Phase 4
N=60
A Study of Brentuximab Vedotin in Participants With Relapsed or Refractory Hodgkin Lymphoma
Hodgkin Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT01990534 ↗Enrolled (actual)
60
Serious AEs
18.3%
Results posted
May 2017
Primary outcome: Primary: Objective Response Rate (ORR) — 50 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Brentuximab Vedotin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Millennium Pharmaceuticals, Inc.
- Primary completion
- Mar 2016
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 | — |
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.
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.