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← CARMUSTINE: metastatic Hodgkin's Lymphoma

NCT01771107 · STUDY IN CONTEXT

Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With Stage II-IV HIV-Associated Hodgkin Lymphoma

Draft scope assessment: unclear. Attached because the study's own record describes metastatic 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 by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

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

Defined as the dose level at which =\< 1 of 6 subjects experience dose limiting toxicity.

Participants entered into the phase I portion of the study

→

primary · POSTED

2-year PFS is determined based on the Kaplan-Meier estimates and corresponding 95% confidence intervals based on standard errors using Greenwood's formula.

Source null

→

secondary · POSTED

Number of Participants who had one or more adverse events

Participants who were treated with brentuximab and combination chemotherapy

→

secondary · POSTED

Number of participants who achieved a partial response per RECIST v1.0 criteria

Patients who completed therapy

→

secondary · POSTED

Number of participants who achieved a partial response per RECIST v1.0 criteria

Source null

→

secondary · POSTED

Number of participants who experienced a complete response per RECIST v1.0 criteria

Source null

→

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-carmustine-66189746
nct id
NCT01771107
trial label
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With Stage II-IV HIV-Associated Hodgkin Lymphoma
applicability
unclear
applicability note
Attached because the study's own record describes metastatic 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
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
6
harms Count
2
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-carmustine-66189746
    nct id
    NCT01771107
    outcome key
    om-0000
    source section id
    NCT01771107-om-0000
    source outcome index
    0
    endpoint
    Maximal Tolerated Dose of Brentuximab Vedotin (Phase I)
    endpoint definition
    Defined as the dose level at which =\< 1 of 6 subjects experience dose limiting toxicity.
    time origin
    28 days
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Participants entered into the phase I portion of the study
    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-carmustine-66189746
    nct id
    NCT01771107
    outcome key
    om-0001
    source section id
    NCT01771107-om-0001
    source outcome index
    1
    endpoint
    2-year Progression-free Survival (PFS) (Phase II)
    endpoint definition
    2-year PFS is determined based on the Kaplan-Meier estimates and corresponding 95% confidence intervals based on standard errors using Greenwood's formula.
    time origin
    2 years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    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-carmustine-66189746
    nct id
    NCT01771107
    outcome key
    om-0002
    source section id
    NCT01771107-om-0002
    source outcome index
    2
    endpoint
    Frequency of Adverse Events
    endpoint definition
    Number of Participants who had one or more adverse events
    time origin
    Up to 5 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Participants who were treated with brentuximab and combination chemotherapy
    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-carmustine-66189746
    nct id
    NCT01771107
    outcome key
    om-0003
    source section id
    NCT01771107-om-0003
    source outcome index
    3
    endpoint
    Partial Response Rate
    endpoint definition
    Number of participants who achieved a partial response per RECIST v1.0 criteria
    time origin
    2 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients who completed therapy
    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-carmustine-66189746
    nct id
    NCT01771107
    outcome key
    om-0004
    source section id
    NCT01771107-om-0004
    source outcome index
    4
    endpoint
    Partial Response Rate
    endpoint definition
    Number of participants who achieved a partial response per RECIST v1.0 criteria
    time origin
    5 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    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-carmustine-66189746
    nct id
    NCT01771107
    outcome key
    om-0005
    source section id
    NCT01771107-om-0005
    source outcome index
    5
    endpoint
    Complete Response Rate
    endpoint definition
    Number of participants who experienced a complete response per RECIST v1.0 criteria
    time origin
    2 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    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-carmustine-66189746
    nct id
    NCT01771107
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Treatment (Brentuximab and Combination Chemotherapy)
    regimen
    Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01771107-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-carmustine-66189746
    nct id
    NCT01771107
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Phase I - Brentuximab 1.2 mg/kg
    regimen
    Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01771107-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-carmustine-66189746
    nct id
    NCT01771107
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Phase II - Brentuximab 1.2 mg/kg
    regimen
    Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV
    analyzed count
    35
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01771107-om-0001#groups/OG001
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-carmustine-66189746
    nct id
    NCT01771107
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Phase I - Brentuximab 1.2 mg/kg
    regimen
    Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01771107-om-0002#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-carmustine-66189746
    nct id
    NCT01771107
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Phase II - Brentuximab 1.2 mg/kg
    regimen
    Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV
    analyzed count
    35
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01771107-om-0002#groups/OG001
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-carmustine-66189746
    nct id
    NCT01771107
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Phase I - Brentuximab 1.2 mg/kg
    regimen
    Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01771107-om-0003#groups/OG000
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-carmustine-66189746
    nct id
    NCT01771107
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Phase II - Brentuximab 1.2 mg/kg
    regimen
    Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV
    analyzed count
    35
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01771107-om-0003#groups/OG001
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-carmustine-66189746
    nct id
    NCT01771107
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Phase I - Brentuximab 1.2 mg/kg
    regimen
    Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01771107-om-0004#groups/OG000
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-carmustine-66189746
    nct id
    NCT01771107
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Phase II - Brentuximab 1.2 m/kg
    regimen
    Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV
    analyzed count
    35
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01771107-om-0004#groups/OG001
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-carmustine-66189746
    nct id
    NCT01771107
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Phase I - Brentuximab 1.2 mg/kg
    regimen
    Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01771107-om-0005#groups/OG000
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-carmustine-66189746
    nct id
    NCT01771107
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Phase II - Brentuximab 1.2 mg/kg
    regimen
    Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV
    analyzed count
    35
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01771107-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-carmustine-66189746
    nct id
    NCT01771107
    harm key
    EG000
    source section id
    NCT01771107-ae
    event group key
    EG000
    event group label
    Phase I - Brentuximab 1.2 mg/kg
    serious affected
    3
    serious at risk
    6
    other affected
    6
    other at risk
    6
    frequency threshold
    5
    collection period
    2 years
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-carmustine-66189746
    nct id
    NCT01771107
    harm key
    EG001
    source section id
    NCT01771107-ae
    event group key
    EG001
    event group label
    Phase II - Brentuximab 1.2 mg/kg
    serious affected
    16
    serious at risk
    35
    other affected
    34
    other at risk
    35
    frequency threshold
    5
    collection period
    2 years
    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