Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 22 of 178 for:    LENALIDOMIDE AND Leukemia

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01169298
Recruitment Status : Completed
First Posted : July 26, 2010
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

Tracking Information
First Submitted Date  ICMJE July 22, 2010
First Posted Date  ICMJE July 26, 2010
Last Update Posted Date November 8, 2019
Actual Study Start Date  ICMJE July 1, 2010
Actual Primary Completion Date December 1, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2010)
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 Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01169298 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2012)
  • 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 Measures  ICMJE
 (submitted: July 23, 2010)
  • 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)"
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Adult T-cell Leukemia-Lymphoma
  • Peripheral T-cell Lymphoma
Intervention  ICMJE 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)
Study Arms  ICMJE 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
Publications * Ogura M, Imaizumi Y, Uike N, Asou N, Utsunomiya A, Uchida T, Aoki T, Tsukasaki K, Taguchi J, Choi I, Maruyama D, Nosaka K, Chen N, Midorikawa S, Ohtsu T, Tobinai K. Lenalidomide in relapsed adult T-cell leukaemia-lymphoma or peripheral T-cell lymphoma (ATLL-001): a phase 1, multicentre, dose-escalation study. Lancet Haematol. 2016 Mar;3(3):e107-18. doi: 10.1016/S2352-3026(15)00284-7. Epub 2016 Feb 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 19, 2012)
13
Original Estimated Enrollment  ICMJE
 (submitted: July 23, 2010)
18
Actual Study Completion Date  ICMJE December 20, 2013
Actual Primary Completion Date December 1, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01169298
Other Study ID Numbers  ICMJE CC-5013-ATLL-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Celgene
Study Sponsor  ICMJE Celgene
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Hiroya Asou, MD Celgene KK
PRS Account Celgene
Verification Date November 2019

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