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
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.
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.
Reported safety
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
- 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
- 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
- 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
- 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
- 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
Triangle