A Phase 2 interventional study of brentuximab vedotin in Lymphoma, Large-Cell, Anaplastic and Lymphoma, Non-Hodgkin, sponsored by Seagen Inc.. Completed at 22 sites in 5 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2017-03-22.
Sponsored by Seagen Inc. · Phase 2, Interventional, and Treatment
This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory ALCL.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 58 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Seagen Inc. is the lead sponsor of 84 studies on the registry; 1 is open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 13 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion
Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
Also known as: SGN-35, ADCETRIS
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.
Time frame: up to 12 months
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.
Time frame: up to 12 months
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.
Time frame: up to approximately 3 years
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.
Time frame: up to approximately 3 years
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.
Time frame: up to approximately 3 years
Overall Survival
Time from start of study treatment to date of death due to any cause.
Time frame: up to approximately 7 years
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.
Time frame: up to 12 months
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.
Time frame: up to 12 months
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.
Time frame: up to 12 months
Area Under the Curve
Area under the serum concentration-time curve from time 0 to 21 days following the first dose of brentuximab vedotin
Time frame: 3 weeks
Maximum Serum Concentration
Maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin
Time frame: 3 weeks
Time of Maximum Serum Concentration
Time of maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin
Time frame: 3 weeks
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.
Time frame: up to 12 months
Enrollment period: Jun 2009 - May 2010
| Milestone | Brentuximab Vedotin |
|---|---|
| Started | 58 |
| Completed | 10 |
| Not completed | 48 |
| Withdrew: Progressive disease | 13 |
| Withdrew: Adverse event | 16 |
| Withdrew: Physician decision | 14 |
| Withdrew: Withdrawal by subject | 5 |
| Milestone | Brentuximab Vedotin |
|---|---|
| Started | 58 |
| Completed | 53 |
| Not completed | 5 |
| Withdrew: Lost to follow-up | 5 |
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.
| percent of participants | Brentuximab Vedotin |
|---|---|
| Objective Response Rate by Independent Review Group | 86 (74.6 to 93.9) |
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.
| percent of participants | Brentuximab Vedotin |
|---|---|
| Complete Remission Rate by Independent Review Group | 59 (44.9 to 71.4) |
Duration of objective response (CR + PR) by independent review group, defined as time of initial response until disease progression or death.
| months | Brentuximab Vedotin |
|---|---|
| Duration of Objective Response by Kaplan-Meier Analysis | 13.2 (5.7 to 26.3) |
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.
| months | Brentuximab Vedotin |
|---|---|
| Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis | 26.3 (13.2 to NA) |
Time from start of study treatment to disease progression per independent review group or death due to any cause.
| months | Brentuximab Vedotin |
|---|---|
| Progression-free Survival by Kaplan-Meier Analysis | 14.6 (6.9 to 20.6) |
Time from start of study treatment to date of death due to any cause.
| months | Brentuximab Vedotin |
|---|---|
| Overall Survival | NA (21.3 to NA) |
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.
| participants | Brentuximab Vedotin |
|---|---|
| Any TEAE | 58 |
| TEAE related to study drug | 53 |
| TEAE with CTCAE severity grade >/=3 | 36 |
| Serious adverse event | 25 |
| Serious adverse event related to study drug | 11 |
| Discontinued treatment due to adverse event | 16 |
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.
| participants | Brentuximab Vedotin |
|---|---|
| Any >/= Grade 3 hematology laboratory abnormality | 17 |
| Leukocytes (low) | 3 |
| Lymphocytes (low) | 10 |
| Neutrophils (low) | 7 |
| Platelets (low) | 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.
| participants | Brentuximab Vedotin |
|---|---|
| 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 |
Area under the serum concentration-time curve from time 0 to 21 days following the first dose of brentuximab vedotin
| day * microgram/mL | Brentuximab Vedotin |
|---|---|
| Area Under the Curve | 98 ± 69 |
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.
| percent of participants | Brentuximab Vedotin |
|---|---|
| B Symptom Resolution | 82 (56.6 to 96.2) |
Maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin
| microgram/mL | Brentuximab Vedotin |
|---|---|
| Maximum Serum Concentration | 37 ± 20 |
Time of maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin
| days | Brentuximab Vedotin |
|---|---|
| Time of Maximum Serum Concentration | 0.02 (0.02 to 0.02) |
Collected over Adverse events through 30 days after last dose (up to 12 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Brentuximab Vedotin | — | 25/58 (43.1%) | 58/58 (100%) |
| Event | Brentuximab Vedotin |
|---|---|
| Anaplastic large cell lymphoma t- and null-cell types recurrentNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 3/58 |
| Arrhythmia supraventricularCardiac disorders | 2/58 |
| Septic shockInfections and infestations | 2/58 |
| Urinary tract infectionInfections and infestations | 2/58 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 2/58 |
| AnaemiaBlood and lymphatic system disorders | 1/58 |
| NeutropeniaBlood and lymphatic system disorders | 1/58 |
| Acute myocardial infarctionCardiac disorders | 1/58 |
| Atrial fibrillationCardiac disorders | 1/58 |
| Atrioventricular block completeCardiac disorders | 1/58 |
| Event | Brentuximab Vedotin |
|---|---|
| Peripheral sensory neuropathyNervous system disorders | 24/58 |
| NauseaGastrointestinal disorders | 23/58 |
| FatigueGeneral disorders | 22/58 |
| PyrexiaGeneral disorders | 20/58 |
| DiarrhoeaGastrointestinal disorders | 16/58 |
| RashSkin and subcutaneous tissue disorders | 14/58 |
| ConstipationGastrointestinal disorders | 12/58 |
| NeutropeniaBlood and lymphatic system disorders | 11/58 |
| Upper respiratory tract infectionInfections and infestations | 11/58 |
| HeadacheNervous system disorders | 11/58 |
| Age, Customized(years) | Brentuximab Vedotin |
|---|---|
| Median | 52.0 (14 to 76) |
| Sex: Female, Male(Participants) | Brentuximab Vedotin |
|---|---|
| Female | 25 |
| Male | 33 |
| Race (NIH/OMB)(Participants) | Brentuximab Vedotin |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 7 |
| White | 48 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
| Eastern Cooperative Oncology Group Performance Status(participants) | Brentuximab Vedotin |
|---|---|
| 0 | 19 |
| 1 | 38 |
| 2 | 1 |
| 3-5 | 0 |
| ALK Status(participants) | Brentuximab Vedotin |
|---|---|
| Positive | 16 |
| Negative | 42 |
This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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Seagen Inc.