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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dose-escalation to 5 mg lenalidomide (len) | Experimental | escalate up to 5 mg once daily / 28-day cycle |
|
| dose-escalation to 10 mg lenalidomide (len) | Experimental | escalate up to 10 mg once daily / 28-day cycle |
|
| dose-escalation to 15 mg lenalidomide (len) | Experimental | escalate up to 15 mg once daily / 28-day cycle |
|
| dose-escalation to 20 mg lenalidomide (len) | Experimental | escalate up to 20 mg once daily / 28-day cycle |
|
| dose-escalation to 25 mg lenalidomide (len) | Experimental | escalate up to 25 mg once daily / 28-day cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lenalidomide | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | February 2010 |
| Measure | Description | Time Frame |
|---|---|---|
| Response | February 2010 | |
| Duration of response | February 2010 | |
| Time to response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elayne Lombardy, MD | Celgene Corporation | Study Director |
| Asher Chanan-Khan, MD | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Cancer Center | Tucson | Arizona | 85724 | United States | ||
| Alta Bates Summit Comprehensive Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21879809 | Background | 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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| lenalidomide |
| Drug |
|
|
| lenalidomide | Drug |
|
|
| lenalidomide | Drug |
|
|
| lenalidomide | Drug |
|
|
| 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 |
| Berkeley |
| California |
| 94704 |
| United States |
| Desert Hematology Oncology Medical Group, Inc. | Rancho Mirage | California | 92270 | United States |
| Baptist Cancer Institute | Jacksonville | Florida | 32207 | United States |
| Cancer & Blood Disease Center | Lecanto | Florida | 34461 | United States |
| Northwest Georgia Oncology Centers, PC., Wellstar Health System | Marietta | Georgia | 30060 | United States |
| Mountain States Tumor Institute | Boise | Idaho | 83712 | United States |
| Robert H. Lurie Comprehensive Cancer Center | Chicago | Illinois | 60611 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637-1470 | United States |
| Indiana University Medical center | Indianapolis | Indiana | 46202-5149 | United States |
| LSU Health Sciences Center, Feist-Weiller Cancer Center | Shreveport | Louisiana | 71130 | United States |
| Karmanos Cancer Institute/Wayne State University School of Medicine | Detroit | Michigan | 48201 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Weill Medical College of Cornell University, Division of Hematology & Oncology | New York | New York | 10021 | United States |
| SUNY Upstate Medical Center | Syracuse | New York | 13210 | United States |
| Wake Forest University School of Medicine | Winston-Salem | North Carolina | 27157 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Abington Hematology Oncology Assoc., Inc. | Willow Grove | Pennsylvania | 19090 | United States |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Swedish Cancer Institute | Seattle | Washington | 98104 | United States |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| Cancer Care Manitoba | Winnipeg | Manitoba | R3E 0V9 | Canada |
| Juravinski Cancer Centre | Hamilton | Ontario | L8V 5C2 | Canada |
| London Helath Science Centre | London | Ontario | N6C 6B5 | Canada |
| Saskatoon Cancer Centre | Saskatoon | Saskatchewan | S7N 4H4 | Canada |
| Uniklinik Köln, Klinik I für Innere Medizin, Klinisches Studienzentrum Hämatologie | Bettenhaus Ebene 04, Raum 001/048, Kerpener Str. 62 | Koln | 50924 | Germany |
| Charité, Campus Benjamin Franklin, Medizinische Klinik III | Hindenburgdamm 30 | State of Berlin | 12203 | Germany |
| University of Schleswig Holstein, Director Medizinische Klinik II | Campus Kiel, Chemnitzstrasse 33, Kiel | 24116 | Germany |
| University of Ulm, Abteilung Innere Medizin III, Robert-Koch-Strasse 8 | Ulm | 89081 | Germany |
| Clinica Ematologica- A.O.U. San Martino, Clinica Ematologica Dipartimento di Medicina Interna | Genova | 16132 | Italy |
| Hospital Clinic Provincial de Barcelona, Servicio de Hematología, Institute of Haematology and Oncology | Villaroel, 170, Barcelona | 8036 | Spain |
| Karolinska Universitetssjukhuset, Hematologiskt Centrum, Karolinska Universitetssjukhuset, | Stockholm | 141 86 | Sweden |
| St James's Institute of Oncology, Dept. of Haematology, Level 3, Bexley Wing, Beckett Street | Leeds | LS9 7TF | United Kingdom |
| Bart's and the London NHS Trust, St. Bartholomew's Hospital, 7th Floor Gloucester House, Cancer Services | London | EC1A 7BE | United Kingdom |
| Christie Hospital NHS Foundation Trust, Haematology and Transplant Unit, | Manchester | M20 4BX | United Kingdom |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D012008 | Recurrence |
| D015448 | Leukemia, B-Cell |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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