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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
ClinicalTrials.gov Identifier:
NCT00963105
First received: August 20, 2009
Last updated: May 10, 2017
Last verified: May 2017
  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: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: A Phase 2, Multi-Center, Randomized, Double-Blinded, Parallel Group Study of the Safety and Efficacy of Different Lenalidomide 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:

Primary Outcome Measures:
  • Safety [type, frequency, and severity of adverse events (AEs) and relationship of AEs to lenalidomide] [ Time Frame: up to 55 months ]
    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 ]
    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 ]
    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 ]
    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 ]
    TTP is defined as the time from randomization to the first documented progression.

  • Event-Free survival (EFS) [ Time Frame: up to 55 months ]
    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 ]
    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 ]
    Overall survival (OS) was defined as the time from randomization to death of any cause.


Enrollment: 104
Actual Study Start Date: October 19, 2009
Estimated Study Completion Date: September 11, 2017
Estimated Primary Completion Date: September 11, 2017 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Investigators
Study Director: Kenichi Takeshita, M.D., MPH Celgene Corporation
  More Information

Publications:
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT00963105     History of Changes
Other Study ID Numbers: CC-5013-CLL-009
Study First Received: August 20, 2009
Last Updated: May 10, 2017

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Lenalidomide
Thalidomide
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on June 26, 2017