A Dose Escalation Study of Lenalidomide in Relapsed or Refractory B-cell Chronic Lymphocytic Leukemia
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: dose-escalation to 5 mg lenalidomide (len) escalate up to 5 mg once daily / 28-day cycle |
Drug: lenalidomide
Other Names:
|
Experimental: dose-escalation to 10 mg lenalidomide (len) escalate up to 10 mg once daily / 28-day cycle |
Drug: lenalidomide
Other Names:
|
Experimental: dose-escalation to 15 mg lenalidomide (len) escalate up to 15 mg once daily / 28-day cycle |
Drug: lenalidomide
Other Names:
|
Experimental: dose-escalation to 20 mg lenalidomide (len) escalate up to 20 mg once daily / 28-day cycle |
Drug: lenalidomide
Other Names:
|
Experimental: dose-escalation to 25 mg lenalidomide (len) escalate up to 25 mg once daily / 28-day cycle |
Drug: lenalidomide
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Safety [February 2010]
Secondary Outcome Measures
- Response [February 2010]
- Duration of response [February 2010]
- Time to response [February 2010]
- Progression free survival [February 2010]
- Overall survival [February 2010]
- Absolute lymphocyte count [February 2010]
- Evaluation of minimal residual disease (MRD) by flow cytometry [February 2010]
Eligibility Criteria
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
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Willing to agree to follow the pregnancy precautions.
Exclusion Criteria:
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Pregnant or nursing women
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Systemic treatment for B-cell CLL within 28 days of study start
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Central nervous system involvement
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History of renal failure requiring dialysis
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Prior treatment with lenalidomide
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Alemtuzumab therapy within 56 days of initiating lenalidomide treatment
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ANC < 1000 / ul
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Platelet count < 50,000 / ul
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Calculated creatinine clearance < 60 mL/min (Cockroft-Gault method)
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AST or ALT > 3.0 x upper limit of normal
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Serum total bilirubin > 2.0 mg/dl
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Neuropathy > or = Grade 2
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Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
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Richter's transformation (active)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Arizona Cancer Center | Tucson | Arizona | United States | 85724 |
2 | Alta Bates Summit Comprehensive Cancer Center | Berkeley | California | United States | 94704 |
3 | Desert Hematology Oncology Medical Group, Inc. | Rancho Mirage | California | United States | 92270 |
4 | Baptist Cancer Institute | Jacksonville | Florida | United States | 32207 |
5 | Cancer & Blood Disease Center | Lecanto | Florida | United States | 34461 |
6 | Northwest Georgia Oncology Centers, PC., Wellstar Health System | Marietta | Georgia | United States | 30060 |
7 | Mountain States Tumor Institute | Boise | Idaho | United States | 83712 |
8 | Robert H. Lurie Comprehensive Cancer Center | Chicago | Illinois | United States | 60611 |
9 | University of Chicago Medical Center | Chicago | Illinois | United States | 60637-1470 |
10 | Indiana University Medical center | Indianapolis | Indiana | United States | 46202-5149 |
11 | LSU Health Sciences Center, Feist-Weiller Cancer Center | Shreveport | Louisiana | United States | 71130 |
12 | Karmanos Cancer Institute/Wayne State University School of Medicine | Detroit | Michigan | United States | 48201 |
13 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263 |
14 | Weill Medical College of Cornell University, Division of Hematology & Oncology | New York | New York | United States | 10021 |
15 | SUNY Upstate Medical Center | Syracuse | New York | United States | 13210 |
16 | Wake Forest University School of Medicine | Winston-Salem | North Carolina | United States | 27157 |
17 | The Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
18 | Abington Hematology Oncology Assoc., Inc. | Willow Grove | Pennsylvania | United States | 19090 |
19 | University of Texas MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
20 | Swedish Cancer Institute | Seattle | Washington | United States | 98104 |
21 | Cross Cancer Institute | Edmonton | Alberta | Canada | T6G 1Z2 |
22 | Cancer Care Manitoba | Winnipeg | Manitoba | Canada | R3E 0V9 |
23 | Juravinski Cancer Centre | Hamilton | Ontario | Canada | L8V 5C2 |
24 | London Helath Science Centre | London | Ontario | Canada | N6C 6B5 |
25 | Saskatoon Cancer Centre | Saskatoon | Saskatchewan | Canada | S7N 4H4 |
26 | Charité, Campus Benjamin Franklin, Medizinische Klinik III | Hindenburgdamm 30 | Berlin | Germany | 12203 |
27 | Uniklinik Köln, Klinik I für Innere Medizin, Klinisches Studienzentrum Hämatologie | Bettenhaus Ebene 04, Raum 001/048, Kerpener Str. 62 | Koln | Germany | 50924 |
28 | University of Schleswig Holstein, Director Medizinische Klinik II | Campus Kiel, Chemnitzstrasse 33, Kiel | Germany | 24116 | |
29 | University of Ulm, Abteilung Innere Medizin III, Robert-Koch-Strasse 8 | Ulm | Germany | 89081 | |
30 | Clinica Ematologica- A.O.U. San Martino, Clinica Ematologica Dipartimento di Medicina Interna | Genova | Italy | 16132 | |
31 | Hospital Clinic Provincial de Barcelona, Servicio de Hematología, Institute of Haematology and Oncology | Villaroel, 170, Barcelona | Spain | 8036 | |
32 | Karolinska Universitetssjukhuset, Hematologiskt Centrum, Karolinska Universitetssjukhuset, | Stockholm | Sweden | 141 86 | |
33 | St James's Institute of Oncology, Dept. of Haematology, Level 3, Bexley Wing, Beckett Street | Leeds | United Kingdom | LS9 7TF | |
34 | Bart's and the London NHS Trust, St. Bartholomew's Hospital, 7th Floor Gloucester House, Cancer Services | London | United Kingdom | EC1A 7BE | |
35 | Christie Hospital NHS Foundation Trust, Haematology and Transplant Unit, | Manchester | United Kingdom | M20 4BX |
Sponsors and Collaborators
- Celgene
Investigators
- Study Director: Elayne Lombardy, MD, Celgene Corporation
- Principal Investigator: Asher Chanan-Khan, MD, Roswell Park Cancer Institute
Study Documents (Full-Text)
None provided.More Information
Publications
- CC-5013-CLL-001