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← Ann Arbor Stage II Noncutaneous Anaplastic Large Cell Lymphoma

NCT03113500 · STUDY IN CONTEXT

Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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.

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-ann-arbor-stage-ii-noncutaneous-anaplastic-large-cell-lymphoma
nct id
NCT03113500
trial label
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
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
2
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-ann-arbor-stage-ii-noncutaneous-anaplastic-large-cell-lymphoma
    nct id
    NCT03113500
    outcome key
    om-0000
    source section id
    NCT03113500-om-0000
    source outcome index
    0
    endpoint
    Complete Response (CR) Rate After Cyclophosphamide, Doxorubicin, Etoposide, Prednisone, and Brentuximab Vedotin (CHEP-BV) Induction Therapy
    endpoint definition
    CR rate was estimated by the proportion of evaluable patients achieving CR after CHEP-BV induction therapy, along with the 95% exact binomial confidence interval.
    time origin
    Up to the end of the CHEP-BV treatment
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    1 subject had no disease assessment.
    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-ann-arbor-stage-ii-noncutaneous-anaplastic-large-cell-lymphoma
    nct id
    NCT03113500
    outcome key
    om-0001
    source section id
    NCT03113500-om-0001
    source outcome index
    1
    endpoint
    Overall Survival at 1 Year
    endpoint definition
    Overall survival (OS) was measured from enrollment to death from any cause. OS was estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error.
    time origin
    The time from enrollment to death from any cause assessed up to 1 year.
    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-ann-arbor-stage-ii-noncutaneous-anaplastic-large-cell-lymphoma
    nct id
    NCT03113500
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Treatment (CHEP-BV)
    regimen
    INDUCTION: Patients receive cyclophosphamide IV and doxorubicin IV on day 1, etoposide IV on days 1-3, and prednisone PO on days 1-5. Patients also receive brentuximab vedotin IV over approximately 30 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles (or for up to 5 cycles for patients who received 1 cycle of CHOP-like or CHP-BV therapy prior to induction, per investigator's discretion) in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Between 30-60 days post-consolidative autologous stem cell therapy, post-consolidative radiation therapy, or after completing induction cycle 6 (cycle 5 for patients who qualify for receiving 5 cycles of CHEP-BV instead of 6), patients with objective response (complete response or partial response) receive brentuximab vedotin IV over approximately 30 minutes on day 1. Treatment repeats every 21 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Cyclophosphamide: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Etoposide Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Prednisone: Given PO
    analyzed count
    47
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03113500-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-ann-arbor-stage-ii-noncutaneous-anaplastic-large-cell-lymphoma
    nct id
    NCT03113500
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Treatment (CHEP-BV)
    regimen
    INDUCTION: Patients receive cyclophosphamide IV and doxorubicin IV on day 1, etoposide IV on days 1-3, and prednisone PO on days 1-5. Patients also receive brentuximab vedotin IV over approximately 30 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles (or for up to 5 cycles for patients who received 1 cycle of CHOP-like or CHP-BV therapy prior to induction, per investigator's discretion) in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Between 30-60 days post-consolidative autologous stem cell therapy, post-consolidative radiation therapy, or after completing induction cycle 6 (cycle 5 for patients who qualify for receiving 5 cycles of CHEP-BV instead of 6), patients with objective response (complete response or partial response) receive brentuximab vedotin IV over approximately 30 minutes on day 1. Treatment repeats every 21 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Cyclophosphamide: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Etoposide Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Prednisone: Given PO
    analyzed count
    48
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03113500-om-0001#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-ann-arbor-stage-ii-noncutaneous-anaplastic-large-cell-lymphoma
    nct id
    NCT03113500
    harm key
    EG000
    source section id
    NCT03113500-ae
    event group key
    EG000
    event group label
    Treatment (CHEP-BV)
    serious affected
    22
    serious at risk
    48
    other affected
    48
    other at risk
    48
    frequency threshold
    0
    collection period
    Up to 30 days post treatment
    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