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Trial record 31 of 846 for:    LENALIDOMIDE AND Angiogenesis

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01724177
Recruitment Status : Completed
First Posted : November 9, 2012
Results First Posted : January 5, 2016
Last Update Posted : May 28, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Adult T-Cell Leukemia-Lymphoma
Intervention Drug: Lenalidomide
Enrollment 26
Recruitment Details  
Pre-assignment Details This study included Japanese participants with relapsed or recurrent adult T-cell leukemia (ATL) who had previously received anti- ATL chemotherapy and who were categorized as having acute-lymphoma or unfavorable chronic-type ATL.
Arm/Group Title Lenalidomide
Hide Arm/Group Description Lenalidomide 25 mg administered by mouth (PO) once daily (QD) until progressive disease or unacceptable toxicity
Period Title: Overall Study
Started 26
Safety Population 26 [1]
Completed 0
Not Completed 26
Reason Not Completed
Adverse Event             8
Progressive disease or Relapsed Disease             16
Nervous participant             1
Serious Adverse Event Related             1
[1]
Safety Population includes participants who received at least one dose of lenalidomide
Arm/Group Title Lenalidomide
Hide Arm/Group Description Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity.
Overall Number of Baseline Participants 26
Hide Baseline Analysis Population Description
Intent to treat population consisted of all participants enrolled independent of whether they received study treatment or not.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants
67.5  (7.20)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Female
12
  46.2%
Male
14
  53.8%
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] [2] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants
0 = Fully Active 13
1 = Restrictive but Ambulatory 9
2 = Ambulatory but Unable to Work 4
3 = Limited Self-Care 0
[1]
Measure Description: ECOG performance status is used by doctors and researchers to assess how a subject's disease is progressing, assess how the disease affects the daily living activities of the subject and determine appropriate treatment and prognosis. 0 = Fully Active (Most Favorable Activity); 1 = Restricted activity but ambulatory; 2 = Ambulatory but unable to carry out work activities; 3 = Limited Self-Care; 4 = Completely Disabled, No self-care (Least Favorable Activity)
[2]
Measure Analysis Population Description: Intent to Treat population was defined as all participants who were enrolled in this study independent of whether they received lenalidomide or not.
1.Primary Outcome
Title Percentage of Participants Who Achieved a Complete Response, Unconfirmed Complete Response, or Partial Response as Assessed by the Efficacy-Safety Evaluation Committee (ESEC)
Hide 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
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
Hide Outcome Measure Data
Hide Analysis Population Description
The Efficacy Evaluable (EE) population consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
Overall Number of Participants Analyzed 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
42.3
(23.352 to 63.082)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lenalidomide
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments

A one sample binomial one sided exact test for the ORR (CR, CRu, or PR) was performed to provide the p-value (significance level: 0.05). The hypotheses of interest:

H0: ORR ≤ 5% versus H1: ORR > 5%

Method Exact Test
Comments [Not Specified]
2.Secondary Outcome
Title Kaplan Meier Estimate of Progression Free Survival (PFS) as Assessed by the ESEC
Hide 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
The EE population consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
Overall Number of Participants Analyzed 26
Median (95% Confidence Interval)
Unit of Measure: weeks
16.30
(8.100 to 24.000)
3.Secondary Outcome
Title Kaplan-Meier Estimate of Time to Progression (TTP)
Hide 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
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
Hide Outcome Measure Data
Hide Analysis Population Description
The EE population consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
Overall Number of Participants Analyzed 26
Median (95% Confidence Interval)
Unit of Measure: weeks
16.30
(8.100 to 24.000)
4.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events
Hide 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population was defined as all participants who received at least one dose of lenalidomide. All safety analyses were based on the safety population.
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
Overall Number of Participants Analyzed 26
Measure Type: Number
Unit of Measure: participants
≥ 1 TEAE 26
≥ 1 TEAE Related to Lenalidomide 26
≥ 1 NCI CTCAE Grade (GR) 3 or Greater TEAE 25
≥ 1 NCI CTCAE ≥ GR 3 TEAE Related to Lenalidomide 25
≥ 1 Serious TEAE 11
≥ 1 Serious TEAE Related to Lenalidomide 9
≥ 1 TEAE Leading to Discontinuation 8
≥ 1 Related TEAE Leading to Discontinuation 8
≥ 1 TEAE Leading to Dose Reduction/Interruption 17
≥ 1 related TEAE Leading to Decrease/Interruption 17
≥ 1 TEAE Resulting in Death 0
5.Secondary Outcome
Title Kaplan-Meier Estimate of Duration of Response (DOR) for Responders as Assessed by the ESEC
Hide 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
The EE population who had a documented response and consisted of participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
Lenalidomide 25 mg administered by mouth (PO) once daily (QD) until progressive disease or unacceptable toxicity
Overall Number of Participants Analyzed 11
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: weeks
24.10 [1] 
(2.000 to NA)
[1]
Only one event data observed exceeding the median value, and maximum value was censored data, so the upper bound of confidence interval (CI) could not be estimated
6.Secondary Outcome
Title Percentage of Participants Who Achieved a Complete Response, Unconfirmed Complete Response (CRu), Partial Response or Stable Disease (SD) as Assessed by the ESEC
Hide 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
The EE population with a response (CR, CRu, PR or SD) and consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
Overall Number of Participants Analyzed 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
73.1
(52.213 to 88.427)
7.Secondary Outcome
Title Kaplan-Meier Estimate for Overall Survival
Hide 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
The EE population consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide.
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
Overall Number of Participants Analyzed 26
Median (95% Confidence Interval)
Unit of Measure: weeks
88.10
(43.000 to 109.100)
8.Other Pre-specified Outcome
Title Time to Response
Hide 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)
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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with a response of PR or better.
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
Overall Number of Participants Analyzed 11
Median (Full Range)
Unit of Measure: weeks
8.10
(7.9 to 16.0)
Time Frame From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lenalidomide
Hide Arm/Group Description Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
All-Cause Mortality
Lenalidomide
Affected / at Risk (%)
Total   22/26 (84.62%) 
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide
Affected / at Risk (%)
Total   11/26 (42.31%) 
Blood and lymphatic system disorders   
Thrombocytopenia  1  2/26 (7.69%) 
Anaemia  1  1/26 (3.85%) 
Cardiac disorders   
Acute left ventricular failure  1  1/26 (3.85%) 
Ear and labyrinth disorders   
Vertigo positional  1  1/26 (3.85%) 
General disorders   
Non-cardiac chest pain  1  1/26 (3.85%) 
Pyrexia  1  1/26 (3.85%) 
Hepatobiliary disorders   
Acute hepatic failure  1  1/26 (3.85%) 
Infections and infestations   
Enterocolitis infectious  1  1/26 (3.85%) 
Meningitis bacterial  1  1/26 (3.85%) 
Pneumonia  1  1/26 (3.85%) 
Sinusitis fungal * 2  1/26 (3.85%) 
Investigations   
Blood pressure decreased  1  1/26 (3.85%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumour flare  1  1/26 (3.85%) 
Nervous system disorders   
Syncope  1  1/26 (3.85%) 
Transient ischaemic attack  1  1/26 (3.85%) 
Renal and urinary disorders   
Renal failure acute  1  1/26 (3.85%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary oedema  1  1/26 (3.85%) 
Skin and subcutaneous tissue disorders   
Erythema multiforme  1  1/26 (3.85%) 
Rash  1  2/26 (7.69%) 
Toxic skin eruption  1  1/26 (3.85%) 
1
Term from vocabulary, MedDRA (15.1)
2
Term from vocabulary, MedDra 15.1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lenalidomide
Affected / at Risk (%)
Total   26/26 (100.00%) 
Blood and lymphatic system disorders   
Thrombocytopenia  1  20/26 (76.92%) 
Neutropenia  1  19/26 (73.08%) 
Lymphopenia  1  18/26 (69.23%) 
Anaemia  1  15/26 (57.69%) 
Leukopenia  1  13/26 (50.00%) 
Leukocytosis  1  5/26 (19.23%) 
Basophilia  1  3/26 (11.54%) 
Eosinophilia  1  3/26 (11.54%) 
Disseminated intravascular coagulation  1  2/26 (7.69%) 
Cardiac disorders   
Bradycardia  1  2/26 (7.69%) 
Supraventricular extrasystoles  1  2/26 (7.69%) 
Gastrointestinal disorders   
Constipation  1  8/26 (30.77%) 
Nausea  1  7/26 (26.92%) 
Vomiting  1  6/26 (23.08%) 
Stomatitis  1  3/26 (11.54%) 
Diarrhoea  1  2/26 (7.69%) 
General disorders   
Malaise  1  5/26 (19.23%) 
Fatigue  1  4/26 (15.38%) 
Pyrexia  1  4/26 (15.38%) 
Oedema peripheral  1  2/26 (7.69%) 
Hepatobiliary disorders   
Hepatic function abnormal  1  6/26 (23.08%) 
Hyperbilirubinaemia  1  2/26 (7.69%) 
Immune system disorders   
Hypogammaglobulinaemia  1  2/26 (7.69%) 
Infections and infestations   
Nasopharyngitis  1  4/26 (15.38%) 
Pneumonia  1  2/26 (7.69%) 
Upper respiratory tract infection  1  2/26 (7.69%) 
Injury, poisoning and procedural complications   
Contusion  1  2/26 (7.69%) 
Fall  1  2/26 (7.69%) 
Investigations   
C-reactive protein increased  1  11/26 (42.31%) 
Alanine aminotransferase increased  1  8/26 (30.77%) 
Aspartate aminotransferase increased  1  7/26 (26.92%) 
Blood alkaline phosphatase increased  1  5/26 (19.23%) 
Blood urea increased  1  5/26 (19.23%) 
Blood creatinine increased  1  4/26 (15.38%) 
Differential white blood cell count abnormal  1  3/26 (11.54%) 
Glucose urine present  1  3/26 (11.54%) 
Blood lactate dehydrogenase increased  1  3/26 (11.54%) 
Blood urine present  1  2/26 (7.69%) 
Neutrophil count decreased  1  2/26 (7.69%) 
Weight decreased  1  2/26 (7.69%) 
Eosinophil count increased  1  2/26 (7.69%) 
Basophil count increased  1  2/26 (7.69%) 
Blood albumin decreased  1  2/26 (7.69%) 
Metabolism and nutrition disorders   
Hypoalbuminaemia  1  9/26 (34.62%) 
Hypoproteinaemia  1  9/26 (34.62%) 
Hypocalcaemia  1  8/26 (30.77%) 
Hyponatraemia  1  9/26 (34.62%) 
Hypophosphataemia  1  9/26 (34.62%) 
Hypokalaemia  1  6/26 (23.08%) 
Hyperkalaemia  1  4/26 (15.38%) 
Hyperchloraemia  1  3/26 (11.54%) 
Hypouricaemia  1  3/26 (11.54%) 
Decreased appetite  1  2/26 (7.69%) 
Dehydration  1  2/26 (7.69%) 
Hyperglycaemia  1  2/26 (7.69%) 
Hyperuricaemia  1  2/26 (7.69%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  3/26 (11.54%) 
Muscle spasms  1  2/26 (7.69%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumour flare  1  3/26 (11.54%) 
Nervous system disorders   
Neuropathy peripheral  1  5/26 (19.23%) 
Dysgeusia  1  3/26 (11.54%) 
Psychiatric disorders   
Insomnia  1  3/26 (11.54%) 
Renal and urinary disorders   
Proteinuria  1  2/26 (7.69%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  2/26 (7.69%) 
Upper respiratory tract inflammation  1  2/26 (7.69%) 
Skin and subcutaneous tissue disorders   
Rash  1  6/26 (23.08%) 
Pruritus  1  5/26 (19.23%) 
Rash maculo-papular  1  3/26 (11.54%) 
Drug eruption  1  2/26 (7.69%) 
Dry skin  1  2/26 (7.69%) 
Haemorrhage subcutaneous  1  2/26 (7.69%) 
Toxic skin eruption  1  2/26 (7.69%) 
Vascular disorders   
Phlebitis  1  2/26 (7.69%) 
1
Term from vocabulary, MedDRA (15.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Disclosure agreements varied; the Investigators shall not disclose any material/information disclosed by the Sponsor (Celgene KK) with the clinical trial or information obtained by conducting the clinical trial to third parties without Sponsor's prior written approval.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Anne McClain, Senior Manager, Clinical Trial Disclosure
Organization: Celgene Corporation
Phone: 1-888-260-1599
EMail: ClinicalTrialDisclosure@Celgene.com
Layout table for additonal information
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT01724177     History of Changes
Other Study ID Numbers: CC-5013-ATLL-002
First Submitted: November 7, 2012
First Posted: November 9, 2012
Results First Submitted: September 4, 2015
Results First Posted: January 5, 2016
Last Update Posted: May 28, 2018