Trial · NCT00947856

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

NCT00947856, Phase 2, Completed, Seagen Inc.; results first posted 2014-05-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Brentuximab Vedotin Trial for Patients Who Have Previously Participated in a Brentuximab Vedotin Study. Trials, record NCT00947856. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00947856

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Brentuximab Vedotin Trial for Patients Who Have Previously Participated in a Brentuximab Vedotin Study
NCT number: NCT00947856
Status: Completed
Phases: Phase 2
Enrollment: 110 participants, actual
Lead sponsor: Seagen Inc.
Conditions: Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin
Interventions: brentuximab vedotin
First posted: 2009-07-28
Last updated: 2017-02-02
Other registries' IDs: eudract:2010-019932-11
Results first posted: 2014-05-26

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Objective Response Rate by Investigator	Up to approximately 38 months	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.
Primary	Adverse Events by Severity, Seriousness, and Relationship to Treatment	up to 39 months	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.
Primary	Laboratory Abnormalities >/= Grade 3	Up to 39 months	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.
Secondary	Duration of Objective Response by Kaplan-Meier Analysis	Up to 38 months	Duration of objective response (CR + PR) on retreatment, defined as time of initial response until disease progression or death
Secondary	Progression-free Survival by Kaplan-Meier Analysis	Up to approximately 29 months	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
Secondary	Overall Survival	Up to approximately 41 months	Overall survival for both extension and retreatment arms, defined as time from start of study treatment to date of death due to any cause
Secondary	Incidence of Antitherapeutic Antibodies	Up to 39 months	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

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Objective Response Rate by Investigator	Up to approximately 38 months	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.	percentage of retreatment experiences	NUMBER
PRIMARY	Adverse Events by Severity, Seriousness, and Relationship to Treatment	up to 39 months	All participants who received treatment	participants	NUMBER
PRIMARY	Laboratory Abnormalities >/= Grade 3	Up to 39 months	All participants who received treatment	participants	NUMBER
SECONDARY	Duration of Objective Response by Kaplan-Meier Analysis	Up to 38 months	Participants with objective response among those who received retreatment	months	MEDIAN
SECONDARY	Progression-free Survival by Kaplan-Meier Analysis	Up to approximately 29 months	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.	months	MEDIAN
SECONDARY	Overall Survival	Up to approximately 41 months	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.	months	MEDIAN
SECONDARY	Incidence of Antitherapeutic Antibodies	Up to 39 months	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.	participants or experiences	NUMBER

Source ClinicalTrials.gov

Results by group59

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Objective Response Rate by Investigator	BV Retreatment - HL		60	95% Confidence Interval 36.1 to 80.9	percentage of retreatment experiences
Objective Response Rate by Investigator	BV Retreatment - ALCL		91	95% Confidence Interval 58.7 to 99.8	percentage of retreatment experiences
Objective Response Rate by Investigator	BV Retreatment - Other		33	95% Confidence Interval 0.8 to 90.6	percentage of retreatment experiences
Objective Response Rate by Investigator	BV Retreatment Total		68	95% Confidence Interval 49.5 to 82.6	percentage of retreatment experiences
Adverse Events by Severity, Seriousness, and Relationship to Treatment	BV Extension	Any TEAE	75		participants
Adverse Events by Severity, Seriousness, and Relationship to Treatment	BV Retreatment	Any TEAE	31		participants
Adverse Events by Severity, Seriousness, and Relationship to Treatment	BV Extension	TEAE related to study drug	65		participants
Adverse Events by Severity, Seriousness, and Relationship to Treatment	BV Retreatment	TEAE related to study drug	27		participants
Adverse Events by Severity, Seriousness, and Relationship to Treatment	BV Extension	TEAE with severity grade >/=3	37		participants
Adverse Events by Severity, Seriousness, and Relationship to Treatment	BV Retreatment	TEAE with severity grade >/=3	16		participants

1 to 10 of 59Source ClinicalTrials.gov

See all 59 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Treatment Period	STARTED	BV Extension	78
Treatment Period	STARTED	BV Retreatment	32
Treatment Period	COMPLETED	BV Extension	0
Treatment Period	COMPLETED	BV Retreatment	0
Treatment Period	NOT COMPLETED	BV Extension	78
Treatment Period	NOT COMPLETED	BV Retreatment	32
Follow-up Period	STARTED	BV Extension	78
Follow-up Period	STARTED	BV Retreatment	32
Follow-up Period	COMPLETED	BV Extension	27
Follow-up Period	COMPLETED	BV Retreatment	9

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events250

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	BV Extension	7	78
other	Anaemia	Blood and lymphatic system disorders	BV Retreatment	7	32
other	Neutropenia	Blood and lymphatic system disorders	BV Extension	10	78
other	Neutropenia	Blood and lymphatic system disorders	BV Retreatment	3	32
other	Thrombocytopenia	Blood and lymphatic system disorders	BV Extension	4	78
other	Thrombocytopenia	Blood and lymphatic system disorders	BV Retreatment	4	32
other	Tachycardia	Cardiac disorders	BV Extension	4	78
other	Tachycardia	Cardiac disorders	BV Retreatment	2	32
other	Adrenal insufficiency	Endocrine disorders	BV Extension	0	78
other	Adrenal insufficiency	Endocrine disorders	BV Retreatment	2	32

1 to 10 of 250Source ClinicalTrials.gov

See all 250 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	BV Extension
Total, all-cause mortality	BV Retreatment
Total, other adverse events	BV Extension	75	78
Total, other adverse events	BV Retreatment	31	32
Total, serious adverse events	BV Extension	16	78
Total, serious adverse events	BV Retreatment	9	32

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
22510871	DERIVED	PubMed
24642247	RESULT	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
BV Extension vs BV Retreatment: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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