A Phase 4 interventional study of Brentuximab vedotin in Lymphoma, sponsored by Takeda. Completed at 40 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-19.
Sponsored by Takeda · Phase 4, Interventional, and Treatment
The purpose of this study is to assess the antitumor efficacy of single-agent brentuximab vedotin 1.8 mg/kg administered intravenously (IV) every 3 weeks, as measured by the overall objective response rate (ORR) in patients with r/r sALCL following at least 1 multiagent chemotherapy regimen (cyclophosphamide, doxorubicin hydrochloride [hydroxydaunorubicin], vincristine sulfate [Oncovin], and prednisone [CHOP] or equivalent multiagent chemotherapy regimens with curative intent).
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 50 is above the median of 40 across 4,509 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants received brentuximab vedotin 1.8 mg/kg as a 30 minute intravenous (IV) infusion on Day 1 of each 3 week cycle. Participants with stable disease or better and without unacceptable toxicity were to receive a minimum of 8 cycles with the opportunity to receive a maximum of 16 cycles.
Drug: Brentuximab vedotin
Brentuximab vedotin IV infusion
Also known as: SGN-35, ADCETRIS
Objective Response Rate (ORR)
ORR was defined as the percentage of participants with a complete remission (CR) or partial remission (PR) by Independent Review Facility (IRF) response assessment according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.
Time frame: Up to data cut-off date: 04 May 2021 (Up to approximately 7 years)
Duration of Response (DOR) Per IRF
DOR was defined as the time between initial response and documented tumor progression in the subset of participants who achieved an objective response, either CR or PR. DOR per IRF was based upon the radiological assessment of measured lesions from an independent review facility. DOR was censored on the date of the last disease assessment documenting absence of progressive disease (PD) for participants who were lost to follow-up, withdrew consent, started a new anticancer therapy other than stem cell transplant (SCT), or discontinued treatment due to undocumented PD after the last adequate disease assessment.
Time frame: Until disease progression, death, or the data cut-off date: 4 May 2021 (Up to approximately 7 years)
Progression-free Survival (PFS) Per IRF
PFS is defined as the time from start of study treatment to first documentation of objective tumor progression or to death due to any cause, whichever comes first. PFS per IRF is based upon the radiological assessment from an independent review facility.
Time frame: Until disease progression, death, or the data cut-off date: 4 May 2021 (Up to approximately 7 years)
Complete Remission Rate (CRR) Per IRF
CRR is defined as percentage of participants with CR. CR is defined as the disappearance of all evidence of disease.
Time frame: Until disease progression, death, or the data cut-off date: 4 May 2021 (Up to approximately 7 years)
Overall Survival (OS)
OS is defined as the time from start of study treatment to date of death due to any cause.
Time frame: Until disease progression, death, or end of study (Up to approximately 10.7 years)
Percentage of Participants Receiving Hematopoietic Stem Cell Transplant (SCT) Following Treatment With Brentuximab Vedotin
Time frame: Until disease progression, death, or end of study (Up to approximately 10.7 years)
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Related TEAEs and TEAEs by Severity (Grade 3 or Higher)
An adverse event (AE): any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to medicinal product. TEAE was defined as any AE that started after the first administration of study drug in this continuation study. Serious TEAEs: defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect, or is a medically important event.
Time frame: From first dose up to 30 days post last dose of study drug (Up to approximately 1 year)
Concentration of Serum Antibody-drug Conjugate (ADC) at the End of Infusion
Time frame: Cycle 1, Day 1 and Cycle 3, Day 1 at the end of infusion
Concentration of Serum Total Antibody (TAb) Conjugate Plus Free Total Antibody
Time frame: Cycle 1, Day 1 and Cycle 3, Day 1 at the end of infusion
Maximum Concentration for Unconjugated Drug- Monomethyl Auristatin E (MMAE)
Time frame: Cycle 1, Day 1 and Cycle 3, Day 1 at the end of infusion
Percentage of Participants With Presence of Anti-Therapeutic Antibodies (ATA) and Neutralizing Antibodies (NAb) to Brentuximab Vedotin
Time frame: Up to 16 cycles (each cycle = 21 days)
Participants took part in the study at various investigative sites globally from 23 January 2014 to 29 August 2024.
| Milestone | Brentuximab Vedotin 1.8 mg/kg |
|---|---|
| Started | 50 |
| Completed | 19 |
| Not completed | 31 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Death | 25 |
| Withdrew: Withdrawal of informed consent | 1 |
| Withdrew: Reason not specified | 1 |
ORR was defined as the percentage of participants with a complete remission (CR) or partial remission (PR) by Independent Review Facility (IRF) response assessment according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.
| percentage of participants | Brentuximab Vedotin 1.8 mg/kg |
|---|---|
| Objective Response Rate (ORR) | 64 (49 to 77) |
DOR was defined as the time between initial response and documented tumor progression in the subset of participants who achieved an objective response, either CR or PR. DOR per IRF was based upon the radiological assessment of measured lesions from an independent review facility. DOR was censored on the date of the last disease assessment documenting absence of progressive disease (PD) for participants who were lost to follow-up, withdrew consent, started a new anticancer therapy other than stem cell transplant (SCT), or discontinued treatment due to undocumented PD after the last adequate disease assessment.
| months | Brentuximab Vedotin 1.8 mg/kg |
|---|---|
| Duration of Response (DOR) Per IRF | NA (19.71 to NA) |
PFS is defined as the time from start of study treatment to first documentation of objective tumor progression or to death due to any cause, whichever comes first. PFS per IRF is based upon the radiological assessment from an independent review facility.
| months | Brentuximab Vedotin 1.8 mg/kg |
|---|---|
| Progression-free Survival (PFS) Per IRF | 20.9 (4.17 to NA) |
CRR is defined as percentage of participants with CR. CR is defined as the disappearance of all evidence of disease.
| percentage of participants | Brentuximab Vedotin 1.8 mg/kg |
|---|---|
| Complete Remission Rate (CRR) Per IRF | 30 (18 to 45) |
OS is defined as the time from start of study treatment to date of death due to any cause.
| months | Brentuximab Vedotin 1.8 mg/kg |
|---|---|
| Overall Survival (OS) | 67.6 (17.68 to NA) |
| percentage of participants | Brentuximab Vedotin 1.8 mg/kg |
|---|---|
| Percentage of Participants Receiving Hematopoietic Stem Cell Transplant (SCT) Following Treatment With Brentuximab Vedotin | 28 |
An adverse event (AE): any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to medicinal product. TEAE was defined as any AE that started after the first administration of study drug in this continuation study. Serious TEAEs: defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect, or is a medically important event.
| percentage of participants | Brentuximab Vedotin 1.8 mg/kg |
|---|---|
| TEAEs | 94 |
| Serious TEAEs | 32 |
| Drug-Related TEAEs | 70 |
| TEAEs by Severity (Grade 3 or Higher) | 58 |
| micrograms per liter (µg/L) | Brentuximab Vedotin 1.8 mg/kg |
|---|---|
| Cycle 1, Day 1 | 35 ± 35 |
| Cycle 3, Day 1 | 38 ± 25 |
| µg/L | Brentuximab Vedotin 1.8 mg/kg |
|---|---|
| Cycle 1, Day 1 | 33 ± 29 |
| Cycle 3, Day 1 | 38 ± 23 |
| nanogram per milliliter (ng/ml) | Brentuximab Vedotin 1.8 mg/kg |
|---|---|
| Cycle 1, Day 1 | 0.25 ± 87 |
| Cycle 3, Day 1 | 0.29 ± 88 |
| percentage of participants | Brentuximab Vedotin 1.8 mg/kg |
|---|---|
| ATA Positive | 30 |
| Neutralizing ATA Positive | 0.0 |
Collected over All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Brentuximab Vedotin 1.8 mg/kg | 25/50 (50%) | 16/50 (32%) | 37/50 (74%) |
| Event | Brentuximab Vedotin 1.8 mg/kg |
|---|---|
| Anaplastic large cell lymphoma T- and null-cell typesNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/50 |
| DiarrhoeaGastrointestinal disorders | 2/50 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 2/50 |
| General physical health deteriorationGeneral disorders | 2/50 |
| HypotensionVascular disorders | 2/50 |
| PneumoniaInfections and infestations | 2/50 |
| Abdominal incarcerated herniaGastrointestinal disorders | 1/50 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 1/50 |
| Aortic stenosisVascular disorders | 1/50 |
| Autonomic neuropathyNervous system disorders | 1/50 |
| Event | Brentuximab Vedotin 1.8 mg/kg |
|---|---|
| Peripheral sensory neuropathyNervous system disorders | 9/50 |
| PyrexiaGeneral disorders | 9/50 |
| DiarrhoeaGastrointestinal disorders | 8/50 |
| NeutropeniaBlood and lymphatic system disorders | 8/50 |
| AnaemiaBlood and lymphatic system disorders | 7/50 |
| FatigueGeneral disorders | 6/50 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 5/50 |
| NauseaGastrointestinal disorders | 5/50 |
| Back painMusculoskeletal and connective tissue disorders | 4/50 |
| ConstipationGastrointestinal disorders | 4/50 |
Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
| Age, Continuous(years) | Brentuximab Vedotin 1.8 mg/kg |
|---|---|
| Mean | 56.4 ± 16.70 |
| Sex: Female, Male(Participants) | Brentuximab Vedotin 1.8 mg/kg |
|---|---|
| Female | 31 |
| Male | 19 |
| Ethnicity (NIH/OMB)(Participants) | Brentuximab Vedotin 1.8 mg/kg |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 45 |
| Unknown or Not Reported | 3 |
| Race (NIH/OMB)(Participants) | Brentuximab Vedotin 1.8 mg/kg |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 50 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Brentuximab Vedotin 1.8 mg/kg |
|---|---|
| Belgium | 1 |
| Croatia | 2 |
| Czech Republic | 12 |
| Hungary | 5 |
| Poland | 8 |
| Portugal | 3 |
| Romania | 3 |
| Spain | 4 |
| Turkey | 6 |
| United Kingdom | 6 |
| Height(centimeters (cm)) | Brentuximab Vedotin 1.8 mg/kg |
|---|---|
| Mean | 166.8 ± 10.40 |
| Weight(kilograms (kg)) | Brentuximab Vedotin 1.8 mg/kg |
|---|---|
| Mean | 75.2 ± 20.73 |
| Body Mass Index (BMI)(kilograms per meter squared (kg/m^2)) | Brentuximab Vedotin 1.8 mg/kg |
|---|---|
| Mean | 26.9 ± 6.39 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting information: Study protocol, Sap, Icf, Csr
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