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Efficacy and Safety Study of CC-5013 Monotherapy in Subjects With Myelodysplastic Syndromes

Primary Purpose

Myelodysplastic Syndromes

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CC-5013
Sponsored by
Celgene Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelodysplastic Syndromes focused on measuring MDS, CC-5013, Revlimid, Celgene

Eligibility Criteria

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

Inclusion Criteria: Must understand and voluntarily sign an informed consent form. 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. Diagnosis of low - or intermediate-1-risk IPSS (Appendix III) MDS without an abnormality of chromosome 5 involving a deletion between bands q31 and q33. Red blood cell (RBC) transfusion-dependent anemia defined as having received ≥ to 2 units of RBCs within 8 weeks of the first day of study drug treatment. Eastern Cooperative Oncology Group (ECOG) (Appendix IV) performance status score of 0, 1, or 2. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days of starting study drug. Sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug. WCBP must agree to have pregnancy tests every 4 weeks while on study drug. Exclusion Criteria: Pregnant or lactating females. Prior therapy with lenalidomide. An abnormality of chromosome 5 involving a deletion between bands q31 and q33. Lab Abnormality: Absolute neutrophil count (ANC) <500 cells/mm3 (0.5 x 109/L) Lab Abnormality: Platelet count <50,000/mm3 (50 x 109/L) Lab Abnormality: Serum creatinine >2.5 mg/dL (221 mmol/L) Lab Abnormality: Serum glutamic oxaloacetic transaminase/Aspartate transaminase (SGOT/AST) or Serum glutamic pyruvic transaminase/Alanine transaminase (SGPT/ALT) >3.0 x upper limit of normal (ULN) Lab Abnormality: Serum total bilirubin >2.0 mg/dL (34 mmol/L) Prior ≥ grade 3 National Cancer Institute (NCI) Common Toxicity Criteria (CTC) (Appendix VI) allergic reaction/hypersensitivity to thalidomide. Prior ≥ grade 3 NCI CTC (Appendix VI) rash or any desquamation (blistering) while taking thalidomide. Clinically significant anemia due to factors such as iron, B12 or folate deficiencies, autoimmune or hereditary hemolysis or gastrointestinal bleeding If a marrow aspirate is not evaluable for storage iron, transferrin saturation must be > 20 % and serum ferritin not less than 50 ng/mL. Use of hematopoietic growth factors within 7 days of the first day of study drug treatment. Chronic use (>2 weeks) of greater than physiologic doses of a corticosteroid agent (dose equivalent to >10 mg/day of prednisone) within 28 days of the first day of study drug treatment. Use of experimental or standard drugs (i.e. chemotherapeutic, immunosuppressive, and cytoprotective agents) for the treatment of MDS within 28 days of the first day of study drug treatment. Prior history of malignancy other than MDS (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been free of disease for greater than or equal to 3 years. Use of any other experimental therapy within 28 days of the first day of study drug treatment.

Sites / Locations

  • Arizona Cancer Center
  • Mayo Clinic
  • Arizona Cancer Center
  • Alta Bates Cancer Center
  • Desert Hematology Oncology Medical Group, Inc.
  • Stanford University Medical Center
  • Florida Cancer Specialists
  • Mayo Clinic
  • Cancer & Blood Disease Center
  • University of Miami- Sylvester Comp Cancer Center
  • H. Lee Moffitt Cancer Center and Research Institute
  • Northwest Georgia Oncology - Wellstar Cancer Research
  • Rush Presbyterian-St. Luke's Medical Center
  • University of Chicago Medical Center
  • Midwest Cancer Research Group
  • Indiana University Medical Center
  • Johns Hopkins Oncology Center
  • Dana-Farber Cancer Institute
  • Wayne State University School of Medicine
  • St. Luke's Oncology and Hematology Associates
  • Mayo Clinic
  • University of Nebraska Medical Center
  • Roswell Park Cancer Institute
  • Winthrop University Hospital
  • St. Vincents Comprehensive Cancer Center
  • New York Hospital- Cornell
  • Memorial Sloan-Kettering Cancer Center
  • Mt. Sinai Medical Center
  • University of Rochester-James P. Wilmot Cancer Center
  • Wake Forest University School of Medicine
  • The Cleveland Clinic Foundation
  • Oregon Health & Science University
  • Kaiser Permanente Northwest Region
  • Drexel University College of Medicine
  • Western Pennsylvania Cancer Institute
  • MD Anderson Cancer Center
  • Swedish Cancer Institute
  • Fred Hutchinson Cancer Research Center
  • Royal Adelaide Hospital - SA Pathology Haematology
  • Princess Alexandra Hospital - Haematology
  • Royal Prince Alfred Hospital - Institute of Haematology
  • Peter McCallum Cancer Institute - Directorate of Cancer Medecine
  • Frankston Hospital-peninsula Health - Oncology Day Unit
  • The Alfred Hospital - malignant haematology & stem cell transplantation
  • Calvary Mater Newcastle - Haematology
  • Border Medical Oncology
  • Wollongong Hospital - Haematology
  • UZ Gent - Hematology
  • University Hospital Leuven - Hematology
  • Cliniques Universitaires ULC de Mont-Godinne - Hematology
  • Fakultní nemocnice Hradec Králové - Hematology
  • Charles university Hospital - Internal Medicine
  • Aalborg Sygemus - Haematology
  • Aarhus University Hospital
  • Odense University Hospital
  • Vejle Hospital - Hematology
  • CHU Angers - Service des maladies du sang
  • Centre Hospitalier de la côte basque - Hematologie
  • Centre Hospitalier Départemental Vendée - Onco-hematologie
  • CHRU de Lille - Service des maladies du sang
  • Institut Paoli Calmette - Hematology 1
  • CHU Hôtel-Dieu - Hematologie
  • Hôpital Saint Louis - Immuno-hematologie
  • CHU Saint Antoine - Service des maladies du sang
  • CHRU - Hôpital du Haut Lévêque - Centre François Magendie
  • Centre Hospitalier Lyon sud - Hematologie
  • CHRU Hôpital Purpan - Hematologie
  • Hôpital Bretonneau - Hématologie & Thérapie cellulaire
  • CHU Nancy - Hematologie
  • Universitätsklinikum Essen, Klinik für Hämatologie
  • Universitätsklinikum Heidelberg - Medizinische Klinik und Poliklinik V
  • Universitätsklinikum Jena - Klinik fur Innere Medizin II-Hamatologie/Onkologie
  • Universitätsklinikum Leipzig - Medizinische Klinik und Poliklinik II
  • Universitätsklinikum Münster - Medizinische Klinik und Poliklinik A
  • Universitätsklinikum Tübingen - Medizinische Klinik und Poliklinik - Abteilung II
  • Universitätsklinikum Ulm - Klinik fur Innere Medizin III
  • Universitätsklinikum Würzburg - Medizinische Klinik und Poliklinik II
  • University of Athens - Alexandra Hospital; Clinical Therapeutics
  • Università degli Studi di Bologna - Policlinico S. Orsola - Hematology
  • AO Universitaria San Martino - hematooncology
  • Fondazione "G. Pascale" - Hematology
  • Ospedale San Luigi AO Luigi Gonzaga - Hematology
  • Universita degli Studi di Padova - Clinical & Experimental Medicine
  • Ospedale Guglielmo da Saliceto - hematooncology
  • Unità di Ematologia Arcispedale S. Maria Nuova - Haematology
  • Policlinico Umberto I, Università "La Sapienza" di Roma - Hematology
  • A.O.U. San Giovanni Battista - Hematology
  • VUMC - Hematology
  • Erasmus Medical Center - Hematology
  • University Medical Center - Hematology
  • Medical Sciences - Hematology & BMT
  • Moscow State Medical Institution Municipal Clinical Hospital n.a. S.P. Botkin - Hematology
  • Russian Research Institute of Hematology and Blood Transfusion - Hematology
  • State Higher Educational Institution St. Petersburg State Medical University - Onco-hematology
  • Hospital Germans Trias i Pujol - Hematology
  • Hospital Clinic i Provincial de Barcelona - Hematology
  • Hospital de Donostia - Hematology
  • Hospital de La Princesa - Hematology
  • Hospital 12 de Octubre - Hematology
  • Hospital de Salamanca - Hematology
  • Hospital Universitario Marqués de Valdecilla - Hematology
  • Hospital La Fe - Hematology
  • Sahlgrenska Hospital, University of Goteborg - Hematology
  • Karolinska University Hospital Huddinge - Center of hematology
  • Karolinska University Hospital Solna- medicine
  • Overlakare Medocomcentrum - Hematology
  • Inselspital, Institut für Medizinische Onkologie
  • Hôpitaux Universitaire de Genève - Oncologie
  • Klinik und Poliklinik für Onkologie - UniversitätsSpital Zürich
  • Royal Bournemouth Hospital - Haematology
  • St James's University Hospital - Haematology
  • St Bartholomew's Hospital - Medical Oncology
  • King's College Hospital - Haematology Clinical Trials
  • Freeman Hospital - Northern Centre for Cancer Care
  • Nottingham City Hospital - Centre for Clinical Haematology
  • Derriford Hospital - Haematology
  • Royal hallamshire Hospital - Haematology
  • Royal Marsden NHS Foundation Trust - Haematology
  • Royal Wolverhampton hospitals trust - Research and development

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CC-5013

Arm Description

CC-5013 10 mg (two 5 mg capsules) daily on days 1-28 every 28 days (28 day cycles)

Outcomes

Primary Outcome Measures

RBC Transfusion Independence

Secondary Outcome Measures

≥ 50% decrease in RBC transfusion requirement
Platelet Response
Platelet Response
Neutrophil Response
Neutrophil Response
Bone marrow Response
Bone marrow Response
Duration of Response
Duration of Response
Hemoglobin concentration
Change of hemoglobin concentration from baseline
Number of Participants with Adverse Event
Number of Participants with Adverse Event

Full Information

First Posted
July 16, 2003
Last Updated
April 3, 2013
Sponsor
Celgene Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00064974
Brief Title
Efficacy and Safety Study of CC-5013 Monotherapy in Subjects With Myelodysplastic Syndromes
Official Title
A Multicenter, Single-Arm, Open-Label Study of the Efficacy and Safety of CC-5013 Monotherapy in Subjects With Myelodysplastic Syndromes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is a multi-center, single-arm, open-label study of oral CC-5013 monotherapy administered at a dose of 10 mg daily on Days 1-21 every 28 days (28-day cycles) to red blood cell (RBC) transfusion-dependent subjects with low- or intermediate-1-risk MDS who do not have a del (5q31-33) cytogenetic abnormality. Screening procedures will take place within 28 days of first day of study drug treatment. Subjects will receive study drug (CC-5013) in 28-day cycles for up to 6 cycles, or until bone marrow disease progression or progression/relapse following erythroid hematologic improvement (Appendix I) is documented. Study visits will occur every cycle (every 28 days) and laboratory monitoring to assess hematological parameters will occur every 14 days. Safety and efficacy assessments to be performed during the study are outlined in the Schedule of Study Assessments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndromes
Keywords
MDS, CC-5013, Revlimid, Celgene

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
215 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CC-5013
Arm Type
Experimental
Arm Description
CC-5013 10 mg (two 5 mg capsules) daily on days 1-28 every 28 days (28 day cycles)
Intervention Type
Drug
Intervention Name(s)
CC-5013
Other Intervention Name(s)
lenalidomide
Intervention Description
CC-5013 10 mg (two 5 mg capsules) daily on days 1-28 every 28 days (28 day cycles)
Primary Outcome Measure Information:
Title
RBC Transfusion Independence
Secondary Outcome Measure Information:
Title
≥ 50% decrease in RBC transfusion requirement
Title
Platelet Response
Description
Platelet Response
Title
Neutrophil Response
Description
Neutrophil Response
Title
Bone marrow Response
Description
Bone marrow Response
Title
Duration of Response
Description
Duration of Response
Title
Hemoglobin concentration
Description
Change of hemoglobin concentration from baseline
Title
Number of Participants with Adverse Event
Description
Number of Participants with Adverse Event

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must understand and voluntarily sign an informed consent form. 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. Diagnosis of low - or intermediate-1-risk IPSS (Appendix III) MDS without an abnormality of chromosome 5 involving a deletion between bands q31 and q33. Red blood cell (RBC) transfusion-dependent anemia defined as having received ≥ to 2 units of RBCs within 8 weeks of the first day of study drug treatment. Eastern Cooperative Oncology Group (ECOG) (Appendix IV) performance status score of 0, 1, or 2. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days of starting study drug. Sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug. WCBP must agree to have pregnancy tests every 4 weeks while on study drug. Exclusion Criteria: Pregnant or lactating females. Prior therapy with lenalidomide. An abnormality of chromosome 5 involving a deletion between bands q31 and q33. Lab Abnormality: Absolute neutrophil count (ANC) <500 cells/mm3 (0.5 x 109/L) Lab Abnormality: Platelet count <50,000/mm3 (50 x 109/L) Lab Abnormality: Serum creatinine >2.5 mg/dL (221 mmol/L) Lab Abnormality: Serum glutamic oxaloacetic transaminase/Aspartate transaminase (SGOT/AST) or Serum glutamic pyruvic transaminase/Alanine transaminase (SGPT/ALT) >3.0 x upper limit of normal (ULN) Lab Abnormality: Serum total bilirubin >2.0 mg/dL (34 mmol/L) Prior ≥ grade 3 National Cancer Institute (NCI) Common Toxicity Criteria (CTC) (Appendix VI) allergic reaction/hypersensitivity to thalidomide. Prior ≥ grade 3 NCI CTC (Appendix VI) rash or any desquamation (blistering) while taking thalidomide. Clinically significant anemia due to factors such as iron, B12 or folate deficiencies, autoimmune or hereditary hemolysis or gastrointestinal bleeding If a marrow aspirate is not evaluable for storage iron, transferrin saturation must be > 20 % and serum ferritin not less than 50 ng/mL. Use of hematopoietic growth factors within 7 days of the first day of study drug treatment. Chronic use (>2 weeks) of greater than physiologic doses of a corticosteroid agent (dose equivalent to >10 mg/day of prednisone) within 28 days of the first day of study drug treatment. Use of experimental or standard drugs (i.e. chemotherapeutic, immunosuppressive, and cytoprotective agents) for the treatment of MDS within 28 days of the first day of study drug treatment. Prior history of malignancy other than MDS (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been free of disease for greater than or equal to 3 years. Use of any other experimental therapy within 28 days of the first day of study drug treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Knight, MD
Organizational Affiliation
Celgene Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Cancer Center
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-5024
Country
United States
Facility Name
Alta Bates Cancer Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
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 Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5750
Country
United States
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Cancer & Blood Disease Center
City
Lecanto
State/Province
Florida
ZIP/Postal Code
34461
Country
United States
Facility Name
University of Miami- Sylvester Comp Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States
Facility Name
Northwest Georgia Oncology - Wellstar Cancer Research
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Rush Presbyterian-St. Luke's Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-3515
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Midwest Cancer Research Group
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Indiana University Medical Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5149
Country
United States
Facility Name
Johns Hopkins Oncology Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287-8963
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115-6084
Country
United States
Facility Name
Wayne State University School of Medicine
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-2097
Country
United States
Facility Name
St. Luke's Oncology and Hematology Associates
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-7680
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501-3893
Country
United States
Facility Name
St. Vincents Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
New York Hospital- Cornell
City
New York
State/Province
New York
ZIP/Postal Code
10021-0034
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mt. Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of Rochester-James P. Wilmot Cancer Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Wake Forest University School of Medicine
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1082
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
Kaiser Permanente Northwest Region
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Drexel University College of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19129
Country
United States
Facility Name
Western Pennsylvania Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-4417
Country
United States
Facility Name
Royal Adelaide Hospital - SA Pathology Haematology
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Princess Alexandra Hospital - Haematology
City
Brisbane
ZIP/Postal Code
4102
Country
Australia
Facility Name
Royal Prince Alfred Hospital - Institute of Haematology
City
Camperdown
ZIP/Postal Code
2050
Country
Australia
Facility Name
Peter McCallum Cancer Institute - Directorate of Cancer Medecine
City
East Melbourne
ZIP/Postal Code
3002
Country
Australia
Facility Name
Frankston Hospital-peninsula Health - Oncology Day Unit
City
Frankston
ZIP/Postal Code
3199
Country
Australia
Facility Name
The Alfred Hospital - malignant haematology & stem cell transplantation
City
Melbourne
ZIP/Postal Code
3004
Country
Australia
Facility Name
Calvary Mater Newcastle - Haematology
City
Waratah
ZIP/Postal Code
2298
Country
Australia
Facility Name
Border Medical Oncology
City
Wodonga
ZIP/Postal Code
3690
Country
Australia
Facility Name
Wollongong Hospital - Haematology
City
Wollongong
ZIP/Postal Code
2500
Country
Australia
Facility Name
UZ Gent - Hematology
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
University Hospital Leuven - Hematology
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Cliniques Universitaires ULC de Mont-Godinne - Hematology
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Fakultní nemocnice Hradec Králové - Hematology
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czech Republic
Facility Name
Charles university Hospital - Internal Medicine
City
Prague
ZIP/Postal Code
12808
Country
Czech Republic
Facility Name
Aalborg Sygemus - Haematology
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Vejle Hospital - Hematology
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Facility Name
CHU Angers - Service des maladies du sang
City
Angers
ZIP/Postal Code
49033
Country
France
Facility Name
Centre Hospitalier de la côte basque - Hematologie
City
Bayonne
ZIP/Postal Code
64019
Country
France
Facility Name
Centre Hospitalier Départemental Vendée - Onco-hematologie
City
La Roche sur Yon
ZIP/Postal Code
85925
Country
France
Facility Name
CHRU de Lille - Service des maladies du sang
City
Lille
ZIP/Postal Code
cedex 59037
Country
France
Facility Name
Institut Paoli Calmette - Hematology 1
City
Marseille
ZIP/Postal Code
cedex 13009
Country
France
Facility Name
CHU Hôtel-Dieu - Hematologie
City
Nantes
ZIP/Postal Code
cedex 01 44093
Country
France
Facility Name
Hôpital Saint Louis - Immuno-hematologie
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
CHU Saint Antoine - Service des maladies du sang
City
Paris
ZIP/Postal Code
cedex 12 75012
Country
France
Facility Name
CHRU - Hôpital du Haut Lévêque - Centre François Magendie
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Centre Hospitalier Lyon sud - Hematologie
City
Pierre-Benite
ZIP/Postal Code
cedex 69495
Country
France
Facility Name
CHRU Hôpital Purpan - Hematologie
City
Toulouse
ZIP/Postal Code
cedex 9 31059
Country
France
Facility Name
Hôpital Bretonneau - Hématologie & Thérapie cellulaire
City
Tours
ZIP/Postal Code
cedex 37044
Country
France
Facility Name
CHU Nancy - Hematologie
City
Vandoeuvre-les-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Universitätsklinikum Essen, Klinik für Hämatologie
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Universitätsklinikum Heidelberg - Medizinische Klinik und Poliklinik V
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitätsklinikum Jena - Klinik fur Innere Medizin II-Hamatologie/Onkologie
City
Jena
ZIP/Postal Code
7740
Country
Germany
Facility Name
Universitätsklinikum Leipzig - Medizinische Klinik und Poliklinik II
City
Leipzig
ZIP/Postal Code
4103
Country
Germany
Facility Name
Universitätsklinikum Münster - Medizinische Klinik und Poliklinik A
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Universitätsklinikum Tübingen - Medizinische Klinik und Poliklinik - Abteilung II
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitätsklinikum Ulm - Klinik fur Innere Medizin III
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Universitätsklinikum Würzburg - Medizinische Klinik und Poliklinik II
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
University of Athens - Alexandra Hospital; Clinical Therapeutics
City
Athens
ZIP/Postal Code
14572
Country
Greece
Facility Name
Università degli Studi di Bologna - Policlinico S. Orsola - Hematology
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
AO Universitaria San Martino - hematooncology
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Fondazione "G. Pascale" - Hematology
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Ospedale San Luigi AO Luigi Gonzaga - Hematology
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Facility Name
Universita degli Studi di Padova - Clinical & Experimental Medicine
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Ospedale Guglielmo da Saliceto - hematooncology
City
Piacenza
ZIP/Postal Code
29100
Country
Italy
Facility Name
Unità di Ematologia Arcispedale S. Maria Nuova - Haematology
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
Facility Name
Policlinico Umberto I, Università "La Sapienza" di Roma - Hematology
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
A.O.U. San Giovanni Battista - Hematology
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
VUMC - Hematology
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Erasmus Medical Center - Hematology
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
University Medical Center - Hematology
City
Utrecht
ZIP/Postal Code
3584-CX
Country
Netherlands
Facility Name
Medical Sciences - Hematology & BMT
City
Moscow
ZIP/Postal Code
125167
Country
Russian Federation
Facility Name
Moscow State Medical Institution Municipal Clinical Hospital n.a. S.P. Botkin - Hematology
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Russian Research Institute of Hematology and Blood Transfusion - Hematology
City
St. Petersburg
ZIP/Postal Code
191024
Country
Russian Federation
Facility Name
State Higher Educational Institution St. Petersburg State Medical University - Onco-hematology
City
St. Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Hospital Germans Trias i Pujol - Hematology
City
Badalona
ZIP/Postal Code
8916
Country
Spain
Facility Name
Hospital Clinic i Provincial de Barcelona - Hematology
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de Donostia - Hematology
City
Guipúzcoa
ZIP/Postal Code
20014
Country
Spain
Facility Name
Hospital de La Princesa - Hematology
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital 12 de Octubre - Hematology
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital de Salamanca - Hematology
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Universitario Marqués de Valdecilla - Hematology
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital La Fe - Hematology
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Sahlgrenska Hospital, University of Goteborg - Hematology
City
Goteborg
ZIP/Postal Code
S-41345
Country
Sweden
Facility Name
Karolinska University Hospital Huddinge - Center of hematology
City
Stockholm
ZIP/Postal Code
14152
Country
Sweden
Facility Name
Karolinska University Hospital Solna- medicine
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Facility Name
Overlakare Medocomcentrum - Hematology
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Facility Name
Inselspital, Institut für Medizinische Onkologie
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Hôpitaux Universitaire de Genève - Oncologie
City
Genève
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Klinik und Poliklinik für Onkologie - UniversitätsSpital Zürich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Royal Bournemouth Hospital - Haematology
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
St James's University Hospital - Haematology
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
St Bartholomew's Hospital - Medical Oncology
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
King's College Hospital - Haematology Clinical Trials
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Freeman Hospital - Northern Centre for Cancer Care
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Nottingham City Hospital - Centre for Clinical Haematology
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Derriford Hospital - Haematology
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Royal hallamshire Hospital - Haematology
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Facility Name
Royal Marsden NHS Foundation Trust - Haematology
City
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Royal Wolverhampton hospitals trust - Research and development
City
Wolverhampton
ZIP/Postal Code
WV10 OQP
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
17893227
Citation
Raza A, Reeves JA, Feldman EJ, Dewald GW, Bennett JM, Deeg HJ, Dreisbach L, Schiffer CA, Stone RM, Greenberg PL, Curtin PT, Klimek VM, Shammo JM, Thomas D, Knight RD, Schmidt M, Wride K, Zeldis JB, List AF. Phase 2 study of lenalidomide in transfusion-dependent, low-risk, and intermediate-1 risk myelodysplastic syndromes with karyotypes other than deletion 5q. Blood. 2008 Jan 1;111(1):86-93. doi: 10.1182/blood-2007-01-068833. Epub 2007 Sep 24.
Results Reference
derived

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Efficacy and Safety Study of CC-5013 Monotherapy in Subjects With Myelodysplastic Syndromes

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