Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 39 of 881 for:    "Reticulum Cell Sarcoma"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00866047
Recruitment Status : Completed
First Posted : March 20, 2009
Results First Posted : October 26, 2011
Last Update Posted : March 22, 2017
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Lymphoma, Large-Cell, Anaplastic
Lymphoma, Non-Hodgkin
Intervention Drug: brentuximab vedotin
Enrollment 58
Recruitment Details Enrollment period: Jun 2009 - May 2010
Pre-assignment Details  
Arm/Group Title Brentuximab Vedotin
Hide Arm/Group Description Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion
Period Title: Treatment Period
Started 58
Completed 10 [1]
Not Completed 48
Reason Not Completed
Progressive disease             13
Adverse Event             16
Physician Decision             14
Withdrawal by Subject             5
[1]
Number who completed 16 cycles of treatment
Period Title: Follow-up Period
Started 58 [1]
Completed 53 [2]
Not Completed 5
Reason Not Completed
Lost to Follow-up             5
[1]
All participants were to be followed after treatment
[2]
Completed survival follow-up due to death [25] or study completion [28]
Arm/Group Title Brentuximab Vedotin
Hide Arm/Group Description Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
Overall Number of Baseline Participants 58
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 58 participants
52.0
(14 to 76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants
Female
25
  43.1%
Male
33
  56.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   1.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
7
  12.1%
White
48
  82.8%
More than one race
0
   0.0%
Unknown or Not Reported
2
   3.4%
Eastern Cooperative Oncology Group Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 58 participants
0 19
1 38
2 1
3-5 0
[1]
Measure Description:

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] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 58 participants
Positive 16
Negative 42
[1]
Measure Description: Immunophenotype status with respect to anaplastic lymphoma kinase (ALK) protein
1.Primary Outcome
Title Objective Response Rate by Independent Review Group
Hide Description Percentage of participants who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.
Time Frame up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title Brentuximab Vedotin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
Overall Number of Participants Analyzed 58
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of participants
86
(74.6 to 93.9)
2.Secondary Outcome
Title Complete Remission Rate by Independent Review Group
Hide Description Percentage of participants who achieved a best response of CR (disappearance of all evidence of disease) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.
Time Frame up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title Brentuximab Vedotin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
Overall Number of Participants Analyzed 58
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of participants
59
(44.9 to 71.4)
3.Secondary Outcome
Title Duration of Objective Response by Kaplan-Meier Analysis
Hide Description Duration of objective response (CR + PR) by independent review group, defined as time of initial response until disease progression or death.
Time Frame up to approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with objective response among the intention to treat population
Arm/Group Title Brentuximab Vedotin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
Overall Number of Participants Analyzed 50
Median (95% Confidence Interval)
Unit of Measure: months
13.2
(5.7 to 26.3)
4.Secondary Outcome
Title Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis
Hide Description Duration of response from start of first objective tumor response (CR or PR) by independent review group to disease progression or death due to any cause in participants with CR.
Time Frame up to approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with complete remission among the intention to treat population
Arm/Group Title Brentuximab Vedotin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
Overall Number of Participants Analyzed 34
Median (95% Confidence Interval)
Unit of Measure: months
26.3 [1] 
(13.2 to NA)
[1]
Insufficient number of events to estimate upper bound
5.Secondary Outcome
Title Progression-free Survival by Kaplan-Meier Analysis
Hide Description Time from start of study treatment to disease progression per independent review group or death due to any cause.
Time Frame up to approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title Brentuximab Vedotin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
Overall Number of Participants Analyzed 58
Median (95% Confidence Interval)
Unit of Measure: months
14.6
(6.9 to 20.6)
6.Secondary Outcome
Title Overall Survival
Hide Description Time from start of study treatment to date of death due to any cause.
Time Frame up to approximately 7 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title Brentuximab Vedotin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
Overall Number of Participants Analyzed 58
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(21.3 to NA)
[1]
Insufficient number of events to estimate median and upper bound
7.Secondary Outcome
Title Adverse Events by Severity, Seriousness, and Relationship to Treatment
Hide Description Counts of participants who had adverse events or treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.
Time Frame up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received treatment
Arm/Group Title Brentuximab Vedotin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
Overall Number of Participants Analyzed 58
Measure Type: Number
Unit of Measure: participants
Any TEAE 58
TEAE related to study drug 53
TEAE with CTCAE severity grade >/=3 36
Serious adverse event 25
Serious adverse event related to study drug 11
Discontinued treatment due to adverse event 16
8.Secondary Outcome
Title Hematology Laboratory Abnormalities >/= Grade 3
Hide Description Counts of study participants with post-baseline hematology laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.
Time Frame up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received treatment
Arm/Group Title Brentuximab Vedotin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
Overall Number of Participants Analyzed 58
Measure Type: Number
Unit of Measure: participants
Any >/= Grade 3 hematology laboratory abnormality 17
Leukocytes (low) 3
Lymphocytes (low) 10
Neutrophils (low) 7
Platelets (low) 3
9.Secondary Outcome
Title Chemistry Laboratory Abnormalities >/= Grade 3
Hide Description Counts of study participants with post-baseline chemistry laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.
Time Frame up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received treatment
Arm/Group Title Brentuximab Vedotin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
Overall Number of Participants Analyzed 58
Measure Type: Number
Unit of Measure: participants
Any >/= Grade 3 chemistry laboratory abnormality 13
Aspartate aminotransferase (high) 1
Calcium (low) 3
Glucose (high) 4
Potassium (low) 1
Sodium (low) 1
Urate (high) 3
10.Secondary Outcome
Title Area Under the Curve
Hide Description Area under the serum concentration-time curve from time 0 to 21 days following the first dose of brentuximab vedotin
Time Frame 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received treatment
Arm/Group Title Brentuximab Vedotin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
Overall Number of Participants Analyzed 58
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: day * microgram/mL
98
(69%)
11.Secondary Outcome
Title Maximum Serum Concentration
Hide Description Maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin
Time Frame 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received treatment
Arm/Group Title Brentuximab Vedotin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
Overall Number of Participants Analyzed 58
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: microgram/mL
37
(20%)
12.Secondary Outcome
Title Time of Maximum Serum Concentration
Hide Description Time of maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin
Time Frame 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received treatment
Arm/Group Title Brentuximab Vedotin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
Overall Number of Participants Analyzed 58
Median (Full Range)
Unit of Measure: days
0.02
(0.02 to 0.02)
13.Other Pre-specified Outcome
Title B Symptom Resolution
Hide Description Percentage of participants with lymphoma-related symptoms (B symptoms: fever, night sweats, or weight loss >10%) at baseline who achieved resolution of all B symptoms at any time during the treatment period.
Time Frame up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with B symptoms at baseline
Arm/Group Title Brentuximab Vedotin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
Overall Number of Participants Analyzed 17
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of participants
82
(56.6 to 96.2)
Time Frame Adverse events through 30 days after last dose (up to 12 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Brentuximab Vedotin
Hide Arm/Group Description Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
All-Cause Mortality
Brentuximab Vedotin
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Brentuximab Vedotin
Affected / at Risk (%)
Total   25/58 (43.10%) 
Blood and lymphatic system disorders   
Anaemia  1  1/58 (1.72%) 
Neutropenia  1  1/58 (1.72%) 
Cardiac disorders   
Acute myocardial infarction  1  1/58 (1.72%) 
Arrhythmia supraventricular  1  2/58 (3.45%) 
Atrial fibrillation  1  1/58 (1.72%) 
Atrioventricular block complete  1  1/58 (1.72%) 
Bradycardia  1  1/58 (1.72%) 
Eye disorders   
Retinal vein occlusion  1  1/58 (1.72%) 
Gastrointestinal disorders   
Abdominal pain  1  1/58 (1.72%) 
Constipation  1  1/58 (1.72%) 
Diarrhoea  1  1/58 (1.72%) 
Gastrointestinal haemorrhage  1  1/58 (1.72%) 
Vomiting  1  1/58 (1.72%) 
General disorders   
Asthenia  1  1/58 (1.72%) 
Generalised oedema  1  1/58 (1.72%) 
Sudden death  1  1/58 (1.72%) 
Infections and infestations   
Cellulitis  1  1/58 (1.72%) 
Endocarditis staphylococcal  1  1/58 (1.72%) 
Gastroenteritis viral  1  1/58 (1.72%) 
Klebsiella bacteraemia  1  1/58 (1.72%) 
Pneumonia  1  1/58 (1.72%) 
Septic shock  1  2/58 (3.45%) 
Superinfection bacterial  1  1/58 (1.72%) 
Urinary tract infection  1  2/58 (3.45%) 
Injury, poisoning and procedural complications   
Lower limb fracture  1  1/58 (1.72%) 
Metabolism and nutrition disorders   
Decreased appetite  1  1/58 (1.72%) 
Fluid overload  1  1/58 (1.72%) 
Hypercalcaemia  1  1/58 (1.72%) 
Tumour lysis syndrome  1  1/58 (1.72%) 
Musculoskeletal and connective tissue disorders   
Myositis  1  1/58 (1.72%) 
Pain in extremity  1  2/58 (3.45%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Anaplastic large cell lymphoma t- and null-cell types recurrent  1  3/58 (5.17%) 
Mycosis fungoides  1  1/58 (1.72%) 
Tumour flare  1  1/58 (1.72%) 
Nervous system disorders   
Encephalopathy  1  1/58 (1.72%) 
Haemorrhage intracranial  1  1/58 (1.72%) 
Neuralgia  1  1/58 (1.72%) 
Peripheral motor neuropathy  1  1/58 (1.72%) 
Peripheral sensory neuropathy  1  1/58 (1.72%) 
Spinal cord compression  1  1/58 (1.72%) 
Syncope  1  1/58 (1.72%) 
Demyelinating polyneuropathy  1  1/58 (1.72%) 
Psychiatric disorders   
Mental status changes  1  1/58 (1.72%) 
Renal and urinary disorders   
Hydronephrosis  1  1/58 (1.72%) 
Renal failure  1  1/58 (1.72%) 
Renal failure acute  1  1/58 (1.72%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary embolism  1  1/58 (1.72%) 
Pulmonary oedema  1  1/58 (1.72%) 
Respiratory failure  1  1/58 (1.72%) 
Tracheal disorder  1  1/58 (1.72%) 
Skin and subcutaneous tissue disorders   
Rash papular  1  1/58 (1.72%) 
Vascular disorders   
Deep vein thrombosis  1  1/58 (1.72%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Brentuximab Vedotin
Affected / at Risk (%)
Total   58/58 (100.00%) 
Blood and lymphatic system disorders   
Anaemia  1  5/58 (8.62%) 
Lymphadenopathy  1  6/58 (10.34%) 
Neutropenia  1  11/58 (18.97%) 
Thrombocytopenia  1  8/58 (13.79%) 
Cardiac disorders   
Tachycardia  1  3/58 (5.17%) 
Gastrointestinal disorders   
Abdominal distension  1  3/58 (5.17%) 
Abdominal pain  1  5/58 (8.62%) 
Constipation  1  12/58 (20.69%) 
Diarrhoea  1  16/58 (27.59%) 
Dyspepsia  1  5/58 (8.62%) 
Nausea  1  23/58 (39.66%) 
Oral pain  1  5/58 (8.62%) 
Vomiting  1  9/58 (15.52%) 
Gastrooesophageal reflux disease  1  3/58 (5.17%) 
Haemorrhoids  1  3/58 (5.17%) 
General disorders   
Asthenia  1  5/58 (8.62%) 
Chills  1  8/58 (13.79%) 
Fatigue  1  22/58 (37.93%) 
Oedema peripheral  1  8/58 (13.79%) 
Pain  1  6/58 (10.34%) 
Pyrexia  1  20/58 (34.48%) 
Infections and infestations   
Bronchitis  1  3/58 (5.17%) 
Folliculitis  1  5/58 (8.62%) 
Upper respiratory tract infection  1  11/58 (18.97%) 
Nasopharyngitis  1  3/58 (5.17%) 
Sinusitis  1  4/58 (6.90%) 
Injury, poisoning and procedural complications   
Excoriation  1  3/58 (5.17%) 
Investigations   
Weight decreased  1  8/58 (13.79%) 
Metabolism and nutrition disorders   
Decreased appetite  1  8/58 (13.79%) 
Dehydration  1  3/58 (5.17%) 
Hyperglycaemia  1  3/58 (5.17%) 
Hypokalaemia  1  5/58 (8.62%) 
Hypomagnesaemia  1  3/58 (5.17%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  5/58 (8.62%) 
Back pain  1  5/58 (8.62%) 
Groin pain  1  5/58 (8.62%) 
Muscle spasms  1  8/58 (13.79%) 
Musculoskeletal pain  1  4/58 (6.90%) 
Myalgia  1  9/58 (15.52%) 
Neck pain  1  5/58 (8.62%) 
Pain in extremity  1  6/58 (10.34%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumour flare  1  4/58 (6.90%) 
Anaplastic large cell lymphoma t- and null-cell types recurrent  1  3/58 (5.17%) 
Nervous system disorders   
Dizziness  1  9/58 (15.52%) 
Headache  1  11/58 (18.97%) 
Paraesthesia  1  5/58 (8.62%) 
Peripheral motor neuropathy  1  3/58 (5.17%) 
Peripheral sensory neuropathy  1  24/58 (41.38%) 
Memory impairment  1  3/58 (5.17%) 
Neuralgia  1  3/58 (5.17%) 
Psychiatric disorders   
Anxiety  1  4/58 (6.90%) 
Confusional state  1  3/58 (5.17%) 
Depression  1  4/58 (6.90%) 
Insomnia  1  9/58 (15.52%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  10/58 (17.24%) 
Dyspnoea  1  11/58 (18.97%) 
Oropharyngeal pain  1  4/58 (6.90%) 
Productive cough  1  3/58 (5.17%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  8/58 (13.79%) 
Dermatitis  1  4/58 (6.90%) 
Dry skin  1  6/58 (10.34%) 
Night sweats  1  4/58 (6.90%) 
Pruritus  1  11/58 (18.97%) 
Rash  1  14/58 (24.14%) 
Rash pruritic  1  4/58 (6.90%) 
Vascular disorders   
Hot flush  1  3/58 (5.17%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Seattle Genetics, Inc.
Phone: 855-473-2436
EMail: medinfo@seagen.com
Layout table for additonal information
Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT00866047     History of Changes
Other Study ID Numbers: SG035-0004
2008-006035-12 ( EudraCT Number )
First Submitted: March 19, 2009
First Posted: March 20, 2009
Results First Submitted: September 15, 2011
Results First Posted: October 26, 2011
Last Update Posted: March 22, 2017