Study of Lenalidomide to Evaluate Safety and Efficacy in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia - Full Text View

Sponsor:	Celgene Corporation
Information provided by (Responsible Party):	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00963105

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 II

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:

MedlinePlus related topics: Acute Lymphocytic Leukemia Chronic Lymphocytic Leukemia Leukemia

Drug Information available for: Lenalidomide CC 5013

U.S. FDA Resources

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: Treatment Arm 1: 5 mg →10 mg →15 mg →20 mg →25 mg/daily Treatment Arm 2: 10 mg →15 mg →20 mg →25 mg/daily Treatment Arm 3: 15 mg →20 mg →25 mg/daily Subjects will continue treatment until disease progression or unacceptable toxicity
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: Treatment Arm 1: 5 mg →10 mg →15 mg →20 mg →25 mg/daily Treatment Arm 2: 10 mg →15 mg →20 mg →25 mg/daily Treatment Arm 3: 15 mg →20 mg →25 mg/daily Subjects will continue treatment until disease progression or unacceptable toxicity
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: Treatment Arm 1: 5 mg →10 mg →15 mg →20 mg →25 mg/daily Treatment Arm 2: 10 mg →15 mg →20 mg →25 mg/daily Treatment Arm 3: 15 mg →20 mg →25 mg/daily Subjects will continue treatment until disease progression or unacceptable toxicity

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

Contacts

Contact: Duong Nguyen	1-908-673-9803	dnguyen@celgene.com
Contact: Jorge Mouro	1-908-673-2252	jmouro@celgene.com

Show 54 Study Locations

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 19, 2011
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 February 09, 2012