Trial · NCT04569032
A Study of Brentuximab Vedotin and CHP in Frontline Treatment of PTCL With Less Than 10% CD30 Expression
NCT04569032, Phase 2, Completed, Seagen, a wholly owned subsidiary of Pfizer; results first posted 2025-05-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Brentuximab Vedotin and CHP in Frontline Treatment of PTCL With Less Than 10% CD30 Expression. Trials, record NCT04569032. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04569032
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Brentuximab Vedotin and CHP in Frontline Treatment of PTCL With Less Than 10% CD30 Expression
- NCT number
- NCT04569032
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 82 participants, actual
- Lead sponsor
- Seagen, a wholly owned subsidiary of Pfizer
- Conditions
- Peripheral T-cell Lymphoma
- Interventions
- brentuximab vedotin, cyclophosphamide, doxorubicin, prednisone
- First posted
- 2020-09-29
- Last updated
- 2026-08-13
- Results first posted
- 2025-05-15
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) by Revised Response Criteria for Malignant Lymphoma Criteria (Cheson 2007) by Central CD30 Assessment | 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 | 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. |
| Secondary | Complete Response (CR) Rate Per BICR (Cheson 2007) by Central CD30 Assessment | 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 | 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. |
| Secondary | Progression Free Survival (PFS) Per BICR (Cheson 2007) by Central CD30 Assessment | 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) | 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. |
| Secondary | Overall Survival (OS) by Central CD30 Assessment | From the first dose of study treatment until death or censoring date, whichever came first (approximately 61.7 months) | 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. |
| Secondary | Duration of Response (DOR) Per BICR (Cheson 2007) by Central CD30 Assessment | 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) | 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. |
| Secondary | ORR Per BICR by Modified Lugano Criteria (Cheson 2014) by Central CD30 Assessment | 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 | 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. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Treatment Related Adverse Events by Local CD30 Assessment | 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) | 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. |
| Secondary | 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 | 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) | 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 |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) by Revised Response Criteria for Malignant Lymphoma Criteria (Cheson 2007) by Central CD30 Assessment | 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 | Full analysis set (FAS) included all participants who received any amount of brentuximab vedotin or any component of cyclophosphamide, doxorubicin, and prednisone (CHP). Analyses as planned was based on the participants classified based on central laboratory assessment for CD30 expression. | Percentage of participants | NUMBER |
| SECONDARY | Complete Response (CR) Rate Per BICR (Cheson 2007) by Central CD30 Assessment | 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 | FAS included all participants who received any amount of brentuximab vedotin or any component of CHP. Analyses as planned was based on the participants classified based on central laboratory assessment for CD30 expression. | Percentage of participants | NUMBER |
| SECONDARY | Progression Free Survival (PFS) Per BICR (Cheson 2007) by Central CD30 Assessment | 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) | |||
| SECONDARY | Overall Survival (OS) by Central CD30 Assessment | From the first dose of study treatment until death or censoring date, whichever came first (approximately 61.7 months) | |||
| SECONDARY | Duration of Response (DOR) Per BICR (Cheson 2007) by Central CD30 Assessment | 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) | |||
| SECONDARY | ORR Per BICR by Modified Lugano Criteria (Cheson 2014) by Central CD30 Assessment | 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 | FAS included all participants who received any amount of brentuximab vedotin or any component of CHP. Analyses as planned was based on the participants classified based on central laboratory assessment for CD30 expression. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Treatment Related Adverse Events by Local CD30 Assessment | 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) | FAS included all participants who received any amount of brentuximab vedotin or any component of CHP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | 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) | FAS included all participants who received any amount of brentuximab vedotin or any component of CHP. Here, Overall Number of Participants Analyzed were participants evaluable for this outcome measure however all participants reported under Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Here, Number Analyzed signifies participants evaluable for the specified rows. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group92
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) by Revised Response Criteria for Malignant Lymphoma Criteria (Cheson 2007) by Central CD30 Assessment | CD30 <1% [Central Laboratory Assessment] | 61 | 95% Confidence Interval 38.5 to 80.3 | Percentage of participants | |
| Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) by Revised Response Criteria for Malignant Lymphoma Criteria (Cheson 2007) by Central CD30 Assessment | CD30 1% to <10% [Central Laboratory Assessment] | 81 | 95% Confidence Interval 62.5 to 92.5 | Percentage of participants | |
| Complete Response (CR) Rate Per BICR (Cheson 2007) by Central CD30 Assessment | CD30 <1% [Central Laboratory Assessment] | 52 | 95% Confidence Interval 30.6 to 73.2 | Percentage of participants | |
| Complete Response (CR) Rate Per BICR (Cheson 2007) by Central CD30 Assessment | CD30 1% to <10% [Central Laboratory Assessment] | 71 | 95% Confidence Interval 52.0 to 85.8 | Percentage of participants | |
| ORR Per BICR by Modified Lugano Criteria (Cheson 2014) by Central CD30 Assessment | CD30 <1% [Central Laboratory Assessment] | 57 | 95% Confidence Interval 34.5 to 76.8 | Percentage of participants | |
| ORR Per BICR by Modified Lugano Criteria (Cheson 2014) by Central CD30 Assessment | CD30 1% to <10% [Central Laboratory Assessment] | 77 | 95% Confidence Interval 58.9 to 90.4 | Percentage of participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Treatment Related Adverse Events by Local CD30 Assessment | CD30 <1% [Local Laboratory Assessment] | TEAEs | 32 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Treatment Related Adverse Events by Local CD30 Assessment | CD30 1% to <10% [Local Laboratory Assessment] | TEAEs | 46 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Treatment Related Adverse Events by Local CD30 Assessment | CD30 <1% [Local Laboratory Assessment] | TESAEs | 15 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Treatment Related Adverse Events by Local CD30 Assessment | CD30 1% to <10% [Local Laboratory Assessment] | TESAEs | 16 | Participants |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CD30 <1% [Local Laboratory Assessment] | 34 | |
| Overall Study | STARTED | CD30 1% to <10% [Local Laboratory Assessment] | 48 | |
| Overall Study | COMPLETED | CD30 <1% [Local Laboratory Assessment] | 0 | |
| Overall Study | COMPLETED | CD30 1% to <10% [Local Laboratory Assessment] | 0 | |
| Overall Study | NOT COMPLETED | CD30 <1% [Local Laboratory Assessment] | 34 | |
| Overall Study | NOT COMPLETED | CD30 1% to <10% [Local Laboratory Assessment] | 48 |
Source ClinicalTrials.gov
Adverse events190
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | CD30 <1% [Local Laboratory Assessment] | 7 | 34 | 7 |
| other | Anaemia | Blood and lymphatic system disorders | CD30 1% to <10% [Local Laboratory Assessment] | 15 | 48 | 18 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | CD30 <1% [Local Laboratory Assessment] | 2 | 34 | 2 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | CD30 1% to <10% [Local Laboratory Assessment] | 1 | 48 | 1 |
| other | Lymphopenia | Blood and lymphatic system disorders | CD30 <1% [Local Laboratory Assessment] | 1 | 34 | 1 |
| other | Lymphopenia | Blood and lymphatic system disorders | CD30 1% to <10% [Local Laboratory Assessment] | 5 | 48 | 6 |
| other | Neutropenia | Blood and lymphatic system disorders | CD30 <1% [Local Laboratory Assessment] | 4 | 34 | 4 |
| other | Neutropenia | Blood and lymphatic system disorders | CD30 1% to <10% [Local Laboratory Assessment] | 12 | 48 | 19 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | CD30 <1% [Local Laboratory Assessment] | 0 | 34 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | CD30 1% to <10% [Local Laboratory Assessment] | 5 | 48 | 5 |
1 to 10 of 190Source ClinicalTrials.gov
See all 190 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CD30 <1% [Local Laboratory Assessment] | 11 | 34 |
| Total, all-cause mortality | CD30 1% to <10% [Local Laboratory Assessment] | 13 | 48 |
| Total, other adverse events | CD30 <1% [Local Laboratory Assessment] | 31 | 34 |
| Total, other adverse events | CD30 1% to <10% [Local Laboratory Assessment] | 43 | 48 |
| Total, serious adverse events | CD30 <1% [Local Laboratory Assessment] | 15 | 34 |
| Total, serious adverse events | CD30 1% to <10% [Local Laboratory Assessment] | 16 | 48 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| CD30 <1% [Local Laboratory Assessment] vs CD30 1% to <10% [Local Laboratory Assessment]: deaths from any cause | Trial comparisons |
| CD30 <1% [Local Laboratory Assessment] vs CD30 1% to <10% [Local Laboratory Assessment]: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04569032
GET https://conductscience.org/api/trials/v1/NCT04569032/results?page=2