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Adult T-cell Leukemia-LymphomaPhase 1NCT01169298

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 1 study testing Lenalidomide in people with Adult T-cell Leukemia-Lymphoma and Peripheral T-cell Lymphoma, run by Celgene at 6 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
6 sitesJapan
Study dates
1 Jul 2010to 20 Dec 2013
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject must understand and voluntarily sign the written informed consent;
  • Aged 20 years or older;
  • Subject have a documented diagnosis of either:
  • Acute-, lymphoma-, or unfavorable chronic-type ATL or
  • Peripheral T-cell Lymphomaperipheral (PTCL)
  • 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;
  • Subject have an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 2 at enrollment;

Who cannot join

  • Natural Killer cell lymphoma (NK-cell lymphoma);
  • T-cell leukemia;
  • Cutaneous T-cell lymphoma (CTCL) including;
  • Mycosis fungoides
  • Sezary syndrome
  • CD30-positive lympho-proliferative disorders
Show all 37Show fewer
  • Cutaneous gamma/delta T-cell lymphoma
  • 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;
  • Are pregnant or lactating;
  • 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
  • Exhibit grade 4 neurological disorders;
  • Subject have a history or complication of deep vein thrombosis or pulmonary embolism within 6 months before the start of study treatment;
  • Develop active tuberculous disease, herpes simplex, systemic mycosis, or other active infections requiring systemic administration of antibiotics, antiviral agents, or antifungal drugs;
  • Are tested positive for HBs antigen, anti-HCV antibody, or anti-HIV antibody;
  • 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;
  • Subjects have a history of allogeneic stem cell transplantation;
  • Subjects 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 (bullous) 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 chemotherapeutic agents or immunomodulators for the treatment of ATL or PTCL 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 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)
  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Japan6 sites

  • National Kyusyu Cancer Center

    Fukuoka, 811-1395

  • Imamura Bun-in Hospital

    Kagoshima, 890-0064

  • Kumamoto University Hospital

    Kumamoto, 860-8556

  • Nagasaki University Hospital

    Nagasaki, 852-8501

  • Nagoya Daini Red Cross Hospital

    Nagoya, 466-8650

  • National Cancer Center Hospital

    Tokyo, 104-0045

Other trials in Japan

About this study

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

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

Being tested
Lenalidomide
Keywords
Adult T-cell Leukemia-Lymphoma, Peripheral T-cell Lymphoma, PTCL, HTLV-1
Medical subject headings
Leukemia-Lymphoma, Adult T-Cell, Lymphoma, T-Cell, Peripheral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LenalidomideDrug

    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 groups in NCT01169298
Study groupRoleWhat they receive
LenalidomideExperimentalLenalidomide: 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)
Receives: Drug: Lenalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The safety of lenalidomide evaluated based on the severity of adverse events and their causality

    The safety of lenalidomide evaluated based on the severity of adverse events and their causality

    Measured: Up to 2.5 years

Secondary outcomes (9)

  1. Response

    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

    Measured: Up to 2.5 years

  2. PK-Time to Maximum Plasma Concentration (Tmax)

    PK-Time to Maximum Plasma Concentration (Tmax)

    Measured: Day 8 of Cycle 1

  3. PK-Apparent Total Body Clearance (CL/F)

    PK-Apparent Total Body Clearance (CL/F)

    Measured: Day 8 of Cycle 1

  4. PK-Apparent Volume of Distribution (Vz/F)

    PK-Apparent Volume of Distribution (Vz/F)

    Measured: Day 8 of Cycle 1

  5. PK-Terminal half-life (T1/2)

    PK-Terminal half-life (T1/2)

    Measured: Day 8 of Cycle 1

  6. PK-Area under the Plasma concentration time curve (AUC)

    PK-Area under the Plasma concentration time curve (AUC)

    Measured: Day 8 of Cycle 1

  7. Accumulation ratio (Cmax)

    Accumulation ratio (Cmax)

    Measured: Day 8 of Cycle 1

  8. Accumulation ratio (AUCτ)

    Accumulation ratio (AUCτ)

    Measured: Day 8 of Cycle 1

  9. PK-Maximum Concentration in Plasma (Cmax)

    PK-Maximum Concentration in Plasma (Cmax)

    Measured: Day 8 of cycle 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2010 (estimated)
  2. Study start1 Jul 2010
  3. Primary completion1 Dec 2013
  4. Study completion20 Dec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01169298
Sponsor's protocol ID
CC-5013-ATLL-001
Status last verified
Nov 2019
First submitted
22 Jul 2010
Last updated
8 Nov 2019
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 26947199

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lenalidomide in people with Adult T-cell Leukemia-Lymphoma and Peripheral T-cell Lymphoma, run by Celgene at 6 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01169298, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2019.

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