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

Disease, Hodgkin Clinical Trial

Official title:

A Pivotal Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00848926
• Other study ID #: SG035-0003
• Secondary ID: 2008-006034-10
• Status: Completed
• Phase: Phase 2
• First received: February 18, 2009
• Last updated: March 9, 2017
• Start date: February 2009
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: Seattle Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: May 2015
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Disease, Hodgkin
• Hodgkin Disease
• Lymphoma

Intervention

Drug:
• brentuximab vedotin
1.8 mg/kg every 3 weeks by intravenous infusion

Locations

Country	Name	City	State
Belgium	UZ Gasthuisberg	Leuven
Belgium	Cliniques Universitaires UCL de Mont-Goddine	Yvoir
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	B.C Cancer Agency	Vancouver	British Columbia
France	Institut Paoli Calmettes	Marseille
France	Hospital Saint Louis	Paris
France	Centre Henri Becquerel	Rouen
Italy	Instituto di Ematologia ed Oncologia Medica	Bologna
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Ohio State University	Columbus	Ohio
United States	Baylor Sammons Cancer Center	Dallas	Texas
United States	Rocky Mountain Cancer Center	Denver	Colorado
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	City of Hope National Medical Center	Duarte	California
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	University of California at Los Angeles	Los Angeles	California
United States	Loyola University Medical Center Cardinal Bernardin Cancer Center	Maywood	Illinois
United States	University of Miami	Miami	Florida
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Weill Cornell Medical College	New York	New York
United States	Stanford University Medical Center	Palo Alto	California
United States	Oregon Health & Science University	Portland	Oregon
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	University of Rochester Medical Center	Rochester	New York
United States	University of Washington	Seattle	Washington
United States	Washington University School of Medicine	St. Louis	Missouri
United States	Georgetown University	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Seattle Genetics, Inc.	Millennium Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France,  Italy, 

References & Publications (1)

Younes A, Gopal AK, Smith SE, Ansell SM, Rosenblatt JD, Savage KJ, Ramchandren R, Bartlett NL, Cheson BD, de Vos S, Forero-Torres A, Moskowitz CH, Connors JM, Engert A, Larsen EK, Kennedy DA, Sievers EL, Chen R. Results of a pivotal phase II study of bren — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	B Symptom Resolution	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.	up to 12 months
Primary	Objective Response Rate by Independent Review Group	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.	up to 12 months
Secondary	Complete Remission Rate by Independent Review Group	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.	up to 12 months
Secondary	Duration of Objective Response by Kaplan-Meier Analysis	Duration of objective response (CR + PR) by independent review group, defined as time of initial response until disease progression or death.	up to approximately 4 years
Secondary	Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis	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.	up to approximately 4 years
Secondary	Progression-free Survival by Kaplan-Meier Analysis	Time from start of study treatment to disease progression per independent review group or death due to any cause.	up to approximately 4 years
Secondary	Overall Survival	Time from start of study treatment to date of death due to any cause.	up to approximately 6 years
Secondary	Adverse Events by Severity, Seriousness, and Relationship to Treatment	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.	up to 12 months
Secondary	Hematology Laboratory Abnormalities >/= Grade 3	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.	up to 12 months
Secondary	Chemistry Laboratory Abnormalities >/= Grade 3	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.	up to 12 months
Secondary	Area Under the Curve	Area under the serum concentration-time curve from time 0 to 21 days following the first dose of brentuximab vedotin	3 weeks
Secondary	Maximum Serum Concentration	Maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin	3 weeks
Secondary	Time of Maximum Serum Concentration	Time of maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin	3 weeks