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KW-0761 or Investigator's Choice in Subjects With Previously Treated Adult T-cell Leukemia-Lymphoma (ATL)

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ClinicalTrials.gov Identifier: NCT01626664
Recruitment Status : Completed
First Posted : June 25, 2012
Results First Posted : June 15, 2018
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
Kyowa Kirin Pharmaceutical Development, Inc.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Adult T-cell Leukemia-Lymphoma
Interventions: Biological: KW-0761
Drug: Pralatrexate
Drug: gemcitabine plus oxaliplatin
Drug: DHAP

  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
No text entered.

Reporting Groups
  Description
KW-0761

anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab)

KW-0761: 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression

Investigator's Choice

Comparator is investigator's choice of pralatrexate or gemcitabine plus oxaliplatin or DHAP

Pralatrexate: 30 mg/m2 weekly for 3 weeks followed by 1 week of no therapy until progression

gemcitabine plus oxaliplatin: gemcitabine 1000 mg/m2, followed by oxaliplatin 100 mg/m2 every 2 weeks until progression

DHAP: dexamethasone 40 mg on Day 1-4, cisplatin 100 mg/m2 on Day 1 followed by 2 doses of cytarabine 2000 mg/m2 every 4 weeks until progression

IC Original Then Crossover to KW-0761 Subjects who were randomized to the Investigator’s Choice regimen could be crossed over to receive mogamulizumab upon disease progression and with permission from the Medical Monitor.

Participant Flow for 2 periods

Period 1:   Randomization Period
    KW-0761   Investigator's Choice   IC Original Then Crossover to KW-0761
STARTED   47   24   0 
COMPLETED   47   24   0 
NOT COMPLETED   0   0   0 

Period 2:   Crossover Period
    KW-0761   Investigator's Choice   IC Original Then Crossover to KW-0761
STARTED   0   0   18 
COMPLETED   0   0   18 
NOT COMPLETED   0   0   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.
No text entered.

Reporting Groups
  Description
KW-0761

anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab)

KW-0761: 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression

Investigator's Choice

Comparator is investigator's choice of pralatrexate or gemcitabine plus oxaliplatin or DHAP

Pralatrexate: 30 mg/m2 weekly for 3 weeks followed by 1 week of no therapy until progression

gemcitabine plus oxaliplatin: gemcitabine 1000 mg/m2, followed by oxaliplatin 100 mg/m2 every 2 weeks until progression

DHAP: dexamethasone 40 mg on Day 1-4, cisplatin 100 mg/m2 on Day 1 followed by 2 doses of cytarabine 2000 mg/m2 every 4 weeks until progression

Total Total of all reporting groups

Baseline Measures
   KW-0761   Investigator's Choice   Total 
Overall Participants Analyzed 
[Units: Participants]
 47   24   71 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      35  74.5%      22  91.7%      57  80.3% 
>=65 years      12  25.5%      2   8.3%      14  19.7% 
Age 
[Units: Years]
Mean (Full Range)
 55 
 (22 to 82) 
 49 
 (24 to 80) 
 53 
 (22 to 82) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      23  48.9%      14  58.3%      37  52.1% 
Male      24  51.1%      10  41.7%      34  47.9% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      9  19.1%      6  25.0%      15  21.1% 
Not Hispanic or Latino      31  66.0%      14  58.3%      45  63.4% 
Unknown or Not Reported      7  14.9%      4  16.7%      11  15.5% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Race       
White      6  12.8%      5  20.8%      11  15.5% 
Asian      2   4.3%      1   4.2%      3   4.2% 
Black or African American      32  68.1%      15  62.5%      47  66.2% 
Other      1   2.1%      0   0.0%      1   1.4% 
Not Applicable      6  12.8%      3  12.5%      9  12.7% 
Region of Enrollment 
[Units: Participants]
     
United States   25   14   39 
Brazil   3   0   3 
United Kingdom   9   4   13 
France   6   3   9 
Peru   4   3   7 


  Outcome Measures

1.  Primary:   Overall Response Rate   [ Time Frame: every 8 weeks from date of randomization until the date of first documented progression or date of death from any cause, whichever came first ]

2.  Secondary:   Progression Free Survival   [ Time Frame: From date of randomization until the date of first documented progression, start of alternative therapy, or date of death from any cause, whichever came first, up to 36 months ]

3.  Secondary:   Overall Survival   [ Time Frame: up to 36 months ]


  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 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: Fiona Herr, Associate Director, Medical Communications
Organization: Kyowa Kirin Inc
phone: 1 (908) 234-1096
e-mail: medinfo-US@kyowakirin.com



Responsible Party: Kyowa Kirin Pharmaceutical Development, Inc.
ClinicalTrials.gov Identifier: NCT01626664     History of Changes
Other Study ID Numbers: PROTOCOL 0761-009
First Submitted: June 19, 2012
First Posted: June 25, 2012
Results First Submitted: April 2, 2018
Results First Posted: June 15, 2018
Last Update Posted: June 15, 2018