ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    lym2001
Previous Study | Return to List | Next Study

An Efficacy and Safety Proof of Concept Study of Daratumumab in Relapsed/Refractory Mantle Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular 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: NCT02413489
Recruitment Status : Terminated (DLBCL and FL cohorts met the pre-specified futility criteria and will not proceed. The MCL cohort was terminated due to slow recruitment and aggressive disease.)
First Posted : April 10, 2015
Results First Posted : June 25, 2018
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Lymphoma, Mantle-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Follicular
Intervention Drug: Daratumumab
Enrollment 36
Recruitment Details  
Pre-assignment Details In total 36 participants were treated (15 participants in the diffuse large B-cell lymphoma [DLBCL] cohort, 16 participants in the follicular lymphoma [FL] cohort, and 5 participants in the mantle cell lymphoma [MCL] cohort).
Arm/Group Title Diffuse Large B-cell Lymphoma (DLBCL) Follicular Lymphoma (FL) Mantle Cell Lymphoma (MCL)
Hide Arm/Group Description Participants received daratumumab 16 milligram per kilogram (mg/kg) as intravenous infusion once every week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end. Participants received daratumumab 16 mg/kg as intravenous infusion once every week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end. Participants received daratumumab 16 mg/kg as intravenous infusion once every week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end.
Period Title: Overall Study
Started 15 16 5
Completed 0 0 0
Not Completed 15 16 5
Reason Not Completed
Death             11             3             4
Withdrawal by Subject             2             0             0
Study Terminated By Sponsor             2             13             1
Arm/Group Title Diffuse Large B-cell Lymphoma (DLBCL) Follicular Lymphoma (FL) Mantle Cell Lymphoma (MCL) Total
Hide Arm/Group Description Participants received daratumumab 16 milligram per kilogram (mg/kg) as intravenous infusion once every week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end. Participants received daratumumab 16 mg/kg as intravenous infusion once every week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end. Participants received daratumumab 16 mg/kg as intravenous infusion once every week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end. Total of all reporting groups
Overall Number of Baseline Participants 15 16 5 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 16 participants 5 participants 36 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
  33.3%
9
  56.3%
4
  80.0%
18
  50.0%
>=65 years
10
  66.7%
7
  43.8%
1
  20.0%
18
  50.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 16 participants 5 participants 36 participants
66.7  (11.88) 62.3  (9.77) 59.8  (6.69) 63.8  (10.45)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 16 participants 5 participants 36 participants
Female
6
  40.0%
5
  31.3%
0
   0.0%
11
  30.6%
Male
9
  60.0%
11
  68.8%
5
 100.0%
25
  69.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 16 participants 5 participants 36 participants
Hispanic or Latino
0
   0.0%
1
   6.3%
2
  40.0%
3
   8.3%
Not Hispanic or Latino
12
  80.0%
15
  93.8%
2
  40.0%
29
  80.6%
Unknown or Not Reported
3
  20.0%
0
   0.0%
1
  20.0%
4
  11.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 16 participants 5 participants 36 participants
Asian
4
  26.7%
2
  12.5%
0
   0.0%
6
  16.7%
White
7
  46.7%
13
  81.3%
2
  40.0%
22
  61.1%
Unknown
1
   6.7%
0
   0.0%
0
   0.0%
1
   2.8%
Not Reported
3
  20.0%
1
   6.3%
1
  20.0%
5
  13.9%
Other
0
   0.0%
0
   0.0%
2
  40.0%
2
   5.6%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 16 participants 5 participants 36 participants
Australia
0
   0.0%
2
  12.5%
0
   0.0%
2
   5.6%
Belgium
2
  13.3%
0
   0.0%
0
   0.0%
2
   5.6%
France
4
  26.7%
2
  12.5%
0
   0.0%
6
  16.7%
Netherlands
2
  13.3%
3
  18.8%
2
  40.0%
7
  19.4%
Republic of Korea
4
  26.7%
2
  12.5%
0
   0.0%
6
  16.7%
Turkey
2
  13.3%
2
  12.5%
1
  20.0%
5
  13.9%
United States
1
   6.7%
5
  31.3%
2
  40.0%
8
  22.2%
CD38 expression value   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage of CD38 expression
Number Analyzed 15 participants 16 participants 5 participants 36 participants
76.3  (18.07) 70.3  (16.78) 64  (8.22) 71.9  (16.66)
[1]
Measure Description: The expression levels of CD38 were used to do diagnosis of MCL, DLBCL, or FL and measurable disease.
1.Primary Outcome
Title Overall Response Rate (ORR)
Hide Description ORR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR). As per Revised Response Criteria for Malignant Lymphoma, Lymph node measurements were taken from Computed Tomography (CT), CT portion of the Positron Emission Tomography/Computed Tomography (PET/CT), or Magnetic resonance imaging (MRI) scans where applicable. CR is defined as complete disappearance of all evidence of disease; PR as a greater than (>) 50 percent (%) decrease in the sum of the products of the maximal perpendicular diameters of measured lesions (SPD) and no new sites.
Time Frame After the first dose until disease progression, withdrawal of consent from study participation, or the end of study (approximately 1.9 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population was all participants that were treated with daratumumab.
Arm/Group Title Diffuse Large B-cell Lymphoma (DLBCL) Follicular Lymphoma (FL) Mantle Cell Lymphoma (MCL)
Hide Arm/Group Description:
Participants received daratumumab 16 milligram per kilogram (mg/kg) as intravenous infusion once every week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end.
Participants received daratumumab 16 mg/kg as intravenous infusion once every week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end.
Participants received daratumumab 16 mg/kg as intravenous infusion once every week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end.
Overall Number of Participants Analyzed 15 16 5
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
6.7
(0.2 to 31.9)
12.5
(1.6 to 38.3)
0 [1] 
(NA to NA)
[1]
Confidence interval was not estimable as no participants had response.
2.Secondary Outcome
Title Duration of Response
Hide Description Duration of response was the duration from the date of the initial documentation of a response to the date of first documented evidence of progressive disease (PD). PD is defined as any new lesion >1.5 centimeter (cm) in any axis or greater than or equal to (>=) 50% increase in previously involved sites.
Time Frame Approximately 1.9 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population was all participants that were treated with daratumumab and who achieved overall response There was insufficient data to perform Kaplan Meier analysis, therefore individual data for each evaluable participant was reported.
Arm/Group Title Diffuse Large B-cell Lymphoma (DLBCL) Follicular Lymphoma (FL) Mantle Cell Lymphoma (MCL)
Hide Arm/Group Description:
Participants received daratumumab 16 milligram per kilogram (mg/kg) as intravenous infusion once every week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end.
Participants received daratumumab 16 mg/kg as intravenous infusion once every week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end.
Participants received daratumumab 16 mg/kg as intravenous infusion once every week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end.
Overall Number of Participants Analyzed 1 2 0
Measure Type: Number
Unit of Measure: Months
Participant 1 1.6 0.7
Participant 2 NA [1]  7.4
[1]
Only 1 participant achieved response in DLBCL group.
3.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description PFS was defined as the duration from the date of the first daratumumab dose to the date of progression or death, whichever comes first.
Time Frame Approximately 1.9 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population was all participants that were treated with daratumumab.
Arm/Group Title Diffuse Large B-cell Lymphoma (DLBCL) Follicular Lymphoma (FL) Mantle Cell Lymphoma (MCL)
Hide Arm/Group Description:
Participants received daratumumab 16 milligram per kilogram (mg/kg) as intravenous infusion once every week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end.
Participants received daratumumab 16 mg/kg as intravenous infusion once every week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end.
Participants received daratumumab 16 mg/kg as intravenous infusion once every week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end.
Overall Number of Participants Analyzed 15 16 5
Median (95% Confidence Interval)
Unit of Measure: Months
1.2
(0.6 to 1.7)
3.3
(1.9 to 3.8)
1.3
(0.5 to 1.9)
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall survival was defined as the duration from the date of the first daratumumab dose to the date of death.
Time Frame Approximately 1.9 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population was all participants that were treated with daratumumab.
Arm/Group Title Diffuse Large B-cell Lymphoma (DLBCL) Follicular Lymphoma (FL) Mantle Cell Lymphoma (MCL)
Hide Arm/Group Description:
Participants received daratumumab 16 milligram per kilogram (mg/kg) as intravenous infusion once every week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end.
Participants received daratumumab 16 mg/kg as intravenous infusion once every week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end.
Participants received daratumumab 16 mg/kg as intravenous infusion once every week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end.
Overall Number of Participants Analyzed 15 16 5
Median (95% Confidence Interval)
Unit of Measure: Months
4.9
(2.1 to 9.0)
17.2 [1] 
(15.0 to NA)
4.8 [2] 
(1.7 to NA)
[1]
NA indicates upper limit of Confidence Interval was not estimable due to less number of participants with events.
[2]
Upper limit of CI could not be estimated due to less number of participants analyzed.
5.Secondary Outcome
Title Time to Response
Hide Description Time to response was defined as the duration from the date of the first dose of daratumumab to the earliest date that a response (CR/PR) is first documented.
Time Frame Approximately 1.9 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population was all participants that were treated with daratumumab and who achieved overall response There was insufficient data to perform Kaplan Meier analysis, therefore individual data for each evaluable participant was reported.
Arm/Group Title Diffuse Large B-cell Lymphoma (DLBCL) Follicular Lymphoma (FL) Mantle Cell Lymphoma (MCL)
Hide Arm/Group Description:
Participants received daratumumab 16 milligram per kilogram (mg/kg) as intravenous infusion once every week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end.
Participants received daratumumab 16 mg/kg as intravenous infusion once every week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end.
Participants received daratumumab 16 mg/kg as intravenous infusion once every week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end.
Overall Number of Participants Analyzed 1 2 0
Measure Type: Number
Unit of Measure: Months
Participant 1 1.9 2.3
Participant 2 NA [1]  1.9
[1]
Only 1 participant achieved response in DLBCL group.
Time Frame Up to 1.9 years
Adverse Event Reporting Description Analysis set included all participants who received at least 1 dose of study treatment and contributed any safety data after the start of study treatment.
 
Arm/Group Title Diffuse Large B-cell Lymphoma (DLBCL) Follicular Lymphoma (FL) Mantle Cell Lymphoma (MCL)
Hide Arm/Group Description Participants received daratumumab 16 milligram per kilogram (mg/kg) as intravenous infusion once every week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end. Participants received daratumumab 16 mg/kg as intravenous infusion once every week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end. Participants received daratumumab 16 mg/kg as intravenous infusion once every week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end.
All-Cause Mortality
Diffuse Large B-cell Lymphoma (DLBCL) Follicular Lymphoma (FL) Mantle Cell Lymphoma (MCL)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/15 (73.33%)   3/16 (18.75%)   4/5 (80.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Diffuse Large B-cell Lymphoma (DLBCL) Follicular Lymphoma (FL) Mantle Cell Lymphoma (MCL)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/15 (40.00%)   6/16 (37.50%)   3/5 (60.00%) 
Blood and lymphatic system disorders       
Febrile Neutropenia * 1  0/15 (0.00%)  1/16 (6.25%)  1/5 (20.00%) 
Lymphadenopathy * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Thrombocytopenia * 1  1/15 (6.67%)  0/16 (0.00%)  0/5 (0.00%) 
Gastrointestinal disorders       
Abdominal Pain Lower * 1  1/15 (6.67%)  0/16 (0.00%)  0/5 (0.00%) 
General disorders       
General Physical Health Deterioration * 1  1/15 (6.67%)  0/16 (0.00%)  1/5 (20.00%) 
Pyrexia * 1  0/15 (0.00%)  0/16 (0.00%)  2/5 (40.00%) 
Infections and infestations       
Pneumonia * 1  1/15 (6.67%)  1/16 (6.25%)  0/5 (0.00%) 
Pneumonia Cytomegaloviral * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Urinary Tract Infection * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Injury, poisoning and procedural complications       
Spinal Fracture * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Metabolism and nutrition disorders       
Decreased Appetite * 1  1/15 (6.67%)  0/16 (0.00%)  0/5 (0.00%) 
Musculoskeletal and connective tissue disorders       
Musculoskeletal Pain * 1  1/15 (6.67%)  0/16 (0.00%)  0/5 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Diffuse Large B-Cell Lymphoma * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Renal and urinary disorders       
Acute Kidney Injury * 1  1/15 (6.67%)  0/16 (0.00%)  0/5 (0.00%) 
Chronic Kidney Disease * 1  1/15 (6.67%)  0/16 (0.00%)  0/5 (0.00%) 
1
Term from vocabulary, MedDRA Version 19.1
*
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%
Diffuse Large B-cell Lymphoma (DLBCL) Follicular Lymphoma (FL) Mantle Cell Lymphoma (MCL)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   15/15 (100.00%)   16/16 (100.00%)   5/5 (100.00%) 
Blood and lymphatic system disorders       
Anaemia * 1  1/15 (6.67%)  5/16 (31.25%)  1/5 (20.00%) 
Leukopenia * 1  1/15 (6.67%)  1/16 (6.25%)  0/5 (0.00%) 
Lymph Node Pain * 1  2/15 (13.33%)  2/16 (12.50%)  0/5 (0.00%) 
Lymphadenopathy * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Lymphocytosis * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Lymphopenia * 1  0/15 (0.00%)  2/16 (12.50%)  0/5 (0.00%) 
Neutropenia * 1  1/15 (6.67%)  1/16 (6.25%)  1/5 (20.00%) 
Thrombocytopenia * 1  3/15 (20.00%)  3/16 (18.75%)  1/5 (20.00%) 
Cardiac disorders       
Sinus Bradycardia * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Ear and labyrinth disorders       
Ear Pain * 1  0/15 (0.00%)  2/16 (12.50%)  0/5 (0.00%) 
Eye disorders       
Diplopia * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Erythema of Eyelid * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Eyelid Oedema * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Ocular Hyperaemia * 1  0/15 (0.00%)  1/16 (6.25%)  1/5 (20.00%) 
Visual Acuity Reduced * 1  0/15 (0.00%)  0/16 (0.00%)  1/5 (20.00%) 
Gastrointestinal disorders       
Abdominal Discomfort * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Abdominal Pain * 1  2/15 (13.33%)  5/16 (31.25%)  1/5 (20.00%) 
Abdominal Pain Lower * 1  1/15 (6.67%)  0/16 (0.00%)  0/5 (0.00%) 
Abdominal Pain Upper * 1  1/15 (6.67%)  1/16 (6.25%)  0/5 (0.00%) 
Anal Incontinence * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Constipation * 1  2/15 (13.33%)  2/16 (12.50%)  1/5 (20.00%) 
Dental Caries * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Diarrhoea * 1  1/15 (6.67%)  2/16 (12.50%)  0/5 (0.00%) 
Dry Mouth * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Gastrooesophageal Reflux Disease * 1  0/15 (0.00%)  0/16 (0.00%)  1/5 (20.00%) 
Nausea * 1  5/15 (33.33%)  1/16 (6.25%)  2/5 (40.00%) 
Paraesthesia Oral * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Swollen Tongue * 1  0/15 (0.00%)  0/16 (0.00%)  1/5 (20.00%) 
Vomiting * 1  4/15 (26.67%)  0/16 (0.00%)  1/5 (20.00%) 
General disorders       
Asthenia * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Catheter Site Erythema * 1  1/15 (6.67%)  0/16 (0.00%)  0/5 (0.00%) 
Catheter Site Inflammation * 1  1/15 (6.67%)  0/16 (0.00%)  0/5 (0.00%) 
Chest Discomfort * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Chills * 1  2/15 (13.33%)  1/16 (6.25%)  1/5 (20.00%) 
Fatigue * 1  4/15 (26.67%)  3/16 (18.75%)  1/5 (20.00%) 
General Physical Health Deterioration * 1  1/15 (6.67%)  0/16 (0.00%)  0/5 (0.00%) 
Influenza Like Illness * 1  0/15 (0.00%)  2/16 (12.50%)  0/5 (0.00%) 
Malaise * 1  3/15 (20.00%)  1/16 (6.25%)  0/5 (0.00%) 
Non-Cardiac Chest Pain * 1  0/15 (0.00%)  1/16 (6.25%)  1/5 (20.00%) 
Oedema Peripheral * 1  1/15 (6.67%)  2/16 (12.50%)  1/5 (20.00%) 
Pain * 1  1/15 (6.67%)  1/16 (6.25%)  0/5 (0.00%) 
Pyrexia * 1  2/15 (13.33%)  4/16 (25.00%)  1/5 (20.00%) 
Hepatobiliary disorders       
Hyperbilirubinaemia * 1  0/15 (0.00%)  0/16 (0.00%)  1/5 (20.00%) 
Infections and infestations       
Cellulitis * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Fungal Skin Infection * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Gastroenteritis * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Genital Herpes * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Groin Infection * 1  1/15 (6.67%)  0/16 (0.00%)  0/5 (0.00%) 
Herpes Zoster * 1  0/15 (0.00%)  1/16 (6.25%)  1/5 (20.00%) 
Lower Respiratory Tract Infection * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Nasopharyngitis * 1  1/15 (6.67%)  1/16 (6.25%)  1/5 (20.00%) 
Pneumonia * 1  0/15 (0.00%)  0/16 (0.00%)  1/5 (20.00%) 
Rhinitis * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Sinusitis * 1  0/15 (0.00%)  2/16 (12.50%)  0/5 (0.00%) 
Upper Respiratory Tract Infection * 1  1/15 (6.67%)  3/16 (18.75%)  0/5 (0.00%) 
Urinary Tract Infection * 1  1/15 (6.67%)  0/16 (0.00%)  0/5 (0.00%) 
Viral Upper Respiratory Tract Infection * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Injury, poisoning and procedural complications       
Contusion * 1  1/15 (6.67%)  0/16 (0.00%)  0/5 (0.00%) 
Hip Fracture * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Procedural Pain * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Skin Abrasion * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Investigations       
Alanine Aminotransferase Increased * 1  1/15 (6.67%)  0/16 (0.00%)  1/5 (20.00%) 
Aspartate Aminotransferase Increased * 1  2/15 (13.33%)  0/16 (0.00%)  0/5 (0.00%) 
C-Reactive Protein Increased * 1  1/15 (6.67%)  0/16 (0.00%)  0/5 (0.00%) 
Cytomegalovirus Test Positive * 1  1/15 (6.67%)  0/16 (0.00%)  0/5 (0.00%) 
Oxygen Saturation Decreased * 1  1/15 (6.67%)  1/16 (6.25%)  0/5 (0.00%) 
Prostatic Specific Antigen Increased * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Weight Decreased * 1  3/15 (20.00%)  2/16 (12.50%)  0/5 (0.00%) 
Weight Increased * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Metabolism and nutrition disorders       
Decreased Appetite * 1  1/15 (6.67%)  1/16 (6.25%)  0/5 (0.00%) 
Hyperglycaemia * 1  0/15 (0.00%)  0/16 (0.00%)  1/5 (20.00%) 
Hypertriglyceridaemia * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Hyperuricaemia * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Hypoalbuminaemia * 1  1/15 (6.67%)  0/16 (0.00%)  0/5 (0.00%) 
Hypokalaemia * 1  1/15 (6.67%)  0/16 (0.00%)  0/5 (0.00%) 
Hyponatraemia * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Vitamin B12 Deficiency * 1  1/15 (6.67%)  0/16 (0.00%)  0/5 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  0/15 (0.00%)  2/16 (12.50%)  0/5 (0.00%) 
Back Pain * 1  1/15 (6.67%)  4/16 (25.00%)  1/5 (20.00%) 
Flank Pain * 1  1/15 (6.67%)  0/16 (0.00%)  0/5 (0.00%) 
Mobility Decreased * 1  1/15 (6.67%)  0/16 (0.00%)  0/5 (0.00%) 
Muscle Spasms * 1  0/15 (0.00%)  1/16 (6.25%)  2/5 (40.00%) 
Musculoskeletal Chest Pain * 1  1/15 (6.67%)  0/16 (0.00%)  0/5 (0.00%) 
Musculoskeletal Pain * 1  2/15 (13.33%)  1/16 (6.25%)  0/5 (0.00%) 
Myalgia * 1  1/15 (6.67%)  2/16 (12.50%)  0/5 (0.00%) 
Pain in Extremity * 1  0/15 (0.00%)  3/16 (18.75%)  1/5 (20.00%) 
Pain in Jaw * 1  0/15 (0.00%)  0/16 (0.00%)  1/5 (20.00%) 
Peripheral Arthritis * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Tumour Pain * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Nervous system disorders       
Dizziness * 1  1/15 (6.67%)  1/16 (6.25%)  1/5 (20.00%) 
Dysarthria * 1  0/15 (0.00%)  0/16 (0.00%)  1/5 (20.00%) 
Headache * 1  0/15 (0.00%)  5/16 (31.25%)  1/5 (20.00%) 
Nerve Compression * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Neuralgia * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Paraesthesia * 1  1/15 (6.67%)  0/16 (0.00%)  0/5 (0.00%) 
Peripheral Sensory Neuropathy * 1  1/15 (6.67%)  0/16 (0.00%)  0/5 (0.00%) 
Post Herpetic Neuralgia * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Sensory Disturbance * 1  0/15 (0.00%)  0/16 (0.00%)  1/5 (20.00%) 
Somnolence * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Product Issues       
Thrombosis in Device * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Psychiatric disorders       
Anxiety * 1  2/15 (13.33%)  0/16 (0.00%)  0/5 (0.00%) 
Delirium * 1  1/15 (6.67%)  0/16 (0.00%)  0/5 (0.00%) 
Depressed Mood * 1  1/15 (6.67%)  0/16 (0.00%)  0/5 (0.00%) 
Insomnia * 1  3/15 (20.00%)  2/16 (12.50%)  1/5 (20.00%) 
Renal and urinary disorders       
Chronic Kidney Disease * 1  1/15 (6.67%)  0/16 (0.00%)  0/5 (0.00%) 
Haematuria * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Urinary Tract Obstruction * 1  1/15 (6.67%)  0/16 (0.00%)  0/5 (0.00%) 
Urine Flow Decreased * 1  0/15 (0.00%)  0/16 (0.00%)  1/5 (20.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  7/15 (46.67%)  6/16 (37.50%)  4/5 (80.00%) 
Dysphonia * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Dyspnoea * 1  1/15 (6.67%)  2/16 (12.50%)  2/5 (40.00%) 
Hiccups * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Hypoxia * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Laryngeal Oedema * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Nasal Congestion * 1  0/15 (0.00%)  3/16 (18.75%)  1/5 (20.00%) 
Oropharyngeal Discomfort * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Oropharyngeal Pain * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Pharyngeal Oedema * 1  0/15 (0.00%)  0/16 (0.00%)  1/5 (20.00%) 
Pleural Effusion * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Productive Cough * 1  0/15 (0.00%)  2/16 (12.50%)  0/5 (0.00%) 
Rales * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Respiratory Failure * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Rhinorrhoea * 1  0/15 (0.00%)  2/16 (12.50%)  0/5 (0.00%) 
Sinus Congestion * 1  0/15 (0.00%)  0/16 (0.00%)  1/5 (20.00%) 
Sneezing * 1  0/15 (0.00%)  2/16 (12.50%)  0/5 (0.00%) 
Throat Irritation * 1  0/15 (0.00%)  2/16 (12.50%)  2/5 (40.00%) 
Upper-Airway Cough Syndrome * 1  0/15 (0.00%)  0/16 (0.00%)  1/5 (20.00%) 
Wheezing * 1  0/15 (0.00%)  0/16 (0.00%)  1/5 (20.00%) 
Skin and subcutaneous tissue disorders       
Acne * 1  1/15 (6.67%)  0/16 (0.00%)  0/5 (0.00%) 
Blood Blister * 1  1/15 (6.67%)  0/16 (0.00%)  0/5 (0.00%) 
Eczema * 1  1/15 (6.67%)  0/16 (0.00%)  0/5 (0.00%) 
Erythema * 1  0/15 (0.00%)  0/16 (0.00%)  1/5 (20.00%) 
Night Sweats * 1  1/15 (6.67%)  2/16 (12.50%)  0/5 (0.00%) 
Pain of Skin * 1  1/15 (6.67%)  2/16 (12.50%)  0/5 (0.00%) 
Pruritus * 1  1/15 (6.67%)  0/16 (0.00%)  1/5 (20.00%) 
Rash * 1  1/15 (6.67%)  1/16 (6.25%)  0/5 (0.00%) 
Skin Burning Sensation * 1  0/15 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Urticaria * 1  1/15 (6.67%)  3/16 (18.75%)  0/5 (0.00%) 
Vascular disorders       
Flushing * 1  0/15 (0.00%)  2/16 (12.50%)  1/5 (20.00%) 
Hot Flush * 1  0/15 (0.00%)  0/16 (0.00%)  1/5 (20.00%) 
Hypertension * 1  2/15 (13.33%)  3/16 (18.75%)  0/5 (0.00%) 
Hypotension * 1  1/15 (6.67%)  1/16 (6.25%)  0/5 (0.00%) 
1
Term from vocabulary, MedDRA Version 19.1
*
Indicates events were collected by non-systematic assessment
The study was terminated due to 2 non-Hodgkin’s lymphoma (NHL) sub types (DLBCL and FL cohorts) meeting the futility criteria defined in the protocol and the MCL cohort not having adequate recruitment.
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.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Results Point of Contact
Name/Title: Study Director
Organization: Janssen Research & Development, LLC
Phone: 844-434-4210
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02413489     History of Changes
Other Study ID Numbers: CR106660
54767414LYM2001 ( Other Identifier: Janssen Research & Development, LLC )
2014-005299-26 ( EudraCT Number )
First Submitted: April 7, 2015
First Posted: April 10, 2015
Results First Submitted: May 28, 2018
Results First Posted: June 25, 2018
Last Update Posted: June 25, 2018