TriangleNCT03220022 · STUDY IN CONTEXT
Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B
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
Will be descriptive and will be reported in tabular format with the appropriate summary statistics (count and percentage). In the dose-finding portion, the number of dose limiting toxicities (DLTs) identified among the DLT-evaluable subjects will be listed and summarized by dose level. The safety variables will be listed and summarized for (1) subjects in the dose-finding portion, (2) subjects in the dose expansion cohort (DEC), and (3) all subjects in the study.
Will be descriptive and will be reported in tabular format with the appropriate summary statistics (count and percentage). In the dose-finding portion, the number of DLTs identified among the DLT-evaluable subjects will be listed and summarized by dose level. The safety variables will be listed and summarized for (1) subjects in the dose-finding portion, (2) subjects in the DEC, and (3) all subjects in the study.
Toxicity data will be presented by type and severity for each dose cohort. Incidence of toxicity related dose reductions and treatment discontinuations will be summarized for each dose group.
The complete response rates and their corresponding 95% confidence intervals will be calculated for participants with AIDS-related lymphomas (ARL) treated with combination ibrutinib and rituximab (R)-dose adjusted (da)-etoposide, prednisone, vincristine sulfate, cyclophosphamide and doxorubicin hydrochloride (EPOCH). Response is currently assessed on the basis of clinical, radiologic, and pathologic (i.e., bone marrow) criteria. Radiologic response will be based on the Lugano Classification. Complete metabolic response with Score 1, 2, or 3 with or without a residual mass on 5PS. Partial metabolic response with Score 4 or 5† with reduced uptake compared with baseline and residual mass(es) of any size. Overall Response (OR) consists of complete response and partial response.
PFS will be estimated using Kaplan Meier method, as well as, their corresponding 95% confidence intervals. Progressive disease requires at least 1 of the following Perpendicular diameters: An individual node/lesion must be abnormal with: longest diameter 1.5 cm and Increase by 50% from perpendicular diameters nadir and an increase in longest diameter or shortest diameter from nadir 0.5 cm for lesions 2 cm 1.0 cm for lesions 2 cm. In the setting of splenomegaly, the splenic length must increase by 50% of the extent of its prior increase beyond baseline (e.g., a 15-cm spleen must increase to 16 cm). If no prior splenomegaly, must increase by at least 2 cm from baseline.
PFS will be estimated using Kaplan Meier method, as well as, their corresponding 95% confidence intervals. Progressive disease requires at least 1 of the following Perpendicular diameters: An individual node/lesion must be abnormal with: longest diameter 1.5 cm and Increase by 50% from perpendicular diameters nadir and an increase in longest diameter or shortest diameter from nadir 0.5 cm for lesions 2 cm 1.0 cm for lesions 2 cm. In the setting of splenomegaly, the splenic length must increase by 50% of the extent of its prior increase beyond baseline (e.g., a 15-cm spleen must increase to 16 cm). If no prior splenomegaly, must increase by at least 2 cm from baseline.
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
- NCT03220022
- trial label
- Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B
- 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
- NCT03220022
- outcome key
- om-0000
- source section id
- NCT03220022-om-0000
- source outcome index
- 0
- endpoint
- Maximum Tolerated Dose (MTD) of Ibrutinib in Combination With Chemotherapy
- endpoint definition
- Will be descriptive and will be reported in tabular format with the appropriate summary statistics (count and percentage). In the dose-finding portion, the number of dose limiting toxicities (DLTs) identified among the DLT-evaluable subjects will be listed and summarized by dose level. The safety variables will be listed and summarized for (1) subjects in the dose-finding portion, (2) subjects in the dose expansion cohort (DEC), and (3) all subjects in the study.
- time origin
- Up to 21 days
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participant who receive study treatment (Ibrutinib 560 mg)
- 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
- NCT03220022
- outcome key
- om-0001
- source section id
- NCT03220022-om-0001
- source outcome index
- 1
- endpoint
- Recommended Phase II Dose (RP2D) of Ibrutinib in Combination With Chemotherapy
- endpoint definition
- Will be descriptive and will be reported in tabular format with the appropriate summary statistics (count and percentage). In the dose-finding portion, the number of DLTs identified among the DLT-evaluable subjects will be listed and summarized by dose level. The safety variables will be listed and summarized for (1) subjects in the dose-finding portion, (2) subjects in the DEC, and (3) all subjects in the study.
- time origin
- Up to 21 days
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants who receive study treatment
- 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
- NCT03220022
- outcome key
- om-0002
- source section id
- NCT03220022-om-0002
- source outcome index
- 2
- endpoint
- Incidence of Adverse Events Graded Using Common Terminology Criteria for Adverse Events Version 4.0
- endpoint definition
- Toxicity data will be presented by type and severity for each dose cohort. Incidence of toxicity related dose reductions and treatment discontinuations will be summarized for each dose group.
- time origin
- Up to 5 years
- analysis role
- secondary
- reporting status
- NOT_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
- NCT03220022
- outcome key
- om-0003
- source section id
- NCT03220022-om-0003
- source outcome index
- 3
- endpoint
- Complete Response Rates
- endpoint definition
- The complete response rates and their corresponding 95% confidence intervals will be calculated for participants with AIDS-related lymphomas (ARL) treated with combination ibrutinib and rituximab (R)-dose adjusted (da)-etoposide, prednisone, vincristine sulfate, cyclophosphamide and doxorubicin hydrochloride (EPOCH). Response is currently assessed on the basis of clinical, radiologic, and pathologic (i.e., bone marrow) criteria. Radiologic response will be based on the Lugano Classification. Complete metabolic response with Score 1, 2, or 3 with or without a residual mass on 5PS. Partial metabolic response with Score 4 or 5† with reduced uptake compared with baseline and residual mass(es) of any size. Overall Response (OR) consists of complete response and partial response.
- time origin
- Up to 5 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants with response 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-aids-related-lymphoma
- nct id
- NCT03220022
- outcome key
- om-0004
- source section id
- NCT03220022-om-0004
- source outcome index
- 4
- endpoint
- Progression Free Survival (PFS)
- endpoint definition
- PFS will be estimated using Kaplan Meier method, as well as, their corresponding 95% confidence intervals. Progressive disease requires at least 1 of the following Perpendicular diameters: An individual node/lesion must be abnormal with: longest diameter 1.5 cm and Increase by 50% from perpendicular diameters nadir and an increase in longest diameter or shortest diameter from nadir 0.5 cm for lesions 2 cm 1.0 cm for lesions 2 cm. In the setting of splenomegaly, the splenic length must increase by 50% of the extent of its prior increase beyond baseline (e.g., a 15-cm spleen must increase to 16 cm). If no prior splenomegaly, must increase by at least 2 cm from baseline.
- time origin
- 1 year
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants received study treatment (ibrutinib 560mg plus R-da-EPOCH)
- 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
- NCT03220022
- outcome key
- om-0005
- source section id
- NCT03220022-om-0005
- source outcome index
- 5
- endpoint
- Progression Free Survival (PFS)
- endpoint definition
- PFS will be estimated using Kaplan Meier method, as well as, their corresponding 95% confidence intervals. Progressive disease requires at least 1 of the following Perpendicular diameters: An individual node/lesion must be abnormal with: longest diameter 1.5 cm and Increase by 50% from perpendicular diameters nadir and an increase in longest diameter or shortest diameter from nadir 0.5 cm for lesions 2 cm 1.0 cm for lesions 2 cm. In the setting of splenomegaly, the splenic length must increase by 50% of the extent of its prior increase beyond baseline (e.g., a 15-cm spleen must increase to 16 cm). If no prior splenomegaly, must increase by at least 2 cm from baseline.
- time origin
- 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants received study treatment (ibrutinib plus R-da-EPOCH)
- 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
- NCT03220022
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Dose-finding Cohort
- regimen
- Each participant in the dose-finding cohort must have completed at least cycle 1 (or 21 days) of ibrutinib plus rituximab (R)-dose adjusted (da)-etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin (EPOCH). Starting dose of ibrutinib is 560 mg PO.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03220022-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- nct id
- NCT03220022
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Dose-finding Cohort
- regimen
- Each participant in the dose-finding cohort must have completed at least cycle 1 (or 21 days) of ibrutinib plus rituximab (R)-dose adjusted (da)-etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin (EPOCH). Starting dose of ibrutinib is 560 mg PO. RP2D is dose level which DLT rate is less than 33%.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03220022-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- nct id
- NCT03220022
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Dose-finding Cohort
- regimen
- Each participant in the dose-finding cohort must have completed at least cycle 1 (or 21 days) of ibrutinib plus rituximab (R)-dose adjusted (da)-etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin (EPOCH). Starting dose of ibrutinib is 560 mg PO.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03220022-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- nct id
- NCT03220022
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Dose Expansion Cohort
- regimen
- Each participant in the dose expansion cohort may receive treatment for a maximum of 6 cycles (21-day cycle length) of ibrutinib plus rituximab (R)-dose adjusted (da)-etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin (EPOCH). MTD of ibrutinib is 560 mg PO.
- analyzed count
- 40
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03220022-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- nct id
- NCT03220022
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Dose-finding Cohort
- regimen
- Each participant in the dose-finding cohort must have completed at least cycle 1 (or 21 days) of ibrutinib plus rituximab (R)-dose adjusted (da)-etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin (EPOCH). Starting dose of ibrutinib is 560 mg PO.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03220022-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- nct id
- NCT03220022
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Dose Expansion Cohort
- regimen
- Each participant in the dose expansion cohort may receive treatment for a maximum of 6 cycles (21-day cycle length) of ibrutinib plus rituximab (R)-dose adjusted (da)-etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin (EPOCH). MTD of ibrutinib is 560 mg PO.
- analyzed count
- 40
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03220022-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- nct id
- NCT03220022
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Dose-finding Cohort
- regimen
- Each participant in the dose-finding cohort must have completed at least cycle 1 (or 21 days) of ibrutinib plus rituximab (R)-dose adjusted (da)-etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin (EPOCH). Starting dose of ibrutinib is 560 mg PO.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03220022-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- nct id
- NCT03220022
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Dose Expansion Cohort
- regimen
- Each participant in the dose expansion cohort may receive treatment for a maximum of 6 cycles (21-day cycle length) of ibrutinib plus rituximab (R)-dose adjusted (da)-etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin (EPOCH). MTD of ibrutinib is 560 mg PO.
- analyzed count
- 40
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03220022-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- nct id
- NCT03220022
- harm key
- EG000
- source section id
- NCT03220022-ae
- event group key
- EG000
- event group label
- Dose-finding Cohort
- serious affected
- 3
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 5
- collection period
- Up to 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
- NCT03220022
- harm key
- EG001
- source section id
- NCT03220022-ae
- event group key
- EG001
- event group label
- Dose Expansion Cohort
- serious affected
- 21
- serious at risk
- 40
- other affected
- 38
- other at risk
- 40
- frequency threshold
- 5
- collection period
- Up to 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