Brentuximab Vedotin in Chinese Participants With Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL) or Systemic Anaplastic Large Cell Lymphoma (sALCL)
CompletedPhase 2Results postedLast updated 24 February 2021
What this trial tests
Phase 2 trial testing Brentuximab Vedotin in Hodgkin Disease in 39 participants. Completed in 3 February 2020.
18 and older, any sex, with Hodgkin Disease or Lymphoma, Large-Cell, Anaplastic. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Response Rate (ORR)Primary· Baseline, at Cycles (each cycle was of 3 weeks) 2, 4, 7, 10, 13, and 16 during treatment until disease progression death or end of treatment (approximately 12 months)
ORR is defined as the percentage of participants who have achieved 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 site by end of treatment (EOT) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.
Group
Value
95% CI
Brentuximab Vedotin 1.8 mg/kg (HL)
70.0
50.60 – 85.27
Brentuximab Vedotin 1.8 mg/kg (sALCL)
66.7
29.93 – 92.51
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)Primary· First dose of study drug up to 30 days after last dose of study drug (approximately 12 months)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs or worsens after receiving study drug.
Group
Value
95% CI
Brentuximab Vedotin 1.8 mg/kg (HL)
30
Brentuximab Vedotin 1.8 mg/kg (sALCL)
9
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse EventsPrimary· First dose of study drug up to 30 days after last dose of study drug (approximately 12 months)
Clinical Laboratory tests included tests of Chemistry, Hematology and Urinalysis prespecified in the protocol. Abnormal laboratory values assessed by the investigator that lead to discontinuation or delay in treatment, dose modification, therapeutic intervention, or were considered by the investigator to be clinically significant changes from Baseline were recorded as Adverse Events. Neutropenia (pooled) includes preferred terms Neutropenia and Neutrophil count decreased.
Alanine aminotransferase increased
Group
Value
95% CI
Brentuximab Vedotin 1.8 mg/kg (HL)
18
Brentuximab Vedotin 1.8 mg/kg (sALCL)
6
Aspartate aminotransferase increased
Group
Value
95% CI
Brentuximab Vedotin 1.8 mg/kg (HL)
17
Brentuximab Vedotin 1.8 mg/kg (sALCL)
6
Gamma-glutamyltransferase increased
Group
Value
95% CI
Brentuximab Vedotin 1.8 mg/kg (HL)
3
Brentuximab Vedotin 1.8 mg/kg (sALCL)
4
Blood bilirubin increased
Group
Value
95% CI
Brentuximab Vedotin 1.8 mg/kg (HL)
0
Brentuximab Vedotin 1.8 mg/kg (sALCL)
2
Reticulocyte count decreased
Group
Value
95% CI
Brentuximab Vedotin 1.8 mg/kg (HL)
9
Brentuximab Vedotin 1.8 mg/kg (sALCL)
2
Reticulocyte count increased
Group
Value
95% CI
Brentuximab Vedotin 1.8 mg/kg (HL)
6
Brentuximab Vedotin 1.8 mg/kg (sALCL)
1
Haemoglobin decreased
Group
Value
95% CI
Brentuximab Vedotin 1.8 mg/kg (HL)
1
Brentuximab Vedotin 1.8 mg/kg (sALCL)
1
Reticulocyte percentage increased
Group
Value
95% CI
Brentuximab Vedotin 1.8 mg/kg (HL)
1
Brentuximab Vedotin 1.8 mg/kg (sALCL)
0
Number of Participants With Abnormal Vital Signs Reported as Adverse EventsPrimary· First dose of study drug up to 30 days after last dose of study drug (approximately 12 months)
Vital signs included blood pressure in the sitting position, pulse rate, axillary temperature and weight. Abnormal vital sign values considered by the investigator to be clinically significant were recorded as Adverse Events.
Weight increased
Group
Value
95% CI
Brentuximab Vedotin 1.8 mg/kg (HL)
4
Brentuximab Vedotin 1.8 mg/kg (sALCL)
2
Weight decreased
Group
Value
95% CI
Brentuximab Vedotin 1.8 mg/kg (HL)
1
Brentuximab Vedotin 1.8 mg/kg (sALCL)
2
Complete Remission (CR) RateSecondary· Baseline, at Cycles (each cycle was of 3 weeks) 2, 4, 7, 10, 13, and 16 during treatment, and every 12 weeks during PFS follow-up period, until disease progression death or end of treatment (approximately 12 months)
CR rate is defined as the percentage of participants who have achieved CR by EOT. CR is defined as disappearance of all evidence of disease per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.
Group
Value
95% CI
Brentuximab Vedotin 1.8 mg/kg (HL)
20.0
7.71 – 38.57
Brentuximab Vedotin 1.8 mg/kg (sALCL)
55.6
21.20 – 86.30
Duration of Response (DOR)Secondary· Up to 3.2 years
DOR is defined as the time between the first documentation of objective tumor response (CR or PR) and the first subsequent documentation of objective tumor progression or death due to any cause, whichever occurs first. CR is defined as disappearance of all evidence of disease. PR is defined as regression of greater than or equal to 50% of measurable disease and no new sites.
Group
Value
95% CI
Brentuximab Vedotin 1.8 mg/kg (HL)
12.0
4.37 – NA
Brentuximab Vedotin 1.8 mg/kg (sALCL)
NA
1.41 – NA
Progression Free Survival (PFS)Secondary· Up to 3.2 years
PFS is defined as the time from the start of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.
Group
Value
95% CI
Brentuximab Vedotin 1.8 mg/kg (HL)
13.5
6.77 – 17.81
Brentuximab Vedotin 1.8 mg/kg (sALCL)
23.2
1.25 – NA
Overall Survival (OS)Secondary· Up to 3.2 years
Overall survival is defined as the time from the start of treatment to the date of death.
Group
Value
95% CI
Brentuximab Vedotin 1.8 mg/kg (HL)
NA
NA – NA
Brentuximab Vedotin 1.8 mg/kg (sALCL)
NA
3.19 – NA
B Symptom Resolution RateSecondary· Day 1 of each cycle (each cycle was of 3 weeks) up to 30 days after last dose of study drug (approximately 12 months)
B Symptom Resolution Rate is defined as the 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.
Group
Value
95% CI
Brentuximab Vedotin 1.8 mg/kg (HL)
50.0
1.26 – 98.74
Brentuximab Vedotin 1.8 mg/kg (sALCL)
100.00
15.81 – 100.00
Cmax: Maximum Observed Serum Concentration for Brentuximab Vedotin Antibody-drug Conjugate (ADC)Secondary· Cycles (each cycle was of 3 weeks) 1 and 2: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Cycle 1
Group
Value
95% CI
Brentuximab Vedotin 1.8 mg/kg
36.9504
± 9.90360
Cycle 2
Group
Value
95% CI
Brentuximab Vedotin 1.8 mg/kg
32.4341
± 5.83197
Cmax: Maximum Observed Serum Concentration for Total Antibody (TAb)Secondary· Cycles (each cycle was of 3 weeks) 1 and 2: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Cycle 1
Group
Value
95% CI
Brentuximab Vedotin 1.8 mg/kg
38.2293
± 7.95483
Cycle 2
Group
Value
95% CI
Brentuximab Vedotin 1.8 mg/kg
39.9859
± 12.43445
Cmax: Maximum Observed Plasma Concentration for Monomethyl Auristatin E (MMAE)Secondary· Cycles (each cycle was of 3 weeks) 1 and 2: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Cycle 1
Group
Value
95% CI
Brentuximab Vedotin 1.8 mg/kg
5.1623
± 3.69893
Cycle 2
Group
Value
95% CI
Brentuximab Vedotin 1.8 mg/kg
3.6218
± 2.89331
Adverse events — posted to ClinicalTrials.gov
Time frame: All-Cause Mortality: up to 3.2 years; Serious and Other Adverse Events: First dose of study drug up to 30 days post last dose of study drug (up to 12 months).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics (PK) of brentuximab vedotin as a single agent in Chinese participants with relapsed/refractory CD30+ Hodgkin Lymphoma (HL) or Systemic Anaplastic Large Cell Lymphoma (sALCL).
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem
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NCT07275216 — Pembrolizumab in Combination With Chemotherapy for the Treatment of Frail Hodgkin Lymphoma Patients Ineligible for Stand
· Phase 2
· not yet recruiting
NCT06831370 — A Study of Brentuximab Vedotin With Doxorubicin, Vinblastine and Dacarbazine in Adults With Hodgkin Lymphoma in India
· Phase 4
· recruiting
NCT05711628 — A Trial Comparing Chemotherapy Versus Novel Immune Checkpoint Inhibitor (Pembrolizumab) Plus Chemotherapy in Treating Re
· Phase 3
· withdrawn
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Takeda
Last refreshed: 24 February 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02939014.