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NCT01100502 · CITED IN SOURCE DOCUMENTS

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)

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2021-05-14

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).

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Progression-free Survival by Independent Review

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outcome · POSTED

Overall Survival

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outcome · POSTED

Incidence of Adverse Events or Laboratory Abnormalities

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outcome · POSTED

Incidence of Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
    intervention Names
    1. Drug: brentuximab vedotin
    label
    Brentuximab vedotin
    type
    EXPERIMENTAL
  2. description
    placebo every 3 weeks by IV infusion
    intervention Names
    1. Drug: placebo
    label
    Placebo
    type
    PLACEBO_COMPARATOR
interventions
  1. arm Group Labels
    1. Brentuximab vedotin
    description
    Every 21 days by IV infusion (1.8 mg/kg)
    name
    brentuximab vedotin
    other Names
    1. SGN-35
    2. Adcetris
    type
    DRUG
  2. arm Group Labels
    1. Placebo
    description
    Every 21 days by IV infusion
    name
    placebo
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
QUADRUPLE
who Masked
  1. PARTICIPANT
  2. CARE_PROVIDER
  3. INVESTIGATOR
  4. OUTCOMES_ASSESSOR
primary Purpose
TREATMENT
Enrollment
count
329
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Time from date of randomization to the first documentation of disease progression by independent review or to death due to any cause, whichever comes first
    measure
    Progression-free Survival by Independent Review
    time Frame
    Up to approximately 4 years
secondary Outcomes
  1. description
    Time from date of randomization to date of death due to any cause
    measure
    Overall Survival
    time Frame
    Up to approximately 10 years
  2. measure
    Incidence of Adverse Events or Laboratory Abnormalities
    time Frame
    Up to 12 months
  3. measure
    Incidence of Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin
    time Frame
    Up to 12 months
Full study description
brief 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).
Source references
references
  1. citation
    Moskowitz CH, Nademanee A, Masszi T, Agura E, Holowiecki J, Abidi MH, Chen AI, Stiff P, Gianni AM, Carella A, Osmanov D, Bachanova V, Sweetenham J, Sureda A, Huebner D, Sievers EL, Chi A, Larsen EK, Hunder NN, Walewski J; AETHERA Study Group. Brentuximab vedotin as consolidation therapy after autologous stem-cell transplantation in patients with Hodgkin's lymphoma at risk of relapse or progression (AETHERA): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2015 May 9;385(9980):1853-62. doi: 10.1016/S0140-6736(15)60165-9. Epub 2015 Mar 19.
    pmid
    25796459
    type
    RESULT
  2. citation
    Moskowitz CH, Walewski J, Nademanee A, Masszi T, Agura E, Holowiecki J, Abidi MH, Chen AI, Stiff P, Viviani S, Bachanova V, Sureda A, McClendon T, Lee C, Lisano J, Sweetenham J. Five-year PFS from the AETHERA trial of brentuximab vedotin for Hodgkin lymphoma at high risk of progression or relapse. Blood. 2018 Dec 20;132(25):2639-2642. doi: 10.1182/blood-2018-07-861641. Epub 2018 Sep 28.
    pmid
    30266774
    type
    DERIVED
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        aracteristic (disease stage). 0.0002 Randomized Placebo-Controlled Clinical Trial in Classical Hodgkin Lymphoma Post-Auto-HSCT Consolidation (Study 3: AETHERA, NCT01100502) The efficacy of ADCETRIS in patients with cHL at high risk of relapse or disease progression post-auto-HSCT was studied in a randomized, double-blind, placebo
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        alse);">Level of evidence C3</a>]</li><li>For 329 patients at high risk of residual HL after SCT, the double-blind <a href="https://clinicaltrials.gov/ct2/show/NCT01100502" title="https://clinicaltrials.gov/ct2/show/NCT01100502">AETHERA</a> trial (NCT01100502) evaluated brentuximab vedotin versus placebo.[<a href="#cit/section_8.
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        ts at high risk of residual HL after SCT, the double-blind <a href="https://clinicaltrials.gov/ct2/show/NCT01100502" title="https://clinicaltrials.gov/ct2/show/NCT01100502">AETHERA</a> trial (NCT01100502) evaluated brentuximab vedotin versus placebo.[<a href="#cit/section_8.22">22</a>,<a href="#cit/section_8.23">23</a>]<div class
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        fter SCT, the double-blind <a href="https://clinicaltrials.gov/ct2/show/NCT01100502" title="https://clinicaltrials.gov/ct2/show/NCT01100502">AETHERA</a> trial (NCT01100502) evaluated brentuximab vedotin versus placebo.[<a href="#cit/section_8.22">22</a>,<a href="#cit/section_8.23">23</a>]<div class="pdq-content-list"><ul id="_105
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        utologous SCT for recurrent HL, 329 patients were randomly assigned to receive brentuximab vedotin or placebo in a double-blind trial (<a href="/clinicaltrials/NCT01100502">AETHERA</a> [NCT01100502]).[<a href="#cit/section_8.22">22</a>,<a href="#cit/section_8.23">23</a>]</p> <div class="pdq-content-list"><ul id="_1093"><l
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        t HL, 329 patients were randomly assigned to receive brentuximab vedotin or placebo in a double-blind trial (<a href="/clinicaltrials/NCT01100502">AETHERA</a> [NCT01100502]).[<a href="#cit/section_8.22">22</a>,<a href="#cit/section_8.23">23</a>]</p> <div class="pdq-content-list"><ul id="_1093"><li>With a median follow-up
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      1. context
        Updated: February 12, 2025
        datetime
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    Preserved source evidence · Not medical advice