Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT01461538
First received: October 24, 2011
Last updated: February 5, 2016
Last verified: February 2016
Results First Received: December 18, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Acute Lymphoid Leukemia
Acute Myeloid Leukemia
Anemia, Refractory, With Excess of Blasts
Solid Tumors
Intervention: Drug: brentuximab vedotin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Oct 2011 - Dec 2014

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

Reporting Groups
  Description
BV 1.8 mg/kg Q3Week Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
BV 2.4 mg/kg Q3Week Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
BV 1.2 mg/kg Q1Week Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)

Participant Flow:   Overall Study
    BV 1.8 mg/kg Q3Week     BV 2.4 mg/kg Q3Week     BV 1.2 mg/kg Q1Week  
STARTED     46     28     9  
COMPLETED     28     20     7  
NOT COMPLETED     18     8     2  
Death                 15                 6                 2  
Study Stopped by Sponsor                 2                 1                 0  
Withdrawal by Subject                 1                 1                 0  



  Baseline Characteristics
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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. One additional patient enrolled, but withdrew prior to treatment group assignment.

Reporting Groups
  Description
BV 1.8 mg/kg Q3Week Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
BV 2.4 mg/kg Q3Week Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
BV 1.2 mg/kg Q1Week Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
Total Total of all reporting groups

Baseline Measures
    BV 1.8 mg/kg Q3Week     BV 2.4 mg/kg Q3Week     BV 1.2 mg/kg Q1Week     Total  
Number of Participants  
[units: participants]
  46     28     9     83  
Age  
[units: years]
Median (Full Range)
  64  
  (24 to 85)  
  64  
  (18 to 85)  
  76  
  (33 to 87)  
  65  
  (18 to 87)  
Gender  
[units: participants]
       
Female     21     12     4     37  
Male     25     16     5     46  
Ethnicity (NIH/OMB)  
[units: participants]
       
Hispanic or Latino     2     2     0     4  
Not Hispanic or Latino     44     26     9     79  
Unknown or Not Reported     0     0     0     0  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     0     0     0     0  
Asian     1     2     0     3  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     2     0     0     2  
White     42     25     9     76  
More than one race     0     0     0     0  
Unknown or Not Reported     1     1     0     2  
Region of Enrollment  
[units: participants]
       
United States     46     28     9     83  
Eastern Cooperative Oncology Group Performance Status [1]
[units: participants]
       
0     13     5     1     19  
1     20     15     5     40  
2     0     0     1     1  
3-5     0     0     0     0  
Missing     13     8     2     23  
Height  
[units: centimeters (cm)]
Median (Full Range)
  170.2  
  (142 to 188)  
  171.9  
  (150 to 186)  
  167.6  
  (144 to 180)  
  170.2  
  (142 to 188)  
Weight  
[units: kilograms (kg)]
Median (Full Range)
  74.8  
  (46 to 109)  
  75.1  
  (49 to 104)  
  73.4  
  (45 to 137)  
  74.8  
  (45 to 137)  
Body Mass Index  
[units: kg per meter squared (kg/m^2)]
Median (Full Range)
  25.3  
  (19 to 40)  
  27.4  
  (18 to 36)  
  26.3  
  (20 to 47)  
  26.0  
  (18 to 47)  
[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



  Outcome Measures
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1.  Primary:   Objective Response Rate (ORR) by Investigator   [ Time Frame: Up to approximately 3 years ]

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

3.  Secondary:   Duration of Objective Response by Kaplan-Meier Analysis   [ Time Frame: Up to approximately 2 years ]

4.  Secondary:   Duration of Complete Response by Kaplan-Meier Analysis   [ Time Frame: Up to approximately 2 years ]

5.  Secondary:   Progression-Free Survival by Kaplan-Meier Analysis   [ Time Frame: Up to approximately 2 years ]

6.  Secondary:   Adverse Events by Severity, Seriousness, and Relationship to Treatment   [ Time Frame: Up to approximately 3 years ]

7.  Secondary:   Laboratory Abnormalities >/= Grade 3   [ Time Frame: Up to approximately 3 years ]

8.  Secondary:   Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi)   [ Time Frame: Up to approximately 3 years ]

9.  Secondary:   Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough)   [ Time Frame: Up to approximately 3 years ]

10.  Secondary:   Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE)   [ Time Frame: Up to approximately 3 years ]

11.  Secondary:   Brentuximab Vedotin Monomethyl Auristatin E (MMAE) Trough Concentration (Ctrough)   [ Time Frame: Up to approximately 3 years ]

12.  Secondary:   Incidence of Anti-therapeutic Antibodies (ATA)   [ Time Frame: Up to approximately 3 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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 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 Office
Organization: Seattle Genetics, Inc.
phone: 855-473-2436
e-mail: medinfo@seagen.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT01461538     History of Changes
Other Study ID Numbers: SGN35-013
Study First Received: October 24, 2011
Results First Received: December 18, 2015
Last Updated: February 5, 2016
Health Authority: United States: Food and Drug Administration