A Pivotal Open-Label Trial of Brentuximab Vedotin for Hodgkin Lymphoma - Full Text View

Sponsor:	Seattle Genetics, Inc.
Collaborator:	Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):	Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:	NCT00848926

Purpose

This is a single-arm, open-label, multicenter, pivotal clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory Hodgkin lymphoma.

Condition	Intervention	Phase
Disease, Hodgkin	Drug: brentuximab vedotin	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Pivotal Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)

Resource links provided by NLM:

MedlinePlus related topics: Hodgkin Disease Lymphoma

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Further study details as provided by Seattle Genetics, Inc.:

Primary Outcome Measures:

Objective Response Rate by Independent Review Group [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Complete Remission Rate by Independent Review Group [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
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.
Duration of Objective Response by Kaplan-Meier Analysis [ Time Frame: up to 23.5 months ] [ Designated as safety issue: No ]
Duration of objective response (CR + PR) by independent review group, defined as time of initial response until disease progression or death.
Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis [ Time Frame: up to 23.5 months ] [ Designated as safety issue: No ]
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.
Progression-free Survival by Kaplan-Meier Analysis [ Time Frame: up to 23.5 months ] [ Designated as safety issue: No ]
Time from start of study treatment to disease progression per independent review group or death due to any cause.
Overall Survival [ Time Frame: up to 23.5 months ] [ Designated as safety issue: No ]
Time from start of study treatment to date of death due to any cause.
Adverse Events by Severity, Seriousness, and Relationship to Treatment [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]
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.
Hematology Laboratory Abnormalities >/= Grade 3 [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]
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.
Chemistry Laboratory Abnormalities >/= Grade 3 [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]
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.
Area Under the Curve [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Area under the serum concentration-time curve from time 0 to 21 days following the first dose of brentuximab vedotin
Maximum Serum Concentration [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin
Time of Maximum Serum Concentration [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Time of maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin

Enrollment:	102
Study Start Date:	February 2009
Estimated Study Completion Date:	August 2015
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Brentuximab vedotin	Drug: brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous infusion Other Names: SGN-35 ADCETRIS

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with relapsed or refractory Hodgkin lymphoma who have previously received autologous stem cell transplant.
Histologically confirmed CD30-positive disease; tissue from the most recent post diagnostic biopsy of relapsed/refractory disease must be available for confirmation of CD30 expression via slides or tumor block.
Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease of at least 1.5 cm as documented by spiral computed tomography.
At US sites patients greater than or equal to 12 years of age may be enrolled. At non-US sites patients must be greater than or equal to 18 years of age.

Exclusion Criteria:

Previous treatment with brentuximab vedotin.
Previously received an allogeneic transplant.
Congestive heart failure, Class III or IV, by the New York Heart Association criteria.
History of another primary malignancy that has not been in remission for at least 3 years.
Known cerebral/meningeal disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00848926

Show 27 Study Locations

Sponsors and Collaborators

Seattle Genetics, Inc.

Millennium Pharmaceuticals, Inc.

Investigators

Study Director:

Eric Sievers, MD

Seattle Genetics, Inc.

More Information

No publications provided

Responsible Party:	Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:	NCT00848926 History of Changes
Other Study ID Numbers:	SG035-0003, 2008-006034-10
Study First Received:	February 18, 2009
Results First Received:	September 15, 2011
Last Updated:	November 10, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Seattle Genetics, Inc.:

Antigens, CD30
Antibody-Drug Conjugate
Antibodies, Monoclonal
Disease, Hodgkin
Hematologic Diseases

Lymphoma
monomethylauristatin E
Drug Therapy
Immunotherapy

Additional relevant MeSH terms:

Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases

Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 02, 2012