Adult T-Cell Leukemia-LymphomaPhase 2NCT01724177
A Phase 2 Study of Lenalidomide in Patients With Relapsed or Recurrent Adult T-cell Leukemia-lymphoma
A Phase 2 study testing Lenalidomide in people with Adult T-Cell Leukemia-Lymphoma, run by Celgene at 18 sites in Japan.
Trial summary
To evaluate the efficacy of lenalidomide in patients with Adult T-cell Leukemia-lymphoma (ATL) who have previously received chemotherapy for ATL. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Adult T-Cell Leukemia-Lymphoma
- What is being tested?
- Lenalidomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 18 sitesJapan
- Study dates
- 12 Nov 2012to 21 Mar 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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
Who cannot join
- 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)
Show all 36Show fewer
- 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.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Japan18 sites
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395
Kyushu University Hospital
Fukuoka, 812-8582
Shimane University Hospital
Izumo, Shimane, 693-8501
Imamura Bunin Hospital
Kagoshima, 890-0064
Kagoshima University Medical and Dental Hospital
Kagoshima, 890-8520
National Hospital Organization Kagoshima Medical Center
Kagoshima, 892-0853
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
Kumamoto University Hospital
Kumamoto, 860-8556
Iwate Medical University Hospital
Morioka, Iwate, 020-8505
Nagasaki University Hospital
Nagasaki, 852-8501
The Japanese Red Cross Nagasaki Genbaku Hospital
Nagasaki, 852-8511
Nagoya City University Hospital
Nagoya, Aichi-ken, 467-8602
Heart Life Hospital
Nakagami, Okinawa, 901-2492
Oita Prefectual Hospital
Ōita, 870-8511
Sasebo City General Hospital
Sasebo, Nagasaki, 857-8511
Tohoku University Hospital
Sendai, Miyagi, 980-8574
National Cancer Center Hospital
Tokyo, 104-0045
Ehime University Hospital
Tōon, Ehime, 791-0295
About this study
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
To evaluate the efficacy of lenalidomide in patients with Adult T-cell Leukemia-lymphoma (ATL) who have previously received chemotherapy for ATL.
- Conditions
- Adult T-Cell Leukemia-Lymphoma
- Being tested
- Lenalidomide
- Keywords
- Lenalidomide, ATL, ATLL
- Medical subject headings
- Leukemia-Lymphoma, Adult T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
Also called Revlimid
25 mg of Lenalidomide administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| Lenalidomide | Experimental | Lenalidomide 25mg by mouth (PO) daily until progressive disease or unacceptable toxicity Receives: Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Achieved a Complete Response, Unconfirmed Complete Response, or Partial Response as Assessed by the Efficacy-Safety Evaluation Committee (ESEC)
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
Measured: 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 (6)
Kaplan Meier Estimate of Progression Free Survival (PFS) as Assessed by the ESEC
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.
Measured: 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
Kaplan-Meier Estimate of Time to Progression (TTP)
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
Measured: 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
Number of Participants With Treatment Emergent Adverse Events
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.
Measured: 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
Kaplan-Meier Estimate of Duration of Response (DOR) for Responders as Assessed by the ESEC
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.
Measured: 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
Percentage of Participants Who Achieved a Complete Response, Unconfirmed Complete Response (CRu), Partial Response or Stable Disease (SD) as Assessed by the ESEC
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.
Measured: 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
Kaplan-Meier Estimate for Overall Survival
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2012 (estimated)
- Study start12 Nov 2012
- Primary completion20 Nov 2014
- Study completion21 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adult T-Cell Leukemia-LymphomaStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Toru Sasaki, Study director, Celgene K.K.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01724177
- Sponsor's protocol ID
- CC-5013-ATLL-002
- Status last verified
- Mar 2018
- First submitted
- 7 Nov 2012
- Last updated
- 29 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 27621400
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01724177
- Acronym / sponsor ID
- CC-5013-ATLL-002
- Conditions
- Adult T-Cell Leukemia-Lymphoma
- Keywords
- Lenalidomide, ATL, ATLL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2012 (actual)
- Primary completion
- 20 Nov 2014 (actual)
- Study completion
- 21 Mar 2017 (actual)
- First posted
- 9 Nov 2012 (estimated)
- Results
- Posted 5 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy of lenalidomide in patients with Adult T-cell Leukemia-lymphoma (ATL) who have previously received chemotherapy for ATL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenalidomide | Experimental | Drug: LenalidomideLenalidomide 25mg by mouth (PO) daily until progressive disease or unacceptable toxicity |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (36 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LenalidomideAlso: Revlimid25 mg of Lenalidomide administered orally once daily | Drug | Lenalidomide |
Primary outcome
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
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
6 secondary outcomes
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
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
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
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27621400Ishida 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Toru Sasaki study director
Celgene K.K.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lenalidomide in people with Adult T-Cell Leukemia-Lymphoma, run by Celgene at 18 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 8 inclusion and 36 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 29 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
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). 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 NCT01724177, 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 29 May 2018.