Clinical Trial: A Phase I, Multicenter, Open-label, Dose-escalation Study to Assess the Safety of Lenalidomide in Patients With Advanced Adult T-cell Leukemia-lymphoma and Peripheral T-cell Lymphomaperipheral T-cell Lymphoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase I, Multicenter, Open-label, Dose-escalation Study to Assess the Safety of Lenalidomide in Patients With Advanced Adult T-cell Leukemia-lymphoma and Peripheral T-ce

Brief Summary: To determine the maximum tolerated dose of lenalidomide in patients with adult T-cell leukemia-lymphoma (ATL) and peripheral T-cell lymphoma (PTCL) who have previously received therapy for ATL and PTCL

Detailed Summary:
Sponsor: Celgene Corporation

Current Primary Outcome: The safety of lenalidomide evaluated based on the severity of adverse events and their causality [ Time Frame: Up to 2.5 years ]

The safety of lenalidomide evaluated based on the severity of adverse events and their causality


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Response [ Time Frame: Up to 2.5 years ]

    The response of ATL patient to lenalidomide will be evaluated according to the criteria proposed by the International Consensus Meeting.

    The response of PTCL will be assessed by the Japan Clinical Oncology Group (JCOG) response criteria that have been established by the Lymphoma Study Group of the JCOG based on criteria of Cheson et al.in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas

  • PK-Time to Maximum Plasma Concentration (Tmax) [ Time Frame: Day 8 of Cycle 1 ]
    PK-Time to Maximum Plasma Concentration (Tmax)
  • PK-Apparent Total Body Clearance (CL/F) [ Time Frame: Day 8 of Cycle 1 ]
    PK-Apparent Total Body Clearance (CL/F)
  • PK-Apparent Volume of Distribution (Vz/F) [ Time Frame: Day 8 of Cycle 1 ]
    PK-Apparent Volume of Distribution (Vz/F)
  • PK-Terminal half-life (T1/2) [ Time Frame: Day 8 of Cycle 1 ]
    PK-Terminal half-life (T1/2)
  • PK-Area under the Plasma concentration time curve (AUC) [ Time Frame: Day 8 of Cycle 1 ]
    PK-Area under the Plasma concentration time curve (AUC)
  • Accumulation ratio (Cmax) [ Time Frame: Day 8 of Cycle 1 ]
    Accumulation ratio (Cmax)
  • Accumulation ratio (AUCτ) [ Time Frame: Day 8 of Cycle 1 ]
    Accumulation ratio (AUCτ)
  • PK-Maximum Concentration in Plasma (Cmax) [ Time Frame: Day 8 of cycle 1 ]
    PK-Maximum Concentration in Plasma (Cmax)


Original Secondary Outcome:

  • Response [ Time Frame: Up to 2.5 years ]

    The response of ATL patient to lenalidomide will be evaluated according to the criteria proposed by the International Consensus Meeting.

    The response of PTCL will be assessed by the JCOG response criteria that have been established by the Lymphoma Study Group of the JCOG based on criteria of Cheson et al.in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas

  • Pharmacokinetics [ Time Frame: Day 8 of Cycle 1 ]
    Pharmacokinetic (PK) Parameters: Cmax, Tmax, AUCτ, CL/F, Vz/F, t1/2, AR(Cmax), and AR(AUCτ)"


Information By: Celgene Corporation

Dates:
Date Received: July 22, 2010
Date Started: July 2010
Date Completion:
Last Updated: October 27, 2016
Last Verified: October 2016