11 and older, any sex, with Recurrent Hodgkin Lymphoma or Refractory Hodgkin Lymphoma. 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 Among Patients With Salvage Brentuximab Vedotin (BV)Primary· 21 days after completion of last course of study treatment, up to 5 years
The overall response rate is calculated as the percent of evaluable patients that have confirmed CR or PR by radiographic imaging, and the exact 95% confidence interval is calculated for this estimate. Per Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007) for target lesions and assessed by CT/PET scans: Complete Response (CR), complete disappearance of all detectable clinical and radiographic evidence of disease; Partial Response (PR), ≥50% decrease in the sum of the product of the diameters of up to six of the largest dominant nodes or nodal masses.
Group
Value
95% CI
Patients Receive Brentuximab Vedotin
75.0
61.6 – 85.6
Complete Response (CR) Rate Among Patients With Salvage Brentuximab Vedotin (BV)Primary· 21 days after completion of last course of study treatment, up to 5 years
The CR rate is calculated as the percent of evaluable patients that have confirmed CR by radiographic imaging, and the exact 95% confidence interval is calculated for this estimate. Per Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007) for target lesions and assessed by CT/PET scans: Complete Response (CR), complete disappearance of all detectable clinical and radiographic evidence of disease.
Group
Value
95% CI
Patients Receive Brentuximab Vedotin
42.9
29.7 – 56.8
Overall Response Rate in Cohort #2Primary· 21 days after completion of last course of study treatment, up to 5 years
The overall response rate is calculated as the percent of evaluable patients that have confirmed CR or PR by radiographic imaging, and the exact 95% confidence interval is calculated for this estimate. Per Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007) for target lesions and assessed by CT/PET scans: Complete Response (CR), complete disappearance of all detectable clinical and radiographic evidence of disease; Partial Response (PR), ≥50% decrease in the sum of the product of the diameters of up to six of the largest dominant nodes or nodal masses.
Group
Value
95% CI
Patients in Cohort #2
85.0
62.1 – 96.8
Complete Response (CR) Rate in Cohort #2Primary· 21 days after completion of last course of study treatment, up to 5 years
The CR rate is calculated as the percent of evaluable patients that have confirmed CR by radiographic imaging, and the exact 95% confidence interval is calculated for this estimate. Per Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007) for target lesions and assessed by CT/PET scans: Complete Response (CR), complete disappearance of all detectable clinical and radiographic evidence of disease.
Group
Value
95% CI
Patients in Cohort #2
55.0
31.5 – 76.9
Total CD34+ Cell Dose Among Patients Receiving Brentuximab Vedotin Followed by Autologous Hematopoietic Stem Cell TransplantationSecondary· 60 days after completion of last course of study treatment, up to conditioning regimens
Among the patients receiving salvage Brentuximab Vedotin (BV) followed by Autologous Hematopoietic Stem Cell Transplantation (AutoHCT), their total CD34+ cell yield by stem cell mobilization.
Group
Value
95% CI
Cohort #1
6.0
2.6 – 34.0
Cohort #2
8.0
2.8 – 30.5
Progression Free Survival at Year Two Among AutoHCT Patients With BVSecondary· Assessed for up to 5 years, at least half of the surviving participants followed 2+ years
Progression Free Survival (PFS) defined as the time from first treatment day (post AHCT) until objective or symptomatic relapse or death as a result of lymphoma or acute toxicity of treatment. Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formula.
Group
Value
95% CI
Patients With BV Followed by AutoHCT
0.67
0.52 – 0.78
Overall Survival at Year Two Among AutoHCT Patients With BVSecondary· Assessed for up to 5 years, at least half of the surviving participants followed 2+ years
Overall Survival (OS) defined as the time from first treatment day (post AHCT) until death. Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formula.
Group
Value
95% CI
Patients Received BV Followed by AutoHCT
0.93
0.80 – 0.98
Adverse events — posted to ClinicalTrials.gov
Time frame: Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Cohort #1
Serious: 4/37 (11%)
Deaths: 6/37
Cohort #2
Serious: 0/20 (0%)
Deaths: 2/20
Serious adverse events (4 terms)
Reaction
System
Cohort #1
Cohort #2
Fever
General disorders
—
—
Pneumonitis
Respiratory, thoracic and mediastinal disorders
—
—
Non-cardiac chest pain
General disorders
—
—
Depressed level of consciousness
Nervous system disorders
—
—
Other adverse events (111 terms — click to expand)
This phase II trial studies how well brentuximab vedotin before autologous (taken from an individual's own cells) stem cell transplant works in treating patients with Hodgkin lymphoma. Monoclonal antibody-drug conjugates, such as brentuximab vedotin, can block cancer growth in different ways by targeting certain cells.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05244473 — A Safety Study of Brentuximab Vedotin in Participants With HIV
· Phase 1
· withdrawn
NCT04609566 — Brentuximab Vedotin With Pembrolizumab in Metastatic Solid Tumors
· Phase 2
· completed
NCT04569032 — A Study of Brentuximab Vedotin and CHP in Frontline Treatment of PTCL With Less Than 10% CD30 Expression
· Phase 2
· completed
NCT04254107 — A Safety Study of SEA-TGT (SGN-TGT) in Advanced Cancer
· Phase 1
· terminated
NCT03947255 — A Study of Retreatment With Brentuximab Vedotin in Subjects With Classic Hodgkin Lymphoma or CD30-expressing Peripheral
· Phase 2
· terminated
Other recruiting trials for Recurrent Hodgkin Lymphoma
Currently open trials in the same condition.
NCT05272384 — Testing the Combination of Nivolumab and ASTX727 for Relapsed or Refractory B-Cell Lymphoma
· Phase 1
· recruiting
NCT04871607 — Yttrium-90 Labeled Anti-CD25 Monoclonal Antibody Combined With BEAM Chemotherapy Conditioning for the Treatment of Prima
· Phase 2
· recruiting
NCT04640779 — Low-Dose Selinexor and Choline Salicylate for Non-Hodgkin or Hodgkin Lymphoma, Histiocytic/Dendritic Cell Neoplasm, or R
· Phase 1
· active not recruiting
NCT03418038 — Ascorbic Acid and Chemotherapy for the Treatment of Relapsed or Refractory Lymphoma, CCUS, and Chronic Myelomonocytic Le
· Phase 2
· recruiting
NCT03016871 — Nivolumab, Ifosfamide, Carboplatin, and Etoposide as Second-Line Therapy in Treating Patients With Refractory or Relapse
· Phase 2
· active not recruiting
Other City of Hope Medical Center trials
Trials by the same sponsor.
NCT07365306 — Epcoritamab, Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) as Salvage Therapy Before Autologous Stem Cell Transplant
· Phase 2
· not yet recruiting
NCT07218692 — RP2 and Tivozanib for the Treatment of Metastatic Renal Cell Cancer After Progression on Immunotherapy
· Phase 2
· not yet recruiting
NCT07363408 — Ivonescimab and ADG126, Alone, and in Combination With Leucovorin and Fluorouracil or FOLFIRI Regimen for the Treatment
· Phase 1
· not yet recruiting
NCT07226102 — Virtual Mental Health Intervention to Address Fear of Progression for Women With High Risk or Stage III-IV Gynecologic o
· NA
· withdrawn
NCT07225855 — Geriatric Assessment and Management for Older Adults Undergoing Chemotherapy and Radiation Therapy for Head and Neck Can
· NA
· not yet recruiting
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 City of Hope Medical Center
Last refreshed: 26 April 2018
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/NCT01393717.