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

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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

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
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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	10 ^[1]
NOT COMPLETED	48
Progressive disease	13
Adverse Event	16
Physician Decision	14
Withdrawal by Subject	5

^[1]	Number who completed 16 cycles of treatment

Period 2: Follow-up Period

	Brentuximab Vedotin
STARTED	58 ^[1]
COMPLETED	53 ^[2]
NOT COMPLETED	5
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]

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.
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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]

Age, Customized
[Units: Years]
Median (Full Range)

52.0
(14 to 76)

Sex: Female, Male
[Units: Participants]
Count of Participants

Female

25 43.1%

Male

33 56.9%

Race (NIH/OMB)
[Units: Participants]
Count of 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]
[Units: Participants]

3-5

^[1]	0 = Normal activity = Symptoms but ambulatory = In bed <50% of the time = In bed >50% of the time = 100% bedridden = Dead

ALK Status ^[1]
[Units: Participants]

Positive

Negative

^[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 ]

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2. Secondary:

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

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3. Secondary:

Duration of Objective Response by Kaplan-Meier Analysis [ Time Frame: up to approximately 3 years ]

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4. Secondary:

Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis [ Time Frame: up to approximately 3 years ]

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5. Secondary:

Progression-free Survival by Kaplan-Meier Analysis [ Time Frame: up to approximately 3 years ]

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6. Secondary:

Overall Survival [ Time Frame: up to approximately 7 years ]

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7. Secondary:

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

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8. Secondary:

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

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9. Secondary:

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

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Measure Type	Secondary
Measure Title	Chemistry Laboratory Abnormalities >/= Grade 3
Measure 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

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.
All participants who received treatment

Reporting Groups

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

Measured Values

	Brentuximab Vedotin
Participants Analyzed [Units: Participants]	58
Chemistry Laboratory Abnormalities >/= Grade 3 [Units: 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