Trial Outcomes & Findings for A Brentuximab Vedotin Trial for Patients Who Have Previously Participated in a Brentuximab Vedotin Study (NCT NCT00947856)

Last Updated: 2017-02-02

Results Overview

Percentage of participants in the retreatment arm 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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

110 participants

Primary outcome timeframe

Up to approximately 38 months

Results posted on

2017-02-02

Participant Flow

Jul 2009 - Mar 2013

Participant milestones

Participant milestones
Measure	BV Extension Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment)	BV Retreatment Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse)
Treatment Period STARTED	78	32
Treatment Period COMPLETED	0	0
Treatment Period NOT COMPLETED	78	32
Follow-up Period STARTED	78	32
Follow-up Period COMPLETED	27	9
Follow-up Period NOT COMPLETED	51	23

Reasons for withdrawal

Reasons for withdrawal
Measure	BV Extension Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment)	BV Retreatment Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse)
Treatment Period Progressive Disease	33	12
Treatment Period Adverse Event	15	9
Treatment Period Physician Decision	14	6
Treatment Period Study Stopped by Sponsor	4	4
Treatment Period Withdrawal by Subject	12	1
Follow-up Period Study Stopped by Sponsor	40	20
Follow-up Period Re-enrolled for Retreatment	2	3
Follow-up Period Lost to Follow-up	7	0
Follow-up Period Patient unavailable for site visits	1	0
Follow-up Period Withdrawal by Subject	1	0

Baseline Characteristics

A Brentuximab Vedotin Trial for Patients Who Have Previously Participated in a Brentuximab Vedotin Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BV Extension n=78 Participants Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment)	BV Retreatment n=32 Participants Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse)	Total n=110 Participants Total of all reporting groups
Age, Customized	32 years n=5 Participants	37 years n=7 Participants	33.5 years n=5 Participants
Gender Female	35 Participants n=5 Participants	17 Participants n=7 Participants	52 Participants n=5 Participants
Gender Male	43 Participants n=5 Participants	15 Participants n=7 Participants	58 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) White	66 Participants n=5 Participants	27 Participants n=7 Participants	93 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment France	0 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment United States	78 participants n=5 Participants	29 participants n=7 Participants	107 participants n=5 Participants
Eastern Cooperative Oncology Group Performance Status 0	47 participants n=5 Participants	12 participants n=7 Participants	59 participants n=5 Participants
Eastern Cooperative Oncology Group Performance Status 1	30 participants n=5 Participants	18 participants n=7 Participants	48 participants n=5 Participants
Eastern Cooperative Oncology Group Performance Status 2	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants
Eastern Cooperative Oncology Group Performance Status 3-5	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Eastern Cooperative Oncology Group Performance Status Missing	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Disease diagnosis Hodgkin lymphoma (HL)	68 participants n=5 Participants	21 participants n=7 Participants	89 participants n=5 Participants
Disease diagnosis Systemic anaplastic large cell lymphoma (ALCL)	8 participants n=5 Participants	8 participants n=7 Participants	16 participants n=5 Participants
Disease diagnosis Other	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 38 months

Population: Any patient who received retreatment and had postbaseline response results; 1 HL patient did not have postbaseline response results and 3 ALCL patients were retreated more than once.

Outcome measures

Outcome measures
Measure	BV Retreatment - HL n=20 Retreatment Experiences Patients with Hodgkin lymphoma (HL) enrolled and treated on the retreatment arm	BV Retreatment - ALCL n=11 Retreatment Experiences Patients with anaplastic large cell lymphoma (ALCL) enrolled and treated on the retreatment arm	BV Retreatment - Other n=3 Retreatment Experiences Patients with other disease diagnoses enrolled and treated on the retreatment arm	BV Retreatment Total n=34 Retreatment Experiences All patients enrolled and treated on the retreatment arm, including 3 patients retreated more than once	BV Retreatment Total All patients enrolled and treated on the retreatment arm, including 3 patients retreated more than once
Objective Response Rate by Investigator	60 percentage of retreatment experiences Interval 36.1 to 80.9	91 percentage of retreatment experiences Interval 58.7 to 99.8	33 percentage of retreatment experiences Interval 0.8 to 90.6	68 percentage of retreatment experiences Interval 49.5 to 82.6	—

PRIMARY outcome

Timeframe: up to 39 months

Population: All participants who received treatment

Counts of participants who had adverse events or treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on SGN35-006). 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.

Outcome measures

Outcome measures
Measure	BV Retreatment - HL n=78 Participants Patients with Hodgkin lymphoma (HL) enrolled and treated on the retreatment arm	BV Retreatment - ALCL n=32 Participants Patients with anaplastic large cell lymphoma (ALCL) enrolled and treated on the retreatment arm	BV Retreatment - Other Patients with other disease diagnoses enrolled and treated on the retreatment arm	BV Retreatment Total All patients enrolled and treated on the retreatment arm, including 3 patients retreated more than once	BV Retreatment Total All patients enrolled and treated on the retreatment arm, including 3 patients retreated more than once
Adverse Events by Severity, Seriousness, and Relationship to Treatment Discontinued treatment due to adverse event	13 participants	9 participants	—	—	—
Adverse Events by Severity, Seriousness, and Relationship to Treatment TEAE with severity grade >/=3	37 participants	16 participants	—	—	—
Adverse Events by Severity, Seriousness, and Relationship to Treatment Serious adverse event	16 participants	9 participants	—	—	—
Adverse Events by Severity, Seriousness, and Relationship to Treatment Serious adverse event related to study drug	10 participants	4 participants	—	—	—
Adverse Events by Severity, Seriousness, and Relationship to Treatment TEAE related to study drug	65 participants	27 participants	—	—	—
Adverse Events by Severity, Seriousness, and Relationship to Treatment Any TEAE	75 participants	31 participants	—	—	—

PRIMARY outcome

Timeframe: Up to 39 months

Population: All participants who received treatment

Counts of study participants with post-baseline 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.

Outcome measures

Outcome measures
Measure	BV Retreatment - HL n=78 Participants Patients with Hodgkin lymphoma (HL) enrolled and treated on the retreatment arm	BV Retreatment - ALCL n=32 Participants Patients with anaplastic large cell lymphoma (ALCL) enrolled and treated on the retreatment arm	BV Retreatment - Other Patients with other disease diagnoses enrolled and treated on the retreatment arm	BV Retreatment Total All patients enrolled and treated on the retreatment arm, including 3 patients retreated more than once	BV Retreatment Total All patients enrolled and treated on the retreatment arm, including 3 patients retreated more than once
Laboratory Abnormalities >/= Grade 3 Any >/= Grade 3 laboratory abnormality	29 participants	12 participants	—	—	—
Laboratory Abnormalities >/= Grade 3 Lymphocytes (low)	16 participants	8 participants	—	—	—
Laboratory Abnormalities >/= Grade 3 Leukocytes (low)	3 participants	3 participants	—	—	—
Laboratory Abnormalities >/= Grade 3 Neutrophils (low)	7 participants	3 participants	—	—	—
Laboratory Abnormalities >/= Grade 3 Phosphate (low)	7 participants	3 participants	—	—	—
Laboratory Abnormalities >/= Grade 3 Platelets (low)	4 participants	3 participants	—	—	—
Laboratory Abnormalities >/= Grade 3 Aspartate aminotransferase (high)	1 participants	2 participants	—	—	—
Laboratory Abnormalities >/= Grade 3 Glucose (high)	3 participants	2 participants	—	—	—
Laboratory Abnormalities >/= Grade 3 Alanine aminotransferase (high)	1 participants	1 participants	—	—	—
Laboratory Abnormalities >/= Grade 3 Bilirubin (high)	0 participants	1 participants	—	—	—
Laboratory Abnormalities >/= Grade 3 Calcium (low)	0 participants	1 participants	—	—	—
Laboratory Abnormalities >/= Grade 3 Hemoglobin (low)	1 participants	1 participants	—	—	—
Laboratory Abnormalities >/= Grade 3 Potassium (low)	0 participants	1 participants	—	—	—
Laboratory Abnormalities >/= Grade 3 Sodium (low)	2 participants	0 participants	—	—	—

SECONDARY outcome

Timeframe: Up to 38 months

Population: Participants with objective response among those who received retreatment

Duration of objective response (CR + PR) on retreatment, defined as time of initial response until disease progression or death

Outcome measures

Outcome measures
Measure	BV Retreatment - HL n=12 Retreatment Experiences Patients with Hodgkin lymphoma (HL) enrolled and treated on the retreatment arm	BV Retreatment - ALCL n=10 Retreatment Experiences Patients with anaplastic large cell lymphoma (ALCL) enrolled and treated on the retreatment arm	BV Retreatment - Other n=1 Retreatment Experiences Patients with other disease diagnoses enrolled and treated on the retreatment arm	BV Retreatment Total n=23 Retreatment Experiences All patients enrolled and treated on the retreatment arm, including 3 patients retreated more than once	BV Retreatment Total All patients enrolled and treated on the retreatment arm, including 3 patients retreated more than once
Duration of Objective Response by Kaplan-Meier Analysis	9.2 months Interval 2.1 to Insufficient number of events to estimate upper bound	8.8 months Interval 1.4 to 12.9	NA months Insufficient number of events to estimate median and upper and lower bounds	9.2 months Interval 6.6 to 12.9	—

SECONDARY outcome

Timeframe: Up to approximately 29 months

Population: Any patient who received retreatment and had postbaseline response results; 1 HL patient did not have postbaseline response results and 3 ALCL patients were retreated more than once.

Progression-free survival, defined as time from start of study treatment in the retreatment arm to disease progression per investigator or death due to any cause

Outcome measures

Outcome measures
Measure	BV Retreatment - HL n=20 Retreatment Experiences Patients with Hodgkin lymphoma (HL) enrolled and treated on the retreatment arm	BV Retreatment - ALCL n=11 Retreatment Experiences Patients with anaplastic large cell lymphoma (ALCL) enrolled and treated on the retreatment arm	BV Retreatment - Other n=3 Retreatment Experiences Patients with other disease diagnoses enrolled and treated on the retreatment arm	BV Retreatment Total n=34 Retreatment Experiences All patients enrolled and treated on the retreatment arm, including 3 patients retreated more than once	BV Retreatment Total All patients enrolled and treated on the retreatment arm, including 3 patients retreated more than once
Progression-free Survival by Kaplan-Meier Analysis	9.9 months Interval 3.4 to 13.4	12.9 months Interval 3.4 to 18.5	4.4 months Interval 1.2 to Insufficient number of events to estimate upper bound	9.9 months Interval 4.4 to 13.4	—

SECONDARY outcome

Timeframe: Up to approximately 41 months

Population: Patients who received treatment on the extension arm, and patients who received retreatment and had postbaseline response results; 1 HL patient on the retreatment arm did not have postbaseline response results and 3 ALCL patients on the retreatment arm were retreated more than once.

Overall survival for both extension and retreatment arms, defined as time from start of study treatment to date of death due to any cause

Outcome measures

Outcome measures
Measure	BV Retreatment - HL n=78 Retreatment or Extension Trt Experiences Patients with Hodgkin lymphoma (HL) enrolled and treated on the retreatment arm	BV Retreatment - ALCL n=20 Retreatment or Extension Trt Experiences Patients with anaplastic large cell lymphoma (ALCL) enrolled and treated on the retreatment arm	BV Retreatment - Other n=11 Retreatment or Extension Trt Experiences Patients with other disease diagnoses enrolled and treated on the retreatment arm	BV Retreatment Total n=3 Retreatment or Extension Trt Experiences All patients enrolled and treated on the retreatment arm, including 3 patients retreated more than once	BV Retreatment Total n=34 Retreatment or Extension Trt Experiences All patients enrolled and treated on the retreatment arm, including 3 patients retreated more than once
Overall Survival	NA months Interval 32.1 to Insufficient number of events to estimate median and upper bound	NA months Interval 11.4 to Insufficient number of events to estimate median and upper bound	NA months Insufficient number of events to estimate median and upper and lower bounds	NA months Interval 5.1 to Insufficient number of events to estimate median and upper bound	NA months Interval 19.5 to Insufficient number of events to estimate median and upper bound

SECONDARY outcome

Timeframe: Up to 39 months

Population: Any patient who received extension treatment or retreatment and had baseline and postbaseline sample results; 1 HL patient on the retreatment arm did not have postbaseline sample results and 3 ALCL patients on the retreatment arm were retreated more than once and had samples.

Counts of participants with anti-brentuximab vedotin antibodies at any time during extension treatment on Study SGN35-006 or number of retreatment experiences with anti-brentuximab vedotin antibodies at any time during retreatment

Outcome measures

Outcome measures
Measure	BV Retreatment - HL n=78 Retreatment or Extension Txt Experiences Patients with Hodgkin lymphoma (HL) enrolled and treated on the retreatment arm	BV Retreatment - ALCL n=34 Retreatment or Extension Txt Experiences Patients with anaplastic large cell lymphoma (ALCL) enrolled and treated on the retreatment arm	BV Retreatment - Other Patients with other disease diagnoses enrolled and treated on the retreatment arm	BV Retreatment Total All patients enrolled and treated on the retreatment arm, including 3 patients retreated more than once	BV Retreatment Total All patients enrolled and treated on the retreatment arm, including 3 patients retreated more than once
Incidence of Antitherapeutic Antibodies	15 participants or experiences	12 participants or experiences	—	—	—

Adverse Events

BV Extension

Serious events: 16 serious events

Other events: 75 other events

Deaths: 0 deaths

BV Retreatment

Serious events: 9 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Chief Medical Officer

Seattle Genetics, Inc.

Phone: 855-473-2436

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER