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A Phase 3 Trial of Brentuximab Vedotin(SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Participants With CD30-Positive Cutaneous T-Cell Lymphoma (ALCANZA Study)

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ClinicalTrials.gov Identifier: NCT01578499
Recruitment Status : Active, not recruiting
First Posted : April 17, 2012
Results First Posted : March 16, 2018
Last Update Posted : March 16, 2018
Sponsor:
Collaborator:
Seattle Genetics, Inc.
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Primary Cutaneous Anaplastic Large Cell Lymphoma
Mycosis Fungoides
Cutaneous T-Cell Lymphoma
Interventions: Drug: Brentuximab Vedotin
Drug: Methotrexate
Drug: Bexarotene

  Participant Flow

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 34 investigative sites in Australia, Belgium, Brazil, France, Germany, Italy, Poland, Spain, Switzerland, United Kingdom, United States from 11 June 2012 to the Primary Completion data of 31 May 2016. The study is ongoing.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with a diagnosis of cluster of differentiation antigen 30 (CD30)-Positive Cutaneous T-Cell Lymphoma were enrolled equally in 1 of 2 arms: brentuximab vedotin 1.8 mg/kg or physician’s choice (Methotrexate or Bexarotene).

Reporting Groups
  Description
Brentuximab Vedotin Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
Methotrexate or Bexarotene Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.

Participant Flow:   Overall Study
    Brentuximab Vedotin   Methotrexate or Bexarotene
STARTED   66   65 
Safety Population: Treated   66   62 
Intent to Treat Population: CD30+   64   64 
COMPLETED   0   0 
NOT COMPLETED   66   65 
Death                11                14 
Withdrawal by Participant                8                10 
Lost to Follow-up                2                1 
Reason not Specified                0                1 
Participants in Follow-up                42                39 
Participants on Study Treatment                3                0 



  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.
Safety population included participants who received at least 1 dose of study drug, analyzed according to the actual treatment received (n=66,62). Intent-to-treat population (ITT) population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment (n=64,64).

Reporting Groups
  Description
Brentuximab Vedotin Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
Methotrexate or Bexarotene Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.
Total Total of all reporting groups

Baseline Measures
   Brentuximab Vedotin   Methotrexate or Bexarotene   Total 
Overall Participants Analyzed 
[Units: Participants]
 66   64   130 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed   66   62   128 
   59.4  (13.80)   56.6  (14.43)   58.0  (14.12) 
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed   66   62   128 
Female      33  50.0%      28  45.2%      61  47.7% 
Male      33  50.0%      34  54.8%      67  52.3% 
Race/Ethnicity, Customized [1] 
[Units: Participants]
     
White       
Participants Analyzed   64   64   128 
White   56   53   109 
Black or African American       
Participants Analyzed   64   64   128 
Black or African American   3   3   6 
Asian       
Participants Analyzed   64   64   128 
Asian   1   5   6 
Not reported       
Participants Analyzed   64   64   128 
Not reported   3   1   4 
Other       
Participants Analyzed   64   64   128 
Other   1   2   3 
[1] ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment.
Race/Ethnicity, Customized [1] 
[Units: Participants]
     
Hispanic or Latino       
Participants Analyzed   64   64   128 
Hispanic or Latino   2   6   8 
Not Hispanic or Latino       
Participants Analyzed   64   64   128 
Not Hispanic or Latino   60   50   110 
Not reported       
Participants Analyzed   64   64   128 
Not reported   2   8   10 
[1] ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment.
Region of Enrollment [1] 
[Units: Participants]
Count of Participants
     
Australia       
Participants Analyzed   66   62   128 
Australia   12   8   20 
Belgium       
Participants Analyzed   66   62   128 
Belgium   4   2   6 
France       
Participants Analyzed   66   62   128 
France   4   3   7 
Germany       
Participants Analyzed   66   62   128 
Germany   3   2   5 
Italy       
Participants Analyzed   66   62   128 
Italy   12   6   18 
Poland       
Participants Analyzed   66   62   128 
Poland   2   1   3 
Spain       
Participants Analyzed   66   62   128 
Spain   2   3   5 
Switzerland       
Participants Analyzed   66   62   128 
Switzerland   3   3   6 
United Kingdom       
Participants Analyzed   66   62   128 
United Kingdom   8   15   23 
United States       
Participants Analyzed   66   62   128 
United States   14   17   31 
Brazil       
Participants Analyzed   66   62   128 
Brazil   2   2   4 
[1] Safety population included participants who received at least 1 dose of study drug, analyzed according to the actual treatment received.


  Outcome Measures

1.  Primary:   Percentage of Participants Achieving an Objective Response That Lasts at Least 4 Months (ORR4)   [ Time Frame: Each Cycle until disease progression, death or data cutoff (Median overall follow-up 22.9 months) ]

2.  Secondary:   Percentage of Participants Achieving a CR   [ Time Frame: Each Cycle until disease progression, death or data cutoff (Median overall follow-up 22.9 months) ]

3.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: Until disease progression, death or data cutoff (Median PFS follow-up of 17.5 months) ]

4.  Secondary:   Maximum Change From Baseline in Symptom Domain Score of the Skindex-29 Questionnaire   [ Time Frame: Baseline up to End of Treatment (Week 52) ]

5.  Secondary:   Duration of Response (DOR)   [ Time Frame: Until disease progression, death or data cutoff (Median follow-up 22.9 months) ]

6.  Secondary:   DOR of Skin Response   [ Time Frame: Until disease progression, death or data cutoff (Median follow-up 22.9 months) ]

7.  Secondary:   Event-Free Survival (EFS)   [ Time Frame: From randomization until disease progression, death or data cutoff (Median follow-up 26.1 months) ]

8.  Secondary:   Cmax: Maximum Observed Concentration for Brentuximab Vedotin   [ Time Frame: Day 1 pre-dose and 30 minutes after infusion in Cycles 1 and 3 ]

9.  Secondary:   Ctrough: Observed Concentration at the End of a Dosing Interval for Brentuximab Vedotin   [ Time Frame: Day 1 pre-dose of Cycles 2 and 4 ]

10.  Secondary:   Cmax: Maximum Observed Concentration for Monomethyl Auristatin (MMAE) for Brentuximab Vedotin   [ Time Frame: Day 1 pre-dose and 30 minutes after infusion ended in Cycles 1 and 3 ]

11.  Secondary:   Ctrough: Observed Concentration at the End of a Dosing Interval for MMAE for Brentuximab Vedotin   [ Time Frame: Day 1 pre-dose of Cycles 2 and 4 ]

12.  Secondary:   Number of Participants With Antitherapeutic Antibodies (ATA) to Brentuximab Vedotin   [ Time Frame: Baseline up to End of Treatment (Week 52) ]

13.  Secondary:   Change From Baseline in the Skindex-29 Questionnaire Total Score   [ Time Frame: Day 1 of Cycles 1, 2, 4, 6, 8, 10, 12, 14, 16, at End of Treatment (EOT) and during posttreatment long treatment follow-up (LTFU) - (Median follow-up 22.9 months) ]

14.  Secondary:   Change From Baseline in Functional Assessment of Cancer Therapy General Questionnaire (FACT-G) Score   [ Time Frame: Day 1 of Cycles 1, 2, 4, 6, 8, 10, 12, 14, 16, at EOT and during posttreatment (LTFU) - (Median follow-up 22.9 months) ]

15.  Secondary:   Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: First dose of study drug through 30 days after last dose of study drug (Up to 395 days) ]


  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
No text entered.


  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: Medical Director
Organization: Takeda
phone: +1-844-662-8532
e-mail: globaloncologymedinfo@takeda.com


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

Responsible Party: Takeda ( Millennium Pharmaceuticals, Inc. )
ClinicalTrials.gov Identifier: NCT01578499     History of Changes
Other Study ID Numbers: C25001
2010-024215-14 ( EudraCT Number )
First Submitted: March 27, 2012
First Posted: April 17, 2012
Results First Submitted: December 9, 2017
Results First Posted: March 16, 2018
Last Update Posted: March 16, 2018