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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01169298
First received: July 22, 2010
Last updated: March 26, 2014
Last verified: March 2014

July 22, 2010
March 26, 2014
July 2010
December 2013   (final data collection date for primary outcome measure)
The safety of lenalidomide evaluated based on the severity of adverse events and their causality [ Time Frame: Up to 2.5 years ] [ Designated as safety issue: Yes ]
The safety of lenalidomide evaluated based on the severity of adverse events and their causality
Same as current
Complete list of historical versions of study NCT01169298 on ClinicalTrials.gov Archive Site
  • Response [ Time Frame: Up to 2.5 years ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    PK-Time to Maximum Plasma Concentration (Tmax)
  • PK-Apparent Total Body Clearance (CL/F) [ Time Frame: Day 8 of Cycle 1 ] [ Designated as safety issue: No ]
    PK-Apparent Total Body Clearance (CL/F)
  • PK-Apparent Volume of Distribution (Vz/F) [ Time Frame: Day 8 of Cycle 1 ] [ Designated as safety issue: No ]
    PK-Apparent Volume of Distribution (Vz/F)
  • PK-Terminal half-life (T1/2) [ Time Frame: Day 8 of Cycle 1 ] [ Designated as safety issue: No ]
    PK-Terminal half-life (T1/2)
  • PK-Area under the Plasma concentration time curve (AUC) [ Time Frame: Day 8 of Cycle 1 ] [ Designated as safety issue: No ]
    PK-Area under the Plasma concentration time curve (AUC)
  • Accumulation ratio (Cmax) [ Time Frame: Day 8 of Cycle 1 ] [ Designated as safety issue: No ]
    Accumulation ratio (Cmax)
  • Accumulation ratio (AUCτ) [ Time Frame: Day 8 of Cycle 1 ] [ Designated as safety issue: No ]
    Accumulation ratio (AUCτ)
  • PK-Maximum Concentration in Plasma (Cmax) [ Time Frame: Day 8 of cycle 1 ] [ Designated as safety issue: No ]
    PK-Maximum Concentration in Plasma (Cmax)
  • Response [ Time Frame: Up to 2.5 years ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    Pharmacokinetic (PK) Parameters: Cmax, Tmax, AUCτ, CL/F, Vz/F, t1/2, AR(Cmax), and AR(AUCτ)"
Not Provided
Not Provided
 
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
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 Lymphoma

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

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Adult T-cell Leukemia-Lymphoma
  • Peripheral T-cell Lymphoma
Drug: Lenalidomide
Lenalidomide: 25mg daily on day 1-21 of each 28days cycle (1st cohort), 25 mg daily of each 28 days (2nd cohort, or 35 mg daily of each 28 days (3rd cohort)
Experimental: Lenalidomide
Lenalidomide: 25mg daily on day1-21 of each 28days cycle (1st cohort), 25 mg daily of each 28 days (2nd cohort) or 35 mg daily of each 28 days (3rd cohort)
Intervention: Drug: Lenalidomide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
13
December 2014
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Subject must understand and voluntarily sign the written informed consent;
  2. Aged 20 years or older;
  3. Subject have a documented diagnosis of either:

    • Acute-, lymphoma-, or unfavorable chronic-type ATL or
    • Peripheral T-cell Lymphomaperipheral (PTCL)
  4. Subject have received ≥1 prior anti-cancer therapy, have achieved stable disease (SD) or better on their immediately prior therapy and have relapsed or progressed at the time of obtaining signed informed consent;
  5. Subject have an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 2 at enrollment;

Exclusion Criteria:

  1. Natural Killer cell lymphoma (NK-cell lymphoma);
  2. T-cell leukemia;
  3. Cutaneous T-cell lymphoma (CTCL) including;

    • Mycosis fungoides
    • Sezary syndrome
    • CD30-positive lympho-proliferative disorders
    • Cutaneous gamma/delta T-cell lymphoma
  4. Subject have a history of central nervous system (CNS) involvement or present with CNS symptoms, and are diagnosed with CNS lymphoma by cerebrospinal fluid (CSF) cytology examination, head CT scan or brain MRI during the screening;
  5. Are pregnant or lactating;
  6. Subject have uncontrolled inter-current illness including:

    • Uncontrolled diabetes mellitus
    • Chronic congestive heart failure (NYHA Class III or IV)
    • Unstable angina pectoris, angioplasty, stenting, or myocardial infarction (within 6 months before starting the study drug)
    • Clinically significant cardiac arrhythmia that is symptomatic or requires treatment, or asymptomatic sustained ventricular tachycardia
    • Other uncontrolled diseases
  7. Exhibit grade 4 neurological disorders;
  8. Subject have a history or complication of deep vein thrombosis or pulmonary embolism within 6 months before the start of study treatment;
  9. Develop active tuberculous disease, herpes simplex, systemic mycosis, or other active infections requiring systemic administration of antibiotics, antiviral agents, or antifungal drugs;
  10. Are tested positive for HBs antigen, anti-HCV antibody, or anti-HIV antibody;
  11. Subjects have a history or complication for which the investigator or subinvestigator deems them inappropriate for this study, or have serious diseases or mental illness that is likely to be aggravated by participation in this study;
  12. Subjects have a history of allogeneic stem cell transplantation;
  13. Subjects have received autologous stem cell transplantation within 12 weeks (84 days) of the start of study treatment;
  14. Have previously used lenalidomide;
  15. Have a history of desquamating (bullous) rash while taking thalidomide;
  16. Have received any investigational drugs (unapproved drugs in Japan) within 4 weeks (28 days) of the start of study medication;
  17. Have received chemotherapeutic agents or immunomodulators for the treatment of ATL or PTCL within 4 weeks (28 days) of the start of study treatment;
  18. Have received radiotherapy within 4 weeks (28 days) of the start of study treatment;
  19. Have a history or complication of another malignant tumor than ATL or PTCL (excluding malignant tumors below), unless the patients have been free of the disease for 5 years or longer;

    • Cutaneous basal cell carcinoma or squamous cell carcinoma
    • Cervical carcinoma in situ
    • An incidental histological finding of prostate carcinoma (TNM stage T1a or T1b)
  20. Have had any of the following abnormal measurements at screening performed within 1 week (7 days) prior to the enrollment;

    • Neutrophil count: < 1,200/µL (1.2 x 109/L)
    • Platelet count: < 75,000/µL (75 x 109/L)
    • Serum aspartate aminotransferase/ Serum glutamic oxaloacetic transaminase (AST/SGOT) or Alanine transaminase/Serum Glutamic Pyruvate Transaminase (ALT/SGPT): > 3 times the Upper Limit of Normal (ULN)
    • Bilirubin level: > 1.5 times of the ULN
    • Creatinine clearance: < 60 mL/min
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01169298
CC-5013-ATLL-001
Yes
Celgene Corporation
Celgene Corporation
Not Provided
Principal Investigator: Kensei Tobinai, MD., Ph.D National Cancer Center Hospital
Celgene Corporation
March 2014

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