Back to resultsA Dose Escalation Study of Lenalidomide in Relapsed or Refractory B-cell Chronic Lymphocytic Leukemia
Primary Purpose
Chronic Lymphocytic Leukemia, Leukemia, B-Cell, Chronic
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
lenalidomide
lenalidomide
lenalidomide
lenalidomide
lenalidomide
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring relapsed, refractory, fludarabine, Revlimid, lenalidomide, CLL, B-cell CLL, CC-5013, Chronic Lymphocytic Leukemia
Eligibility Criteria
Inclusion Criteria:
- Documented diagnosis of B-cell CLL that has relapsed after or is refractory to at least one prior regimen. The prior regimen(s) must have included an alkylating agent and fludarabine (used in combination or separately)
- ECOG < or = 2
- Willing to agree to follow the pregnancy precautions.
Exclusion Criteria:
- Pregnant or nursing women
- Systemic treatment for B-cell CLL within 28 days of study start
- Central nervous system involvement
- History of renal failure requiring dialysis
- Prior treatment with lenalidomide
- Alemtuzumab therapy within 56 days of initiating lenalidomide treatment
- ANC < 1000 / ul
- Platelet count < 50,000 / ul
- Calculated creatinine clearance < 60 mL/min (Cockroft-Gault method)
- AST or ALT > 3.0 x upper limit of normal
- Serum total bilirubin > 2.0 mg/dl
- Neuropathy > or = Grade 2
- Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
- Richter's transformation (active)
Sites / Locations
- Arizona Cancer Center
- Alta Bates Summit Comprehensive Cancer Center
- Desert Hematology Oncology Medical Group, Inc.
- Baptist Cancer Institute
- Cancer & Blood Disease Center
- Northwest Georgia Oncology Centers, PC., Wellstar Health System
- Mountain States Tumor Institute
- Robert H. Lurie Comprehensive Cancer Center
- University of Chicago Medical Center
- Indiana University Medical center
- LSU Health Sciences Center, Feist-Weiller Cancer Center
- Karmanos Cancer Institute/Wayne State University School of Medicine
- Roswell Park Cancer Institute
- Weill Medical College of Cornell University, Division of Hematology & Oncology
- SUNY Upstate Medical Center
- Wake Forest University School of Medicine
- The Cleveland Clinic Foundation
- Abington Hematology Oncology Assoc., Inc.
- University of Texas MD Anderson Cancer Center
- Swedish Cancer Institute
- Cross Cancer Institute
- Cancer Care Manitoba
- Juravinski Cancer Centre
- London Helath Science Centre
- Saskatoon Cancer Centre
- Charité, Campus Benjamin Franklin, Medizinische Klinik III
- Uniklinik Köln, Klinik I für Innere Medizin, Klinisches Studienzentrum Hämatologie
- University of Schleswig Holstein, Director Medizinische Klinik II
- University of Ulm, Abteilung Innere Medizin III, Robert-Koch-Strasse 8
- Clinica Ematologica- A.O.U. San Martino, Clinica Ematologica Dipartimento di Medicina Interna
- Hospital Clinic Provincial de Barcelona, Servicio de Hematología, Institute of Haematology and Oncology
- Karolinska Universitetssjukhuset, Hematologiskt Centrum, Karolinska Universitetssjukhuset,
- St James's Institute of Oncology, Dept. of Haematology, Level 3, Bexley Wing, Beckett Street
- Bart's and the London NHS Trust, St. Bartholomew's Hospital, 7th Floor Gloucester House, Cancer Services
- Christie Hospital NHS Foundation Trust, Haematology and Transplant Unit,
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
dose-escalation to 5 mg lenalidomide (len)
dose-escalation to 10 mg lenalidomide (len)
dose-escalation to 15 mg lenalidomide (len)
dose-escalation to 20 mg lenalidomide (len)
dose-escalation to 25 mg lenalidomide (len)
Arm Description
escalate up to 5 mg once daily / 28-day cycle
escalate up to 10 mg once daily / 28-day cycle
escalate up to 15 mg once daily / 28-day cycle
escalate up to 20 mg once daily / 28-day cycle
escalate up to 25 mg once daily / 28-day cycle
Outcomes
Primary Outcome Measures
Safety
Secondary Outcome Measures
Response
Duration of response
Time to response
Progression free survival
Overall survival
Absolute lymphocyte count
Evaluation of minimal residual disease (MRD) by flow cytometry
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00419250
Brief Title
A Dose Escalation Study of Lenalidomide in Relapsed or Refractory B-cell Chronic Lymphocytic Leukemia
Official Title
A Phase 1, Multi-center, Open-label Study of the Safety and Efficacy of a Stepwise Dose-escalation Schedule of Lenalidomide Monotherapy in Subjects With Relapsed or Refractory B-cell Chronic Lymphocytic Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
December 1, 2006 (Actual)
Primary Completion Date
February 1, 2010 (Actual)
Study Completion Date
June 1, 2010 (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 evaluate the safety of lenalidomide and to define the maximum tolerated escalation dose level (MTEDL) when administered by a stepwise dose-escalation schedule in subjects with relapsed or refractory B-cell CLL.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia, Leukemia, B-Cell, Chronic
Keywords
relapsed, refractory, fludarabine, Revlimid, lenalidomide, CLL, B-cell CLL, CC-5013, Chronic Lymphocytic Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dose-escalation to 5 mg lenalidomide (len)
Arm Type
Experimental
Arm Description
escalate up to 5 mg once daily / 28-day cycle
Arm Title
dose-escalation to 10 mg lenalidomide (len)
Arm Type
Experimental
Arm Description
escalate up to 10 mg once daily / 28-day cycle
Arm Title
dose-escalation to 15 mg lenalidomide (len)
Arm Type
Experimental
Arm Description
escalate up to 15 mg once daily / 28-day cycle
Arm Title
dose-escalation to 20 mg lenalidomide (len)
Arm Type
Experimental
Arm Description
escalate up to 20 mg once daily / 28-day cycle
Arm Title
dose-escalation to 25 mg lenalidomide (len)
Arm Type
Experimental
Arm Description
escalate up to 25 mg once daily / 28-day cycle
Intervention Type
Drug
Intervention Name(s)
lenalidomide
Other Intervention Name(s)
Revlimid, CC-5013
Intervention Type
Drug
Intervention Name(s)
lenalidomide
Other Intervention Name(s)
Revlimid, CC-5013
Intervention Type
Drug
Intervention Name(s)
lenalidomide
Other Intervention Name(s)
Revlimid, CC-5013
Intervention Type
Drug
Intervention Name(s)
lenalidomide
Other Intervention Name(s)
Revlimid, CC-5013
Intervention Type
Drug
Intervention Name(s)
lenalidomide
Other Intervention Name(s)
Revlimid, CC-5013
Primary Outcome Measure Information:
Title
Safety
Time Frame
February 2010
Secondary Outcome Measure Information:
Title
Response
Time Frame
February 2010
Title
Duration of response
Time Frame
February 2010
Title
Time to response
Time Frame
February 2010
Title
Progression free survival
Time Frame
February 2010
Title
Overall survival
Time Frame
February 2010
Title
Absolute lymphocyte count
Time Frame
February 2010
Title
Evaluation of minimal residual disease (MRD) by flow cytometry
Time Frame
February 2010
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Documented diagnosis of B-cell CLL that has relapsed after or is refractory to at least one prior regimen. The prior regimen(s) must have included an alkylating agent and fludarabine (used in combination or separately)
ECOG < or = 2
Willing to agree to follow the pregnancy precautions.
Exclusion Criteria:
Pregnant or nursing women
Systemic treatment for B-cell CLL within 28 days of study start
Central nervous system involvement
History of renal failure requiring dialysis
Prior treatment with lenalidomide
Alemtuzumab therapy within 56 days of initiating lenalidomide treatment
ANC < 1000 / ul
Platelet count < 50,000 / ul
Calculated creatinine clearance < 60 mL/min (Cockroft-Gault method)
AST or ALT > 3.0 x upper limit of normal
Serum total bilirubin > 2.0 mg/dl
Neuropathy > or = Grade 2
Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
Richter's transformation (active)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elayne Lombardy, MD
Organizational Affiliation
Celgene Corporation
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Asher Chanan-Khan, MD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Alta Bates Summit Comprehensive 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
Baptist Cancer Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Cancer & Blood Disease Center
City
Lecanto
State/Province
Florida
ZIP/Postal Code
34461
Country
United States
Facility Name
Northwest Georgia Oncology Centers, PC., Wellstar Health System
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Mountain States Tumor Institute
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Robert H. Lurie Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
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
Indiana University Medical center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5149
Country
United States
Facility Name
LSU Health Sciences Center, Feist-Weiller Cancer Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130
Country
United States
Facility Name
Karmanos Cancer Institute/Wayne State University School of Medicine
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Weill Medical College of Cornell University, Division of Hematology & Oncology
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
SUNY Upstate Medical Center
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Wake Forest University School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Abington Hematology Oncology Assoc., Inc.
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Facility Name
University of Texas 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
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Cancer Care Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
London Helath Science Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 6B5
Country
Canada
Facility Name
Saskatoon Cancer Centre
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada
Facility Name
Charité, Campus Benjamin Franklin, Medizinische Klinik III
City
Hindenburgdamm 30
State/Province
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Uniklinik Köln, Klinik I für Innere Medizin, Klinisches Studienzentrum Hämatologie
City
Bettenhaus Ebene 04, Raum 001/048, Kerpener Str. 62
State/Province
Koln
ZIP/Postal Code
50924
Country
Germany
Facility Name
University of Schleswig Holstein, Director Medizinische Klinik II
City
Campus Kiel, Chemnitzstrasse 33, Kiel
ZIP/Postal Code
24116
Country
Germany
Facility Name
University of Ulm, Abteilung Innere Medizin III, Robert-Koch-Strasse 8
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Clinica Ematologica- A.O.U. San Martino, Clinica Ematologica Dipartimento di Medicina Interna
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Hospital Clinic Provincial de Barcelona, Servicio de Hematología, Institute of Haematology and Oncology
City
Villaroel, 170, Barcelona
ZIP/Postal Code
8036
Country
Spain
Facility Name
Karolinska Universitetssjukhuset, Hematologiskt Centrum, Karolinska Universitetssjukhuset,
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
St James's Institute of Oncology, Dept. of Haematology, Level 3, Bexley Wing, Beckett Street
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Bart's and the London NHS Trust, St. Bartholomew's Hospital, 7th Floor Gloucester House, Cancer Services
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Christie Hospital NHS Foundation Trust, Haematology and Transplant Unit,
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
21879809
Citation
Wendtner CM, Hillmen P, Mahadevan D, Buhler A, Uharek L, Coutre S, Frankfurt O, Bloor A, Bosch F, Furman RR, Kimby E, Gribben JG, Gobbi M, Dreisbach L, Hurd DD, Sekeres MA, Ferrajoli A, Shah S, Zhang J, Moutouh-de Parseval L, Hallek M, Heerema NA, Stilgenbauer S, Chanan-Khan AA. Final results of a multicenter phase 1 study of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia. Leuk Lymphoma. 2012 Mar;53(3):417-23. doi: 10.3109/10428194.2011.618232. Epub 2011 Nov 15.
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A Dose Escalation Study of Lenalidomide in Relapsed or Refractory B-cell Chronic Lymphocytic Leukemia
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