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Trial record 15 of 792 for:    LENALIDOMIDE AND cells

A Phase II Study of Single-Agent Lenalidomide in Subjects With Relapsed Or Refractory T-Cell Non-Hodgkin's Lymphoma (EXPECT)

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: NCT00655668
Recruitment Status : Terminated (Decision not to pursue as single agent in the study population.)
First Posted : April 10, 2008
Results First Posted : January 5, 2012
Last Update Posted : March 1, 2017
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 T-cell Non-Hodgkin's Lymphoma
Intervention Drug: Lenalidomide
Enrollment 54
Recruitment Details Recruiting began March 2008; first participant enrolled 16 June 2008 and last participant enrolled 29 January 2010.
Pre-assignment Details Participants with relapsed or refractory, biopsy-proven, T-cell Non-Hodgkin's Lymphoma. Must have received at least one prior chemotherapy regimen which contained two cytotoxic agents.
Arm/Group Title Single Agent Lenalidomide
Hide Arm/Group Description Oral lenalidomide 25 mg daily for 21 days every 28 days as tolerated for up to 24 months, until disease progression, or an unacceptable adverse event occurs.
Period Title: Overall Study
Started 54 [1]
Completed 0 [2]
Not Completed 54
Reason Not Completed
Adverse Event             6
Death             5
Disease Progression             27
Study Terminated             9
Other             1
New Lymphoma Treatment Started             4
Withdrawal by Subject             2
[1]
Planned enrollment: 80 participants
[2]
Participants dosed up to 24 months, disease progression or unacceptable adverse events developed.
Arm/Group Title Single Agent Lenalidomide
Hide Arm/Group Description Oral lenalidomide 25 mg daily for 21 days every 28 days as tolerated for up to 24 months, until disease progression, or an unacceptable adverse event occurs.
Overall Number of Baseline Participants 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 54 participants
63.2  (11.25)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 54 participants
<=18 years 0
>18 years and < = 65 years 28
>65 years 26
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
Female
18
  33.3%
Male
36
  66.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 54 participants
American Indian or Alaska Native 0
Asian/Pacific Islander 3
Black 4
Hispanic 1
White 45
Other 1
Missing 0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 54 participants
France 40
United States 3
Belgium 3
Australia 8
Non-Hodgkin's Lymphoma Diagnosis/Histopathology   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 54 participants
Anaplastic large cell lymphoma, primary cutaneous 1
Anaplastic large cell lymphoma, primary systemic 3
Angioimmunoblastic T-cell lymphoma 26
Cutaneous T-cell lymphoma, mycosis fungoides var. 3
Extranodal NK T-cell lymphoma, nasal type 1
Peripheral T-cell lymphoma, not otherwise charac 20
[1]
Measure Description:

Non-Hodgkin's Lymphoma Diagnosis/Histopathology as assessed by local laboratory at study baseline.

Cutaneous T-cell lymphoma,mycosis fungoides varient Extranodal Natural Killer (NK)T-cell lymphoma, nasal type Peripheral T-cell lymphoma, not otherwise characterized

1.Primary Outcome
Title Participants Categorized by Best Response as Determined by Investigator
Hide Description

Participant response assessed by investigator; criteria by B. Cheson in Journal of Clinical Oncology, 1999 (see article for more detail):

  • Complete Response(CR): Complete disappearance of all detectable disease
  • Complete Response Unconfirmed(CRu): CR, but indeterminate bone marrow
  • Partial Response(PR): >50% decrease in six largest nodes/nodal masses
  • Stable Disease(SD): Less than PR, but not progressive disease
  • Relapsed Disease: In CR/CRu Patients, new lesions seen or increased by >=50% in previous sites
  • Progressive Disease(PD): >=50% increase from low in PR/Non-Responders
Time Frame Up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) Population
Arm/Group Title Single Agent Lenalidomide
Hide Arm/Group Description:
Oral lenalidomide 25 mg daily for 21 days every 28 days as tolerated for up to 24 months, until disease progression, or an unacceptable adverse event occurs.
Overall Number of Participants Analyzed 54
Measure Type: Number
Unit of Measure: Participants
Complete Response (CR) 4
Complete Response Unconfirmed (CRu) 2
Partial Response (PR) 6
Stable Disease (SD) 16
Progressive Disease (PD) 16
No Response Assessment 9
Other 1
Tumor Control (CR+CRu+PR+SD) 28
2.Secondary Outcome
Title Duration of Response
Hide Description Kaplan-Meier Estimate of duration of response calculated as the time from first computed tomography (CT) Scan or magnetic resonance imaging (MRI) that demonstrates at least a partial response to the first documentation of disease progression, including death due to Non-Hodgkin's Lymphoma.
Time Frame Up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) Population
Arm/Group Title Single Agent Lenalidomide
Hide Arm/Group Description:
Oral lenalidomide 25 mg daily for 21 days every 28 days as tolerated for up to 24 months, until disease progression, or an unacceptable adverse event occurs.
Overall Number of Participants Analyzed 54
Median (95% Confidence Interval)
Unit of Measure: Months
3.55
(3.1562 to 7.6274)
3.Secondary Outcome
Title Time-to-Progression
Hide Description Kaplan-Meier estimate of time-to-progression is calculated as the time from the start of study drug therapy to the first documentation of progressive disease.
Time Frame Up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Due to early termination of study, data not analyzed. See outcome #4 for progression-free survival.
Arm/Group Title Single Agent Lenalidomide
Hide Arm/Group Description:
Oral lenalidomide 25 mg daily for 21 days every 28 days as tolerated for up to 24 months, until disease progression, or an unacceptable adverse event occurs.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Progression-Free Survival
Hide Description Kaplan-Meier estimate of progression-free survival is defined as the start of study drug therapy to the first observation of disease progression or death due to any cause.
Time Frame Up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) Population
Arm/Group Title Single Agent Lenalidomide
Hide Arm/Group Description:
Oral lenalidomide 25 mg daily for 21 days every 28 days as tolerated for up to 24 months, until disease progression, or an unacceptable adverse event occurs.
Overall Number of Participants Analyzed 54
Median (95% Confidence Interval)
Unit of Measure: Months
2.53
(1.7753 to 4.6356)
5.Secondary Outcome
Title Safety
Hide Description Summary of Treatment-Emergent Events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE, Version 3: Following is the scale: Grade 1=Mild Adverse Event (AE), Grade 2=Moderate AE, Grade 3=Severe and Undesirable AE, Grade 4=Life-threatening or Disabling AE, and Grade 5=Death Related to AE.)
Time Frame Up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population (received at least one dose of study drug)
Arm/Group Title Single Agent Lenalidomide
Hide Arm/Group Description:
Oral lenalidomide 25 mg daily for 21 days every 28 days as tolerated for up to 24 months, until disease progression, or an unacceptable adverse event occurs.
Overall Number of Participants Analyzed 54
Measure Type: Number
Unit of Measure: Participants
At least 1 adverse event (AE) 53
At least 1 AE related to drug 40
At least 1 NCI CTCAE Grade 3-4 AE 34
At least 1 NCI CTCAE Gr 3-4 AE related to drug 19
At least 1 serious adverse event (SAE) 29
At least 1 SAE related to drug 16
At least 1 AE leading to drug withdrawal (WD) 21
At least 1 AE leading to drug interruption/WD 19
Time Frame Up to 24 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single Agent Lenalidomide
Hide Arm/Group Description Oral lenalidomide 25 mg daily for 21 days every 28 days as tolerated for up to 24 months, until disease progression, or an unacceptable adverse event occurs.
All-Cause Mortality
Single Agent Lenalidomide
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Single Agent Lenalidomide
Affected / at Risk (%)
Total   29/54 (53.70%) 
Blood and lymphatic system disorders   
Anaemia  1  2/54 (3.70%) 
Febrile neutropenia  1  2/54 (3.70%) 
Haemolytic anaemia  1  1/54 (1.85%) 
Leukopenia  1  1/54 (1.85%) 
Lymph Node Pain  1  1/54 (1.85%) 
Neutropenia  1  3/54 (5.56%) 
Thrombocytopenia  1  3/54 (5.56%) 
Cardiac disorders   
Arrhythmia  1  1/54 (1.85%) 
Tachycardia  1  1/54 (1.85%) 
Congenital, familial and genetic disorders   
Aplasia  1  1/54 (1.85%) 
Endocrine disorders   
Hypothyroidism  1  1/54 (1.85%) 
Eye disorders   
Occular Vasculitis  1  1/54 (1.85%) 
Gastrointestinal disorders   
Odynophagia  1  1/54 (1.85%) 
General disorders   
Asthenia  1  2/54 (3.70%) 
General Physical Health Deterioration  1  3/54 (5.56%) 
Hyperthermia  1  1/54 (1.85%) 
Oedema Peripheral  1  1/54 (1.85%) 
Pyrexia  1  2/54 (3.70%) 
Infections and infestations   
Bacterial Sepsis  1  1/54 (1.85%) 
Cytomegalovirus Infection  1  1/54 (1.85%) 
Infection  1  1/54 (1.85%) 
Neutropenic Infection  1  1/54 (1.85%) 
Neutropenic Sepsis  1  1/54 (1.85%) 
Oral Candidiasis  1  1/54 (1.85%) 
Pneumonia  1  3/54 (5.56%) 
Pneumonia Pneumococcal  1  1/54 (1.85%) 
Sepsis  1  2/54 (3.70%) 
Septic Shock  1  1/54 (1.85%) 
Investigations   
Prothrombin Level Decreased  1  1/54 (1.85%) 
Metabolism and nutrition disorders   
Decreased Appetite  1  2/54 (3.70%) 
Hyperglycaemia  1  1/54 (1.85%) 
Musculoskeletal and connective tissue disorders   
Back Pain  1  1/54 (1.85%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Histiocytosis Haematophagic  1  1/54 (1.85%) 
Kaposi's Sarcoma  1  1/54 (1.85%) 
Metastasis  1  1/54 (1.85%) 
Peripheral T-cell Lymphoma Unspecified  1  1/54 (1.85%) 
Tumour Flare  1  1/54 (1.85%) 
Nervous system disorders   
Ataxia  1  1/54 (1.85%) 
Carotid Artery Stenosis  1  1/54 (1.85%) 
Cerebral Ischaemia  1  1/54 (1.85%) 
Somnolence  1  1/54 (1.85%) 
Syncope  1  2/54 (3.70%) 
Transient Ischaemic Attack  1  1/54 (1.85%) 
Psychiatric disorders   
Confusional State  1  1/54 (1.85%) 
Renal and urinary disorders   
Renal Failure  1  1/54 (1.85%) 
Respiratory, thoracic and mediastinal disorders   
Acute Pulmonary Oedema  1  1/54 (1.85%) 
Acute Respiratory Distress Syndrome  1  1/54 (1.85%) 
Bronchopneumopathy  1  1/54 (1.85%) 
Dyspnoea  1  4/54 (7.41%) 
Lung Infiltration  1  1/54 (1.85%) 
Skin and subcutaneous tissue disorders   
Drug Eruption  1  1/54 (1.85%) 
Toxic Epidermal Necrolysis  1  1/54 (1.85%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Single Agent Lenalidomide
Affected / at Risk (%)
Total   53/54 (98.15%) 
Blood and lymphatic system disorders   
Anaemia  1  7/54 (12.96%) 
Neutropenia  1  9/54 (16.67%) 
Thrombocytopenia  1  10/54 (18.52%) 
Gastrointestinal disorders   
Abdominal Pain  1  5/54 (9.26%) 
Constipation  1  12/54 (22.22%) 
Diarrhoea  1  8/54 (14.81%) 
Dry Mouth  1  3/54 (5.56%) 
Dysphagia  1  6/54 (11.11%) 
Nausea  1  7/54 (12.96%) 
Rectal Haemorrhage  1  3/54 (5.56%) 
Stomatitis  1  3/54 (5.56%) 
Vomiting  1  6/54 (11.11%) 
General disorders   
Asthenia  1  11/54 (20.37%) 
Fatigue  1  5/54 (9.26%) 
Oedema Peripheral  1  8/54 (14.81%) 
Pain  1  3/54 (5.56%) 
Pyrexia  1  14/54 (25.93%) 
Investigations   
Weight Decreased  1  6/54 (11.11%) 
Musculoskeletal and connective tissue disorders   
Back Pain  1  3/54 (5.56%) 
Muscle Spasms  1  3/54 (5.56%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumour Flare  1  3/54 (5.56%) 
Nervous system disorders   
Headache  1  6/54 (11.11%) 
Paraesthesia  1  3/54 (5.56%) 
Psychiatric disorders   
Anxiety  1  5/54 (9.26%) 
Renal and urinary disorders   
Renal Failure Acute  1  3/54 (5.56%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  5/54 (9.26%) 
Dyspnoea  1  5/54 (9.26%) 
Oropharyngeal Pain  1  4/54 (7.41%) 
Skin and subcutaneous tissue disorders   
Night Sweats  1  5/54 (9.26%) 
Pruritus  1  5/54 (9.26%) 
Rash  1  6/54 (11.11%) 
Vascular disorders   
Hypotension  1  4/54 (7.41%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
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.
Results from a center cannot be submitted for publication before results of multicenter study are published unless it is more than 1 year since study completion. Then, Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to 90 days. Investigator must delete confidential information before submission or defer publication to permit patent applications.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Associate Director, Clinical Trial Disclosure
Organization: Celgene
Phone: 1-888-260-1599
EMail: clinicaltrialdisclosure@celgene.com
Layout table for additonal information
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT00655668     History of Changes
Other Study ID Numbers: CC-5013-TCL-001
2007-002171-13 ( EudraCT Number )
First Submitted: April 4, 2008
First Posted: April 10, 2008
Results First Submitted: November 30, 2011
Results First Posted: January 5, 2012
Last Update Posted: March 1, 2017