Phase 4
Completed N=60
A Study of Brentuximab Vedotin in Participants With Relapsed or Refractory Hodgkin Lymphoma
Source: ClinicalTrials.gov NCT01990534 ↗Enrolled (actual)
60
Serious AEs
18.3%
Results posted
May 2017
Primary outcomePrimary: Objective Response Rate (ORR) — 50 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This phase 4, single-arm, open-label, multicenter study is designed to evaluate the efficacy and safety of brentuximab vedotin as a single agent in adult participants with histologically confirmed CD30+ relapsed or refractory classical Hodgkin Lymphoma who have not received a prior stem cell transplantation (SCT) and are considered to be not suitable for SCT or multiagent chemotherapy at the time of study entry.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) |
50 | — |
| SECONDARY Duration of Response (DOR) |
4.6 | — |
| SECONDARY Progression Free Survival (PFS) |
4.8 | — |
| SECONDARY Complete Remission Rate |
13 | — |
| SECONDARY Duration of Complete Remission |
6.1 | — |
| SECONDARY Overall Survival (OS) |
NA | — |
| SECONDARY Percentage of Participants Who Received Hematopoietic SCT |
53 | — |
| SECONDARY Number of Participants With Adverse Events (AEs), Drug-Related AEs, Grade 3 or Higher AEs, Serious Adverse Events (SAEs), Drug-Related SAEs and Grade 3 or Higher SAEs |
52; 21; 41; 11; 11; 3 | — |
| SECONDARY Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs |
2; 1; 2; 2; 1; 1 | — |
| SECONDARY Antibody-drug Conjugate (ADC) Serum Concentrations |
0.00; 35504.65; 14517.67; 1410.43; 526.42; 37118.32 | — |
| SECONDARY Serum Concentration of Total Antibodies (Conjugated and Unconjugated) |
0.00; 37329.59; 23248.90; 2791.49; 1254.86; 39801.87 | — |
| SECONDARY Monomethyl Auristatin E (MMAE) Serum Concentrations |
0.78; 591.09; 6056.44; 746.12; 140.11; 539.38 | — |
| SECONDARY Number of Participants With Antitherapeutic Antibodies (ATA) |
21; 17; 4; 21; 0 | — |
Eligibility Criteria
Inclusion Criteria
Each participant must meet all of the following inclusion criteria to be enrolled in the study:
- Male or female participants 18 years or older, with relapsed or refractory classical Hodgkin lymphoma (HL), who have previously received at least 1 prior systemic chemotherapeutic regimen
- Not suitable for stem cell transplantation (SCT) or multiagent chemotherapy, according to 1 of the following criteria:
- Disease progression within 90 days of the earliest date of complete remission (CR) or complete remission unconfirmed (CRu) after the end of treatment with multiagent chemotherapeutic regimens and/or radiotherapy
- Progressive disease during frontline multiagent chemotherapy
- Disease relapse after treatment with at least 2 chemotherapeutic regimens, including any salvage treatments
- Bidimensional measurable disease
- An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Female participants who are postmenopausal for at least 1 year before the screening visit, surgically sterile, or agree to practice 2 effective methods of contraception at the same time, or agree to practice true abstinence.
- Male participants who agree to practice effective barrier contraception during the entire study treatment period through 6 months after the last dose of study drug or agree to practice true abstinence.
- Clinical laboratory values as specified in the study protocol.
Exclusion Criteria
Participants who meet any of the following exclusion criteria are not to be enrolled in the study:
- Previous treatment with brentuximab vedotin
- Previously received an autologous stem cell transplantation (ASCT) or alloSCT
- Known cerebral/meningeal disease, including signs or symptoms suggestive of progressive multifocal leukoencephalopathy (PML), or any history of PML.
- Female participants who are lactating and breastfeeding or pregnant.
- Known human immunodeficiency virus (HIV).
- Known hepatitis B surface antigen positive, or known or suspected active hepatitis C infection.
- Grade 2 or higher peripheral neuropathy.
Data sourced from ClinicalTrials.gov (NCT01990534). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.