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A Phase 2 Open Label Trial of Brentuximab Vedotin (SGN-35) for Systemic Anaplastic Large Cell Lymphoma

This study has been completed.
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT00866047
First received: March 19, 2009
Last updated: August 12, 2016
Last verified: August 2016
Results First Received: September 15, 2011  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Lymphoma, Large-Cell, Anaplastic
Lymphoma, Non-Hodgkin
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
Enrollment period: Jun 2009 - May 2010

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
Brentuximab Vedotin Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion

Participant Flow for 2 periods

Period 1:   Treatment Period
    Brentuximab Vedotin
STARTED   58 
COMPLETED   3 [1] 
NOT COMPLETED   55 
Progressive disease                13 
Adverse Event                14 
Physician Decision                14 
Withdrawal by Subject                5 
Continuing on treatment                9 
[1] Number who completed 16 cycles of treatment

Period 2:   Follow-up Period
    Brentuximab Vedotin
STARTED   43 [1] 
COMPLETED   12 [2] 
NOT COMPLETED   31 
Continuing in follow-up                31 
[1] All participants were to be followed after treatment
[2] Completed survival follow-up due to death



  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.
No text entered.

Reporting Groups
  Description
Brentuximab Vedotin Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion

Baseline Measures
   Brentuximab Vedotin 
Overall Participants Analyzed 
[Units: Participants]
 58 
Age, Customized 
[Units: Years]
Median (Full Range)
 52.0 
 (14 to 76) 
Gender 
[Units: Participants]
 
Female   25 
Male   33 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   1 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   7 
White   48 
More than one race   0 
Unknown or Not Reported   2 
Eastern Cooperative Oncology Group Performance Status [1] 
[Units: Participants]
 
 19 
 38 
 1 
3-5   0 
[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
ALK Status [1] 
[Units: Participants]
 
Positive   16 
Negative   42 
[1] Immunophenotype status with respect to anaplastic lymphoma kinase (ALK) protein


  Outcome Measures
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1.  Primary:   Objective Response Rate by Independent Review Group   [ Time Frame: up to 12 months ]

2.  Secondary:   Complete Remission Rate by Independent Review Group   [ Time Frame: up to 12 months ]

3.  Secondary:   Duration of Objective Response by Kaplan-Meier Analysis   [ Time Frame: up to 17.5 months ]

4.  Secondary:   Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis   [ Time Frame: up to 17.5 months ]

5.  Secondary:   Progression-free Survival by Kaplan-Meier Analysis   [ Time Frame: up to 17.5 months ]

6.  Secondary:   Overall Survival   [ Time Frame: up to 17.5 months ]

7.  Secondary:   Adverse Events by Severity, Seriousness, and Relationship to Treatment   [ Time Frame: up to 12 months ]

8.  Secondary:   Hematology Laboratory Abnormalities >/= Grade 3   [ Time Frame: up to 12 months ]

9.  Secondary:   Chemistry Laboratory Abnormalities >/= Grade 3   [ Time Frame: up to 12 months ]

10.  Secondary:   Area Under the Curve   [ Time Frame: 3 weeks ]

11.  Secondary:   Maximum Serum Concentration   [ Time Frame: 3 weeks ]

12.  Secondary:   Time of Maximum Serum Concentration   [ Time Frame: 3 weeks ]

13.  Other Pre-specified:   B Symptom Resolution   [ Time Frame: up to 12 months ]


  Serious Adverse Events
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Time Frame Treatment-emergent adverse events through 30 days after last dose (up to 12 months)
Additional Description No text entered.

Reporting Groups
  Description
Brentuximab Vedotin Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion

Serious Adverse Events
    Brentuximab Vedotin
Total, Serious Adverse Events   
# participants affected / at risk   24/58 (41.38%) 
Blood and lymphatic system disorders   
Anaemia † 1   
# participants affected / at risk   1/58 (1.72%) 
Neutropenia † 1   
# participants affected / at risk   1/58 (1.72%) 
Cardiac disorders   
Acute myocardial infarction † 1   
# participants affected / at risk   1/58 (1.72%) 
Arrhythmia supraventricular † 1   
# participants affected / at risk   2/58 (3.45%) 
Atrial fibrillation † 1   
# participants affected / at risk   1/58 (1.72%) 
Atrioventricular block complete † 1   
# participants affected / at risk   1/58 (1.72%) 
Bradycardia † 1   
# participants affected / at risk   1/58 (1.72%) 
Eye disorders   
Retinal vein occlusion † 1   
# participants affected / at risk   1/58 (1.72%) 
Gastrointestinal disorders   
Abdominal pain † 1   
# participants affected / at risk   1/58 (1.72%) 
Constipation † 1   
# participants affected / at risk   1/58 (1.72%) 
Diarrhoea † 1   
# participants affected / at risk   1/58 (1.72%) 
Gastrointestinal haemorrhage † 1   
# participants affected / at risk   1/58 (1.72%) 
Vomiting † 1   
# participants affected / at risk   1/58 (1.72%) 
General disorders   
Asthenia † 1   
# participants affected / at risk   1/58 (1.72%) 
Generalised oedema † 1   
# participants affected / at risk   1/58 (1.72%) 
Sudden death † 1   
# participants affected / at risk   1/58 (1.72%) 
Infections and infestations   
Cellulitis † 1   
# participants affected / at risk   1/58 (1.72%) 
Endocarditis staphylococcal † 1   
# participants affected / at risk   1/58 (1.72%) 
Gastroenteritis viral † 1   
# participants affected / at risk   1/58 (1.72%) 
Klebsiella bacteraemia † 1   
# participants affected / at risk   1/58 (1.72%) 
Pneumonia † 1   
# participants affected / at risk   1/58 (1.72%) 
Septic shock † 1   
# participants affected / at risk   2/58 (3.45%) 
Superinfection bacterial † 1   
# participants affected / at risk   1/58 (1.72%) 
Urinary tract infection † 1   
# participants affected / at risk   2/58 (3.45%) 
Injury, poisoning and procedural complications   
Lower limb fracture † 1   
# participants affected / at risk   1/58 (1.72%) 
Metabolism and nutrition disorders   
Decreased appetite † 1   
# participants affected / at risk   1/58 (1.72%) 
Fluid overload † 1   
# participants affected / at risk   1/58 (1.72%) 
Hypercalcaemia † 1   
# participants affected / at risk   1/58 (1.72%) 
Tumour lysis syndrome † 1   
# participants affected / at risk   1/58 (1.72%) 
Musculoskeletal and connective tissue disorders   
Myositis † 1   
# participants affected / at risk   1/58 (1.72%) 
Pain in extremity † 1   
# participants affected / at risk   2/58 (3.45%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Anaplastic large cell lymphoma t- and null-cell types recurrent † 1   
# participants affected / at risk   3/58 (5.17%) 
Mycosis fungoides † 1   
# participants affected / at risk   1/58 (1.72%) 
Tumour flare † 1   
# participants affected / at risk   1/58 (1.72%) 
Nervous system disorders   
Encephalopathy † 1   
# participants affected / at risk   1/58 (1.72%) 
Haemorrhage intracranial † 1   
# participants affected / at risk   1/58 (1.72%) 
Neuralgia † 1   
# participants affected / at risk   1/58 (1.72%) 
Peripheral motor neuropathy † 1   
# participants affected / at risk   1/58 (1.72%) 
Peripheral sensory neuropathy † 1   
# participants affected / at risk   1/58 (1.72%) 
Spinal cord compression † 1   
# participants affected / at risk   1/58 (1.72%) 
Syncope † 1   
# participants affected / at risk   1/58 (1.72%) 
Psychiatric disorders   
Mental status changes † 1   
# participants affected / at risk   1/58 (1.72%) 
Renal and urinary disorders   
Hydronephrosis † 1   
# participants affected / at risk   1/58 (1.72%) 
Renal failure † 1   
# participants affected / at risk   1/58 (1.72%) 
Renal failure acute † 1   
# participants affected / at risk   1/58 (1.72%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary embolism † 1   
# participants affected / at risk   1/58 (1.72%) 
Pulmonary oedema † 1   
# participants affected / at risk   1/58 (1.72%) 
Respiratory failure † 1   
# participants affected / at risk   1/58 (1.72%) 
Tracheal disorder † 1   
# participants affected / at risk   1/58 (1.72%) 
Skin and subcutaneous tissue disorders   
Rash papular † 1   
# participants affected / at risk   1/58 (1.72%) 
Vascular disorders   
Deep vein thrombosis † 1   
# participants affected / at risk   1/58 (1.72%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (13.0)




  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
Maximum duration of follow-up was 17.5 months; 9 participants were continuing on treatment and 31 participants remained in survival follow-up at the time of the efficacy analyses.


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