Study of Lenalidomide to Evaluate Safety and Efficacy in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
This study is ongoing, but not recruiting participants.
Sponsor:
Celgene Corporation
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00963105
First received: August 20, 2009
Last updated: October 3, 2012
Last verified: October 2012
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Purpose
The purpose of this study is to determine the safety and effectiveness of different dose regimen of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Relapsed or Refractory Chronic Lymphocytic Leukemia |
Drug: lenalidomide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase II, Multi-center, Randomized, Double-blind, Parallel-group Study of the Safety and Efficacy of Different Lenalidomide (Revlimid) Dose Regimens in Subjects With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia |
Resource links provided by NLM:
Further study details as provided by Celgene Corporation:
Primary Outcome Measures:
- Safety [type, frequency, and severity of adverse events (AEs) and relationship of AEs to lenalidomide] [ Time Frame: 24 months post LPFV ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Response rate [per the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines for diagnosis and treatment of CLL (Hallek, 2008)] [ Time Frame: 24 months post LPFV ] [ Designated as safety issue: No ]
- Duration of response, Time to response, Time to progression, Event-free survival, Progression-free survival, Overall survival [ Time Frame: 24 months post LPFV ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 90 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Treatment Arm 1
Treatment Arm 1: 5 mg →10 mg →15 mg →20 mg →25 mg/daily Subjects will continue treatment until disease progression or unacceptable toxicity |
Drug: lenalidomide
Depending on the starting dose, subjects will be allocated in a double-blind fashion to three different regimens and will escalate every 28 days, based on individual subject tolerability, as follows:
|
|
Active Comparator: Treatment Arm 2
Treatment Arm 2: 10 mg →15 mg →20 mg →25 mg/daily Subjects will continue treatment until disease progression or unacceptable toxicity |
Drug: lenalidomide
Depending on the starting dose, subjects will be allocated in a double-blind fashion to three different regimens and will escalate every 28 days, based on individual subject tolerability, as follows:
|
|
Active Comparator: Treatment Arm 3
Treatment Arm 3: 15 mg →20 mg →25 mg/daily Subjects will continue treatment until disease progression or unacceptable toxicity |
Drug: lenalidomide
Depending on the starting dose, subjects will be allocated in a double-blind fashion to three different regimens and will escalate every 28 days, based on individual subject tolerability, as follows:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age ≥ 18 years at the time of signing the informed consent form
- Must be able to adhere to the study visit schedule and other protocol requirements
- Must have a documented diagnosis of B-cell CLL
- Must be relapsed or refractory to at least 1 regimen for treatment of CLL . At least one of the prior treatments must have included a purine analog-based or bendamustine-based regimen
- Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2.
Exclusion Criteria:
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
- Active infections requiring systemic antibiotics
- Systemic treatment for B-cell CLL within 28 days of initiation of lenalidomide treatment
- Alemtuzumab therapy within 120 days of initiating lenalidomide treatment
- Prior therapy with lenalidomide
- History of grade 4 rash due to prior thalidomide treatment
- Planned autologous or allogeneic bone marrow transplantation
- Central nervous system (CNS) involvement as documented by spinal fluid cytology or imaging.
- Uncontrolled hyperthyroidism or hypothyroidism
- Venous thromboembolism within 12 months
- ≥ Grade-2 neuropathy
- Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
- Disease transformation [i.e. Richter's Syndrome (lymphomas) or prolymphocytic leukemia]
- Participation in any clinical study or having taken any investigational therapy within 28 days prior to initiating lenalidomide therapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00963105
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Hide Study LocationsLocations
| United States, California | |
| Moores Cancer Center | |
| La Jolla, California, United States, 92093-0820 | |
| Desert Hematology Oncology Medical Group, Inc. | |
| Rancho Mirage, California, United States, 92270 | |
| Stanford University | |
| Stanford, California, United States, 94305 | |
| United States, Connecticut | |
| Cancer Center of Central Connecticut | |
| Southington, Connecticut, United States, 06489 | |
| United States, Florida | |
| Cancer & Blood Disease Center | |
| Lecanto, Florida, United States, 34461 | |
| United States, Illinois | |
| Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| Robert H. Lurie Comprehensive Cancer Center | |
| Chicago, Illinois, United States, 60611 | |
| United States, Indiana | |
| Indiana University Melvin and Bren Simon Cancer Center | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Michigan | |
| Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201 | |
| United States, New Jersey | |
| Hackensack University Medical Center | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263 | |
| Long Island Jewish Medical Center Biomedical Research Alliance of NY (BRANY) | |
| New Hyde Park, New York, United States, 11042 | |
| United States, North Carolina | |
| Wake Forest University School of Medicine | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
| Gabrail Cancer Center Research | |
| Canton, Ohio, United States, 44718 | |
| The Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Pennsylvania | |
| Drexel University, College of Medicine | |
| Philadelphia, Pennsylvania, United States, 19102 | |
| Canada, Alberta | |
| Cross Cancer Institute University of Alberta | |
| Edmonton, Alberta, Canada, T6G1Z2 | |
| Canada, Ontario | |
| Juravinski Cancer Centre | |
| Hamilton, Ontario, Canada, L8V 1C3 | |
| France | |
| Hôpital Sud | |
| Amiens, France, 80054 | |
| Hopital Avicenne | |
| Bobigny, France, 93009 | |
| CHU de Grenoble | |
| Grenoble Cedex 09, France, 38043 | |
| Centre Jean-Bernard - Clinique Victor Hugo | |
| Le Mans, France, 72000 | |
| Institut Paoli Calmettes | |
| Marseille, France, 13273 | |
| Hôpital Lapeyronie | |
| Montpellier Cedex 05, France, 34295 | |
| Centre Hospitalier de Mulhouse - Hopital Emile Muller | |
| Mulhouse, France, 68100 | |
| Hôpital Pitié Salpétrière | |
| Paris, France, 75013 | |
| CH Perpignan - Hopital Saint-Jean | |
| Perpignan, France, 66046 | |
| CHU Haut-Leveque | |
| Pessac, France, 33600 | |
| Centre Hospitalier Lyon sud | |
| Pierre Bénite, France, 69310 | |
| Hôpital Robert Debré, CHU de Reims | |
| Reims Cedex, France, 51092 | |
| CHU de Rennes Hôpital de Pontchaillou | |
| Rennes Cedex, France, 35033 | |
| CHRU - Hôpital de Brabois | |
| Vandoeuvre cedex, France, 54511 | |
| Germany | |
| Charite Campus Benjamin Franklin | |
| Berlin, Germany, 12203 | |
| Universitaetsklinikum Essen | |
| Essen, Germany, 45122 | |
| Ernst-Moritz-Arndt-Universitaet Greifswald | |
| Greifswald, Germany, 17487 | |
| University of Schleswig Holstein | |
| Kiel, Germany, 24105 | |
| Klinikum der Universität zu Koeln | |
| Koeln, Germany, 50924 | |
| University of Ulm | |
| Ulm, Germany, 89081 | |
| Italy | |
| Clinica Ematologica- A.O.U. San Martino | |
| Genova, Italy, 16132 | |
| U.O. Ematologia "Vito Fazzi" Lecce | |
| Lecce, Italy, 73100 | |
| I.R.C.C.S Ospedale S. Raffaele | |
| Milano, Italy, 20132 | |
| Instito Europeo di Oncologia | |
| Milano, Italy, 20141 | |
| Universita degli Studi di Padova | |
| Padova, Italy, 35128 | |
| Universita degli Studi di Peugla | |
| Perugia, Italy, 06100 | |
| Spain | |
| Hospital Germans Trias I Pujol | |
| Badalona, Spain, 08918 | |
| Hospital Clinic Provincial de Barcelona | |
| Barcelona, Spain, 08036 | |
| Sweden | |
| Karolinska Universitetssjukhuset | |
| Stockholm, Sweden, 141 86 | |
| United Kingdom | |
| St James's Institute of Oncology | |
| Leeds, United Kingdom, LS9 7TF | |
| Bart's and the London NHS Trust - St. Bartholomew's Hospital | |
| London, United Kingdom, EC1A 7BE | |
| The Royal Marsden Hospital | |
| London, United Kingdom, SW3 6JJ | |
| Kings College Hospital | |
| London, United Kingdom, SE5 9RS | |
| Christie Hospital NHS Foundation Trust | |
| Manchester, United Kingdom, M20 4BX | |
Sponsors and Collaborators
Celgene Corporation
Investigators
| Study Director: | Jay Mei, M.D. | Celgene Corporation |
More Information
No publications provided
| Responsible Party: | Celgene Corporation |
| ClinicalTrials.gov Identifier: | NCT00963105 History of Changes |
| Other Study ID Numbers: | CC-5013-CLL-009 |
| Study First Received: | August 20, 2009 |
| Last Updated: | October 3, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lenalidomide Thalidomide Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013