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Study of Lenalidomide to Evaluate Safety and Efficacy in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Primary Purpose

Relapsed or Refractory Chronic Lymphocytic Leukemia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
lenalidomide
Sponsored by
Celgene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed or Refractory Chronic Lymphocytic Leukemia

Eligibility Criteria

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

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

Sites / Locations

  • UCSD Moores Cancer Center
  • Desert Hematology Oncology Medical Group, Inc.
  • Stanford University School of Medicine
  • Cancer Center of Central Connecticut
  • Cancer and Blood Disease Center
  • Northwestern University Medical Center Division of Hematology Oncology
  • Rush University Medical Center
  • Indiana University Cancer Center
  • Karmanos Cancer Institute
  • Hackensack University Medical Center
  • Roswell Park Cancer Institute
  • Long Island Jewish Medical Center CLL Research and Treatment Program
  • Wake Forest University School of Medicine
  • Gabrail Cancer Center Research
  • Cleveland Clinic Foundation
  • Drexel University, College of Medicine, Clinical Research Group
  • Cross Cancer Institute
  • Juravinski Cancer Centre
  • CHU Sud
  • Hopital Avicenne
  • CHU Grenoble
  • Clinique Victor Hugo
  • Institut Paoli Calmettes
  • CHU Montpellier - Hôpital Saint Eloi
  • Hopital Emile Muller
  • Hopital Pitie Salpetriere
  • CH Perpignan - Hopital Saint-Jean
  • CHRU - Hopital du Haut Leveque
  • Centre Hospitalier Lyon Sud
  • Hopital Robert Debre
  • CHU Rennes Hematology
  • CHRU Hopital Brabois
  • Charite -Universitätsmedizin Berlin
  • Universitatsklinikum Essen
  • Ernst-Moritz-Arndt-Universität Greifswald
  • Universitatsklinikum Schleswig Holstein
  • Klinikum der Universitat zu Koln
  • University of Ulm Abteilung Innere Medizin III
  • Azienda Ospedaliera Universitaria San Martino
  • Ematologia ed Immunologia, Azienda Ospedaliera "Vito Fazzi" di Lecce
  • I.R.C.C.S. Ospedale San Raffaele
  • Istituto Europeo di Oncologia - IEO
  • Universita degli Studi di Padova
  • Universita' Degli Studi Di Perugia
  • Hospital Clinic Provincial de Barcelona
  • Hospital Universitari Germans Trias i Pujol
  • Karolinska Universitetssjukhuset
  • St James's Institute of Oncology
  • St.Bartholomew's Hospital
  • King's College Hospital
  • The Royal Marsden Hospital
  • Christie Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Lenalidomide 5 mg

Lenalidomide 10 mg

Lenalidomide 15 mg

Arm Description

Participants received a starting dose of 5 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability. Participants continued receiving study drug until disease progression or unacceptable toxicity, unless they withdrew consent or had other reasons to discontinue from study drug

Participants received a starting dose of 10 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability. Participants continued receiving study drug until disease progression or unacceptable toxicity, unless they withdrew consent or had other reasons to discontinue from study drug

Participants received a starting dose of 15 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability. Participants continued receiving study drug until disease progression or unacceptable toxicity, unless they withdrew consent or had other reasons to discontinue from study drug

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-emergent Adverse Events
Adverse events (AEs) were graded for severity by the investigator according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 with the exceptions of hematologic toxicities and tumor lysis syndrome, according to the following scale: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life Threatening or disabling AE Grade 5 = Death The investigator determined the relationship of each AE to study drug based on the timing of the AE and whether other medications, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the observed event.

Secondary Outcome Measures

Overall Response Rate (ORR)
ORR was defined as the percentage of patients with a complete response (CR), CR with incomplete bone marrow (BM) recovery (CRi) or partial response (PR) during treatment. Response was assessed according to the 2008 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines. Per the guidelines, a CR required peripheral blood lymphocytes below 4 x 10^9/L, absence of lymphadenopathy, no hepatomegaly or splenomegaly, absence of disease and blood counts neutrophils >1.5 x 10^9/L, platelets >100 x 10^9/L, hemoglobin (hgb) >11g/dL) and BM at least normocellular for age. CRi = CR with incomplete BM recovery. PR = required at least 2 months from end of treatment, a ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value and either a ≥ 50% reduction in lymphadenopathy or ≥50% reduction of liver enlargement or ≥50% reduction of spleen enlargement plus neutrophils >1.5 x 10^9/ or ≥50% increase, platelets >100 x 10^9/L or ≥50% increase, hgb 11 g/dL.
Kaplan-Meier Estimate of Duration of Response
Duration of response (DOR) was defined as the time from the first visit where PR, CRi, or CR was documented to progressive disease (PD). Duration of response was censored at the last date that the participant was known to be progression-free for participants who had not progressed at the time of analysis or who withdrew consent or were lost to follow-up prior to documentation of progression.
Time to Response
Time to response (TTR) was calculated as the time from randomization to the first documented date of response (PR, CRi or CR) based on iwCLL guidelines for participants with an objective response during the treatment period.
Kaplan-Meier Estimate of Time to Progression
Time to progression (TTP) was defined as the time from randomization to the first documented progression. For participants who did not progress during the study, TTP was censored at the last adequate response assessment showing evidence of no disease progression.
Kaplan-Meier Estimate of Event-Free Survival
Event-free survival (EFS) is the interval between the start of treatment to the first sign of disease progression, or treatment for relapse or death (whichever occurred first). If withdrawal of consent or loss to follow-up occurred before documented progression or death, then these observations were censored at the date when the last complete tumor assessments determined a lack of progression.
Kaplan-Meier Estimate of Progression Free Survival
Progression-free survival (PFS) was calculated as the time from randomization to the first documented progression or death due to any cause during or after the treatment period, whichever occurred first. The progression date was assigned to the earliest time when any progression is observed without prior missing assessments. If withdrawal of consent or loss to follow-up occurred before documented progression or death, then these observations were censored at the date when the last complete tumor assessments determined a lack of progression.
Kaplan-Meier Estimate of Overall Survival
Overall survival (OS) was defined as the time from randomization to death from any cause. Overall survival was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who had withdrawn consent or were lost to follow-up before death was documented.

Full Information

First Posted
August 20, 2009
Last Updated
October 2, 2018
Sponsor
Celgene
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1. Study Identification

Unique Protocol Identification Number
NCT00963105
Brief Title
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

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 19, 2009 (Actual)
Primary Completion Date
September 5, 2017 (Actual)
Study Completion Date
September 5, 2017 (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 determine the safety and effectiveness of different dose regimens of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia (CLL).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed or Refractory Chronic Lymphocytic Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lenalidomide 5 mg
Arm Type
Experimental
Arm Description
Participants received a starting dose of 5 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability. Participants continued receiving study drug until disease progression or unacceptable toxicity, unless they withdrew consent or had other reasons to discontinue from study drug
Arm Title
Lenalidomide 10 mg
Arm Type
Experimental
Arm Description
Participants received a starting dose of 10 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability. Participants continued receiving study drug until disease progression or unacceptable toxicity, unless they withdrew consent or had other reasons to discontinue from study drug
Arm Title
Lenalidomide 15 mg
Arm Type
Experimental
Arm Description
Participants received a starting dose of 15 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability. Participants continued receiving study drug until disease progression or unacceptable toxicity, unless they withdrew consent or had other reasons to discontinue from study drug
Intervention Type
Drug
Intervention Name(s)
lenalidomide
Intervention Description
Depending on the starting dose, subjects will be allocated in a double-blind fashion to three different regimens and will escalate every 28 days, based on individual subject tolerability, as follows: Treatment Arm 1: 5 mg →10 mg →15 mg →20 mg →25 mg/daily Treatment Arm 2: 10 mg →15 mg →20 mg →25 mg/daily Treatment Arm 3: 15 mg →20 mg →25 mg/daily Subjects will continue treatment until disease progression or unacceptable toxicity
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-emergent Adverse Events
Description
Adverse events (AEs) were graded for severity by the investigator according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 with the exceptions of hematologic toxicities and tumor lysis syndrome, according to the following scale: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life Threatening or disabling AE Grade 5 = Death The investigator determined the relationship of each AE to study drug based on the timing of the AE and whether other medications, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the observed event.
Time Frame
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 Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
ORR was defined as the percentage of patients with a complete response (CR), CR with incomplete bone marrow (BM) recovery (CRi) or partial response (PR) during treatment. Response was assessed according to the 2008 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines. Per the guidelines, a CR required peripheral blood lymphocytes below 4 x 10^9/L, absence of lymphadenopathy, no hepatomegaly or splenomegaly, absence of disease and blood counts neutrophils >1.5 x 10^9/L, platelets >100 x 10^9/L, hemoglobin (hgb) >11g/dL) and BM at least normocellular for age. CRi = CR with incomplete BM recovery. PR = required at least 2 months from end of treatment, a ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value and either a ≥ 50% reduction in lymphadenopathy or ≥50% reduction of liver enlargement or ≥50% reduction of spleen enlargement plus neutrophils >1.5 x 10^9/ or ≥50% increase, platelets >100 x 10^9/L or ≥50% increase, hgb 11 g/dL.
Time Frame
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.
Title
Kaplan-Meier Estimate of Duration of Response
Description
Duration of response (DOR) was defined as the time from the first visit where PR, CRi, or CR was documented to progressive disease (PD). Duration of response was censored at the last date that the participant was known to be progression-free for participants who had not progressed at the time of analysis or who withdrew consent or were lost to follow-up prior to documentation of progression.
Time Frame
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.
Title
Time to Response
Description
Time to response (TTR) was calculated as the time from randomization to the first documented date of response (PR, CRi or CR) based on iwCLL guidelines for participants with an objective response during the treatment period.
Time Frame
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.
Title
Kaplan-Meier Estimate of Time to Progression
Description
Time to progression (TTP) was defined as the time from randomization to the first documented progression. For participants who did not progress during the study, TTP was censored at the last adequate response assessment showing evidence of no disease progression.
Time Frame
From randomization until the end of the study; maximum time on study was 91 months.
Title
Kaplan-Meier Estimate of Event-Free Survival
Description
Event-free survival (EFS) is the interval between the start of treatment to the first sign of disease progression, or treatment for relapse or death (whichever occurred first). If withdrawal of consent or loss to follow-up occurred before documented progression or death, then these observations were censored at the date when the last complete tumor assessments determined a lack of progression.
Time Frame
From randomization until the end of the study; maximum time on study was 91 months.
Title
Kaplan-Meier Estimate of Progression Free Survival
Description
Progression-free survival (PFS) was calculated as the time from randomization to the first documented progression or death due to any cause during or after the treatment period, whichever occurred first. The progression date was assigned to the earliest time when any progression is observed without prior missing assessments. If withdrawal of consent or loss to follow-up occurred before documented progression or death, then these observations were censored at the date when the last complete tumor assessments determined a lack of progression.
Time Frame
From randomization until the end of the study; maximum time on study was 91 months.
Title
Kaplan-Meier Estimate of Overall Survival
Description
Overall survival (OS) was defined as the time from randomization to death from any cause. Overall survival was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who had withdrawn consent or were lost to follow-up before death was documented.
Time Frame
From randomization until the end of the study; maximum time on study was 91 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffery Jones, M.D., MPH
Organizational Affiliation
Celgene Corporation
Official's Role
Study Director
Facility Information:
Facility Name
UCSD Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0820
Country
United States
Facility Name
Desert Hematology Oncology Medical Group, Inc.
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5821
Country
United States
Facility Name
Cancer Center of Central Connecticut
City
Southington
State/Province
Connecticut
ZIP/Postal Code
06489
Country
United States
Facility Name
Cancer and Blood Disease Center
City
Lecanto
State/Province
Florida
ZIP/Postal Code
34461
Country
United States
Facility Name
Northwestern University Medical Center Division of Hematology Oncology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-2927
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 Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5149
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Long Island Jewish Medical Center CLL Research and Treatment Program
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Wake Forest University School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27104
Country
United States
Facility Name
Gabrail Cancer Center Research
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Drexel University, College of Medicine, Clinical Research Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
CHU Sud
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Hopital Avicenne
City
Bobigny Cedex
ZIP/Postal Code
93009
Country
France
Facility Name
CHU Grenoble
City
Grenoble Cedex 09
ZIP/Postal Code
38043
Country
France
Facility Name
Clinique Victor Hugo
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
Institut Paoli Calmettes
City
Marseille Cedex 9
ZIP/Postal Code
13273
Country
France
Facility Name
CHU Montpellier - Hôpital Saint Eloi
City
Montpellier Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Hopital Emile Muller
City
Mulhouse
ZIP/Postal Code
68000
Country
France
Facility Name
Hopital Pitie Salpetriere
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
CH Perpignan - Hopital 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
Centre Hospitalier Lyon Sud
City
Pierre Bénite
ZIP/Postal Code
69310
Country
France
Facility Name
Hopital Robert Debre
City
REIMS cedex
ZIP/Postal Code
51092
Country
France
Facility Name
CHU Rennes Hematology
City
Rennes cedex
ZIP/Postal Code
35033
Country
France
Facility Name
CHRU Hopital Brabois
City
Vandoeuvre les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Charite -Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitatsklinikum Essen
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Ernst-Moritz-Arndt-Universität Greifswald
City
Greifswald
ZIP/Postal Code
17487
Country
Germany
Facility Name
Universitatsklinikum Schleswig Holstein
City
Kiel
ZIP/Postal Code
24116
Country
Germany
Facility Name
Klinikum der Universitat zu Koln
City
Köln
ZIP/Postal Code
50924
Country
Germany
Facility Name
University of Ulm Abteilung Innere Medizin III
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Azienda Ospedaliera Universitaria San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Ematologia ed Immunologia, Azienda Ospedaliera "Vito Fazzi" di Lecce
City
Lecce
ZIP/Postal Code
73100
Country
Italy
Facility Name
I.R.C.C.S. Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Istituto Europeo di Oncologia - IEO
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Universita degli Studi di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Universita' Degli Studi Di Perugia
City
Perugia
ZIP/Postal Code
06100
Country
Italy
Facility Name
Hospital Clinic Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Karolinska Universitetssjukhuset
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
Facility Name
St James's Institute of Oncology
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
St.Bartholomew's Hospital
City
London
ZIP/Postal Code
EC1M 6BQ
Country
United Kingdom
Facility Name
King's College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
The Royal Marsden Hospital
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Christie Hospital NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
26763349
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.
Results Reference
background
PubMed Identifier
26967821
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.
Results Reference
background

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Study of Lenalidomide to Evaluate Safety and Efficacy in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

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