TriangleNCT00848926 · CITED IN SOURCE DOCUMENTS
A Pivotal Open-Label Trial of Brentuximab Vedotin for Hodgkin Lymphoma
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE2
- Status at capture
- COMPLETED
- Registry last update
- 2017-03-13
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Objective Response Rate by Independent Review Group
Complete Remission Rate by Independent Review Group
Duration of Objective Response by Kaplan-Meier Analysis
Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis
Progression-free Survival by Kaplan-Meier Analysis
Overall Survival
Adverse Events by Severity, Seriousness, and Relationship to Treatment
Hematology Laboratory Abnormalities >/= Grade 3
Chemistry Laboratory Abnormalities >/= Grade 3
Area Under the Curve
B Symptom Resolution
Maximum Serum Concentration
Time of Maximum Serum Concentration
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility 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.
- healthy Volunteers
- false
- minimum Age
- 12 Years
- sex
- ALL
- std Ages
- CHILD
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- intervention Names
- Drug: brentuximab vedotin
- label
- Brentuximab vedotin
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Brentuximab vedotin
- description
- 1.8 mg/kg every 3 weeks by intravenous infusion
- name
- brentuximab vedotin
- other Names
- SGN-35
- ADCETRIS
- type
- DRUG
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 102
- type
- ACTUAL
Registered outcome plans (not posted results)
- other Outcomes
- description
- 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.
- measure
- B Symptom Resolution
- time Frame
- up to 12 months
- primary Outcomes
- description
- 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.
- measure
- Objective Response Rate by Independent Review Group
- time Frame
- up to 12 months
- secondary Outcomes
- description
- 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.
- measure
- Complete Remission Rate by Independent Review Group
- time Frame
- up to 12 months
- description
- Duration of objective response (CR + PR) by independent review group, defined as time of initial response until disease progression or death.
- measure
- Duration of Objective Response by Kaplan-Meier Analysis
- time Frame
- up to approximately 4 years
- description
- 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.
- measure
- Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis
- time Frame
- up to approximately 4 years
- description
- Time from start of study treatment to disease progression per independent review group or death due to any cause.
- measure
- Progression-free Survival by Kaplan-Meier Analysis
- time Frame
- up to approximately 4 years
- description
- Time from start of study treatment to date of death due to any cause.
- measure
- Overall Survival
- time Frame
- up to approximately 6 years
- description
- 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.
- measure
- Adverse Events by Severity, Seriousness, and Relationship to Treatment
- time Frame
- up to 12 months
- description
- 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.
- measure
- Hematology Laboratory Abnormalities >/= Grade 3
- time Frame
- up to 12 months
- 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.
- measure
- Chemistry Laboratory Abnormalities >/= Grade 3
- time Frame
- up to 12 months
- description
- Area under the serum concentration-time curve from time 0 to 21 days following the first dose of brentuximab vedotin
- measure
- Area Under the Curve
- time Frame
- 3 weeks
- description
- Maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin
- measure
- Maximum Serum Concentration
- time Frame
- 3 weeks
- description
- Time of maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin
- measure
- Time of Maximum Serum Concentration
- time Frame
- 3 weeks
Full study description
- brief 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.
Source references
- references
- citation
- 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 brentuximab vedotin for patients with relapsed or refractory Hodgkin's lymphoma. J Clin Oncol. 2012 Jun 20;30(18):2183-9. doi: 10.1200/JCO.2011.38.0410. Epub 2012 Mar 26.
- pmid
- 22454421
- type
- RESULT
- citation
- Chen R, Gopal AK, Smith SE, Ansell SM, Rosenblatt JD, Savage KJ, Connors JM, Engert A, Larsen EK, Huebner D, Fong A, Younes A. Five-year survival and durability results of brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma. Blood. 2016 Sep 22;128(12):1562-6. doi: 10.1182/blood-2016-02-699850. Epub 2016 Jul 18.
- pmid
- 27432875
- type
- DERIVED
- citation
- Gopal AK, Chen R, Smith SE, Ansell SM, Rosenblatt JD, Savage KJ, Connors JM, Engert A, Larsen EK, Chi X, Sievers EL, Younes A. Durable remissions in a pivotal phase 2 study of brentuximab vedotin in relapsed or refractory Hodgkin lymphoma. Blood. 2015 Feb 19;125(8):1236-43. doi: 10.1182/blood-2014-08-595801. Epub 2014 Dec 22.
- pmid
- 25533035
- type
- DERIVED
Source notices and limitations
Discovery and provenance
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- ble ) Stratified Hazard Ratio (95% CI) 0.57 (0.40, 0.81) Stratified Log-Rank Test P-value 0.001 Clinical Trial in Relapsed Classical Hodgkin Lymphoma (Study 1, NCT00848926) The efficacy of ADCETRIS in patients with cHL who relapsed after autologous hematopoietic stem cell transplantation was evaluated in one open-label, single-ar
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Preserved source evidence · Not medical advice