TriangleNCT00006436 · STUDY IN CONTEXT
EPOCH and Rituximab to Treat Non-Hodgkin's Lymphoma in Patients With HIV Infection
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
PFS is the time interval from study entry to documented evidence of disease progression or death due to any cause. Progression is defined according to the Cheson response criteria. Disease progression is defined as increase of 25% or more in the sum of the products of the longest perpendicular diameters of all measured lesions compared to the smallest previous measurements, or the appearance of any new lesion(s). Confidence intervals were made, and a Kaplan-Meier curve of progression free survival was constructed.
PFS is the time interval from start of treatment to documented evidence of disease progression. Progression is defined according to the Cheson response criteria. Disease progression as indicated by imaging scans at one year following therapy. Disease progression is defined as increase of 25% or more in the sum of the products of the longest perpendicular diameters of all measured lesions compared to the smallest previous measurements, or the appearance of any new lesion(s).
Non-hematologic (i.e., not begin in bone marrow or blood) toxicity was assessed by the Common Toxicity Criteria (CTC v2.0). Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event.
Overall survival is time from treatment start date until date of death or date last known alive.
Overall survival is time from treatment start date until date of death or date last known alive.
Complete response (CR) was assessed by the Cheson response criteria. Complete response is disappearance of all signs and symptoms of lymphoma for a period of at least one month. All lymph nodes and nodal masses must have regressed to normal size (1.5 cm in their greatest transverse diameter for nodes \> 1.5 cm before therapy). Complete response unconfirmed (CRu) is when a residual lymph node mass \> 1.5 cm in greatest transverse diameter that has regressed by \> 75% in sum of the products of the greatest diameters, does not change over the last two treatments, and any biopsies obtained are negative will be considered to be in CR. In organs involved by disease, any residual lesions that have decreased by \> 75% in sum of the products of the greatest diameters or are \< 1 cm, are consistent with scar, and stable over the last two treatments will be considered to fulfill criteria for CR.
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
- NCT00006436
- trial label
- EPOCH and Rituximab to Treat Non-Hodgkin's Lymphoma in Patients With HIV Infection
- 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
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- nct id
- NCT00006436
- outcome key
- om-0000
- source section id
- NCT00006436-om-0000
- source outcome index
- 0
- endpoint
- Median Progression Free Survival (PFS)
- endpoint definition
- PFS is the time interval from study entry to documented evidence of disease progression or death due to any cause. Progression is defined according to the Cheson response criteria. Disease progression is defined as increase of 25% or more in the sum of the products of the longest perpendicular diameters of all measured lesions compared to the smallest previous measurements, or the appearance of any new lesion(s). Confidence intervals were made, and a Kaplan-Meier curve of progression free survival was constructed.
- time origin
- The participants were followed for a median of 15.4 years.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- One participant declined to participate before treatment started.
- 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
- NCT00006436
- outcome key
- om-0001
- source section id
- NCT00006436-om-0001
- source outcome index
- 1
- endpoint
- Progression Free Survival at 1 Year
- endpoint definition
- PFS is the time interval from start of treatment to documented evidence of disease progression. Progression is defined according to the Cheson response criteria. Disease progression as indicated by imaging scans at one year following therapy. Disease progression is defined as increase of 25% or more in the sum of the products of the longest perpendicular diameters of all measured lesions compared to the smallest previous measurements, or the appearance of any new lesion(s).
- time origin
- 1 year
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- One participant declined to participate before treatment started.
- 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
- NCT00006436
- outcome key
- om-0002
- source section id
- NCT00006436-om-0002
- source outcome index
- 2
- endpoint
- Number of Participants With ≥ Grades 3-5 Non-hematologic Toxicity
- endpoint definition
- Non-hematologic (i.e., not begin in bone marrow or blood) toxicity was assessed by the Common Toxicity Criteria (CTC v2.0). Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event.
- time origin
- Date treatment consent signed to date off study, approximately 209 months and 17 days.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- One participant declined to participate before treatment started.
- 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
- NCT00006436
- outcome key
- om-0003
- source section id
- NCT00006436-om-0003
- source outcome index
- 3
- endpoint
- Median Overall Survival
- endpoint definition
- Overall survival is time from treatment start date until date of death or date last known alive.
- time origin
- The participants were followed for survival for a median of 15.4 years.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- One participant declined to participate before treatment started.
- 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
- NCT00006436
- outcome key
- om-0004
- source section id
- NCT00006436-om-0004
- source outcome index
- 4
- endpoint
- 1 Year Overall Survival
- endpoint definition
- Overall survival is time from treatment start date until date of death or date last known alive.
- time origin
- 1 year
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- One participant declined to participate before treatment started.
- 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
- NCT00006436
- outcome key
- om-0005
- source section id
- NCT00006436-om-0005
- source outcome index
- 5
- endpoint
- Median Duration of Complete Response/Complete Response Unconfirmed
- endpoint definition
- Complete response (CR) was assessed by the Cheson response criteria. Complete response is disappearance of all signs and symptoms of lymphoma for a period of at least one month. All lymph nodes and nodal masses must have regressed to normal size (1.5 cm in their greatest transverse diameter for nodes \> 1.5 cm before therapy). Complete response unconfirmed (CRu) is when a residual lymph node mass \> 1.5 cm in greatest transverse diameter that has regressed by \> 75% in sum of the products of the greatest diameters, does not change over the last two treatments, and any biopsies obtained are negative will be considered to be in CR. In organs involved by disease, any residual lesions that have decreased by \> 75% in sum of the products of the greatest diameters or are \< 1 cm, are consistent with scar, and stable over the last two treatments will be considered to fulfill criteria for CR.
- time origin
- The participants were followed for duration of complete response or complete response unconfirmed for a median of 15.4 years.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- One participant declined to participate before treatment started.
- 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
- NCT00006436
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Arm 1-Combination Chemo and Biological Therapy
- regimen
- Combination chemo and biological therapy Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5 Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles
- analyzed count
- 67
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00006436-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- nct id
- NCT00006436
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Arm 1-Combination Chemo and Biological Therapy
- regimen
- Combination chemo and biological therapy Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5 Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles
- analyzed count
- 67
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00006436-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- nct id
- NCT00006436
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Grade 3
- regimen
- Grade 3 is serious.
- analyzed count
- 67
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00006436-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- nct id
- NCT00006436
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Grade 4
- regimen
- Grade 4 is life threatening.
- analyzed count
- 67
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00006436-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- nct id
- NCT00006436
- outcome key
- om-0002
- arm key
- OG002
- arm label
- Grade 5
- regimen
- Grade 5 is death related to adverse event.
- analyzed count
- 67
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00006436-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- nct id
- NCT00006436
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Arm 1-Combination Chemo and Biological Therapy
- regimen
- Combination chemo and biological therapy Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5 Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles
- analyzed count
- 67
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00006436-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- nct id
- NCT00006436
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Arm 1-Combination Chemo and Biological Therapy
- regimen
- Combination chemo and biological therapy Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5 Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles
- analyzed count
- 67
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00006436-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- nct id
- NCT00006436
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Arm 1-Combination Chemo and Biological Therapy
- regimen
- Combination chemo and biological therapy Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5 Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles
- analyzed count
- 67
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00006436-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- nct id
- NCT00006436
- harm key
- EG000
- source section id
- NCT00006436-ae
- event group key
- EG000
- event group label
- Arm 1-Combination Chemo and Biological Therapy
- serious affected
- 23
- serious at risk
- 67
- other affected
- 66
- other at risk
- 67
- frequency threshold
- 0
- collection period
- Date treatment consent signed to date off study, approximately 209 months and 17 days.
- event definition
- One participant declined to participate before treatment started.
- 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