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← KEYTRUDA: refractory Hodgkin Lymphoma

NCT00848926 · STUDY IN CONTEXT

A Pivotal Open-Label Trial of Brentuximab Vedotin for Hodgkin Lymphoma

Draft scope assessment: unclear. Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Percentage of participants who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.

Intention to treat

→

secondary · POSTED

Percentage of participants who achieved a best response of CR (disappearance of all evidence of disease) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.

Intention to treat

→

secondary · POSTED

Duration of objective response (CR + PR) by independent review group, defined as time of initial response until disease progression or death.

Participants with objective response among the intention to treat population

→

secondary · POSTED

Duration of response from start of first objective tumor response (CR or PR) by independent review group to disease progression or death due to any cause in participants with CR.

Participants with complete remission among the intention to treat population

→

secondary · POSTED

Time from start of study treatment to disease progression per independent review group or death due to any cause.

Intention to treat

→

secondary · POSTED

Time from start of study treatment to date of death due to any cause.

Intention to treat

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-keytruda-7b74c3c0
nct id
NCT00848926
trial label
A Pivotal Open-Label Trial of Brentuximab Vedotin for Hodgkin Lymphoma
applicability
unclear
applicability note
Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-keytruda-7b74c3c0
    nct id
    NCT00848926
    outcome key
    om-0000
    source section id
    NCT00848926-om-0000
    source outcome index
    0
    endpoint
    Objective Response Rate by Independent Review Group
    endpoint definition
    Percentage of participants who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.
    time origin
    up to 12 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intention to treat
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-keytruda-7b74c3c0
    nct id
    NCT00848926
    outcome key
    om-0001
    source section id
    NCT00848926-om-0001
    source outcome index
    1
    endpoint
    Complete Remission Rate by Independent Review Group
    endpoint definition
    Percentage of participants who achieved a best response of CR (disappearance of all evidence of disease) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.
    time origin
    up to 12 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intention to treat
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-keytruda-7b74c3c0
    nct id
    NCT00848926
    outcome key
    om-0002
    source section id
    NCT00848926-om-0002
    source outcome index
    2
    endpoint
    Duration of Objective Response by Kaplan-Meier Analysis
    endpoint definition
    Duration of objective response (CR + PR) by independent review group, defined as time of initial response until disease progression or death.
    time origin
    up to approximately 4 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Participants with objective response among the intention to treat population
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-keytruda-7b74c3c0
    nct id
    NCT00848926
    outcome key
    om-0003
    source section id
    NCT00848926-om-0003
    source outcome index
    3
    endpoint
    Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis
    endpoint definition
    Duration of response from start of first objective tumor response (CR or PR) by independent review group to disease progression or death due to any cause in participants with CR.
    time origin
    up to approximately 4 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Participants with complete remission among the intention to treat population
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-keytruda-7b74c3c0
    nct id
    NCT00848926
    outcome key
    om-0004
    source section id
    NCT00848926-om-0004
    source outcome index
    4
    endpoint
    Progression-free Survival by Kaplan-Meier Analysis
    endpoint definition
    Time from start of study treatment to disease progression per independent review group or death due to any cause.
    time origin
    up to approximately 4 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intention to treat
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-keytruda-7b74c3c0
    nct id
    NCT00848926
    outcome key
    om-0005
    source section id
    NCT00848926-om-0005
    source outcome index
    5
    endpoint
    Overall Survival
    endpoint definition
    Time from start of study treatment to date of death due to any cause.
    time origin
    up to approximately 6 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intention to treat
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-keytruda-7b74c3c0
    nct id
    NCT00848926
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Brentuximab Vedotin
    regimen
    Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
    analyzed count
    102
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00848926-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-keytruda-7b74c3c0
    nct id
    NCT00848926
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Brentuximab Vedotin
    regimen
    Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
    analyzed count
    102
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00848926-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-keytruda-7b74c3c0
    nct id
    NCT00848926
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Brentuximab Vedotin
    regimen
    Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
    analyzed count
    76
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00848926-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-keytruda-7b74c3c0
    nct id
    NCT00848926
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Brentuximab Vedotin
    regimen
    Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
    analyzed count
    34
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00848926-om-0003#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-keytruda-7b74c3c0
    nct id
    NCT00848926
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Brentuximab Vedotin
    regimen
    Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
    analyzed count
    102
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00848926-om-0004#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-keytruda-7b74c3c0
    nct id
    NCT00848926
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Brentuximab Vedotin
    regimen
    Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
    analyzed count
    102
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00848926-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-keytruda-7b74c3c0
    nct id
    NCT00848926
    harm key
    EG000
    source section id
    NCT00848926-ae
    event group key
    EG000
    event group label
    Brentuximab Vedotin
    serious affected
    25
    serious at risk
    102
    other affected
    97
    other at risk
    102
    frequency threshold
    5
    collection period
    Treatment-emergent adverse events through 30 days after last dose (up to 12 months)
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice