maximum Change From Baseline in the EORTC QLQ-C30 Global Health Status / QoL Domain to Treatment Discontinuation Visit
timeFrame: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
measure: Mean Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain
timeFrame: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
measure: Maximum Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain to Treatment Discontinuation Visit
timeFrame: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: UZ Brussels
city: Gent
country: Belgium
facility: UZ Gent
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Yvoir
country: Belgium
facility: Cliniques Universitaires UCL de Mont-Godine
city: Brno
country: Czechia
facility: Teaching Hospital BrnoHemato-oncology Dept
city: Hradec Kralove
country: Czechia
facility: University Hospital2.Dep. of Int.med. hematology
city: Prague
country: Czechia
facility: Charles University General Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet Department of Haematology L4042
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquitaine Service Onco-Hematologie
city: Clermont Ferrand
country: France
facility: Hotel Dieu
city: Grenoble cedex 09
country: France
facility: CHU Hopital Michallon
city: La Roche sur Yon
country: France
facility: Centre Hospitalier Departemental Les Oudrairies
city: Le Mans
country: France
facility: Clinique Victor Hugo
city: Lille
country: France
facility: CHRU-Hopital Claude Huriez
city: Limoges Cedex 1
country: France
facility: CHU Dupuytren
city: Lyon
country: France
facility: Centre Leon Berard
city: Marseille
country: France
facility: Institut Paoli-Calmettes
city: Montpellier CEDEX 5
country: France
facility: CHU Montpellier - Hôpital Saint Eloi
city: Nantes Cedex 1
country: France
facility: CHRU - Hotel Dieu
city: Nice cedex 1
country: France
facility: Centre Antoine Lacassagne Oncologie medicale et Hematologie
city: Paris
country: France
facility: Hopital Saint-Louis
city: Pessac
country: France
facility: CHRU - Hopital du Haut Leveque
city: Pierre-Bénite cedex
country: France
facility: Centre Hospitalier Lyon Sud
city: Rennes
country: France
facility: CHU Rennes Hematology
city: Rouen Cedex
country: France
facility: Centre Henri Becquerel
city: Strasbourg
country: France
facility: Hopital civil
city: Strasbourg
country: France
facility: CHRU Hôpital de Hautepierre
city: Vandoeuvre
country: France
facility: CHRU Hopitaux de Brabois
city: Essen
country: Germany
facility: Universitatsklinikum Essen
city: Freiburg
country: Germany
facility: Universitaetsklinikum FreiburgInnere Med.1, Haematologie
city: Göttingen
country: Germany
facility: UKG Universitatsklinikum Gottingen
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Homburg-Saar
country: Germany
facility: Universitatsklinikum des Saarlandes
city: Karlsruhe
country: Germany
facility: Stadtisches Klinikum Karlsruhe
city: Koeln
country: Germany
facility: Uniklinik Koln
city: Muenster
country: Germany
facility: Universitatsklinik Munster
city: Ulm
country: Germany
facility: University of Ulm
city: Athens
country: Greece
facility: Attikon General University Hospital of Athens
city: Patras
country: Greece
facility: University of Patras
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Hadassah University Hospital
city: Petach-Tikva
country: Israel
facility: Rabin Medical Center
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
city: Bari
country: Italy
facility: A.O. Policlinico - Università di Bari
city: Bologna
country: Italy
facility: A.O.U. di Bologna Policlinico S.Orsola-Malpighi
city: Bolzano
country: Italy
facility: Ospedale Regionale di Bolzano
city: Catania
country: Italy
facility: Ospedale Ferrarotto
city: Genova
country: Italy
facility: Azienda Ospedaliera Universitaria San Martino
city: Lecce
country: Italy
facility: Ematologia ed Immunologia
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia - IEO
city: Milano
country: Italy
facility: San Raffaele Scientific Institute
city: Palermo
country: Italy
facility: Az. Osp. Vincenzo Cervello
city: Pavia
country: Italy
facility: I.R.C.C.S. Policlinico San Matteo
city: Perugia
country: Italy
facility: Az. Osp di Perugia
city: Pisa
country: Italy
facility: Ospedale S. Chiara
city: Reggio Calabria
country: Italy
facility: Azienda Ospedaliera "Bianchi-Melacrino-Morelli"
city: Rionero in Vulture
country: Italy
facility: Reference Cancer Center of Basilicata
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Casa Sollievo della Sofferenza
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum
city: Enshede
country: Netherlands
facility: Medisch Spectrum Twente
city: Zwolle
country: Netherlands
facility: Isala Klinieken
city: Krakow
country: Poland
facility: Uniwersytet Jagiellonski Collegium Medicum
city: Kraków
country: Poland
facility: Malopolskie Centrum medyczne s.c.
city: Lodz
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
city: Warsaw
country: Poland
facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie w Warszawie
city: Wroclaw
country: Poland
facility: Nowotworww Krwi i Transplantacji Szpiku
city: Wroclaw
country: Poland
facility: Dolnoslaskie Centrum Transplantacji Komorkowych
city: Ekaterinburg
country: Russian Federation
facility: Sverdlovsk Regional Clinical Hospital 1
city: Kazan
country: Russian Federation
facility: Republic Clinical Oncology Dispensary
city: Moscow
country: Russian Federation
facility: Institution of Russian Academy of Medical Sciences Russian Oncological Research Centre n.a. N. N. Bl
city: Nizhniy Novgorod
country: Russian Federation
facility: Nizhegorodskiy Regional Clinical Hospital named after N.A. Semashko
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk State Regional Clinical Hospital
city: Obninsk
country: Russian Federation
facility: Medical Radiology Research Centre RAMS
city: Perm
country: Russian Federation
facility: Perm Territorial Oncology Dispensary
city: Rostov-na-Donu
country: Russian Federation
facility: Scientific Research Institute of OncologySoft Tissue Department
city: Saint-Petersburg
country: Russian Federation
facility: St. Petersburg Research Institute of Hematology and Blood Transfusion
city: Saint-Petersburg
country: Russian Federation
facility: St. Petersburg Pavlov State Medical University
city: Saratov
country: Russian Federation
facility: Saratov Medical University Chair of Professional Pathology and Haematology
city: St. Petersburg
country: Russian Federation
facility: Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov
city: Volgograd
country: Russian Federation
facility: Volgograd Regional Clinical Oncology Dispensary 1
city: Barcelona
country: Spain
facility: Hospital Universitario Vall D Hebron
city: Madrid
country: Spain
facility: Hospital de La Princesa
city: Madrid
country: Spain
facility: Hospital La Paz
city: Marbella
country: Spain
facility: Hospital Costa del Sol
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
city: Lund
country: Sweden
facility: Lund University Hosptial
city: Uppsala
country: Sweden
facility: University Hospital Uppsala
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hosp
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
city: Manchester
country: United Kingdom
facility: Christie Hospital
city: Newcastle Upon Tyne
country: United Kingdom
facility: Newcastle Hospital Foundation Trust
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
city: Wolverhampton
country: United Kingdom
facility: The Royal Wolverhampton Hospital NHS Trust
Study officials:
affiliation: Head, Ist Dept Medicine, Charles University Hospital; Director, Institute of Hematology and Blood Transfusion; Chair, Czech Lymphoma Study Group
name: Marek Trneny, MD/PhD/Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Trneny M, Lamy T, Walewski J, Belada D, Mayer J, Radford J, Jurczak W, Morschhauser F, Alexeeva J, Rule S, Afanasyev B, Kaplanov K, Thyss A, Kuzmin A, Voloshin S, Kuliczkowski K, Giza A, Milpied N, Stelitano C, Marks R, Trumper L, Biyukov T, Patturajan M, Bravo MC, Arcaini L; SPRINT trial investigators and in collaboration with the European Mantle Cell Lymphoma Network. Lenalidomide versus investigator's choice in relapsed or refractory mantle cell lymphoma (MCL-002; SPRINT): a phase 2, randomised, multicentre trial. Lancet Oncol. 2016 Mar;17(3):319-331. doi: 10.1016/S1470-2045(15)00559-8. Epub 2016 Feb 16.
citation: Hagner PR, Chiu H, Ortiz M, Apollonio B, Wang M, Couto S, Waldman MF, Flynt E, Ramsay AG, Trotter M, Gandhi AK, Chopra R, Thakurta A. Activity of lenalidomide in mantle cell lymphoma can be explained by NK cell-mediated cytotoxicity. Br J Haematol. 2017 Nov;179(3):399-409. doi: 10.1111/bjh.14866. Epub 2017 Aug 2.