TriangleNCT00267865 · STUDY IN CONTEXT
Chemotherapy and HAART to Treat AIDS-related Primary Brain 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
Recurrent lymphoma as defined by the International Primary Central Nervous System (CNS) Lymphoma Collaborative Group for response assessment of aggressive Non-Hodgkin's Lymphoma (NHL) using fluorodeoxyglucose F 18 (18FDG-PET). Severe cognitive problems are defined as the inability to carry out normal activities with minimal difficulty and not requiring nursing care or hospitalization because of neurological impairment.
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Response was assessed by the International Workshop Criteria for Non-Hodgkin's Lymphoma. Complete Response is disappearance of all enhancing lesions on magnetic resonance imaging of the brain. Partial Response is a reduction of enhancing tumor volume by more than 50% for at least 4 weeks. Progressive Disease is an increase of tumor volume of more than 25% or occurrence of new lesions.
Participants that are estimated to be alive or last known to be alive after Rituximab, High-Dose Methotrexate and Leucovorin treatment.
The MMSE is scored out of a maximum of 30 points. A score of \>25 is considered normal, with scores \<25 indicating different levels of cognitive impairment: mild (21-24) moderate (10-20), and severe (0-10).
An increase in CD4 cells is determined by the number of CD4+ T lymphocytes /µL of peripheral blood.
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
- NCT00267865
- trial label
- Chemotherapy and HAART to Treat AIDS-related Primary Brain 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
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- nct id
- NCT00267865
- outcome key
- om-0000
- source section id
- NCT00267865-om-0000
- source outcome index
- 0
- endpoint
- Number of Patients Alive at 2 Years Without Recurrent Brain Lymphoma or Severe Neurocognitive Defects
- endpoint definition
- Recurrent lymphoma as defined by the International Primary Central Nervous System (CNS) Lymphoma Collaborative Group for response assessment of aggressive Non-Hodgkin's Lymphoma (NHL) using fluorodeoxyglucose F 18 (18FDG-PET). Severe cognitive problems are defined as the inability to carry out normal activities with minimal difficulty and not requiring nursing care or hospitalization because of neurological impairment.
- 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
- NCT00267865
- outcome key
- om-0001
- source section id
- NCT00267865-om-0001
- source outcome index
- 1
- endpoint
- Number of Participants With Serious and Non-serious Adverse Events
- endpoint definition
- Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
- time origin
- Date treatment consent signed to date off study, approximately 142 months and 11 days.
- 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
- NCT00267865
- outcome key
- om-0002
- source section id
- NCT00267865-om-0002
- source outcome index
- 2
- endpoint
- Number of Participants With Response to Treatment After Rituximab, High-Dose Methotrexate (R-HD-MTX) Induction
- endpoint definition
- Response was assessed by the International Workshop Criteria for Non-Hodgkin's Lymphoma. Complete Response is disappearance of all enhancing lesions on magnetic resonance imaging of the brain. Partial Response is a reduction of enhancing tumor volume by more than 50% for at least 4 weeks. Progressive Disease is an increase of tumor volume of more than 25% or occurrence of new lesions.
- time origin
- At the end of 6 cycles or 12 weeks of treatment
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Two participants were not evaluable. One participant received one cycle of therapy and one was not evaluable due to treatment failure.
- 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
- NCT00267865
- outcome key
- om-0003
- source section id
- NCT00267865-om-0003
- source outcome index
- 3
- endpoint
- Estimated Percentage of Participants Overall Survival
- endpoint definition
- Participants that are estimated to be alive or last known to be alive after Rituximab, High-Dose Methotrexate and Leucovorin treatment.
- time origin
- Time from treatment start date until date of death or date last known alive, approximately 60 months
- 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
- NCT00267865
- outcome key
- om-0004
- source section id
- NCT00267865-om-0004
- source outcome index
- 4
- endpoint
- Median Mini Mental Status Exam (MMSE) Score in Surviving Participants After Rituximab, High-Dose Methotrexate & Leucovorin ( R-HD-MTX) Treatment
- endpoint definition
- The MMSE is scored out of a maximum of 30 points. A score of \>25 is considered normal, with scores \<25 indicating different levels of cognitive impairment: mild (21-24) moderate (10-20), and severe (0-10).
- time origin
- up to 2.5 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Two participants were not evaluable. One participant received one cycle of therapy and one was not evaluable due to treatment failure.
- 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
- NCT00267865
- outcome key
- om-0005
- source section id
- NCT00267865-om-0005
- source outcome index
- 5
- endpoint
- Change From Baseline in Cluster of Differentiation 4 (CD4) T Cell Count at up to 2.5 Years
- endpoint definition
- An increase in CD4 cells is determined by the number of CD4+ T lymphocytes /µL of peripheral blood.
- time origin
- Baseline and up to 2.5 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Two participants were not evaluable. One participant received one cycle of therapy and one was not evaluable due to treatment failure.
- 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
- NCT00267865
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Rituximab, High-Dose Methotrexate & Leucovorin Treatment
- regimen
- Induction treatment cycles with rituximab, high-dose methotrexate and leucovorin will be administered every 2 weeks for 6 cycles. Two additional consolidation cycles of high-dose methotrexate without rituximab will be administered at 4 weeks and 8 weeks following completion of the combined therapy. Methotrexate: 6000 mg/m\^2 will be administered by intravenous infusion over 4 hours after confirming that the recipient patients urine pH is within the range greater than or equal to 7 to less than or equal to 8, and urine output is greater than or equal to 100 mL/hour. Rituximab: 375 mg/m\^2 intravenous (IV) day 1 of each cycle prior to administration of high-dose methotrexate Leucovorin: Leucovorin calcium doses will be administered orally or by short intravenous (IV) infusion over 15 minutes
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00267865-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- nct id
- NCT00267865
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Rituximab, High-Dose Methotrexate & Leucovorin Treatment
- regimen
- Induction treatment cycles with rituximab, high-dose methotrexate and leucovorin will be administered every 2 weeks for 6 cycles. Two additional consolidation cycles of high-dose methotrexate without rituximab will be administered at 4 weeks and 8 weeks following completion of the combined therapy. Methotrexate: 6000 mg/m\^2 will be administered by intravenous infusion over 4 hours after confirming that the recipient patients urine pH is within the range greater than or equal to 7 to less than or equal to 8, and urine output is greater than or equal to 100 mL/hour. Rituximab: 375 mg/m\^2 intravenous (IV) day 1 of each cycle prior to administration of high-dose methotrexate Leucovorin: Leucovorin calcium doses will be administered orally or by short intravenous (IV) infusion over 15 minutes
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00267865-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- nct id
- NCT00267865
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Rituximab, High-Dose Methotrexate & Leucovorin Treatment
- regimen
- Induction treatment cycles with rituximab, high-dose methotrexate and leucovorin will be administered every 2 weeks for 6 cycles. Two additional consolidation cycles of high-dose methotrexate without rituximab will be administered at 4 weeks and 8 weeks following completion of the combined therapy. Methotrexate: 6000 mg/m\^2 will be administered by intravenous infusion over 4 hours after confirming that the recipient patients urine pH is within the range greater than or equal to 7 to less than or equal to 8, and urine output is greater than or equal to 100 mL/hour. Rituximab: 375 mg/m\^2 intravenous (IV) day 1 of each cycle prior to administration of high-dose methotrexate Leucovorin: Leucovorin calcium doses will be administered orally or by short intravenous (IV) infusion over 15 minutes
- analyzed count
- 10
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00267865-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- nct id
- NCT00267865
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Rituximab, High-Dose Methotrexate & Leucovorin Treatment
- regimen
- Induction treatment cycles with rituximab, high-dose methotrexate and leucovorin will be administered every 2 weeks for 6 cycles. Two additional consolidation cycles of high-dose methotrexate without rituximab will be administered at 4 weeks and 8 weeks following completion of the combined therapy. Methotrexate: 6000 mg/m\^2 will be administered by intravenous infusion over 4 hours after confirming that the recipient patients urine pH is within the range greater than or equal to 7 to less than or equal to 8, and urine output is greater than or equal to 100 mL/hour. Rituximab: 375 mg/m\^2 intravenous (IV) day 1 of each cycle prior to administration of high-dose methotrexate Leucovorin: Leucovorin calcium doses will be administered orally or by short intravenous (IV) infusion over 15 minutes
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00267865-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- nct id
- NCT00267865
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Rituximab, High-Dose Methotrexate & Leucovorin Treatment
- regimen
- Induction treatment cycles with rituximab, high-dose methotrexate and leucovorin will be administered every 2 weeks for 6 cycles. Two additional consolidation cycles of high-dose methotrexate without rituximab will be administered at 4 weeks and 8 weeks following completion of the combined therapy. Methotrexate: 6000 mg/m\^2 will be administered by intravenous infusion over 4 hours after confirming that the recipient patients urine pH is within the range greater than or equal to 7 to less than or equal to 8, and urine output is greater than or equal to 100 mL/hour. Rituximab: 375 mg/m\^2 intravenous (IV) day 1 of each cycle prior to administration of high-dose methotrexate Leucovorin: Leucovorin calcium doses will be administered orally or by short intravenous (IV) infusion over 15 minutes
- analyzed count
- 10
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00267865-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- nct id
- NCT00267865
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Rituximab, High-Dose Methotrexate & Leucovorin Treatment
- regimen
- Induction treatment cycles with rituximab, high-dose methotrexate and leucovorin will be administered every 2 weeks for 6 cycles. Two additional consolidation cycles of high-dose methotrexate without rituximab will be administered at 4 weeks and 8 weeks following completion of the combined therapy. Methotrexate: 6000 mg/m\^2 will be administered by intravenous infusion over 4 hours after confirming that the recipient patients urine pH is within the range greater than or equal to 7 to less than or equal to 8, and urine output is greater than or equal to 100 mL/hour. Rituximab: 375 mg/m\^2 intravenous (IV) day 1 of each cycle prior to administration of high-dose methotrexate Leucovorin: Leucovorin calcium doses will be administered orally or by short intravenous (IV) infusion over 15 minutes
- analyzed count
- 10
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00267865-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-aids-related-lymphoma
- nct id
- NCT00267865
- harm key
- EG000
- source section id
- NCT00267865-ae
- event group key
- EG000
- event group label
- Rituximab, High-Dose Methotrexate & Leucovorin Treatment
- serious affected
- 3
- serious at risk
- 12
- other affected
- 11
- other at risk
- 12
- frequency threshold
- 0
- collection period
- Date treatment consent signed to date off study, approximately 142 months and 11 days.
- 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