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:

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

History of Changes

Tracking Information

First Received Date ^ICMJE

August 20, 2009

Last Updated Date

October 3, 2012

Start Date ^ICMJE

July 2009

Estimated Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00963105 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Relapsed or Refractory Chronic Lymphocytic Leukemia

Intervention ^ICMJE

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

Study Arm (s)

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

Intervention: Drug: lenalidomide
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

Intervention: Drug: lenalidomide
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

Intervention: Drug: lenalidomide

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2013

Estimated Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

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

Administrative Information

NCT Number ^ICMJE

NCT00963105

Other Study ID Numbers ^ICMJE

CC-5013-CLL-009

Has Data Monitoring Committee

Yes

Responsible Party

Celgene Corporation

Study Sponsor ^ICMJE

Celgene Corporation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Jay Mei, M.D.

Celgene Corporation

Information Provided By

Celgene Corporation

Verification Date

October 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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