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A Study to Evaluate the Efficacy of Lenalidomide as Maintenance Therapy After Completion of First-line Combination Chemotherapy in Patients With Mantle Cell Lymphoma (MCL). (RENEW)

Primary Purpose

Mantle Cell Lymphoma, Non-Hodgkin's Lymphoma

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lenalidomide
Placebo
Sponsored by
Celgene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mantle Cell Lymphoma focused on measuring Mantle Cell Lymphoma, Non-Hodgkin's Lymphoma, CC-5013, Revlimid, Lenalidomide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically-proven mantle cell non-Hodgkin's lymphoma,
  • One of the following first-line induction chemotherapy regimens with rituximab: (1) combination regimen containing all of the following components: cyclophosphamide, vincristine, adriamycin and a glucocorticoid; (2) Fludarabine containing regimen such as FC (fludarabine, cyclophosphamide)
  • Achieved a PR or better response after the first-line induction chemotherapy regimen (assessed by 2007 Revised Response Criteria for Malignant Lymphoma)
  • ECOG performance status score of ≤ 2
  • Willing to follow pregnancy precaution

Exclusion Criteria:

  • Patients who have received more than 1 line of induction chemotherapy;
  • Patients who have received less than 4 cycles of R-CHOP, R-CHOP-like, or R-FC are ineligible;
  • Patients who achieved stable disease or progressive disease as best response with first line-induction chemotherapy;
  • Any of the following laboratory abnormalities:
  • Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5*10^9/L)
  • Platelet count < 60,000/mm^3 (60*10^9/L)
  • Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT)) > 3.0 times upper limit of normal (ULN), except in patients with documented liver involvement by lymphoma
  • Serum bilirubin > 1.5 times ULN, except in case of Gilbert's Syndrome and documented liver involvement by lymphoma
  • Calculated creatinine clearance (i.e. Cockcroft-Gault formula) of < 30 mL /min
  • Active or any history of central nervous system (CNS) lymphoma or leptomeningeal involvement by lymphoma
  • Subjects at high risk for deep vein thrombosis (DVT) not willing to take DVT prophylaxis
  • Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV)

Sites / Locations

  • Sharp Healthcare Oncology Associates of San Diego
  • Rocky Mountain Cancer Center
  • Rush University Medical Center
  • Indiana University Melvin and Bren Simon Cancer Center
  • Providence Cancer Center
  • Nebraska Hematology-Oncology, PC
  • Hackensack University Medical Center
  • Arena Oncology Associates
  • Weill Cornell Medical College/New York Presbyterian Hospital
  • SUNY Upstate Medical University
  • Fox Chase Cancer Center
  • Avera Cancer Institute
  • University of Virginia Health Systems
  • Fakultni nemocnice Hradec Králové II. Interni klinika-Oddeleni klinicke hematologie
  • Fakultni Nemocnice Olomouc, Hemato-Onkologicka Klinika
  • Clinic of Oncology Faculty Hospital Motol
  • Fakultni Nemocnice Kralovske Vinohrady
  • Vseobecna Fakultni Nemocnice
  • CHU Amiens Sud, Centre de Recherche Clinique - Pharmacologie Clinique
  • CHU Hôpital Hotel Dieu
  • CHU ESTAING, Service d'Hématologie
  • Hôpital Henri Mondor Unité Hémopathies Lymphoides
  • CHD Les Oudairies, Service d'Oncologie Hématologie
  • Centre Hospitalier Lyon Sud, Pavillon Marcel Bérard 1F Hématologie
  • CHRU - Hôpital Claude Huriez
  • CHU Montpellier - Hôpital Saint Eloi Hématologie et Oncologie Médicale
  • CHRU - Hotel Dieu
  • Hôpital Saint-Louis
  • CHRU - Hôpital du Haut Lévêque, maladies du sang, Centre François Magendie
  • Centre Hospitalier Lyon Sud, Pavillon Marcel Bérard 1F Hématologie
  • CHU de Poitiers, Pôle Régional de Cancérologie, Service d'Oncologie Hématologie et Thérapie Cellulaire
  • CHU de Reims, Hôpital Robert Debré, Hématologie Clinique
  • Hôpital Pontchaillou Hématologie Clinique
  • Centre Henri Becquerel
  • Hôpital Purpan CHU de Toulouse
  • Hôpital Bretonneau - CHU Tours
  • CHU de Nancy Hôpital de Brabois, Service d'Hématologie et Médecine Interne
  • Universitätsklinikum Essen Zentrum für Innere Medizin
  • Universitätsklinikum Freiburg - Medizinische Klinik - Abteilung Innere Medizin I: Hämatologie und Onkologie
  • UKG Universitätsklinikum Göttingen Zentrum Innere Medizin Hämatologie / Onkologie
  • Asklepios Klinik St. Georg - Abteilung für Hämatologie und Stammzelltransplantation
  • Städtisches Klinikum Karlsruhe - Hämatologie / Onkologie Karlsruhe
  • Klinikum der Universität München - Großhadern, Medizinische Klinik III
  • Universitaetsklinikum Tuebingen
  • Soroka Medical Center The Institute of Hematology
  • Davidoff Cancer Center The Institute of Hematology
  • Az. Osp. SS.Antonio e Biagio SC Ematologia
  • Ospedale Regionale di Bolzano - Divisione di Ematologia
  • Hematology Dept, Azienda Ospedaliero Universitaria Careggi
  • Azienda Ospedaliera Universitaria "San Martino"
  • Az. Osp. Ospedali Riuniti Papardo - Piemonte - S.C. Ematologia
  • Fondazione San Raffaele del Monte Tabor I.R.C.C.S.
  • A,O Ospedale Niguarda Ca Granda Dept Hematology
  • Istituto Nazionale Tumori Fondazione "G. Pascale" - Oncoematologia
  • Università del Piemonte Orientale "Amedeo Avogadro"
  • Policlinico San Matteo - Dip. Di Ematologia
  • Az. Osp. Bianchi Melacrino Morelli, Div. Di Ematologia
  • Università Cattolica del Sacro Cuore Policlinico A. Gemelli
  • IRCCS Casa Sollievo della Sofferenza Div. Di Oncoematologia
  • Azienda Sanitaria Ospedaliera San Giovanni Battista (Molinette)
  • Ospedale Cardinale G. Panico - Ematologia e Immunoematologia
  • Clinica Ematologica - DIRM Azienda Ospedaliera Universitaria
  • Małopolskie Centrum Medyczne
  • Wojewodzki Szpital Specjalistczny im. Mikolaja Kopernika
  • Dolnoslaskie Centrum Transplantacji Komórkowych
  • Serviço de Hematologia
  • Instituto Português de Oncologia (IPO) de Lisboa
  • Instituto Português de Oncologia (IPO) do Porto
  • Centro de Cancer, Hospital Espanol Auxilio de Puerto Rico
  • Sverdlovsk Regional Clinical Hospital - Volgogradskaya
  • Republican Clinical Oncological Dispensary
  • Russian Oncological Research Centre
  • Perm Regional Clinical Hospital
  • Russian Scientific-research Institute of Hematology and Transfusiology of Federal Medical-biological agency
  • State Educational Institution of High Professional Education
  • Federal Center of Heart, Blood and Endocrinology n.a. V.A. Almazov Rosmedtechnologies
  • State Healthcare Institution "Volgograd Regional Clinical OncologyDispensary #1
  • Hospital Universitario Vall d´Hebrón Hematology Department
  • Hospital de Madrid Norte- Sanchinarro
  • Hospital Costa del Sol, Oncology
  • C. H. de Orense
  • Clinica Universitaria de Navarra, Hematology
  • Hospital Clínico Universitario de Salamanca
  • Hospital Marques de Valdecilla
  • Kent and Canterbury Hospital
  • Torbay Hospital
  • Royal Devon & Exeter Hospital
  • Beatson West of Scotland Cancer Centre
  • Barts & The London NHS Trust Medical Oncology
  • Derriford Hospital
  • Salisbury NHS Foundation Trust, Haematology
  • St Helens Hospital, Lilac Lower Ground

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Lenalidomide

Placebo

Arm Description

Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.

Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS)
PFS is defined as the time from randomization into the study to the first observation of disease progression or death due to any cause. Progression, as defined by the 2007 Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), is any new lesion or increase by 50% of previously involved sites from nadir. Study terminated prematurely. Analysis not conducted.

Secondary Outcome Measures

Overall Survival
Overall survival was defined as the time from randomization to death from any cause. Study terminated prematurely. Analysis not conducted.
Participants With Treatment Emergent Adverse Events (TEAEs)
Participants with treatment-emergent adverse events (TEAEs) during the treatment period plus 30 days. A participant with multiple occurrences of an adverse event within a category is counted only once in that category. Adverse events were evaluated by the investigator. The National Cancer Institute (NCI)'s Common Toxicity Criteria for AEs (NCI CTC) was used to grade AE severity. Severity grade 3= severe and undesirable AE. Severity grade 4= life-threatening or disabling AE.
Time to Progression
Time to progression was defined as the time from the date of randomization until the first date of documented disease progression. Study terminated prematurely. Analysis not conducted.
Time to Treatment Failure
Time to treatment failure was defined as the time from randomization until the date at which a participant was removed from treatment due to progression, toxicity, refusal or death or received another Non-Hodgkin Lymphoma (NHL) therapy, whichever occurs first.
Participants With a Tumor Response
Number of participants with a measurable tumor at time of randomization who achieve a response. Complete response (CR) is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms if present before therapy. Partial response (PR) is defined as the regression of measurable disease and no appearance of new sites of disease. For full definitions, please refer to the 2007 Revised Response Criteria for Malignant Lymphoma (Cheson 2007). Study terminated prematurely. Analysis not conducted.

Full Information

First Posted
November 25, 2009
Last Updated
November 6, 2019
Sponsor
Celgene
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1. Study Identification

Unique Protocol Identification Number
NCT01021423
Brief Title
A Study to Evaluate the Efficacy of Lenalidomide as Maintenance Therapy After Completion of First-line Combination Chemotherapy in Patients With Mantle Cell Lymphoma (MCL).
Acronym
RENEW
Official Title
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-Controlled, First Line Maintenance Study Of Lenalidomide (Revlimid®) In Patients With Mantle-Cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Terminated
Why Stopped
Terminated by sponsor due to new unpublished data that rendered the current design of the study no longer clinically relevant. There were no safety concerns.
Study Start Date
April 1, 2010 (Actual)
Primary Completion Date
March 1, 2011 (Actual)
Study Completion Date
March 1, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A study to evaluate the efficacy of lenalidomide as maintenance therapy after completion of first-line combination chemotherapy in patients with mantle cell lymphoma (MCL) who are not candidates for transplantation and have achieved partial response (PR) or complete response (CR). This study was prematurely terminated by the sponsor in light of new unpublished data that rendered the current design of the study no longer clinically relevant. A study design with the control arm of no active treatment was no longer appropriate. The termination of the trial was not based on any safety concerns in the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mantle Cell Lymphoma, Non-Hodgkin's Lymphoma
Keywords
Mantle Cell Lymphoma, Non-Hodgkin's Lymphoma, CC-5013, Revlimid, Lenalidomide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lenalidomide
Arm Type
Experimental
Arm Description
Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Other Intervention Name(s)
Revlimid
Intervention Description
15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
PFS is defined as the time from randomization into the study to the first observation of disease progression or death due to any cause. Progression, as defined by the 2007 Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), is any new lesion or increase by 50% of previously involved sites from nadir. Study terminated prematurely. Analysis not conducted.
Time Frame
up to 7 years
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Overall survival was defined as the time from randomization to death from any cause. Study terminated prematurely. Analysis not conducted.
Time Frame
up to 7 years
Title
Participants With Treatment Emergent Adverse Events (TEAEs)
Description
Participants with treatment-emergent adverse events (TEAEs) during the treatment period plus 30 days. A participant with multiple occurrences of an adverse event within a category is counted only once in that category. Adverse events were evaluated by the investigator. The National Cancer Institute (NCI)'s Common Toxicity Criteria for AEs (NCI CTC) was used to grade AE severity. Severity grade 3= severe and undesirable AE. Severity grade 4= life-threatening or disabling AE.
Time Frame
up to 9 months
Title
Time to Progression
Description
Time to progression was defined as the time from the date of randomization until the first date of documented disease progression. Study terminated prematurely. Analysis not conducted.
Time Frame
up to 7 years
Title
Time to Treatment Failure
Description
Time to treatment failure was defined as the time from randomization until the date at which a participant was removed from treatment due to progression, toxicity, refusal or death or received another Non-Hodgkin Lymphoma (NHL) therapy, whichever occurs first.
Time Frame
up to 2 years
Title
Participants With a Tumor Response
Description
Number of participants with a measurable tumor at time of randomization who achieve a response. Complete response (CR) is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms if present before therapy. Partial response (PR) is defined as the regression of measurable disease and no appearance of new sites of disease. For full definitions, please refer to the 2007 Revised Response Criteria for Malignant Lymphoma (Cheson 2007). Study terminated prematurely. Analysis not conducted.
Time Frame
up to 7 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically-proven mantle cell non-Hodgkin's lymphoma, One of the following first-line induction chemotherapy regimens with rituximab: (1) combination regimen containing all of the following components: cyclophosphamide, vincristine, adriamycin and a glucocorticoid; (2) Fludarabine containing regimen such as FC (fludarabine, cyclophosphamide) Achieved a PR or better response after the first-line induction chemotherapy regimen (assessed by 2007 Revised Response Criteria for Malignant Lymphoma) ECOG performance status score of ≤ 2 Willing to follow pregnancy precaution Exclusion Criteria: Patients who have received more than 1 line of induction chemotherapy; Patients who have received less than 4 cycles of R-CHOP, R-CHOP-like, or R-FC are ineligible; Patients who achieved stable disease or progressive disease as best response with first line-induction chemotherapy; Any of the following laboratory abnormalities: Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5*10^9/L) Platelet count < 60,000/mm^3 (60*10^9/L) Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT)) > 3.0 times upper limit of normal (ULN), except in patients with documented liver involvement by lymphoma Serum bilirubin > 1.5 times ULN, except in case of Gilbert's Syndrome and documented liver involvement by lymphoma Calculated creatinine clearance (i.e. Cockcroft-Gault formula) of < 30 mL /min Active or any history of central nervous system (CNS) lymphoma or leptomeningeal involvement by lymphoma Subjects at high risk for deep vein thrombosis (DVT) not willing to take DVT prophylaxis Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Dreyling, Prof. Dr
Organizational Affiliation
Medizinische Klinik III der Universität München
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sharp Healthcare Oncology Associates of San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Rocky Mountain Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Indiana University Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Providence Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
97213
Country
United States
Facility Name
Nebraska Hematology-Oncology, PC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Arena Oncology Associates
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Weill Cornell Medical College/New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Avera Cancer Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
University of Virginia Health Systems
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Fakultni nemocnice Hradec Králové II. Interni klinika-Oddeleni klinicke hematologie
City
Hradec Králové
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Fakultni Nemocnice Olomouc, Hemato-Onkologicka Klinika
City
Olomouc
ZIP/Postal Code
77520
Country
Czechia
Facility Name
Clinic of Oncology Faculty Hospital Motol
City
Prague 5
Country
Czechia
Facility Name
Fakultni Nemocnice Kralovske Vinohrady
City
Praha 10
ZIP/Postal Code
10034
Country
Czechia
Facility Name
Vseobecna Fakultni Nemocnice
City
Praha 2
ZIP/Postal Code
12808
Country
Czechia
Facility Name
CHU Amiens Sud, Centre de Recherche Clinique - Pharmacologie Clinique
City
Amiens Cedex
ZIP/Postal Code
80054
Country
France
Facility Name
CHU Hôpital Hotel Dieu
City
Angers
ZIP/Postal Code
49000
Country
France
Facility Name
CHU ESTAING, Service d'Hématologie
City
Clermont Ferrand Cedex 1
ZIP/Postal Code
63003
Country
France
Facility Name
Hôpital Henri Mondor Unité Hémopathies Lymphoides
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
CHD Les Oudairies, Service d'Oncologie Hématologie
City
La Roche sur Yon
ZIP/Postal Code
85000
Country
France
Facility Name
Centre Hospitalier Lyon Sud, Pavillon Marcel Bérard 1F Hématologie
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
CHRU - Hôpital Claude Huriez
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
CHU Montpellier - Hôpital Saint Eloi Hématologie et Oncologie Médicale
City
Montpellier cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
CHRU - Hotel Dieu
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
Hôpital Saint-Louis
City
Paris Cedex 10
ZIP/Postal Code
75475
Country
France
Facility Name
CHRU - Hôpital du Haut Lévêque, maladies du sang, Centre François Magendie
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Centre Hospitalier Lyon Sud, Pavillon Marcel Bérard 1F Hématologie
City
Pierre Bénite Cedex
ZIP/Postal Code
69495
Country
France
Facility Name
CHU de Poitiers, Pôle Régional de Cancérologie, Service d'Oncologie Hématologie et Thérapie Cellulaire
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
CHU de Reims, Hôpital Robert Debré, Hématologie Clinique
City
Reims Cedex
ZIP/Postal Code
51092
Country
France
Facility Name
Hôpital Pontchaillou Hématologie Clinique
City
Rennes Cedex
ZIP/Postal Code
35033
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen Cedex 1
ZIP/Postal Code
76038
Country
France
Facility Name
Hôpital Purpan CHU de Toulouse
City
Toulouse cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Hôpital Bretonneau - CHU Tours
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
CHU de Nancy Hôpital de Brabois, Service d'Hématologie et Médecine Interne
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Universitätsklinikum Essen Zentrum für Innere Medizin
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Universitätsklinikum Freiburg - Medizinische Klinik - Abteilung Innere Medizin I: Hämatologie und Onkologie
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
UKG Universitätsklinikum Göttingen Zentrum Innere Medizin Hämatologie / Onkologie
City
Göttingen
ZIP/Postal Code
37099
Country
Germany
Facility Name
Asklepios Klinik St. Georg - Abteilung für Hämatologie und Stammzelltransplantation
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
Städtisches Klinikum Karlsruhe - Hämatologie / Onkologie Karlsruhe
City
Karlsruhe
ZIP/Postal Code
76135
Country
Germany
Facility Name
Klinikum der Universität München - Großhadern, Medizinische Klinik III
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Soroka Medical Center The Institute of Hematology
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Davidoff Cancer Center The Institute of Hematology
City
Petah Tiqwa
ZIP/Postal Code
49100
Country
Israel
Facility Name
Az. Osp. SS.Antonio e Biagio SC Ematologia
City
Alessandria
ZIP/Postal Code
15121
Country
Italy
Facility Name
Ospedale Regionale di Bolzano - Divisione di Ematologia
City
Bolzano
ZIP/Postal Code
39100
Country
Italy
Facility Name
Hematology Dept, Azienda Ospedaliero Universitaria Careggi
City
Florence
ZIP/Postal Code
50139
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria "San Martino"
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Az. Osp. Ospedali Riuniti Papardo - Piemonte - S.C. Ematologia
City
Messina
ZIP/Postal Code
98158
Country
Italy
Facility Name
Fondazione San Raffaele del Monte Tabor I.R.C.C.S.
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
A,O Ospedale Niguarda Ca Granda Dept Hematology
City
Milan
ZIP/Postal Code
20162
Country
Italy
Facility Name
Istituto Nazionale Tumori Fondazione "G. Pascale" - Oncoematologia
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Università del Piemonte Orientale "Amedeo Avogadro"
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Name
Policlinico San Matteo - Dip. Di Ematologia
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Az. Osp. Bianchi Melacrino Morelli, Div. Di Ematologia
City
Reggio Calabria
ZIP/Postal Code
89100
Country
Italy
Facility Name
Università Cattolica del Sacro Cuore Policlinico A. Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
IRCCS Casa Sollievo della Sofferenza Div. Di Oncoematologia
City
S.Giovanni Rotondo (FG)
ZIP/Postal Code
71013
Country
Italy
Facility Name
Azienda Sanitaria Ospedaliera San Giovanni Battista (Molinette)
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Ospedale Cardinale G. Panico - Ematologia e Immunoematologia
City
Tricase
ZIP/Postal Code
73039
Country
Italy
Facility Name
Clinica Ematologica - DIRM Azienda Ospedaliera Universitaria
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Małopolskie Centrum Medyczne
City
Krakow
ZIP/Postal Code
30-510
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistczny im. Mikolaja Kopernika
City
Lodz
ZIP/Postal Code
93510
Country
Poland
Facility Name
Dolnoslaskie Centrum Transplantacji Komórkowych
City
Wroclaw
ZIP/Postal Code
53439
Country
Poland
Facility Name
Serviço de Hematologia
City
Coimbra
ZIP/Postal Code
300-075
Country
Portugal
Facility Name
Instituto Português de Oncologia (IPO) de Lisboa
City
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
Facility Name
Instituto Português de Oncologia (IPO) do Porto
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Centro de Cancer, Hospital Espanol Auxilio de Puerto Rico
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
Facility Name
Sverdlovsk Regional Clinical Hospital - Volgogradskaya
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
Republican Clinical Oncological Dispensary
City
Kazan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Russian Oncological Research Centre
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Perm Regional Clinical Hospital
City
Perm
ZIP/Postal Code
614600
Country
Russian Federation
Facility Name
Russian Scientific-research Institute of Hematology and Transfusiology of Federal Medical-biological agency
City
St. Petersburg
ZIP/Postal Code
191024
Country
Russian Federation
Facility Name
State Educational Institution of High Professional Education
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Federal Center of Heart, Blood and Endocrinology n.a. V.A. Almazov Rosmedtechnologies
City
St. Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
State Healthcare Institution "Volgograd Regional Clinical OncologyDispensary #1
City
Volgograd
ZIP/Postal Code
400138
Country
Russian Federation
Facility Name
Hospital Universitario Vall d´Hebrón Hematology Department
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital de Madrid Norte- Sanchinarro
City
Madrid
Country
Spain
Facility Name
Hospital Costa del Sol, Oncology
City
Marbella (Málaga)
ZIP/Postal Code
29600
Country
Spain
Facility Name
C. H. de Orense
City
Ourense
Country
Spain
Facility Name
Clinica Universitaria de Navarra, Hematology
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Clínico Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Kent and Canterbury Hospital
City
Canterbury, Kent
ZIP/Postal Code
CT1 3NG
Country
United Kingdom
Facility Name
Torbay Hospital
City
County Of Devon
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom
Facility Name
Royal Devon & Exeter Hospital
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
ZIP/Postal Code
G12 OXL
Country
United Kingdom
Facility Name
Barts & The London NHS Trust Medical Oncology
City
London
ZIP/Postal Code
EC1M 6BQ
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Salisbury NHS Foundation Trust, Haematology
City
Salisbury
ZIP/Postal Code
SP2 8BJ
Country
United Kingdom
Facility Name
St Helens Hospital, Lilac Lower Ground
City
St. Helens
ZIP/Postal Code
WA9 3DA
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23834234
Citation
Vose JM, Habermann TM, Czuczman MS, Zinzani PL, Reeder CB, Tuscano JM, Lossos IS, Li J, Pietronigro D, Witzig TE. Single-agent lenalidomide is active in patients with relapsed or refractory aggressive non-Hodgkin lymphoma who received prior stem cell transplantation. Br J Haematol. 2013 Sep;162(5):639-47. doi: 10.1111/bjh.12449. Epub 2013 Jul 9.
Results Reference
derived

Learn more about this trial

A Study to Evaluate the Efficacy of Lenalidomide as Maintenance Therapy After Completion of First-line Combination Chemotherapy in Patients With Mantle Cell Lymphoma (MCL).

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