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

NCT00419250 | Completed Phase 1 DMC

• 1 other identifier: CC-5013-CLL-001
• Study Type: interventional
• Target: 52
• Locations: 7 countries
• Sites: 35

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.

Conditions

Chronic Lymphocytic Leukemia; Leukemia, B-Cell, Chronic

Keywords

relapsed; refractory; fludarabine; Revlimid; lenalidomide; CLL; B-cell CLL; CC-5013; Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

• Safety

  February 2010

Secondary Outcomes (7)

• Response

  February 2010

• Duration of response

  February 2010

• Time to response

  February 2010

• Progression free survival

  February 2010

• Overall survival

  February 2010

Study Arms (5)

dose-escalation to 5 mg lenalidomide (len)

EXPERIMENTAL

escalate up to 5 mg once daily / 28-day cycle

Drug: lenalidomide

dose-escalation to 10 mg lenalidomide (len)

EXPERIMENTAL

escalate up to 10 mg once daily / 28-day cycle

Drug: lenalidomide

dose-escalation to 15 mg lenalidomide (len)

EXPERIMENTAL

escalate up to 15 mg once daily / 28-day cycle

Drug: lenalidomide

dose-escalation to 20 mg lenalidomide (len)

EXPERIMENTAL

escalate up to 20 mg once daily / 28-day cycle

Drug: lenalidomide

dose-escalation to 25 mg lenalidomide (len)

EXPERIMENTAL

escalate up to 25 mg once daily / 28-day cycle

Drug: lenalidomide

Interventions

lenalidomide DRUG

Also known as: Revlimid, CC-5013

dose-escalation to 5 mg lenalidomide (len)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Celgene: lead

Study Sites (35)

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

Alta Bates Summit Comprehensive Cancer Center

Berkeley, California, 94704, United States

Location

Desert Hematology Oncology Medical Group, Inc.

Rancho Mirage, California, 92270, United States

Location

Baptist Cancer Institute

Jacksonville, Florida, 32207, United States

Location

Cancer & Blood Disease Center

Lecanto, Florida, 34461, United States

Location

Northwest Georgia Oncology Centers, PC., Wellstar Health System

Marietta, Georgia, 30060, United States

Location

Mountain States Tumor Institute

Boise, Idaho, 83712, United States

Location

Robert H. Lurie Comprehensive Cancer Center

Chicago, Illinois, 60611, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637-1470, United States

Location

Indiana University Medical center

Indianapolis, Indiana, 46202-5149, United States

Location

LSU Health Sciences Center, Feist-Weiller Cancer Center

Shreveport, Louisiana, 71130, United States

Location

Karmanos Cancer Institute/Wayne State University School of Medicine

Detroit, Michigan, 48201, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Weill Medical College of Cornell University, Division of Hematology & Oncology

New York, New York, 10021, United States

Location

SUNY Upstate Medical Center

Syracuse, New York, 13210, United States

Location

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Abington Hematology Oncology Assoc., Inc.

Willow Grove, Pennsylvania, 19090, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

Cancer Care Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

London Helath Science Centre

London, Ontario, N6C 6B5, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Uniklinik Köln, Klinik I für Innere Medizin, Klinisches Studienzentrum Hämatologie

Bettenhaus Ebene 04, Raum 001/048, Kerpener Str. 62, Koln, 50924, Germany

Location

Charité, Campus Benjamin Franklin, Medizinische Klinik III

Hindenburgdamm 30, State of Berlin, 12203, Germany

Location

University of Schleswig Holstein, Director Medizinische Klinik II

Campus Kiel, Chemnitzstrasse 33, Kiel, 24116, Germany

Location

University of Ulm, Abteilung Innere Medizin III, Robert-Koch-Strasse 8

Ulm, 89081, Germany

Location

Clinica Ematologica- A.O.U. San Martino, Clinica Ematologica Dipartimento di Medicina Interna

Genova, 16132, Italy

Location

Hospital Clinic Provincial de Barcelona, Servicio de Hematología, Institute of Haematology and Oncology

Villaroel, 170, Barcelona, 8036, Spain

Location

Karolinska Universitetssjukhuset, Hematologiskt Centrum, Karolinska Universitetssjukhuset,

Stockholm, 141 86, Sweden

Location

St James's Institute of Oncology, Dept. of Haematology, Level 3, Bexley Wing, Beckett Street

Leeds, LS9 7TF, United Kingdom

Location

Bart's and the London NHS Trust, St. Bartholomew's Hospital, 7th Floor Gloucester House, Cancer Services

London, EC1A 7BE, United Kingdom

Location

Christie Hospital NHS Foundation Trust, Haematology and Transplant Unit,

Manchester, M20 4BX, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 21879809 BACKGROUND

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Recurrence; Leukemia, B-Cell

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Elayne Lombardy, MD

  Celgene Corporation

  STUDY DIRECTOR

• Asher Chanan-Khan, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2007
• First Posted: January 8, 2007
• Study Start: December 1, 2006
• Primary Completion: February 1, 2010
• Study Completion: June 1, 2010
• Last Updated: November 8, 2019

Record last verified: 2019-11

Locations

IT (1); DE (4); CA (5); ES (1); US (20); SE (1); GB (3)