TriangleNCT01775475 · STUDY IN CONTEXT
Intravenous Chemotherapy or Oral Chemotherapy in Treating Patients With Previously Untreated Stage III-IV HIV-Associated Non-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
Proportion of participants who survived 2 years
Overall response is complete or partial response as defined by response definitions of the 2014 International Conference on Malignant Lymphoma Imaging Working Group (i.e. Lugano classification). Complete response is the disappearance of all lesions with no new lesions detected. Partial response is \>=50% decrease in the sum of the perpendicular diameters of up to 6 target measurable nodes and extranodal sites and no new sites of disease.
Proportion of participants who survived without disease progression at 2 years
Number of participants who experienced an adverse event
Number of patients who complete chemotherapy treatment.
Number of patients who did not miss any of their doses of antiretroviral therapy
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
- NCT01775475
- trial label
- Intravenous Chemotherapy or Oral Chemotherapy in Treating Patients With Previously Untreated Stage III-IV HIV-Associated Non-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
- NCT01775475
- outcome key
- om-0000
- source section id
- NCT01775475-om-0000
- source outcome index
- 0
- endpoint
- Overall Survival
- endpoint definition
- Proportion of participants who survived 2 years
- time origin
- Up to 24 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Study participants whose survival status was known at two years.
- 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
- NCT01775475
- outcome key
- om-0001
- source section id
- NCT01775475-om-0001
- source outcome index
- 1
- endpoint
- Overall Response Rate
- endpoint definition
- Overall response is complete or partial response as defined by response definitions of the 2014 International Conference on Malignant Lymphoma Imaging Working Group (i.e. Lugano classification). Complete response is the disappearance of all lesions with no new lesions detected. Partial response is \>=50% decrease in the sum of the perpendicular diameters of up to 6 target measurable nodes and extranodal sites and no new sites of disease.
- time origin
- Up to 24 months
- 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
- NCT01775475
- outcome key
- om-0002
- source section id
- NCT01775475-om-0002
- source outcome index
- 2
- endpoint
- Progression-free Survival
- endpoint definition
- Proportion of participants who survived without disease progression at 2 years
- time origin
- Up to 24 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants whose disease and survival status were known at 2 years
- 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
- NCT01775475
- outcome key
- om-0003
- source section id
- NCT01775475-om-0003
- source outcome index
- 3
- endpoint
- Participants Who Experienced an Adverse Event
- endpoint definition
- Number of participants who experienced an adverse event
- time origin
- Up to 24 months
- 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
- NCT01775475
- outcome key
- om-0004
- source section id
- NCT01775475-om-0004
- source outcome index
- 4
- endpoint
- Number of Patients Who Complete Treatment
- endpoint definition
- Number of patients who complete chemotherapy treatment.
- time origin
- Up to 18 weeks
- 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
- NCT01775475
- outcome key
- om-0005
- source section id
- NCT01775475-om-0005
- source outcome index
- 5
- endpoint
- Proportion of Patients Who Are Adherent to Antiretroviral Therapy
- endpoint definition
- Number of patients who did not miss any of their doses of antiretroviral therapy
- time origin
- Up to 24 months
- 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
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- nct id
- NCT01775475
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Arm I (CHOP)
- regimen
- Patients receive CHOP chemotherapy comprising cyclophosphamide IV on day 1, doxorubicin hydrochloride IV on day 1, vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. cyclophosphamide: Given IV doxorubicin hydrochloride: Given IV vincristine sulfate: Given IV prednisone: Given PO laboratory biomarker analysis: Correlative studies
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01775475-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- nct id
- NCT01775475
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Arm II (Oral Chemotherapy)
- regimen
- Patients receive lomustine PO QD on day 1 (courses 1 and 3 only), etoposide PO QD on days 1-3, cyclophosphamide PO QD on days 22-26, and procarbazine hydrochloride PO QD on days 22-26. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. lomustine: Given PO etoposide: Given PO cyclophosphamide: Given PO procarbazine hydrochloride: Given PO laboratory biomarker analysis: Correlative studies
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01775475-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- nct id
- NCT01775475
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Arm I (CHOP)
- regimen
- Patients receive CHOP chemotherapy comprising cyclophosphamide IV on day 1, doxorubicin hydrochloride IV on day 1, vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. cyclophosphamide: Given IV doxorubicin hydrochloride: Given IV vincristine sulfate: Given IV prednisone: Given PO laboratory biomarker analysis: Correlative studies
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01775475-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- nct id
- NCT01775475
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Arm II (Oral Chemotherapy)
- regimen
- Patients receive lomustine PO QD on day 1 (courses 1 and 3 only), etoposide PO QD on days 1-3, cyclophosphamide PO QD on days 22-26, and procarbazine hydrochloride PO QD on days 22-26. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. lomustine: Given PO etoposide: Given PO cyclophosphamide: Given PO procarbazine hydrochloride: Given PO laboratory biomarker analysis: Correlative studies
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01775475-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- nct id
- NCT01775475
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Arm I (CHOP)
- regimen
- Patients receive CHOP chemotherapy comprising cyclophosphamide IV on day 1, doxorubicin hydrochloride IV on day 1, vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. cyclophosphamide: Given IV doxorubicin hydrochloride: Given IV vincristine sulfate: Given IV prednisone: Given PO laboratory biomarker analysis: Correlative studies
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01775475-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- nct id
- NCT01775475
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Arm II (Oral Chemotherapy)
- regimen
- Patients receive lomustine PO QD on day 1 (courses 1 and 3 only), etoposide PO QD on days 1-3, cyclophosphamide PO QD on days 22-26, and procarbazine hydrochloride PO QD on days 22-26. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. lomustine: Given PO etoposide: Given PO cyclophosphamide: Given PO procarbazine hydrochloride: Given PO laboratory biomarker analysis: Correlative studies
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01775475-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- nct id
- NCT01775475
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Arm I (CHOP)
- regimen
- Patients receive CHOP chemotherapy comprising cyclophosphamide IV on day 1, doxorubicin hydrochloride IV on day 1, vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. cyclophosphamide: Given IV doxorubicin hydrochloride: Given IV vincristine sulfate: Given IV prednisone: Given PO laboratory biomarker analysis: Correlative studies
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01775475-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- nct id
- NCT01775475
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Arm II (Oral Chemotherapy)
- regimen
- Patients receive lomustine PO QD on day 1 (courses 1 and 3 only), etoposide PO QD on days 1-3, cyclophosphamide PO QD on days 22-26, and procarbazine hydrochloride PO QD on days 22-26. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. lomustine: Given PO etoposide: Given PO cyclophosphamide: Given PO procarbazine hydrochloride: Given PO laboratory biomarker analysis: Correlative studies
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01775475-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- nct id
- NCT01775475
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Arm I (CHOP)
- regimen
- Patients receive CHOP chemotherapy comprising cyclophosphamide IV on day 1, doxorubicin hydrochloride IV on day 1, vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. cyclophosphamide: Given IV doxorubicin hydrochloride: Given IV vincristine sulfate: Given IV prednisone: Given PO laboratory biomarker analysis: Correlative studies
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01775475-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- nct id
- NCT01775475
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Arm II (Oral Chemotherapy)
- regimen
- Patients receive lomustine PO QD on day 1 (courses 1 and 3 only), etoposide PO QD on days 1-3, cyclophosphamide PO QD on days 22-26, and procarbazine hydrochloride PO QD on days 22-26. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. lomustine: Given PO etoposide: Given PO cyclophosphamide: Given PO procarbazine hydrochloride: Given PO laboratory biomarker analysis: Correlative studies
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01775475-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- nct id
- NCT01775475
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Arm I (CHOP)
- regimen
- Patients receive CHOP chemotherapy comprising cyclophosphamide IV on day 1, doxorubicin hydrochloride IV on day 1, vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. cyclophosphamide: Given IV doxorubicin hydrochloride: Given IV vincristine sulfate: Given IV prednisone: Given PO laboratory biomarker analysis: Correlative studies
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01775475-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- nct id
- NCT01775475
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Arm II (Oral Chemotherapy)
- regimen
- Patients receive lomustine PO QD on day 1 (courses 1 and 3 only), etoposide PO QD on days 1-3, cyclophosphamide PO QD on days 22-26, and procarbazine hydrochloride PO QD on days 22-26. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. lomustine: Given PO etoposide: Given PO cyclophosphamide: Given PO procarbazine hydrochloride: Given PO laboratory biomarker analysis: Correlative studies
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01775475-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- nct id
- NCT01775475
- harm key
- EG000
- source section id
- NCT01775475-ae
- event group key
- EG000
- event group label
- Arm I (CHOP)
- serious affected
- 4
- serious at risk
- 4
- other affected
- 4
- other at risk
- 4
- frequency threshold
- 0
- 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
- NCT01775475
- harm key
- EG001
- source section id
- NCT01775475-ae
- event group key
- EG001
- event group label
- Arm II (Oral Chemotherapy)
- serious affected
- 3
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 0
- 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