Clinical Trial: A Phase 2 Study of Lenalidomide in Patients With Relapsed or Recurrent Adult T-cell Leukemia-lymphoma

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Phase 2, Multicenter, Single-arm, Open-label Study to Evaluate the Safety and Efficacy of Lenalidomide in Patients With Relapsed or Recurrent Adult T-cell Leukemia-lymph

Brief Summary: To evaluate the efficacy of lenalidomide in patients with Adult T-cell Leukemia-lymphoma (ATL) who have previously received chemotherapy for ATL.

Detailed Summary:
Sponsor: Celgene

Current Primary Outcome: Overall Response Rate (ORR) Based on the Adult T-cell Leukemia-lymphoma (ATLL) Response Criteria and Assessed by the Efficacy-Safety Evaluation Committee (ESEC) [ Time Frame: Up to the data cut-off of 20 November 2014; maximum time on study treatment was 79.7 weeks ]

ORR is a Complete Response (CR) + Complete Response unconfirmed (CRu) + Partial Response (PR). A CR requires that target lesions have regressed to normal; nodal non-target lesions have regressed to normal; extranodal non-target lesions have disappeared; hepatomegaly/splenomegaly has disappeared; skin findings are GR 0; peripheral blood is normal; Bone marrow (BM) infiltration is negative and no new lesions. A CRu requires the sum of the product diameters (SPD) of target lesions have decreased by at least 75% from baseline; nodal non-target lesions have regressed to normal size; extranodal non-target lesions have disappeared; hepatomegaly/splenomegaly has disappeared; skin findings are Grade 0; peripheral blood is normal; BM infiltration is "negative" and no new lesions. A PR requires the SPD of target lesions has decreased by at least 50% from baseline; all nodal non-target lesions have regressed to normal or show no increase in size; all extranodal non-target lesions have disappeared


Original Primary Outcome: Overall Response Rate [ Time Frame: Up to 3 years ]

The primary endpoint is the overall response rate (Complete Response + Complete Response unconfirmed + Partial Response). The response to lenalidomide will be evaluated according to the criteria proposed at the International Consensus Meeting


Current Secondary Outcome:

  • Kaplan Meier Estimate of Progression Free Survival (PFS) Assessed by ESEC [ Time Frame: Up to the cut-off date of 20 November 2014; maximum time on study treatment was 79.7 weeks ]
    PFS was defined as the time from the first dose of study treatment to progressive disease (PD) or death due to any cause on study or within 28 days after study discontinuation, whichever occurred earlier.
  • Kaplan-Meier Estimate of Time to Progression (TTP) [ Time Frame: Up to data cut-off of 20 November 2014; maximum time on study treatment was 79.7 weeks ]
    Time to progression was calculated as the time from the first dosing of study treatment to the first documented PD and assessed by the ESEC
  • Kaplan-Meier Estimate of Duration of Response (DOR) for Responders [ Time Frame: Up to data cut-off of 20 Nov 2014; maximum time on study treatment was 79.7 weeks ]
    The response duration in participants with an objective response was measured from the date of the first Complete Response or Complete Response unconfirmed or Partial Response to the first date of Relapsed Disease or Progressive Disease (PD). For participants who did not progress during the study, DOR was censored at the last adequate response assessment not showing evidence of PD.
  • Percentage of Participants Who Had a Achieved a CR, CRu, PR or Stable Disease (SD) as Assessed by the ESEC [ Time Frame: Up to the data cut-off of 20 November 2014; maximum time on study treatment was 79.7 weeks ]
    The tumor control rate was measured for those with a response of Complete Remission, + CRu, + PR + Stable Disease (SD) in the EE population based on the best responses.
  • Kaplan-Meier Estimate for Overall Survival [ Time Frame: Up to the data cut-off date of 20 November 2014; maximum time on study treatment was 79.7 weeks ]
    Overall Survival was defined as the time from the start of study treatment to the death due to any cause. For participants who were still alive at the time of the data cutoff, survival data were censored at the latest available date the participant was known to be alive.
  • Number of Participants With Adverse Events [ Time Frame: Up to data cutoff of 20 November 2014; maximum time on study treatment was 79.7 weeks ]
    Treatment Emergent Adverse Event (TEAE) was defined as any AE occurring on or after the start of study treatment and within 28 days after the last dose. Severity was assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0): Grade 1= Mild Grade 2= Moderate Grade 3= Severe Grade 4= Life-threatening and Grade 5= Death related to AE. Serious AEs (SAEs) were those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.


Original Secondary Outcome:

  • Progression Free Survival [ Time Frame: Up to 3 years ]
    Time To Progression calculated as the time from the start of study treatment to the first documented progression.
  • Time to progression [ Time Frame: Up to 3 years ]
    Time To Progression calculated as the time from the start of study treatment to the first documented progression.
  • Adverse Events [ Time Frame: Up to 3 years ]
    Number of patients with adverse events
  • Duration of Response [ Time Frame: Up to 3 years ]
    The response duration in patients with objective responses will be measured from the date of the first Complete Response or Complete Response unconfirmed or Partial Response to the first date of Relapsed Disease or Progressive Disease.
  • Tumor Control Rate [ Time Frame: Up to 3 years ]
    The disease control ratio (Stable Disease or Partial Response or Complete Response unconfirmed or Complete Response)
  • Overall Survival [ Time Frame: Up to 3 years ]
    Overall Survival calculated as the time from the start of study treatment to the death due to any cause


Information By: Celgene

Dates:
Date Received: November 7, 2012
Date Started: November 2012
Date Completion: December 2017
Last Updated: February 1, 2017
Last Verified: February 2017