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
  Purpose

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


Condition Intervention Phase
Adult T-cell Leukemia-Lymphoma
Peripheral T-cell Lymphoma
Drug: Lenalidomide
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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-cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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)


Enrollment: 13
Study Start Date: July 2010
Estimated Study Completion Date: December 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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)

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01169298

Locations
Japan
National Kyusyu Cancer Center
Fukuoka, Japan, 811-1395
Imamura Bun-in Hospital
Kagoshima, Japan, 890-0064
Kumamoto University Hospital
Kumamoto, Japan, 860-8556
Nagasaki University Hospital
Nagasaki, Japan, 852-8501
Nagoya Daini Red Cross Hospital
Nagoya, Japan, 466-8650
National Cancer Center Hospital
Tokyo, Japan, 104-0045
Sponsors and Collaborators
Celgene Corporation
Investigators
Principal Investigator: Kensei Tobinai, MD., Ph.D National Cancer Center Hospital
  More Information

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT01169298     History of Changes
Other Study ID Numbers: CC-5013-ATLL-001
Study First Received: July 22, 2010
Last Updated: March 26, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Celgene Corporation:
Adult T-cell Leukemia-Lymphoma
Peripheral T-cell Lymphoma
PTCL
HTLV-1

Additional relevant MeSH terms:
Leukemia
Leukemia, T-Cell
Leukemia-Lymphoma, Adult T-Cell
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Lenalidomide
Thalidomide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on July 26, 2014