Trial Outcomes & Findings for A Phase II Study of Single-Agent Lenalidomide in Subjects With Relapsed Or Refractory T-Cell Non-Hodgkin's Lymphoma (NCT NCT00655668)
NCT ID: NCT00655668
Last Updated: 2019-11-25
Results Overview
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
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
54 participants
Primary outcome timeframe
Up to 24 months
Results posted on
2019-11-25
Participant Flow
Recruiting began March 2008; first participant enrolled 16 June 2008 and last participant enrolled 29 January 2010.
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.
Participant milestones
| Measure |
Single Agent Lenalidomide
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 Study
STARTED
|
54
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
54
|
Reasons for withdrawal
| Measure |
Single Agent Lenalidomide
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 Study
Adverse Event
|
6
|
|
Overall Study
Death
|
5
|
|
Overall Study
Disease Progression
|
27
|
|
Overall Study
Study Terminated
|
9
|
|
Overall Study
Other
|
1
|
|
Overall Study
New Lymphoma Treatment Started
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
A Phase II Study of Single-Agent Lenalidomide in Subjects With Relapsed Or Refractory T-Cell Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
Single Agent Lenalidomide
n=54 Participants
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.
|
|---|---|
|
Age, Continuous
|
63.2 years
STANDARD_DEVIATION 11.25 • n=5 Participants
|
|
Age, Customized
<=18 years
|
0 participants
n=5 Participants
|
|
Age, Customized
>18 years and < = 65 years
|
28 participants
n=5 Participants
|
|
Age, Customized
>65 years
|
26 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
45 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 participants
n=5 Participants
|
|
Region of Enrollment
France
|
40 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
8 participants
n=5 Participants
|
|
Non-Hodgkin's Lymphoma Diagnosis/Histopathology
Anaplastic large cell lymphoma, primary cutaneous
|
1 Participants
n=5 Participants
|
|
Non-Hodgkin's Lymphoma Diagnosis/Histopathology
Anaplastic large cell lymphoma, primary systemic
|
3 Participants
n=5 Participants
|
|
Non-Hodgkin's Lymphoma Diagnosis/Histopathology
Angioimmunoblastic T-cell lymphoma
|
26 Participants
n=5 Participants
|
|
Non-Hodgkin's Lymphoma Diagnosis/Histopathology
Cutaneous T-cell lymphoma, mycosis fungoides var.
|
3 Participants
n=5 Participants
|
|
Non-Hodgkin's Lymphoma Diagnosis/Histopathology
Extranodal NK T-cell lymphoma, nasal type
|
1 Participants
n=5 Participants
|
|
Non-Hodgkin's Lymphoma Diagnosis/Histopathology
Peripheral T-cell lymphoma, not otherwise charac
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: Intent-to-treat (ITT) Population
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
Outcome measures
| Measure |
Single Agent Lenalidomide
n=54 Participants
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.
|
|---|---|
|
Participants Categorized by Best Response as Determined by Investigator
Complete Response (CR)
|
4 Participants
|
|
Participants Categorized by Best Response as Determined by Investigator
Complete Response Unconfirmed (CRu)
|
2 Participants
|
|
Participants Categorized by Best Response as Determined by Investigator
Partial Response (PR)
|
6 Participants
|
|
Participants Categorized by Best Response as Determined by Investigator
Stable Disease (SD)
|
16 Participants
|
|
Participants Categorized by Best Response as Determined by Investigator
Progressive Disease (PD)
|
16 Participants
|
|
Participants Categorized by Best Response as Determined by Investigator
No Response Assessment
|
9 Participants
|
|
Participants Categorized by Best Response as Determined by Investigator
Other
|
1 Participants
|
|
Participants Categorized by Best Response as Determined by Investigator
Tumor Control (CR+CRu+PR+SD)
|
28 Participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Intent-to-treat (ITT) Population
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.
Outcome measures
| Measure |
Single Agent Lenalidomide
n=54 Participants
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.
|
|---|---|
|
Duration of Response
|
3.55 Months
Interval 3.1562 to 7.6274
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Due to early termination of study, data not analyzed. See outcome #4 for progression-free survival.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Intent-to-treat (ITT) Population
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.
Outcome measures
| Measure |
Single Agent Lenalidomide
n=54 Participants
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.
|
|---|---|
|
Progression-Free Survival
|
2.53 Months
Interval 1.7753 to 4.6356
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Safety Population (received at least one dose of study drug)
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.)
Outcome measures
| Measure |
Single Agent Lenalidomide
n=54 Participants
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.
|
|---|---|
|
Safety
At least 1 adverse event (AE)
|
53 Participants
|
|
Safety
At least 1 AE related to drug
|
40 Participants
|
|
Safety
At least 1 NCI CTCAE Grade 3-4 AE
|
34 Participants
|
|
Safety
At least 1 NCI CTCAE Gr 3-4 AE related to drug
|
19 Participants
|
|
Safety
At least 1 serious adverse event (SAE)
|
29 Participants
|
|
Safety
At least 1 SAE related to drug
|
16 Participants
|
|
Safety
At least 1 AE leading to drug withdrawal (WD)
|
21 Participants
|
|
Safety
At least 1 AE leading to drug interruption/WD
|
19 Participants
|
Adverse Events
Single Agent Lenalidomide
Serious events: 29 serious events
Other events: 53 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single Agent Lenalidomide
n=54 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.7%
2/54 • Up to 24 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.7%
2/54 • Up to 24 months
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
1.9%
1/54 • Up to 24 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.9%
1/54 • Up to 24 months
|
|
Blood and lymphatic system disorders
Lymph Node Pain
|
1.9%
1/54 • Up to 24 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.6%
3/54 • Up to 24 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.6%
3/54 • Up to 24 months
|
|
Cardiac disorders
Arrhythmia
|
1.9%
1/54 • Up to 24 months
|
|
Cardiac disorders
Tachycardia
|
1.9%
1/54 • Up to 24 months
|
|
Congenital, familial and genetic disorders
Aplasia
|
1.9%
1/54 • Up to 24 months
|
|
Endocrine disorders
Hypothyroidism
|
1.9%
1/54 • Up to 24 months
|
|
Eye disorders
Occular Vasculitis
|
1.9%
1/54 • Up to 24 months
|
|
Gastrointestinal disorders
Odynophagia
|
1.9%
1/54 • Up to 24 months
|
|
General disorders
Asthenia
|
3.7%
2/54 • Up to 24 months
|
|
General disorders
General Physical Health Deterioration
|
5.6%
3/54 • Up to 24 months
|
|
General disorders
Hyperthermia
|
1.9%
1/54 • Up to 24 months
|
|
General disorders
Oedema Peripheral
|
1.9%
1/54 • Up to 24 months
|
|
General disorders
Pyrexia
|
3.7%
2/54 • Up to 24 months
|
|
Infections and infestations
Bacterial Sepsis
|
1.9%
1/54 • Up to 24 months
|
|
Infections and infestations
Cytomegalovirus Infection
|
1.9%
1/54 • Up to 24 months
|
|
Infections and infestations
Infection
|
1.9%
1/54 • Up to 24 months
|
|
Infections and infestations
Neutropenic Infection
|
1.9%
1/54 • Up to 24 months
|
|
Infections and infestations
Neutropenic Sepsis
|
1.9%
1/54 • Up to 24 months
|
|
Infections and infestations
Oral Candidiasis
|
1.9%
1/54 • Up to 24 months
|
|
Infections and infestations
Pneumonia
|
5.6%
3/54 • Up to 24 months
|
|
Infections and infestations
Pneumonia Pneumococcal
|
1.9%
1/54 • Up to 24 months
|
|
Infections and infestations
Sepsis
|
3.7%
2/54 • Up to 24 months
|
|
Infections and infestations
Septic Shock
|
1.9%
1/54 • Up to 24 months
|
|
Investigations
Prothrombin Level Decreased
|
1.9%
1/54 • Up to 24 months
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
3.7%
2/54 • Up to 24 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.9%
1/54 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.9%
1/54 • Up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Histiocytosis Haematophagic
|
1.9%
1/54 • Up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's Sarcoma
|
1.9%
1/54 • Up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
1.9%
1/54 • Up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peripheral T-cell Lymphoma Unspecified
|
1.9%
1/54 • Up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Flare
|
1.9%
1/54 • Up to 24 months
|
|
Nervous system disorders
Ataxia
|
1.9%
1/54 • Up to 24 months
|
|
Nervous system disorders
Carotid Artery Stenosis
|
1.9%
1/54 • Up to 24 months
|
|
Nervous system disorders
Cerebral Ischaemia
|
1.9%
1/54 • Up to 24 months
|
|
Nervous system disorders
Somnolence
|
1.9%
1/54 • Up to 24 months
|
|
Nervous system disorders
Syncope
|
3.7%
2/54 • Up to 24 months
|
|
Nervous system disorders
Transient Ischaemic Attack
|
1.9%
1/54 • Up to 24 months
|
|
Psychiatric disorders
Confusional State
|
1.9%
1/54 • Up to 24 months
|
|
Renal and urinary disorders
Renal Failure
|
1.9%
1/54 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
|
1.9%
1/54 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
1.9%
1/54 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
|
1.9%
1/54 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.4%
4/54 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infiltration
|
1.9%
1/54 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Drug Eruption
|
1.9%
1/54 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Toxic Epidermal Necrolysis
|
1.9%
1/54 • Up to 24 months
|
Other adverse events
| Measure |
Single Agent Lenalidomide
n=54 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
13.0%
7/54 • Up to 24 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.7%
9/54 • Up to 24 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
18.5%
10/54 • Up to 24 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
9.3%
5/54 • Up to 24 months
|
|
Gastrointestinal disorders
Constipation
|
22.2%
12/54 • Up to 24 months
|
|
Gastrointestinal disorders
Diarrhoea
|
14.8%
8/54 • Up to 24 months
|
|
Gastrointestinal disorders
Dry Mouth
|
5.6%
3/54 • Up to 24 months
|
|
Gastrointestinal disorders
Dysphagia
|
11.1%
6/54 • Up to 24 months
|
|
Gastrointestinal disorders
Nausea
|
13.0%
7/54 • Up to 24 months
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
5.6%
3/54 • Up to 24 months
|
|
Gastrointestinal disorders
Stomatitis
|
5.6%
3/54 • Up to 24 months
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
6/54 • Up to 24 months
|
|
General disorders
Asthenia
|
20.4%
11/54 • Up to 24 months
|
|
General disorders
Fatigue
|
9.3%
5/54 • Up to 24 months
|
|
General disorders
Oedema Peripheral
|
14.8%
8/54 • Up to 24 months
|
|
General disorders
Pain
|
5.6%
3/54 • Up to 24 months
|
|
General disorders
Pyrexia
|
25.9%
14/54 • Up to 24 months
|
|
Investigations
Weight Decreased
|
11.1%
6/54 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.6%
3/54 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
5.6%
3/54 • Up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Flare
|
5.6%
3/54 • Up to 24 months
|
|
Nervous system disorders
Headache
|
11.1%
6/54 • Up to 24 months
|
|
Nervous system disorders
Paraesthesia
|
5.6%
3/54 • Up to 24 months
|
|
Psychiatric disorders
Anxiety
|
9.3%
5/54 • Up to 24 months
|
|
Renal and urinary disorders
Renal Failure Acute
|
5.6%
3/54 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.3%
5/54 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.3%
5/54 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
7.4%
4/54 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
9.3%
5/54 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.3%
5/54 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
6/54 • Up to 24 months
|
|
Vascular disorders
Hypotension
|
7.4%
4/54 • Up to 24 months
|
Additional Information
Associate Director, Clinical Trial Disclosure
Celgene
Phone: 1-888-260-1599
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER