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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
Health authority
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.


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Study Design


Related Conditions & MeSH terms


Intervention

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

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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
See also
  Status Clinical Trial Phase
Completed NCT00430846 - Phase I Open-Label Dose Finding Study of SGN-35 for CD30 Positive Hematologic Malignancies Phase 1
Terminated NCT00649584 - A Phase I Dose Escalation Study of SGN-35 Alone and in Combination With Gemcitabine for CD30-Positive Malignancies Phase 1
Completed NCT00947856 - A Brentuximab Vedotin Trial for Patients Who Have Previously Participated in a Brentuximab Vedotin Study Phase 2
Completed NCT01026233 - Cardiac Safety Study of Brentuximab Vedotin (SGN-35) Phase 1
Completed NCT01060904 - A Phase 1 Study of Brentuximab Vedotin Combined With Multi-Agent Chemotherapy for Hodgkin Lymphoma Phase 1
Completed NCT01026415 - Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35) Phase 1
Completed NCT01100502 - A Phase 3 Study of Brentuximab Vedotin (SGN-35) in Patients at High Risk of Residual Hodgkin Lymphoma Following Stem Cell Transplant (The AETHERA Trial) Phase 3
No longer available NCT01196208 - A Treatment-Option Protocol to Provide Brentuximab Vedotin to Eligible Patients Completing Studies SGN35-005 or C25001