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NCT04569032 · REGISTRY CONDITION SEARCH

A Study of Brentuximab Vedotin and CHP in Frontline Treatment of PTCL With Less Than 10% CD30 Expression

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2026-08-13

This clinical trial will study brentuximab vedotin with CHP to find out if the drugs work for people who have certain types of peripheral T-cell lymphoma (PTCL). It will also find out what side effects occur when brentuximab vedotin and CHP are used together. A side effect is anything the drugs do besides treating cancer. CHP is a type of chemotherapy that uses three drugs (cyclophosphamide, doxorubicin, and prednisone). CHP is approved by the FDA to treat certain types of PTCL.

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

Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) by Revised Response Criteria for Malignant Lymphoma Criteria (Cheson 2007) by Central CD30 Assessment

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outcome · POSTED

Complete Response (CR) Rate Per BICR (Cheson 2007) by Central CD30 Assessment

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outcome · NOT POSTED

Progression Free Survival (PFS) Per BICR (Cheson 2007) by Central CD30 Assessment

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outcome · NOT POSTED

Overall Survival (OS) by Central CD30 Assessment

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outcome · NOT POSTED

Duration of Response (DOR) Per BICR (Cheson 2007) by Central CD30 Assessment

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outcome · POSTED

ORR Per BICR by Modified Lugano Criteria (Cheson 2014) by Central CD30 Assessment

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outcome · POSTED

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Treatment Related Adverse Events by Local CD30 Assessment

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outcome · POSTED

Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment

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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 * Newly diagnosed PTCL, excluding systemic anaplastic large cell lymphoma (sALCL), per the Revised European-American Lymphoma World Health Organization (WHO) 2016 classification * The following non-sALCL PTCL subtypes are eligible: * PTCL - not otherwise specified (PTCL-NOS) * Angioimmunoblastic T-cell lymphoma (AITL) * Adult T-cell leukemia/lymphoma (ATLL; acute and lymphoma types only, must be positive for human T cell leukemia virus 1) * Enteropathy-associated T-cell lymphoma (EATL) * Hepatosplenic T-cell lymphoma * Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITCL) * Indolent T-cell lymphoproliferative disorder (T-LPD) of the gastrointestinal (GI) tract * Follicular T-cell lymphoma * Nodal peripheral T-cell lymphoma with T-follicular helper (TFH) phenotype * CD30 expression \<10% by local assessment in tumor containing lymph node or other extranodal soft tissue biopsy * Fluorodeoxyglucose (FDG)-avid disease by PET and measurable disease of at least 1.5 cm by CT, as assessed by the site radiologist * An Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 Exclusion Criteria * Current diagnosis of any of the following: * sALCL * Primary cutaneous T-cell lymphoproliferative disorders and lymphomas * Mycosis fungoides (MF), including transformed MF * History of another primary invasive cancer, hematologic malignancy, or myelodysplastic syndrome that has not been in remission for at least 3 years. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), such as carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer. * History of progressive multifocal leukoencephalopathy (PML). * Cerebral/meningeal disease related to the underlying malignancy. * Prior treatment with brentuximab vedotin or doxorubicin. * Baseline peripheral neuropathy Grade 2 or higher (per the NCI CTCAE, Version 4.03) or subjects with the demyelinating form of Charcot-Marie-Tooth syndrome. * Left ventricular ejection fraction less than 45% or symptomatic cardiac disease (including symptomatic ventricular dysfunction, symptomatic coronary artery disease, and symptomatic arrhythmias), or myocardial infarction within the past 6 months, or previous treatment with complete cumulative dose of \>300 mg/m2 of doxorubicin. * Any uncontrolled Grade 3 or higher (per the National Cancer Institute's Common Terminology Criteria for Adverse Events, NCI CTCAE Version 4.03) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study drug. Routine antimicrobial prophylaxis is permitted.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Participants with CD30 expression level \< 1%
    intervention Names
    1. Drug: brentuximab vedotin
    2. Drug: cyclophosphamide
    3. Drug: doxorubicin
    4. Drug: prednisone
    label
    CD30-negative Cohort
    type
    EXPERIMENTAL
  2. description
    Participants with CD30 expression level ≥1% to \< 10%
    intervention Names
    1. Drug: brentuximab vedotin
    2. Drug: cyclophosphamide
    3. Drug: doxorubicin
    4. Drug: prednisone
    label
    CD30-positive Cohort
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. CD30-negative Cohort
    2. CD30-positive Cohort
    description
    1.8 mg/kg administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycle
    name
    brentuximab vedotin
    other Names
    1. ADCETRIS
    type
    DRUG
  2. arm Group Labels
    1. CD30-negative Cohort
    2. CD30-positive Cohort
    description
    750 mg/m\^2 administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycle
    name
    cyclophosphamide
    type
    DRUG
  3. arm Group Labels
    1. CD30-negative Cohort
    2. CD30-positive Cohort
    description
    50 mg/m\^2 administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycle
    name
    doxorubicin
    type
    DRUG
  4. arm Group Labels
    1. CD30-negative Cohort
    2. CD30-positive Cohort
    description
    100 mg daily administered orally on Days 1-5 of each cycle
    name
    prednisone
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
82
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    ORR was defined as the percentage of participants with complete response (CR) or partial response (PR) following the completion of study treatment (at end of treatment \[EOT\]). CR and PR per Cheson 2007: CR was defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy and PR was defined as at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses.
    measure
    Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) by Revised Response Criteria for Malignant Lymphoma Criteria (Cheson 2007) by Central CD30 Assessment
    time Frame
    At EOT or the first assessment after the last dose of study treatment (prior to long term follow-up or initiation of subsequent anti-cancer therapies); up to 41.91 months
secondary Outcomes
  1. description
    CR rate was defined as the percentage of participants with CR following the completion of study treatment (at EOT). CR as per Cheson 2007: CR was defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.
    measure
    Complete Response (CR) Rate Per BICR (Cheson 2007) by Central CD30 Assessment
    time Frame
    At EOT or the first assessment after the last dose of study treatment (prior to long term follow-up or initiation of subsequent anti-cancer therapies); up to 41.91 months
  2. description
    PFS was defined as the time from start of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever came first. Kaplan-Meier method was used for analysis. PFS data was censored on the date of the last radiological assessment of measured lesions documenting absence of PD for participants without objective tumor progression and were still on study at the time of an analysis, were given antitumor treatment other than the study treatment or stem cell transplant (included donor lymphocyte infusion) or were removed from study prior to documentation of objective tumor progression. Participants who lacked an evaluation of tumor response after their first dose had their event time censored at 1 day.
    measure
    Progression Free Survival (PFS) Per BICR (Cheson 2007) by Central CD30 Assessment
    time Frame
    From the first dose of study treatment to first documentation of objective tumor progression or death due to any cause or censoring, whichever came first (approximately 61.7 months)
  3. description
    OS was defined as the time from first dose to death due to any cause. Participant not known to have died by the end of study follow-up, observation of OS was censored on the date the participants were last known to be alive (i.e., date of last contact). Participants who lacked data beyond the day of first dose had their survival time censored on the date of first dose (i.e., OS duration of 1 day). Kaplan-Meier method was used for analysis.
    measure
    Overall Survival (OS) by Central CD30 Assessment
    time Frame
    From the first dose of study treatment until death or censoring date, whichever came first (approximately 61.7 months)
  4. description
    DOR was defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression (per Cheson 2007) or death, whichever came first. Participants without progression or death were censored. DOR was only calculated for the subset of participants achieving a CR or PR. CR and PR per Cheson 2007: CR was defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy and PR was defined as at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. Kaplan-Meier method was used for analysis.
    measure
    Duration of Response (DOR) Per BICR (Cheson 2007) by Central CD30 Assessment
    time Frame
    From the first documented CR or PR until the first documentation of tumor progression, death or censoring date, whichever came first (up to 61.7 months)
  5. description
    ORR was defined as the percentage of participants with CR or PR following the completion of study treatment (at EOT) according to the modified Lugano criteria (Cheson 2014). Complete response was defined as complete disappearance of radiologic evidence of disease and PR was defined as at least a 50% decrease in SPD of up to six of the largest dominant nodes or nodal masses.
    measure
    ORR Per BICR by Modified Lugano Criteria (Cheson 2014) by Central CD30 Assessment
    time Frame
    At EOT or the first assessment after the last dose of study treatment (prior to long term follow-up or initiation of subsequent anti-cancer therapies); up to 41.91 months
  6. description
    An adverse event was any untoward medical occurrence in a participant or clinical investigational participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An adverse event was classified as a serious adverse event (SAE) if it met one of the following criteria: fatal, life threatening, hospitalization, disabling/incapacitating, congenital anomaly or birth defect or any medically significant event. TEAEs were events if they were newly occurring or worsen following study treatment. TESAE is any SAE that met treatment emergent definition. Treatment related AEs were which had evidence to suggest a causal relationship between the drugs and the adverse event, such as: an event that was uncommon and known to be strongly associated with drug exposure, an event that was not commonly associated with drug exposure but was otherwise uncommon in the population exposed to the drug. AEs included both SAEs and all non-SAEs.
    measure
    Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Treatment Related Adverse Events by Local CD30 Assessment
    time Frame
    From first dose of the study treatment (Day 1) up to 30-37 days after the last dose of study treatment (approximately up to 6.6 months)
  7. description
    Any Abnormal laboratory tests(Decreased values of hemoglobin,leukocytes,lymphocytes,neutrophils, platelets, calcium corrected for albumin,glomerular filtration rate estimated, glucose, phosphate, potassium,albumin,sodium and increased values of calcium corrected for albumin,creatinine, potassium, glucose, alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, total Bilirubin, urate) that worsen from baseline were considered clinically significant by investigator.Abnormal test were recorded as AE if associated with accompanying symptoms,required additional diagnostic testing or medical/surgical intervention,study dosing change,study discontinuation,significant additional concomitant drug treatment,other therapy.As perNCI CTCAE grade(G)1:mild(asymptomatic or mild symptoms,clinical,diagnostic observations,no intervention),G2:moderate(minimal, local,noninvasive intervention),G3:severe,medically significant,G4:life-threatening,urgent intervention,G5:death related to AE
    measure
    Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment
    time Frame
    From first dose of the study treatment (Day 1) up to 30-37 days after the last dose of study treatment (approximately up to 6.6 months)
Full study description
brief Summary
This clinical trial will study brentuximab vedotin with CHP to find out if the drugs work for people who have certain types of peripheral T-cell lymphoma (PTCL). It will also find out what side effects occur when brentuximab vedotin and CHP are used together. A side effect is anything the drugs do besides treating cancer. CHP is a type of chemotherapy that uses three drugs (cyclophosphamide, doxorubicin, and prednisone). CHP is approved by the FDA to treat certain types of PTCL.
Source references
Source notices and limitations
    Discovery and provenance
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      query cond
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      query disease state id
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      source file
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    Preserved source evidence · Not medical advice