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An Efficacy and Safety Proof of Concept Study of Daratumumab in Relapsed/Refractory Mantle Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma

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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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).

Reporting Groups
  Description
Diffuse Large B-cell Lymphoma (DLBCL) 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.
Follicular Lymphoma (FL) 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.
Mantle Cell Lymphoma (MCL) 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.

Participant Flow:   Overall Study
    Diffuse Large B-cell Lymphoma (DLBCL)   Follicular Lymphoma (FL)   Mantle Cell Lymphoma (MCL)
STARTED   15   16   5 
COMPLETED   0   0   0 
NOT COMPLETED   15   16   5 
Death                11                3                4 
Withdrawal by Subject                2                0                0 
Study Terminated By Sponsor                2                13                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Diffuse Large B-cell Lymphoma (DLBCL) 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.
Follicular Lymphoma (FL) 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.
Mantle Cell Lymphoma (MCL) 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 Total of all reporting groups

Baseline Measures
   Diffuse Large B-cell Lymphoma (DLBCL)   Follicular Lymphoma (FL)   Mantle Cell Lymphoma (MCL)   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   16   5   36 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Mean (Standard Deviation)
 66.7  (11.88)   62.3  (9.77)   59.8  (6.69)   63.8  (10.45) 
Sex: Female, Male 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
       
Australia   0   2   0   2 
Belgium   2   0   0   2 
France   4   2   0   6 
Netherlands   2   3   2   7 
Republic of Korea   4   2   0   6 
Turkey   2   2   1   5 
United States   1   5   2   8 
CD38 expression value [1] 
[Units: Percentage of CD38 expression]
Mean (Standard Deviation)
 76.3  (18.07)   70.3  (16.78)   64  (8.22)   71.9  (16.66) 
[1] The expression levels of CD38 were used to do diagnosis of MCL, DLBCL, or FL and measurable disease.


  Outcome Measures

1.  Primary:   Overall Response Rate (ORR)   [ Time Frame: After the first dose until disease progression, withdrawal of consent from study participation, or the end of study (approximately 1.9 years) ]

2.  Secondary:   Duration of Response   [ Time Frame: Approximately 1.9 years ]

3.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: Approximately 1.9 years ]

4.  Secondary:   Overall Survival (OS)   [ Time Frame: Approximately 1.9 years ]

5.  Secondary:   Time to Response   [ Time Frame: Approximately 1.9 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Janssen Research & Development, LLC
phone: 844-434-4210
e-mail: ClinicalTrialDisclosure@its.jnj.com



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