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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Celgene Corporation
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01724177
First received: November 7, 2012
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

To evaluate the efficacy of lenalidomide in patients with ATL who have previously received chemotherapy for ATL.


Condition Intervention Phase
Adult T-Cell Leukemia-Lymphoma
Drug: Lenalidomide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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-lymphoma

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Overall Response Rate [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Progression Free Survival calculated as the time from the start of study treatment to the first documented progression or death due to any cause, whichever occurs first.

  • Adverse Events [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    Number of patients with adverse events

  • Duration of Response [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The disease control ratio (Stable Disease or Partial Response or Complete Response unconfirmed or Complete Response)

  • Overall Survival [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Overall Survival calculated as the time from the start of study treatment to the death due to any cause


Estimated Enrollment: 25
Study Start Date: October 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lenalidomide Drug: Lenalidomide
25 mg of Lenalidomide administered orally once daily
Other Name: Revlimid

  Eligibility

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

Inclusion Criteria:

  • Must understand and voluntarily sign the informed consent
  • Aged 20 years or older (at the time of signing the informed consent)
  • Have a documented diagnosis of either: acute-, lymphoma-, or unfavorable chronic-type adult T-cell leukemia-lymphoma
  • Have received ≥1 prior anti-adult T-cell leukemia-lymphoma therapy, have achieved stable disease or better on their immediately prior therapy and have relapsed or progressed at the time of obtaining signed informed consent
  • Subjects for whom at least 1 measurable lesion (Measurable lesion of computed tomography scan, peripheral blood or skin lesion) is confirmed in the lesion assessment before registration
  • Have an Eastern Cooperative Oncology Group performance status of 0 to 2 at registration
  • Must be able to adhere to the study visit schedule and other protocol requirements
  • Must agree to comply to Lenalidomide Pregnancy Prevention Risk Management Plan

Exclusion Criteria:

  • Have a history of central nervous system involvement or present with central nervous system symptoms, and are diagnosed with central nervous system lymphoma by cerebrospinal fluid cytology examination, head computed tomography scan or brain magnetic resonance imaging during the screening
  • Are pregnant or lactating
  • Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study. Examples of such medical condition are, but are not limited to, as follows:

    • Uncontrolled diabetes mellitus as defined by the investigator or sub-investigator
    • Chronic congestive heart failure (New York Heart Association 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 (subjects with controlled atrial fibrillation that is asymptomatic are eligible for this study)
    • Major surgery within 28 days of the start of study treatment
  • Exhibit grade 4 neurological disorders
  • Patients who are at a high risk for a thromboembolic event and are not willing to take venous thromboembolic prophylaxis.
  • Develop active tuberculous disease, herpes simplex, systemic mycosis, or other active infections requiring systemic administration of antibiotics, antiviral agents, or antifungal drugs
  • Known human immunodeficiency virus positivity
  • Have hepatitis B surface antigen-positive, or hepatitis C virus anti-body positive. In case hepatitis B core antibody and/or hepatitis B surface antibody is positive even if hepatitis B surface antigen-negative, a hepatitis B virus deoxyribonucleic acid test should be performed and if positive the subject will be excluded
  • Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
  • Have a history of allogenic stem cell transplantation
  • Have received autologous stem cell transplantation within 12 weeks (84 days) of the start of study treatment
  • Have previously used lenalidomide
  • Have a history of desquamating (blistering) rash while taking thalidomide
  • Have received any investigational drugs (unapproved drugs in Japan) within 4 weeks (28 days) of the start of study medication
  • Have received any antibody agents within 12 weeks (84 days) of the start of study medication
  • Have received chemotherapeutic agents or immunomodulatory drugs for the treatment of adult T-cell leukemia-lymphoma within 4 weeks (28 days) of the start of study treatment
  • Have received radiotherapy within 4 weeks (28 days) of the start of study treatment
  • Have a history or complication of another malignant tumor other than adult T-cell leukemia-lymphoma and the following malignant tumors, unless the patients have been free of the disease for 5 years or longer

    • Basal cell carcinoma of the skin
    • Squamous cell carcinoma of the skin
    • Cervical carcinoma in situ
    • Carcinoma in situ of the breast
    • An incidental histological finding of prostate carcinoma (TNM stage T1a or T1b)
    • Early-stage gastric cancer treated with endoscopic mucosal resection or endoscopic submucosal dissection
  • Have had any of the following abnormal measurements at screening performed within 1 week (7 days) prior to the registration;

    • Neutrophil count: < 1,200/µL
    • Platelet count: < 75,000/µL
    • Serum aspartate aminotransferase/glutamyl oxaloacetic transaminase or alanine aminotransferase/glutamyl pyruvic transaminase: > 3 times the upper limit of normal
    • Bilirubin level: > 1.5 times the upper limit of normal
    • Creatinine clearance: < 60 mL/min
  • Any condition that confounds the ability to interpret data from the study.
  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: NCT01724177

Contacts
Contact: Tetsuhiro Shiota +81-3-3580-5125 tshiota@celgene.com

Locations
Japan
Nagoya Daini Red Cross Hospital Withdrawn
Nagoya, Aichi, Japan, 466-8650
Nagoya City University Hospital Recruiting
Nagoya, Aichi, Japan, 467-8602
National Cancer Center Hospital East Recruiting
Kashiwa, Chiba, Japan, 277-8577
Ehime University Hospital Recruiting
Toon, Ehime, Japan, 791-0295
Iwate Medical University Hospital Active, not recruiting
Morioka, Iwate, Japan, 020-8505
Tokai University Hospital Withdrawn
Isehara, Kanagawa, Japan, 259-1193
Tohoku University Hospital Recruiting
Sendai, Miyagi, Japan, 980-8574
Sasebo City General Hospital Recruiting
Sasebo, Nagasaki, Japan, 857-8511
Heart Life Hospital Recruiting
Nakagami, Okinawa, Japan, 901-2492
Shimane University Hospital Recruiting
Izumo, Shimane, Japan, 693-8501
National Hospital Organization Kyushu Cancer Center Recruiting
Fukuoka, Japan, 811-1395
Kyushu University Hospital Recruiting
Fukuoka, Japan, 812-8582
Kagoshima University Medical and Dental Hospital Recruiting
Kagoshima, Japan, 890-8520
Imamura Bunin Hospital Recruiting
Kagoshima, Japan, 890-0064
National Hospital Organization Kagoshima Medical Center Recruiting
Kagoshima, Japan, 892-0853
Kumamoto University Hospital Recruiting
Kumamoto, Japan, 860-8556
The Japanese Red Cross Nagasaki Genbaku Hospital Recruiting
Nagasaki, Japan, 852-8511
Nagasaki University Hospital Recruiting
Nagasaki, Japan, 852-8501
Oita Prefectual Hospital Recruiting
Oita, Japan, 870-8511
National Cancer Center Hospital Recruiting
Tokyo, Japan, 104-0045
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Toru Sasaki Celgene K.K.
  More Information

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT01724177     History of Changes
Other Study ID Numbers: CC-5013-ATLL-002
Study First Received: November 7, 2012
Last Updated: March 28, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Celgene Corporation:
Lenalidomide
ATL
ATLL

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

ClinicalTrials.gov processed this record on August 28, 2014