Trial record 1 of 1 for:    NCT00963105
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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: August 7, 2014
Last verified: August 2014
  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: up to 55 months ] [ Designated as safety issue: Yes ]
    Number, type, frequency, and severity of adverse events (AEs) and treatment emergent adverse events associated to lenalidomide


Secondary Outcome Measures:
  • Response rate (RR); International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines for diagnosis and treatment of CLL [ Time Frame: up to 55 months ] [ Designated as safety issue: No ]
    Best response during the treatment period will be assessed by the IwCLL guidelines for diagnosis and treatment of CLL (Hailek, 2008)

  • Duration of response (DOR) [ Time Frame: up to 55 months ] [ Designated as safety issue: No ]
    The duration of response is defined as the time from first visit or at least partial response was documented until PD.

  • Time to response (TTR) [ Time Frame: up to 55 months ] [ Designated as safety issue: No ]
    Time to first response is calculated as the time from randomization to the first document date of at least partial response

  • Time to progression (TTP) [ Time Frame: up to 55 months ] [ Designated as safety issue: No ]
    TTP is defined as the time from randomization to the first documented progression.

  • Event-Free survival (EFS) [ Time Frame: up to 55 months ] [ Designated as safety issue: No ]
    EFS is the interval between the start of treatment to the first sign of disease progression, or treatment for relapse or death (whichever comes first)

  • Progression Free survival (PFS) [ Time Frame: up to 55 months ] [ Designated as safety issue: No ]
    PFS is defined as the time randomization to the first observation of disease progression or death due to any cause during or after the treatment period, whichever occurs first.

  • Overall Survival (OS) [ Time Frame: up to 55 months ] [ Designated as safety issue: No ]
    Overall survival (OS) was defined as the time from randomization to death of any cause.


Enrollment: 103
Study Start Date: July 2009
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: January 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00963105

  Show 52 Study Locations
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Sabine De Bedout, M.D., MPH 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: August 7, 2014
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
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 19, 2014