A Dose Escalation Study of Lenalidomide in Relapsed or Refractory B-cell Chronic Lymphocytic Leukemia

Chronic Lymphocytic Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00419250
• Other study ID #: CC-5013-CLL-001
• Status: Completed
• Phase: Phase 1
• Start date: December 1, 2006
• Est. completion date: June 1, 2010

Study information

• Verified date: November 2019
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 1, 2010
• Est. primary completion date: February 1, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, B-Cell
• Leukemia, B-Cell, Chronic
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• lenalidomide

• lenalidomide

• lenalidomide

• lenalidomide

• lenalidomide

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Juravinski Cancer Centre	Hamilton	Ontario
Canada	London Helath Science Centre	London	Ontario
Canada	Saskatoon Cancer Centre	Saskatoon	Saskatchewan
Canada	Cancer Care Manitoba	Winnipeg	Manitoba
Germany	Uniklinik Köln, Klinik I für Innere Medizin, Klinisches Studienzentrum Hämatologie	Bettenhaus Ebene 04, Raum 001/048, Kerpener Str. 62	Koln
Germany	University of Schleswig Holstein, Director Medizinische Klinik II	Campus Kiel, Chemnitzstrasse 33, Kiel
Germany	Charité, Campus Benjamin Franklin, Medizinische Klinik III	Hindenburgdamm 30	Berlin
Germany	University of Ulm, Abteilung Innere Medizin III, Robert-Koch-Strasse 8	Ulm
Italy	Clinica Ematologica- A.O.U. San Martino, Clinica Ematologica Dipartimento di Medicina Interna	Genova
Spain	Hospital Clinic Provincial de Barcelona, Servicio de Hematología, Institute of Haematology and Oncology	Villaroel, 170, Barcelona
Sweden	Karolinska Universitetssjukhuset, Hematologiskt Centrum, Karolinska Universitetssjukhuset,	Stockholm
United Kingdom	St James's Institute of Oncology, Dept. of Haematology, Level 3, Bexley Wing, Beckett Street	Leeds
United Kingdom	Bart's and the London NHS Trust, St. Bartholomew's Hospital, 7th Floor Gloucester House, Cancer Services	London
United Kingdom	Christie Hospital NHS Foundation Trust, Haematology and Transplant Unit,	Manchester
United States	Alta Bates Summit Comprehensive Cancer Center	Berkeley	California
United States	Mountain States Tumor Institute	Boise	Idaho
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Robert H. Lurie Comprehensive Cancer Center	Chicago	Illinois
United States	University of Chicago Medical Center	Chicago	Illinois
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Karmanos Cancer Institute/Wayne State University School of Medicine	Detroit	Michigan
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Indiana University Medical center	Indianapolis	Indiana
United States	Baptist Cancer Institute	Jacksonville	Florida
United States	Cancer & Blood Disease Center	Lecanto	Florida
United States	Northwest Georgia Oncology Centers, PC., Wellstar Health System	Marietta	Georgia
United States	Weill Medical College of Cornell University, Division of Hematology & Oncology	New York	New York
United States	Desert Hematology Oncology Medical Group, Inc.	Rancho Mirage	California
United States	Swedish Cancer Institute	Seattle	Washington
United States	LSU Health Sciences Center, Feist-Weiller Cancer Center	Shreveport	Louisiana
United States	SUNY Upstate Medical Center	Syracuse	New York
United States	Arizona Cancer Center	Tucson	Arizona
United States	Abington Hematology Oncology Assoc., Inc.	Willow Grove	Pennsylvania
United States	Wake Forest University School of Medicine	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Italy,  Spain,  Sweden,  United Kingdom, 

References & Publications (1)

Wendtner CM, Hillmen P, Mahadevan D, Bühler A, Uharek L, Coutré 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety		February 2010
Secondary	Response		February 2010
Secondary	Duration of response		February 2010
Secondary	Time to response		February 2010
Secondary	Progression free survival		February 2010
Secondary	Overall survival		February 2010
Secondary	Absolute lymphocyte count		February 2010
Secondary	Evaluation of minimal residual disease (MRD) by flow cytometry		February 2010