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Study of Lenalidomide to Evaluate Safety and Effectiveness in Patients With Diffuse Large B-Cell Lymphoma (DLBCL)

Primary Purpose

Diffuse Large B-cell Lymphoma

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Lenalidomide

Gemcitabine

Oxaliplatin

Rituximab

Etoposide

About this trial

This is an interventional treatment trial for Diffuse Large B-cell Lymphoma focused on measuring Diffuse Large B-Cell Lymphoma, Non Hodgkin's Lymphoma, relapsed, refractory, relapsed/refractory, DLBCL, Diffuse Large B Cell Lymphoma

Eligibility Criteria

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

Inclusion Criteria:

Histologically proven Diffuse Large B-Cell Lymphoma (DLBCL).
Relapsed or refractory to combination chemotherapy for DLBCL that contains rituximab and an anthracycline, and one additional combination chemotherapy or stem cell transplant.
Measurable DLBCL disease by computed tomograph (CT) / magnetic resonance imagining (MRI).
Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.

Exclusion Criteria:

Diagnosis of lymphoma histologies other than DLBCL.
History of malignancies, other than DLBCL, unless the patient has been disease free for 3 years or more.
Eligible for autologous stem cell transplant.
Known seropositive for, or history of, active human immunodeficiency virus (HIV) hepatitis B virus (HBV), hepatitis C virus (HCV)
Neuropathy grade 4.

Sites / Locations

Providence St Joseph Medical Center/Cancer Center
MD Anderson Cancer Center Orlando
Emory University
Northwestern University
Rush University Medical Center
Center for Cancer and Blood Disorders
University of Michigan, Comprehensive Cancer Center
Hattiesburg Clinic
Washington University Siteman Cancer Center
Roswell Park Cancer Institute
Avera Cancer Institute
Vanderbilt-Ingram Cancer Center
MD Anderson Houston
Royal Adelaide Hospital
Royal Brisbaine and Womens Hospital
Princess Alexandra Hospital
Innsbruck University Hospital
Universitätsklinikum Salzburg
Medical University of Vienna
University Hospital Hradec Kralove
Charles University
ICH CHU Brest- C.H.U. MORAVAN
CHU de Grenoble-Hopital Albert Michallon
Chd -Vendee
Centre Hospitalier Lyon Sud
Institute Paoli-Calmette
Hotel Dieu
Hôpital Saint Jean
CHRU-Hopital du Haut -Leveque
CHU de Rennes Hopital de Pontchaillou
University Hospital OF Toulouse Purpan
Hopital de Brabois Adultes
Istituto di Ematologica Istituto di Ematologica " L.e. A. Seragnoli' Azienda Ospedaliera Universitaria Policlinico
Azienda Ospedaliera Universitaria Careggi
Clinica Ematologica, A.O.U. San Martino di Genova
IEO istituto Europeo di Oncologia
Universita Federico II di Napoli Nuovo Policlinico
Fondazione IRCCS Policlinico San Matteo
Irccs/Crob
Policlinico Tor Vergata (Universta Tor Vergata)
Azienda Ospedaliera di Perugai Ospedale S. Maria della Miseri
Hospital Universitari Vll D' Hebron
Hospital Universitario Reina Sofia
Hospital Costa Del Sol
CH de Orense
Complejo Hospitalario de Navarra
Hosptial Clinico Universitario de Salamanca
Onkologiska kliniken
Akademiska Sjukhuset
Royal Bournemouth Hospital Haematology
Royal Devon and Exeter Hospital Haematology Department
St. James Institute of Oncology
Royal Mardsen Hospital - Fulham (Satellite Site)
The Christie Foundation Trust, I'st Floor, Haemotology Oncology Outpatients, Lymphoma Team
Derrford Hospital
Southhampton University Hospital NHS Trust
Royal Mardsen NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lenalidomide

Investigators Choice

Arm Description

Lenalidomide 25 mg capsules by mouth on days 1-21 of each 28 day cycle. For patients with Creatinine Clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10 mg (max escalation is 15 mg).

One of the following: Gemcitabine, Oxaliplatin, Rituximab, or Etoposide

Outcomes

Primary Outcome Measures

Stage 1: Percentage of Participants With an Overall Response According to the International Working Group (IWG) Response Criteria for Non Hodgkin's Lymphoma (NHL), Cheson 1999 and Evaluated by the Independent Response Adjudication Committee (IRAC)

An overall response is a complete response (CR), unconfirmed complete response (CRu) or partial response (PR) and was evaluated by the IRAC. A CR = complete disappearance of disease and related symptoms. Lymph nodes and nodal masses regressed on computed tomography to normal size (≤ 1.5 cm in their greatest transverse diameter for nodes > 1.5 cm prior to therapy and ≤ 1.0 cm in their short axis for nodes 1.1-1.5 cm in their long axis and > 1.0 cm in their short axis prior to therapy). Spleen and/or liver not palpable on exam, normal size by imaging, and absence of nodules related to lymphoma. If bone marrow was involved prior to therapy, infiltrate must have cleared on repeat biopsy. PR = ≥ 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. No increase in other nodes, liver, or spleen. Splenic and hepatic nodules regressed by ≥ 50% in their SPD or for single nodules, in the greatest transverse diameter;no new disease.

Stage 1: Percentage of Participants With an Overall Response According to the IWG Response Criteria Based on the Investigators Assessment at the Final Data Cut During the Core Treatment Phase

Response was defined as having a CR, CRu or PR, based on IWG 1999 Response Criteria for NHL as evaluated by the investigators. CR = complete disappearance of disease and disease related symptoms. All lymph nodes and nodal masses regressed on computed tomography to normal size (≤ 1.5 cm in their greatest transverse diameter for nodes > 1.5 cm prior to therapy and ≤ 1.0 cm in their short axis for nodes 1.1-1.5 cm in their long axis and > 1.0 cm in their short axis prior to therapy). Spleen and/or liver not palpable on physical exam, normal size by imaging, and absence of nodules related to lymphoma. If BM was involved prior to therapy, infiltrate must have cleared on repeat biopsy. PR = ≥ 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. No increase in the other nodes, liver, or spleen. Splenic and hepatic nodules regressed by ≥ 50% in their SPD or, for single nodules, in the greatest transverse diameter. No new disease.

Secondary Outcome Measures

Number of Participants With Treatment Emergent Events (TEAEs) in the Overall Treatment Phase by Initial Treatment Assignment

A TEAE was defined as an AE that begins or worsens in intensity of frequency on or after the first dose of study drug through 28 days after last dose of study drug. A serious adverse event (SAE) is any: Death; Life-threatening event; Any inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant disability or incapacity; Congenital anomaly or birth defect; Any other important medical event The investigator determined the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the event.The severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 4.03) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death

Stage 2: Overall Response Rate (ORR)

ORR is defined as: Complete Response + Complete Response unconfirmed + Partial Response based on the International Lymphoma Workshop Response Criteria [IWRC] (Cheson 1999).

Stage 2: Duration of Response (DoR)

Length of time of overall response (Complete Response + Complete Response unconfirmed + Partial Response) based on the International Lymphoma Workshop Response Criteria [IWRC] (Cheson 1999).

Stage 2: Overall Survival (OS)

Overall survival was defined as time from randomization until death of any cause.

Stage 2: Duration of Complete Response

Length of time of complete response (Complete Response + Complete Response unconfirmed) based on the International Lymphoma Workshop Response Criteria [IWRC] (Cheson 1999).

Stage 2: Overall Response Rate for With a Duration of Response Lasting ≥ 16 Weeks

Complete Response + Complete Response unconfirmed + Partial Response for participants with a duration of response lasting ≥ 16 weeks based on the International Lymphoma Workshop Response Criteria [IWRC] (Cheson 1999).

Stage 2: Time to Progression

Length of time until disease progression occurs

Stage 2: Health Related Quality of Life Questionnaires

Quality of Life based on the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and the EQ-5D assessments

Full Information

NCT ID

NCT01197560

First Posted

July 29, 2010

Last Updated

November 13, 2019

Sponsor

Celgene

1. Study Identification

Unique Protocol Identification Number

NCT01197560

Brief Title

Study of Lenalidomide to Evaluate Safety and Effectiveness in Patients With Diffuse Large B-Cell Lymphoma (DLBCL)

Official Title

A Phase 2/3, Multicenter, Randomized, Open-label Study to Compare the Efficacy and Safety of Lenalidomide (Revlimid ®) Versus Investigator's Choice in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

September 2, 2010 (Actual)

Primary Completion Date

July 4, 2013 (Actual)

Study Completion Date

April 5, 2018 (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

The purpose of this study is to compare lenalidomide to a control drug and see which one delays Diffuse Large B-Cell Lymphoma (DLBCL) disease progression longer.

Detailed Description

This research study is for patients who have been diagnosed with Diffuse Large B-cell Lymphoma (DLBCL) that did not respond to (refractory) or that has come back after chemotherapy treatment (relapsed). Lymphoma is a cancer of a type of blood cell called lymphocytes. DLBCL is just one type of lymphoma. Within DLBCL there are two different subtypes called Germinal Center B-cell (GCB) and non-GCB which can be determined by cell surface marker tests or by gene expression tests. Scientists can look at cells and genes in the laboratory and see that the two kinds are different, but they don't know yet what the difference means. To patients and doctors these two kinds seem the same. Right now doctors don't usually do tests to find out which kind a patient has because the treatment is the same for both. This study will have two stages, 1 and 2. The main purpose of Stage 1 is to separate patients by subtype and then test whether patients taking lenalidomide or any one of four other drugs have a better response. It is possible that lenalidomide will work better than one of the other drugs in zero, one, or both subtypes. Stage 2 will further test only the subtype(s) from Stage 1 that showed a good response to lenalidomide. The main purpose of Stage 2 is to test how long patients are disease free on lenalidomide compared to one of the four other drugs. On 29 January 2013 the enrolment goal for the Stage 1 portion of the study was met and enrollment was stopped. The final analysis for Stage 1 was performed as of the 04 Jul 2013 data cutoff date. According to the Stage 1 results as assessed by the independent response adjudication committee (IRAC), neither subtype met the pre specified requirement to be further studied in Stage 2. Additionally, a suitable assay for the selection of participants for the Stage 2 study was not available. Therefore, on 6 January 2014, Celgene decided to not open Stage 2.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diffuse Large B-cell Lymphoma

Keywords

Diffuse Large B-Cell Lymphoma, Non Hodgkin's Lymphoma, relapsed, refractory, relapsed/refractory, DLBCL, Diffuse Large B Cell Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

111 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lenalidomide

Arm Type

Experimental

Arm Description

Lenalidomide 25 mg capsules by mouth on days 1-21 of each 28 day cycle. For patients with Creatinine Clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10 mg (max escalation is 15 mg).

Arm Title

Investigators Choice

Arm Type

Active Comparator

Arm Description

One of the following: Gemcitabine, Oxaliplatin, Rituximab, or Etoposide

Intervention Type

Drug

Intervention Name(s)

Lenalidomide

Intervention Description

Lenalidomide 25 mg orally for 21/28 days until Diffuse Large B-Cell Lymphoma (DLBCL) progressive disease. For patients with Creatinine Clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10 mg (max escalation is 15 mg).

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Intervention Description

Suggested starting doses and regimens for Gemcitabine is 1,250 mg/m^2 intravenous (IV) administration on days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 every 28 days for 6 Cycles

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin

Intervention Description

Suggested starting dose and regimen for Oxaliplatin is 100 mg/m^2 IV day 1 for 21 days for 6 Cycles

Intervention Type

Drug

Intervention Name(s)

Rituximab

Intervention Description

Suggested starting dose for Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)

Intervention Type

Drug

Intervention Name(s)

Etoposide

Intervention Description

Suggested starting doses for Etoposide are: 100 mg/m^2 IV days 1-5 every 28 days for 6 Cycles, or 100 mg/m^2 IV days 1-3 every 28 days for 6 Cycles, or 50 mg/m^2 oral days 1-21 every 28 days for 6 Cycles, or 50 mg/m^2 oral days 1-14 every 28 days for 6 Cycles, or 50 mg/m^2 oral days 1-10 every 28 days for 6 Cycles

Primary Outcome Measure Information:

Title

Description

Time Frame

From the date of randomization to the data cut-off of 4 July 2013; when all patients reached the scheduled 16-week assessment or had progressed/died before the scheduled 16-week assessment); the median study duration was 27.0 and 19.7 weeks, respectively.

Title

Stage 1: Percentage of Participants With an Overall Response According to the IWG Response Criteria Based on the Investigators Assessment at the Final Data Cut During the Core Treatment Phase

Description

Time Frame

From the date of randomization to the final data cut-off date of 18 May 2018; median study duration was 27.0 and 19.7 weeks, respectively.

Secondary Outcome Measure Information:

Title

Number of Participants With Treatment Emergent Events (TEAEs) in the Overall Treatment Phase by Initial Treatment Assignment

Description

Time Frame

From first dose of study drug to the final data cut-off date of 18 May 2018; median study duration was 27.0 and 19.7 weeks, respectively.

Title

Stage 2: Overall Response Rate (ORR)

Description

ORR is defined as: Complete Response + Complete Response unconfirmed + Partial Response based on the International Lymphoma Workshop Response Criteria [IWRC] (Cheson 1999).

Time Frame

Approximately 3.5 years

Title

Stage 2: Duration of Response (DoR)

Description

Length of time of overall response (Complete Response + Complete Response unconfirmed + Partial Response) based on the International Lymphoma Workshop Response Criteria [IWRC] (Cheson 1999).

Time Frame

Approximately 3.5 years

Title

Stage 2: Overall Survival (OS)

Description

Overall survival was defined as time from randomization until death of any cause.

Time Frame

Approximately 3.5 years

Title

Stage 2: Duration of Complete Response

Description

Length of time of complete response (Complete Response + Complete Response unconfirmed) based on the International Lymphoma Workshop Response Criteria [IWRC] (Cheson 1999).

Time Frame

Approximately 3.5 years

Title

Stage 2: Overall Response Rate for With a Duration of Response Lasting ≥ 16 Weeks

Description

Time Frame

Approximately 3.5 years

Title

Stage 2: Time to Progression

Description

Length of time until disease progression occurs

Time Frame

Approximately 3.5 years

Title

Stage 2: Health Related Quality of Life Questionnaires

Description

Quality of Life based on the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and the EQ-5D assessments

Time Frame

Approximately 3.5 years

Other Pre-specified Outcome Measures:

Title

Stage 1: Percentage of Participants With a Durable Overall Response (dORR) According to the IWG Response Criteria as Assessed by the Investigators at the Final Data Cut During the Core Treatment Phase

Description

Durable overall response rate was defined as the percentage of participants who maintained a response for at least 16 weeks after initial response.

Time Frame

From the date of randomization to the final data cut-off date of 18 May 2018; median study duration was 27.0 and 19.7 weeks, respectively.

Title

Stage 1: Percentage of Participants With a Complete Response According to the IWG Response Criteria as Assessed by the Investigators at the Final Data Cut During the Core Treatment Phase

Description

A complete response was defined as participants with a complete response (CR), or unconfirmed complete response (CRu) based on IWG 1999 Response Criteria for NHL as assessed by the investigator. A CR is a complete disappearance of all disease with the exception of nodes. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRu) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM.

Time Frame

From the date of randomization to the final data cut-off date of 18 May 2018; median study duration was 27.0 and 19.7 weeks, respectively.

Title

Stage 1: Kaplan Meier Estimates of Duration of Overall Response (DoR) as Assessed by the Investigators at the Final Data Cut During the Core Treatment Phase

Description

Duration of overall response was calculated as the time of initial response (CR+CRu+PR) until documented disease progression determinted by computerized scan CT scan or MRI or death due to lymphoma, whichever occurred earlier, for participants who responded.

Time Frame

From the date of randomization to the final data cut-off date of 18 May 2018; median study duration was 27.0 and 19.7 weeks, respectively.

Title

Stage 1: Kaplan Meier Estimates of Duration of Complete Response (DoCR) as Assessed by the Investigators at the Final Data Cut During the Core Treatment Phase

Description

Duration of complete response was defined as the time from the first documented complete response (CR + CRu) until the first disease progression or death for participants who had a CR.

Time Frame

From the date of randomization to the final data cut-off date of 18 May 2018; median study duration was 27.0 and 19.7 weeks, respectively.

Title

Stage 1: Kaplan Meier Estimates of Progression-Free Survival As Assessed By The Investigators At The Final Data Cut During The Core Treatment Phase

Description

Progression-free survival was defined as the time from randomization to the first documented disease progression or death due to any cause.

Time Frame

From the date of randomization to the final data cut-off date of 18 May 2018; median study duration was 27.0 and 19.7 weeks, respectively.

Title

Stage 1: Kaplan Meier Estimates of Overall Survival As Assessed by the Investigators at the Final Data Cut During The Core Treatment Phase

Description

Overall survival was defined as time from randomization until death of any cause.

Time Frame

From the date of randomization to the final data cut-off date of 18 May 2018; median study duration was 27.0 and 19.7 weeks, respectively.

Title

Stage 2: Progression-Free Survival

Description

Number of participants who survive without progressing based on the International Working Group Response Criteria [IWG].

Time Frame

Approximately 3.5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically proven Diffuse Large B-Cell Lymphoma (DLBCL). Relapsed or refractory to combination chemotherapy for DLBCL that contains rituximab and an anthracycline, and one additional combination chemotherapy or stem cell transplant. Measurable DLBCL disease by computed tomograph (CT) / magnetic resonance imagining (MRI). Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2. Exclusion Criteria: Diagnosis of lymphoma histologies other than DLBCL. History of malignancies, other than DLBCL, unless the patient has been disease free for 3 years or more. Eligible for autologous stem cell transplant. Known seropositive for, or history of, active human immunodeficiency virus (HIV) hepatitis B virus (HBV), hepatitis C virus (HCV) Neuropathy grade 4.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adrian Kilcoyne, MD

Organizational Affiliation

Celgene Corporation

Official's Role

Study Director

Facility Information:

Facility Name

Providence St Joseph Medical Center/Cancer Center

City

Burbank

State/Province

California

ZIP/Postal Code

91505

Country

United States

Facility Name

MD Anderson Cancer Center Orlando

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Emory University

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Northwestern University

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Rush University Medical Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

Center for Cancer and Blood Disorders

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20817

Country

United States

Facility Name

University of Michigan, Comprehensive Cancer Center

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48105

Country

United States

Facility Name

Hattiesburg Clinic

City

Hattiesburg

State/Province

Mississippi

ZIP/Postal Code

39402

Country

United States

Facility Name

Washington University Siteman Cancer Center

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Roswell Park Cancer Institute

City

Buffalo

State/Province

New York

ZIP/Postal Code

14263

Country

United States

Facility Name

Avera Cancer Institute

City

Sioux Falls

State/Province

South Dakota

ZIP/Postal Code

57105

Country

United States

Facility Name

Vanderbilt-Ingram Cancer Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Facility Name

MD Anderson Houston

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Royal Adelaide Hospital

City

Adelaide

ZIP/Postal Code

5000

Country

Australia

Facility Name

Royal Brisbaine and Womens Hospital

City

Herston

ZIP/Postal Code

4029

Country

Australia

Facility Name

Princess Alexandra Hospital

City

Woolloongabba

ZIP/Postal Code

4102

Country

Australia

Facility Name

Innsbruck University Hospital

City

Innsbruck

ZIP/Postal Code

A6020

Country

Austria

Facility Name

Universitätsklinikum Salzburg

City

Salzburg

ZIP/Postal Code

A-5020

Country

Austria

Facility Name

Medical University of Vienna

City

Vienna

ZIP/Postal Code

A-1090

Country

Austria

Facility Name

University Hospital Hradec Kralove

City

Hradec Kralove 5

ZIP/Postal Code

5005

Country

Czechia

Facility Name

Charles University

City

Praha

ZIP/Postal Code

12808

Country

Czechia

Facility Name

ICH CHU Brest- C.H.U. MORAVAN

City

Brest Cedex 2

ZIP/Postal Code

29609

Country

France

Facility Name

CHU de Grenoble-Hopital Albert Michallon

City

Grenoble

ZIP/Postal Code

38043

Country

France

Facility Name

Chd -Vendee

City

La Roche Sur Yon

ZIP/Postal Code

85205

Country

France

Facility Name

Centre Hospitalier Lyon Sud

City

Lyon

ZIP/Postal Code

69495

Country

France

Facility Name

Institute Paoli-Calmette

City

Marsielle

ZIP/Postal Code

13009

Country

France

Facility Name

Hotel Dieu

City

Nantes Cedex 1

ZIP/Postal Code

44903

Country

France

Facility Name

Hôpital Saint Jean

City

Perpignan

ZIP/Postal Code

66046

Country

France

Facility Name

CHRU-Hopital du Haut -Leveque

City

Pessac

ZIP/Postal Code

33604

Country

France

Facility Name

CHU de Rennes Hopital de Pontchaillou

City

Rennes

ZIP/Postal Code

35033

Country

France

Facility Name

University Hospital OF Toulouse Purpan

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

Hopital de Brabois Adultes

City

Vandoeuvre-les Nancy cedex

ZIP/Postal Code

54511

Country

France

Facility Name

Istituto di Ematologica Istituto di Ematologica " L.e. A. Seragnoli' Azienda Ospedaliera Universitaria Policlinico

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Azienda Ospedaliera Universitaria Careggi

City

Firenze

ZIP/Postal Code

50141

Country

Italy

Facility Name

Clinica Ematologica, A.O.U. San Martino di Genova

City

Genova

ZIP/Postal Code

16132

Country

Italy

Facility Name

IEO istituto Europeo di Oncologia

City

Miano

ZIP/Postal Code

201401

Country

Italy

Facility Name

Universita Federico II di Napoli Nuovo Policlinico

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Fondazione IRCCS Policlinico San Matteo

City

Pavia

ZIP/Postal Code

27100

Country

Italy

Facility Name

Irccs/Crob

City

Rionero In Vulture (PZ)

ZIP/Postal Code

85208

Country

Italy

Facility Name

Policlinico Tor Vergata (Universta Tor Vergata)

City

Roma

ZIP/Postal Code

00133

Country

Italy

Facility Name

Azienda Ospedaliera di Perugai Ospedale S. Maria della Miseri

City

Terni

ZIP/Postal Code

6156

Country

Italy

Facility Name

Hospital Universitari Vll D' Hebron

City

Barcelona

ZIP/Postal Code

8035

Country

Spain

Facility Name

Hospital Universitario Reina Sofia

City

Cordoba

ZIP/Postal Code

14004

Country

Spain

Facility Name

Hospital Costa Del Sol

City

Marbella

ZIP/Postal Code

29600

Country

Spain

Facility Name

CH de Orense

City

Ourense

ZIP/Postal Code

32005

Country

Spain

Facility Name

Complejo Hospitalario de Navarra

City

Pamplona

ZIP/Postal Code

31008

Country

Spain

Facility Name

Hosptial Clinico Universitario de Salamanca

City

Salamanca

ZIP/Postal Code

37007

Country

Spain

Facility Name

Onkologiska kliniken

City

Umea

ZIP/Postal Code

90185

Country

Sweden

Facility Name

Akademiska Sjukhuset

City

Uppsala

ZIP/Postal Code

75185

Country

Sweden

Facility Name

Royal Bournemouth Hospital Haematology

City

Bournemouth

ZIP/Postal Code

BH7 7DW

Country

United Kingdom

Facility Name

Royal Devon and Exeter Hospital Haematology Department

City

Exeter

ZIP/Postal Code

EX2 5DW

Country

United Kingdom

Facility Name

St. James Institute of Oncology

City

Leeds

ZIP/Postal Code

LS9 7TF

Country

United Kingdom

Facility Name

Royal Mardsen Hospital - Fulham (Satellite Site)

City

London

ZIP/Postal Code

SW3 6U

Country

United Kingdom

Facility Name

The Christie Foundation Trust, I'st Floor, Haemotology Oncology Outpatients, Lymphoma Team

City

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

Facility Name

Derrford Hospital

City

Plymouth

ZIP/Postal Code

PL6 8DH

Country

United Kingdom

Facility Name

Southhampton University Hospital NHS Trust

City

Southhampton

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

Facility Name

Royal Mardsen NHS Foundation Trust

City

Sutton

ZIP/Postal Code

SM2 SPT

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

28381416

Citation

Czuczman MS, Trneny M, Davies A, Rule S, Linton KM, Wagner-Johnston N, Gascoyne RD, Slack GW, Brousset P, Eberhard DA, Hernandez-Ilizaliturri FJ, Salles G, Witzig TE, Zinzani PL, Wright GW, Staudt LM, Yang Y, Williams PM, Lih CJ, Russo J, Thakurta A, Hagner P, Fustier P, Song D, Lewis ID. A Phase 2/3 Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Lenalidomide Versus Investigator's Choice in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma. Clin Cancer Res. 2017 Aug 1;23(15):4127-4137. doi: 10.1158/1078-0432.CCR-16-2818. Epub 2017 Apr 5.

Results Reference

result

PubMed Identifier

21495023

Citation

Hernandez-Ilizaliturri FJ, Deeb G, Zinzani PL, Pileri SA, Malik F, Macon WR, Goy A, Witzig TE, Czuczman MS. Higher response to lenalidomide in relapsed/refractory diffuse large B-cell lymphoma in nongerminal center B-cell-like than in germinal center B-cell-like phenotype. Cancer. 2011 Nov 15;117(22):5058-66. doi: 10.1002/cncr.26135. Epub 2011 Apr 14.

Results Reference

derived

Learn more about this trial

Study of Lenalidomide to Evaluate Safety and Effectiveness in Patients With Diffuse Large B-Cell Lymphoma (DLBCL)

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