TriangleNCT01771107 · STUDY IN CONTEXT
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With Stage II-IV HIV-Associated Hodgkin 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
Defined as the dose level at which =\< 1 of 6 subjects experience dose limiting toxicity.
2-year PFS is determined based on the Kaplan-Meier estimates and corresponding 95% confidence intervals based on standard errors using Greenwood's formula.
Number of Participants who had one or more adverse events
Number of participants who achieved a partial response per RECIST v1.0 criteria
Number of participants who achieved a partial response per RECIST v1.0 criteria
Number of participants who experienced a complete response per RECIST v1.0 criteria
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-aids-related-lymphoma
- nct id
- NCT01771107
- trial label
- Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With Stage II-IV HIV-Associated Hodgkin 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
- 6
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- 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