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

Information source: Celgene Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Lymphocytic Leukemia; Leukemia, B-Cell, Chronic

Intervention: lenalidomide (Drug); lenalidomide (Drug); lenalidomide (Drug); lenalidomide (Drug); lenalidomide (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Celgene Corporation

Official(s) and/or principal investigator(s):
Elayne Lombardy, MD, Study Director, Affiliation: Celgene Corporation
Asher Chanan-Khan, MD, Principal Investigator, Affiliation: Roswell Park Cancer Institute

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Safety

Secondary outcome:

Response

Duration of response

Time to response

Progression free survival

Overall survival

Absolute lymphocyte count

Evaluation of minimal residual disease (MRD) by flow cytometry

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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)

Locations and Contacts

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

Cross Cancer Institute, Edmonton, Alberta T6G 1Z2, Canada

Arizona Cancer Center, Tucson, Arizona 85724, United States

Charité, Campus Benjamin Franklin, Medizinische Klinik III, Hindenburgdamm 30, Berlin 12203, Germany

Alta Bates Summit Comprehensive Cancer Center, 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

Uniklinik Köln, Klinik I für Innere Medizin, Klinisches Studienzentrum Hämatologie, Bettenhaus Ebene 04, Raum 001/048, Kerpener Str. 62, Koln 50924, Germany

LSU Health Sciences Center, Feist-Weiller Cancer Center, Shreveport, Louisiana 71130, United States

Cancer Care Manitoba, Winnipeg, Manitoba R3E 0V9, Canada

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

Juravinski Cancer Centre, Hamilton, Ontario L8V 5C2, Canada

London Helath Science Centre, London, Ontario N6C 6B5, Canada

Abington Hematology Oncology Assoc., Inc., Willow Grove, Pennsylvania 19090, United States

Saskatoon Cancer Centre, Saskatoon, Saskatchewan S7N 4H4, Canada

University of Texas MD Anderson Cancer Center, Houston, Texas 77030, United States

Swedish Cancer Institute, Seattle, Washington 98104, United States

Additional Information

Starting date: December 2006
Last updated: August 26, 2013

Page last updated: August 23, 2015

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