Phase 3 Completed N=329 Randomized Quadruple-blind Treatment

A Phase 3 Study of Brentuximab Vedotin (SGN-35) in Patients at High Risk of Residual Hodgkin Lymphoma Following Stem Cell Transplant (The AETHERA Trial)

Disease, Hodgkin

Source: ClinicalTrials.gov NCT01100502 ↗

Enrolled (actual)

329

Serious AEs

19.6%

Results posted

Nov 2015

Primary outcomePrimary: Progression-free Survival by Independent Review — 42.9; 24.1 months — p=0.001

Summary

This is a randomized, double-blind, placebo-controlled, multicenter phase 3 trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) and best supportive care (BSC) compared to placebo and BSC in treatment of residual Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT).

Outcome Measures

Outcome	Result	p-value
PRIMARY Progression-free Survival by Independent Review	42.9; 24.1	0.001 sig
SECONDARY Overall Survival	NA; NA	—
SECONDARY Incidence of Adverse Events or Laboratory Abnormalities	163; 142; 147; 79; 93; 51	—
SECONDARY Incidence of Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin	138; 142; 92; 104; 36; 27	—

Eligibility Criteria

Inclusion Criteria

Patients with HL who have received ASCT in the previous 30-45 days
Patients at high risk of residual HL post ASCT
Histologically-confirmed HL
ECOG of 0 or 1
Adequate organ function

Exclusion Criteria

Previous treatment with brentuximab vedotin
Previously received an allogeneic transplant
Patients who were determined to have a best clinical response of progressive disease with salvage treatment immediately prior to ASCT
History of another primary malignancy that has not been in remission for at least 3 years
Post ASCT or current therapy with other systemic anti-neoplastic or investigational agents

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01100502). 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.