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NCT01724177 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2018-05-29

To evaluate the efficacy of lenalidomide in patients with Adult T-cell Leukemia-lymphoma (ATL) who have previously received chemotherapy for ATL.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Percentage of Participants Who Achieved a Complete Response, Unconfirmed Complete Response, or Partial Response as Assessed by the Efficacy-Safety Evaluation Committee (ESEC)

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outcome · POSTED

Kaplan Meier Estimate of Progression Free Survival (PFS) as Assessed by the ESEC

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outcome · POSTED

Kaplan-Meier Estimate of Time to Progression (TTP)

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outcome · POSTED

Number of Participants With Treatment Emergent Adverse Events

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outcome · POSTED

Kaplan-Meier Estimate of Duration of Response (DOR) for Responders as Assessed by the ESEC

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outcome · POSTED

Time to Response

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outcome · POSTED

Percentage of Participants Who Achieved a Complete Response, Unconfirmed Complete Response (CRu), Partial Response or Stable Disease (SD) as Assessed by the ESEC

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outcome · POSTED

Kaplan-Meier Estimate for Overall Survival

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility 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.
healthy Volunteers
false
minimum Age
20 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Lenalidomide 25mg by mouth (PO) daily until progressive disease or unacceptable toxicity
    intervention Names
    1. Drug: Lenalidomide
    label
    Lenalidomide
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Lenalidomide
    description
    25 mg of Lenalidomide administered orally once daily
    name
    Lenalidomide
    other Names
    1. Revlimid
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
26
type
ACTUAL
Registered outcome plans (not posted results)
other Outcomes
  1. description
    Time to Response was defined as the time from the first dose of study treatment to the initial documented response (CR or CRu, or PR)
    measure
    Time to Response
    time Frame
    From day 1 of study treatment to first documented response; up to data cut-off date of 19 May 2017; maximum study duration was 134.1 weeks
primary Outcomes
  1. description
    ORR is a Complete Response (CR) + Complete Response unconfirmed (CRu) + Partial Response (PR). A CR requires that target lesions have regressed to normal; nodal non-target lesions have regressed to normal; extranodal non-target lesions have disappeared; hepatomegaly/splenomegaly has disappeared; skin findings are GR 0; peripheral blood is normal; Bone marrow (BM) infiltration is negative and no new lesions. A CRu requires the sum of the product diameters (SPD) of target lesions have decreased by at least 75% from baseline; nodal non-target lesions have regressed to normal size; extranodal non-target lesions have disappeared; hepatomegaly/splenomegaly has disappeared; skin findings are Grade 0; peripheral blood is normal; BM infiltration is "negative" and no new lesions. A PR requires the SPD of target lesions has decreased by at least 50% from baseline; all nodal non-target lesions have regressed to normal or show no increase in size; all extranodal non-target lesions have disappeared
    measure
    Percentage of Participants Who Achieved a Complete Response, Unconfirmed Complete Response, or Partial Response as Assessed by the Efficacy-Safety Evaluation Committee (ESEC)
    time Frame
    From day 1 of study treatment to date of first documented CR, CRU or PR; Up to data cut-off date of 19 May 2017; maximum study duration was 134.1 weeks
secondary Outcomes
  1. description
    PFS was defined as the time from the first dose of study treatment to progressive disease (PD) or death due to any cause on study or within 28 days after study discontinuation, whichever occurred earlier.
    measure
    Kaplan Meier Estimate of Progression Free Survival (PFS) as Assessed by the ESEC
    time Frame
    From day 1 of study treatment to the date of disease progression; up to data cut date of date of 19 May 2017; maximum study duration was 134.1 weeks
  2. description
    Time to progression was calculated as the time from the first dosing of study treatment to the first documented PD and assessed by the ESEC
    measure
    Kaplan-Meier Estimate of Time to Progression (TTP)
    time Frame
    From day 1 of study treatment to the date of disease progression; up to data cut date of 19 May 2017; maximum study duration was 134.1 weeks
  3. description
    Treatment Emergent Adverse Event (TEAE) was defined as any AE occurring on or after the start of study treatment and within 28 days after the last dose. Severity was assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0): Grade 1= Mild Grade 2= Moderate Grade 3= Severe Grade 4= Life-threatening and Grade 5= Death related to AE. Serious AEs (SAEs) were those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.
    measure
    Number of Participants With Treatment Emergent Adverse Events
    time Frame
    From the date of the first dose of study drug up to 28 days after the last dose of study drug; up to data cutoff date of 19 May 2017; maximum treatment duration was 130.1 weeks
  4. description
    The response duration in participants with an objective response was 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 (PD). For participants who did not progress during the study, DOR was censored at the last adequate response assessment not showing evidence of PD.
    measure
    Kaplan-Meier Estimate of Duration of Response (DOR) for Responders as Assessed by the ESEC
    time Frame
    From day 1 of study treatment to first documented response; up to data cut-off date of 19 May 2017; Maximum study duration was 134.1 Weeks
  5. description
    The tumor control rate was measured for those with a response of Complete Remission, + CRu, + PR + Stable Disease (SD) in the EE population based on the best response.
    measure
    Percentage of Participants Who Achieved a Complete Response, Unconfirmed Complete Response (CRu), Partial Response or Stable Disease (SD) as Assessed by the ESEC
    time Frame
    From day 1 of study treatment to first documented response; up to data cut-off date of 19 May 2017; maximum study duration was 134.1 weeks
  6. description
    Overall Survival was defined as the time from the start of study treatment to the death due to any cause. For participants who were still alive at the time of the data cutoff, survival data were censored at the latest available date the participant was known to be alive.
    measure
    Kaplan-Meier Estimate for Overall Survival
    time Frame
    From Day 1 of study treatment to disease progression or death; up to final data cut-off date of 19 May 2017; maximum surivival time was 197.9 weeks
Full study description
brief Summary
To evaluate the efficacy of lenalidomide in patients with Adult T-cell Leukemia-lymphoma (ATL) who have previously received chemotherapy for ATL.
Source references
references
  1. citation
    Ishida T, Fujiwara H, Nosaka K, Taira N, Abe Y, Imaizumi Y, Moriuchi Y, Jo T, Ishizawa K, Tobinai K, Tsukasaki K, Ito S, Yoshimitsu M, Otsuka M, Ogura M, Midorikawa S, Ruiz W, Ohtsu T. Multicenter Phase II Study of Lenalidomide in Relapsed or Recurrent Adult T-Cell Leukemia/Lymphoma: ATLL-002. J Clin Oncol. 2016 Dec;34(34):4086-4093. doi: 10.1200/JCO.2016.67.7732. Epub 2016 Sep 30.
    pmid
    27621400
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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        tion id="_2285"> <h5 id="_2285_toc">Lenalidomide</h5> <p id="_2286" tabindex="-1">In a multicenter phase II study (<a href="/clinicaltrials/NCT01724177">NCT01724177</a>) of 26 patients with relapsed ATL, the overall response rate was 42% (95% CI, 23%&#8211;63%) in patients who received the immunomodulatory age
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        5"> <h5 id="_2285_toc">Lenalidomide</h5> <p id="_2286" tabindex="-1">In a multicenter phase II study (<a href="/clinicaltrials/NCT01724177">NCT01724177</a>) of 26 patients with relapsed ATL, the overall response rate was 42% (95% CI, 23%&#8211;63%) in patients who received the immunomodulatory agent lenalidomi
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      source title
      Peripheral T-Cell Non-Hodgkin Lymphoma Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: May 13, 2025
        datetime
        2025-05-13T12:00:00Z
        display
        May 13, 2025

    Preserved source evidence · Independent clinical review pending · Not medical advice