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Study of Brentuximab Vedotin (SGN-35) in Pediatric Participants With Relapsed or Refractory (r/r) Systemic Anaplastic Large-Cell Lymphoma or Hodgkin Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )
ClinicalTrials.gov Identifier:
NCT01492088
First received: December 12, 2011
Last updated: April 5, 2017
Last verified: April 2017
Results First Received: April 5, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Conditions: Relapsed or Refractory Hodgkin Lymphoma
Relapsed or Refractory Anaplastic Large-cell Lymphoma
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
Participants took part in the study at 12 investigative sites in United States, France, Germany, Netherlands, United Kingdom, Italy, Spain and Mexico from 16-April-2012 to 12-Oct-2016.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with diagnosis of relapsed or refractory (r/r) sALCL/HL were enrolled to receive brentuximab vedotin 1.4-1.8 mg/kg, intravenous infusion on Day 1 of every 21-day cycle for up to 16 cycles. Treatment beyond 16 cycles was permitted at joint discretion of sponsor and investigator for participants experiencing continued clinical benefit.

Reporting Groups
  Description
Brentuximab Vedotin 1.4 mg/kg: Phase 1 Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.

Participant Flow:   Overall Study
    Brentuximab Vedotin 1.4 mg/kg: Phase 1   Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only   Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only
STARTED   3   16   17 
COMPLETED   0   2   4 
NOT COMPLETED   3   14   13 
Withdrawal by Patient                0                2                0 
Death                1                6                1 
Reason Not Specified                2                6                12 



  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.
Safety population is defined as participants who received at least 1 dose of study drug.

Reporting Groups
  Description
Brentuximab Vedotin 1.4 mg/kg: Phase 1 Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Total Total of all reporting groups

Baseline Measures
   Brentuximab Vedotin 1.4 mg/kg: Phase 1   Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only   Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only   Total 
Overall Participants Analyzed 
[Units: Participants]
 3   16   17   36 
Age 
[Units: Years]
Mean (Standard Deviation)
 14.7  (1.15)   14.5  (2.68)   11.5  (3.18)   13.1  (3.19) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      1  33.3%      7  43.8%      3  17.6%      11  30.6% 
Male      2  66.7%      9  56.3%      14  82.4%      25  69.4% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Hispanic or Latino      0   0.0%      0   0.0%      4  23.5%      4  11.1% 
Not Hispanic or Latino      3 100.0%      14  87.5%      12  70.6%      29  80.6% 
Unknown or Not Reported      0   0.0%      2  12.5%      1   5.9%      3   8.3% 
Race/Ethnicity, Customized 
[Units: Participants]
       
White   2   13   16   31 
Asian   1   0   1   2 
Other   0   2   0   2 
Not Reported   0   1   0   1 
Region of Enrollment 
[Units: Participants]
       
United States   2   1   1   4 
France   0   2   0   2 
Germany   0   4   1   5 
Netherlands   0   1   2   3 
United Kingdom   0   1   2   3 
Italy   1   7   6   14 
Spain   0   0   4   4 
Mexico   0   0   1   1 
Height 
[Units: Cm]
Mean (Standard Deviation)
 167.17  (10.865)   165.31  (14.350)   149.54  (17.783)   158.02  (17.493) 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 53.10  (9.924)   57.85  (17.539)   42.16  (15.162)   50.04  (17.361) 
Body Surface Area 
[Units: M^2]
Mean (Standard Deviation)
 1.562  (0.0967)   1.617  (0.2938)   1.313  (0.3103)   1.469  (0.3228) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Phase 1)   [ Time Frame: From the first dose through 30 days after the last dose of study medication (Up to 15 months) ]

2.  Primary:   Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1)   [ Time Frame: From the first dose through 30 days after the last dose of study medication (Up to 15 months) ]

3.  Primary:   Number of Participants With Clinically Significant Vital Signs Values Reported as AEs (Phase 1)   [ Time Frame: From the first dose through 30 days after the last dose of study medication (Up to 15 months) ]

4.  Primary:   Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1)   [ Time Frame: Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose ]

5.  Primary:   Serum Concentration of Total Antibodies (Conjugated and Unconjugated) (Phase 1)   [ Time Frame: Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose ]

6.  Primary:   Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1)   [ Time Frame: Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose ]

7.  Primary:   Overall Response Rate (ORR) (Phase 1 and 2)   [ Time Frame: Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or end of treatment (EOT) (Up to 15 months) ]

8.  Secondary:   Number of Participants With Antitherapeutic Antibodies (ATA) and Neutralizing ATA (nATA) (Phase 1 and 2)   [ Time Frame: Baseline up to EOT (Up to 15 months) ]

9.  Secondary:   Overall Response Rate (ORR) (Phase 1)   [ Time Frame: Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT (Up to 15 months) ]

10.  Secondary:   Time to Progression (TTP) (Phase 1 and 2)   [ Time Frame: Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT and then every 12 weeks for 12 months after EOT, until disease progression, or death (Up to 27 months) ]

11.  Secondary:   Time to Response (Phase 1 and 2)   [ Time Frame: Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT (Up to 15 months) ]

12.  Secondary:   Duration of Response (DOR) (Phase 1 and 2)   [ Time Frame: Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT and then every 12 weeks for 12 months after EOT, until disease progression, or death (Up to 27 months) ]

13.  Secondary:   Event Free Survival (EFS) (Phase 1 and 2)   [ Time Frame: Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT and then every 12 weeks for 12 months after EOT, until disease progression, or death (Up to 27 months) ]

14.  Secondary:   Progression Free Survival (PFS) (Phase 1 and 2)   [ Time Frame: Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT and then every 12 weeks for 12 months after EOT, until disease progression, or death (Up to 27 months) ]

15.  Secondary:   Overall Survival (OS) (Phase 1 and 2)   [ Time Frame: Every 6 months after EOT, until the sooner of death, study closure, or 2 years after enrollment of the last participant (Up to 60 months) ]

16.  Secondary:   Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Phase 1 and 2)   [ Time Frame: From the first dose through 30 days after the last dose of study medication (up to 15 months) ]

17.  Secondary:   Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1 and 2)   [ Time Frame: From the first dose through 30 days after the last dose of study medication (Up to 15 months) ]

18.  Secondary:   Number of Participants With Clinically Significant Vital Signs Reported as AEs (Phase 1 and 2)   [ Time Frame: From the first dose through 30 days after the last dose of study medication (Up to 15 months) ]

19.  Secondary:   Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2)   [ Time Frame: Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose ]

20.  Secondary:   Serum Concentration of Total Antibodies (Conjugated and Unconjugated)   [ Time Frame: Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose ]

21.  Secondary:   Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2)   [ Time Frame: Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose ]


  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
No text entered.


  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 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: Medical Director
Organization: Takeda
phone: +1-877-825-3327
e-mail: trialdisclosures@takeda.com


Publications of Results:

Responsible Party: Takeda ( Millennium Pharmaceuticals, Inc. )
ClinicalTrials.gov Identifier: NCT01492088     History of Changes
Other Study ID Numbers: C25002
2011-001240-29 ( EudraCT Number )
U1111-1158-2613 ( Registry Identifier: WHO )
133300410A0384 ( Registry Identifier: RNEC )
NL38209.078.11 ( Registry Identifier: CCMO )
Study First Received: December 12, 2011
Results First Received: April 5, 2017
Last Updated: April 5, 2017