Try our beta test site

A Study of Brentuximab Vedotin in Relapsed or Refractory Non-Hodgkin Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT01421667
First received: August 19, 2011
Last updated: October 14, 2016
Last verified: June 2015
Results First Received: June 21, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Interventions: Drug: brentuximab vedotin
Drug: rituximab

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Aug 2011 - Jun 2015

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Four additional patients enrolled, but withdrew prior to receiving treatment.

Reporting Groups
  Description
CD30+ T-Cell NHL, BV Part A - Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients in with CD30-positive mature T-cell non-Hodgkin lymphomas (NHL)
CD30+ B-Cell NHL, BV Part A - Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive B-cell non-Hodgkin lymphomas (NHL), including CD30-positive diffuse large B-cell lymphoma (DLBCL) and other CD30-positive B-cell NHLs
CD30u DLBCL, BV Part C - Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with diffuse large B-cell lymphoma (DLBCL) with undetectable CD30 (CD30u)
CD30+ DLBCL, BV+R Part B - Brentuximab vedotin (BV) 1.8 mg/kg plus rituximab (R; first 8 cycles only) (375 mg/m2) every 3 weeks by intravenous (IV) infusion in patients with CD30-positive diffuse large B-cell lymphoma (DLBCL)

Participant Flow:   Overall Study
    CD30+ T-Cell NHL, BV   CD30+ B-Cell NHL, BV   CD30u DLBCL, BV   CD30+ DLBCL, BV+R
STARTED   35   68   53   16 
COMPLETED   35 [1]   66 [2]   51 [3]   15 [4] 
NOT COMPLETED   0   2   2   1 
Withdrawal by Subject                0                1                2                1 
Lost to Follow-up                0                1                0                0 
[1] Completed per protocol due to death [24] or study termination by sponsor [11]
[2] Completed per protocol due to death [45] or study termination by sponsor [21]
[3] Completed per protocol due to death [33] or study termination by sponsor [18]
[4] Completed per protocol due to death [7] or study termination by sponsor [8]



  Baseline Characteristics
  Hide 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.
All participants who received treatment.

Reporting Groups
  Description
CD30+ T-Cell NHL, BV No text entered.
CD30+ B-Cell NHL, BV No text entered.
CD30u DLBCL, BV No text entered.
CD30+ DLBCL, BV+R No text entered.
Total Total of all reporting groups

Baseline Measures
   CD30+ T-Cell NHL, BV   CD30+ B-Cell NHL, BV   CD30u DLBCL, BV   CD30+ DLBCL, BV+R   Total 
Overall Participants Analyzed 
[Units: Participants]
 35   68   53   16   172 
Age 
[Units: Years]
Median (Full Range)
 64 
 (33 to 83) 
 57 
 (16 to 85) 
 65 
 (21 to 91) 
 62 
 (22 to 78) 
 63 
 (16 to 91) 
Gender 
[Units: Participants]
         
Female   8   29   27   4   68 
Male   27   39   26   12   104 
Ethnicity (NIH/OMB) 
[Units: Participants]
         
Hispanic or Latino   3   3   7   1   14 
Not Hispanic or Latino   32   65   46   15   158 
Unknown or Not Reported   0   0   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
         
American Indian or Alaska Native   0   1   1   0   2 
Asian   1   3   4   0   8 
Native Hawaiian or Other Pacific Islander   0   0   1   0   1 
Black or African American   5   6   4   0   15 
White   29   55   41   15   140 
More than one race   0   3   2   1   6 
Unknown or Not Reported   0   0   0   0   0 
Pathological Diagnosis 
[Units: Participants]
         
Diffuse Large B-Cell Lymphoma (DLBCL)   0   43   53   16   112 
Epstein-Barr Virus-Associated DLBCL of Elderly   0   5   0   0   5 
Follicular Lymphoma   0   3   0   0   3 
Gray Zone Lymphoma   0   6   0   0   6 
Primary Mediastinal B-Cell Lymphoma   0   6   0   0   6 
Post-Transplant Lymphoproliferative Disorder   0   3   0   0   3 
Plasmablastic Lymphoma   0   1   0   0   1 
T-Cell Rich B-Cell Lymphoma   0   1   0   0   1 
Angioimmunoblastic T-cell Lymphoma   13   0   0   0   13 
Peripheral T-Cell Lymphoma Not Otherwise Specified   22   0   0   0   22 
Transformed Disease from Prior Non-Hodgkin Lymphoma 
[Units: Participants]
         
Yes   1   14   11   5   31 
No   34   54   42   11   141 
Disease Stage 
[Units: Participants]
         
Stage I   2   4   1   1   8 
Stage II   2   12   7   3   24 
Stage III   13   17   11   6   47 
Stage IV   14   31   33   6   84 
Unknown   4   4   1   0   9 
Bulky Disease (≥5 cm on at least one baseline index lesion) 
[Units: Participants]
         
Yes   5   27   35   4   71 
No   30   41   18   12   101 
Eastern Cooperative Oncology Group Performance Status (ECOG) [1] 
[Units: Participants]
         
 7   25   10   9   51 
 23   35   31   7   96 
 5   7   12   0   24 
3-5   0   0   0   0   0 
Missing   0   1   0   0   1 
[1] 0 = Normal activity; 1 = Symptoms but ambulatory; 2 = In bed <50% of the time; 3 = In bed >50% of the time; 4 = 100% bedridden; 5 = Dead
% CD30 Expression by Visual Immunohistochemistry (vIHC) [1] 
[Units: Percentage]
Median (Full Range)
 15 
 (0 to 95) 
 35 
 (0 to 100) 
 0 
 (0 to 10) 
 50 
 (1 to 100) 
 8 
 (0 to 100) 
[1] Percent CD30 expression by standard immunohistochemistry assessed visually by central laboratory (vIHC)
Refractory to Frontline Therapy 
[Units: Participants]
         
Yes   25   51   34   10   120 
No   10   15   19   6   50 
Missing/Unknown   0   2   0   0   2 
Disease Status Relative to Most Recent Prior Therapy 
[Units: Participants]
         
Refractory   22   55   37   9   123 
Relapsed   13   12   16   7   48 
Missing   0   1   0   0   1 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Objective Response Rate (ORR) by Investigator With Brentuximab Vedotin Monotherapy   [ Time Frame: Up to approximately 3 years ]

2.  Primary:   Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Plus Rituximab   [ Time Frame: Up to 3 years ]

3.  Secondary:   Objective Response Rate (ORR) by Investigator With Brentuximab Vedotin Plus Rituximab   [ Time Frame: Up to approximately 3 years ]

4.  Secondary:   Complete Remission (CR) Rate by Investigator   [ Time Frame: Up to approximately 3 years ]

5.  Secondary:   Duration of Objective Response With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis   [ Time Frame: Up to approximately 3 years ]

6.  Secondary:   Duration of Complete Remission With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis   [ Time Frame: Up to approximately 3 years ]

7.  Secondary:   Progression-Free Survival With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis   [ Time Frame: Up to approximately 3 years ]

8.  Secondary:   Correlation Between Antitumor Activity of Brentuximab Vedotin Monotherapy and CD30 Expression   [ Time Frame: Up to 3 years ]

9.  Secondary:   Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Monotherapy   [ Time Frame: Up to 3 years ]

10.  Secondary:   Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi) (Cycle 1)   [ Time Frame: 1 day ]

11.  Secondary:   Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough) (Cycle 1)   [ Time Frame: 3 weeks ]

12.  Secondary:   Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE) (Cycle 1)   [ Time Frame: 3 weeks ]

13.  Secondary:   Time to Maximum Concentration (Tmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE)   [ Time Frame: 3 weeks ]

14.  Secondary:   Baseline Soluble CD30 Expression   [ Time Frame: Baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


  More Information
  Hide 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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Seattle Genetics, Inc.
phone: 855-473-2436
e-mail: medinfo@seagen.com


Publications of Results:

Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT01421667     History of Changes
Other Study ID Numbers: SGN35-012
Study First Received: August 19, 2011
Results First Received: June 21, 2016
Last Updated: October 14, 2016