Clinical trial NCT00419250: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Lymphocytic Leukemia
Leukemia, B-Cell, Chronic
Keywords: relapsed
refractory
fludarabine
Revlimid
lenalidomide
CLL
B-cell CLL
CC-5013
Chronic Lymphocytic Leukemia
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2007-01-08
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Safety
timeFrame: February 2010
Secondary outcomes:
measure: Response
timeFrame: February 2010
measure: Duration of response
timeFrame: February 2010
measure: Time to response
timeFrame: February 2010
measure: Progression free survival
timeFrame: February 2010
measure: Overall survival
timeFrame: February 2010
measure: Absolute lymphocyte count
timeFrame: February 2010
measure: Evaluation of minimal residual disease (MRD) by flow cytometry
timeFrame: February 2010
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Cancer Center
state: Arizona
city: Berkeley
country: United States
facility: Alta Bates Summit Comprehensive Cancer Center
state: California
city: Rancho Mirage
country: United States
facility: Desert Hematology Oncology Medical Group, Inc.
state: California
city: Jacksonville
country: United States
facility: Baptist Cancer Institute
state: Florida
city: Lecanto
country: United States
facility: Cancer & Blood Disease Center
state: Florida
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers, PC., Wellstar Health System
state: Georgia
city: Boise
country: United States
facility: Mountain States Tumor Institute
state: Idaho
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Medical center
state: Indiana
city: Shreveport
country: United States
facility: LSU Health Sciences Center, Feist-Weiller Cancer Center
state: Louisiana
city: Detroit
country: United States
facility: Karmanos Cancer Institute/Wayne State University School of Medicine
state: Michigan
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: Weill Medical College of Cornell University, Division of Hematology & Oncology
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical Center
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Willow Grove
country: United States
facility: Abington Hematology Oncology Assoc., Inc.
state: Pennsylvania
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Winnipeg
country: Canada
facility: Cancer Care Manitoba
state: Manitoba
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: London
country: Canada
facility: London Helath Science Centre
state: Ontario
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Centre
state: Saskatchewan
city: Hindenburgdamm 30
country: Germany
facility: Charité, Campus Benjamin Franklin, Medizinische Klinik III
state: Berlin
city: Bettenhaus Ebene 04, Raum 001/048, Kerpener Str. 62
country: Germany
facility: Uniklinik Köln, Klinik I für Innere Medizin, Klinisches Studienzentrum Hämatologie
state: Koln
city: Campus Kiel, Chemnitzstrasse 33, Kiel
country: Germany
facility: University of Schleswig Holstein, Director Medizinische Klinik II
city: Ulm
country: Germany
facility: University of Ulm, Abteilung Innere Medizin III, Robert-Koch-Strasse 8
city: Genova
country: Italy
facility: Clinica Ematologica- A.O.U. San Martino, Clinica Ematologica Dipartimento di Medicina Interna
city: Villaroel, 170, Barcelona
country: Spain
facility: Hospital Clinic Provincial de Barcelona, Servicio de Hematología, Institute of Haematology and Oncology
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset, Hematologiskt Centrum, Karolinska Universitetssjukhuset,
city: Leeds
country: United Kingdom
facility: St James's Institute of Oncology, Dept. of Haematology, Level 3, Bexley Wing, Beckett Street
city: London
country: United Kingdom
facility: Bart's and the London NHS Trust, St. Bartholomew's Hospital, 7th Floor Gloucester House, Cancer Services
city: Manchester
country: United Kingdom
facility: Christie Hospital NHS Foundation Trust, Haematology and Transplant Unit,
Study officials:
affiliation: Celgene Corporation
name: Elayne Lombardy, MD
role: STUDY_DIRECTOR
affiliation: Roswell Park Cancer Institute
name: Asher Chanan-Khan, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.