Trial · NCT00267865
Chemotherapy and HAART to Treat AIDS-related Primary Brain Lymphoma
NCT00267865, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2020-05-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Chemotherapy and HAART to Treat AIDS-related Primary Brain Lymphoma. Trials, record NCT00267865. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00267865
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Chemotherapy and HAART to Treat AIDS-related Primary Brain Lymphoma
- NCT number
- NCT00267865
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- AIDS-Related-Primary Central Nervous System Lymphoma
- Interventions
- Methotrexate, Rituximab, Leucovorin
- First posted
- 2005-12-21
- Last updated
- 2020-06-01
- Results first posted
- 2020-05-01
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Alive at 2 Years Without Recurrent Brain Lymphoma or Severe Neurocognitive Defects | 2 years | 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. |
| Secondary | Number of Participants With Serious and Non-serious Adverse Events | Date treatment consent signed to date off study, approximately 142 months and 11 days. | 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. |
| Secondary | Number of Participants With Response to Treatment After Rituximab, High-Dose Methotrexate (R-HD-MTX) Induction | At the end of 6 cycles or 12 weeks of treatment | 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. |
| Secondary | Estimated Percentage of Participants Overall Survival | Time from treatment start date until date of death or date last known alive, approximately 60 months | Participants that are estimated to be alive or last known to be alive after Rituximab, High-Dose Methotrexate and Leucovorin treatment. |
| Secondary | Median Mini Mental Status Exam (MMSE) Score in Surviving Participants After Rituximab, High-Dose Methotrexate & Leucovorin ( R-HD-MTX) Treatment | up to 2.5 years | 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). |
| Secondary | Change From Baseline in Cluster of Differentiation 4 (CD4) T Cell Count at up to 2.5 Years | Baseline and up to 2.5 years | An increase in CD4 cells is determined by the number of CD4+ T lymphocytes /µL of peripheral blood. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients Alive at 2 Years Without Recurrent Brain Lymphoma or Severe Neurocognitive Defects | 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Serious and Non-serious Adverse Events | Date treatment consent signed to date off study, approximately 142 months and 11 days. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Response to Treatment After Rituximab, High-Dose Methotrexate (R-HD-MTX) Induction | At the end of 6 cycles or 12 weeks of treatment | Two participants were not evaluable. One participant received one cycle of therapy and one was not evaluable due to treatment failure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Estimated Percentage of Participants Overall Survival | Time from treatment start date until date of death or date last known alive, approximately 60 months | percentage of participants | NUMBER | |
| SECONDARY | Median Mini Mental Status Exam (MMSE) Score in Surviving Participants After Rituximab, High-Dose Methotrexate & Leucovorin ( R-HD-MTX) Treatment | up to 2.5 years | Two participants were not evaluable. One participant received one cycle of therapy and one was not evaluable due to treatment failure. | Scores on a scale | MEDIAN |
| SECONDARY | Change From Baseline in Cluster of Differentiation 4 (CD4) T Cell Count at up to 2.5 Years | Baseline and up to 2.5 years | Two participants were not evaluable. One participant received one cycle of therapy and one was not evaluable due to treatment failure. | cells/µL | MEDIAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients Alive at 2 Years Without Recurrent Brain Lymphoma or Severe Neurocognitive Defects | Rituximab, High-Dose Methotrexate & Leucovorin Treatment | 8 | Participants | ||
| Number of Participants With Serious and Non-serious Adverse Events | Rituximab, High-Dose Methotrexate & Leucovorin Treatment | 11 | Participants | ||
| Number of Participants With Response to Treatment After Rituximab, High-Dose Methotrexate (R-HD-MTX) Induction | Rituximab, High-Dose Methotrexate & Leucovorin Treatment | Complete Response | 5 | Participants | |
| Number of Participants With Response to Treatment After Rituximab, High-Dose Methotrexate (R-HD-MTX) Induction | Rituximab, High-Dose Methotrexate & Leucovorin Treatment | Partial Response | 4 | Participants | |
| Number of Participants With Response to Treatment After Rituximab, High-Dose Methotrexate (R-HD-MTX) Induction | Rituximab, High-Dose Methotrexate & Leucovorin Treatment | Progressive Disease | 1 | Participants | |
| Estimated Percentage of Participants Overall Survival | Rituximab, High-Dose Methotrexate & Leucovorin Treatment | 66 | 95% Confidence Interval 32 to 86 | percentage of participants | |
| Median Mini Mental Status Exam (MMSE) Score in Surviving Participants After Rituximab, High-Dose Methotrexate & Leucovorin ( R-HD-MTX) Treatment | Rituximab, High-Dose Methotrexate & Leucovorin Treatment | 28 | Full Range 27 to 30 | Scores on a scale | |
| Change From Baseline in Cluster of Differentiation 4 (CD4) T Cell Count at up to 2.5 Years | Rituximab, High-Dose Methotrexate & Leucovorin Treatment | 35 | Full Range -54 to 369 | cells/µL |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction Treatment | STARTED | Rituximab, High-Dose Methotrexate & Leucovorin Treatment | 12 | |
| Induction Treatment | COMPLETED | Rituximab, High-Dose Methotrexate & Leucovorin Treatment | 9 | |
| Induction Treatment | NOT COMPLETED | Rituximab, High-Dose Methotrexate & Leucovorin Treatment | 3 | |
| Consolidation Treatment | STARTED | Rituximab, High-Dose Methotrexate & Leucovorin Treatment | 5 | |
| Consolidation Treatment | COMPLETED | Rituximab, High-Dose Methotrexate & Leucovorin Treatment | 5 | |
| Consolidation Treatment | NOT COMPLETED | Rituximab, High-Dose Methotrexate & Leucovorin Treatment | 0 |
Source ClinicalTrials.gov
Adverse events111
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | Rituximab, High-Dose Methotrexate & Leucovorin Treatment | 9 | 12 | 58 |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | Rituximab, High-Dose Methotrexate & Leucovorin Treatment | 11 | 12 | 64 |
| other | Adrenal insufficiency | Endocrine disorders | Rituximab, High-Dose Methotrexate & Leucovorin Treatment | 1 | 12 | 1 |
| other | Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | Rituximab, High-Dose Methotrexate & Leucovorin Treatment | 10 | 12 | 72 |
| other | Alkaline phosphatase | Metabolism and nutrition disorders | Rituximab, High-Dose Methotrexate & Leucovorin Treatment | 6 | 12 | 39 |
| other | Alkalosis (metabolic or respiratory) | Metabolism and nutrition disorders | Rituximab, High-Dose Methotrexate & Leucovorin Treatment | 1 | 12 | 1 |
| other | Anorexia | Gastrointestinal disorders | Rituximab, High-Dose Methotrexate & Leucovorin Treatment | 1 | 12 | 1 |
| other | Ataxia (incoordination) | Nervous system disorders | Rituximab, High-Dose Methotrexate & Leucovorin Treatment | 2 | 12 | 3 |
| other | Bilirubin (hyperbilirubinemia) | Metabolism and nutrition disorders | Rituximab, High-Dose Methotrexate & Leucovorin Treatment | 2 | 12 | 12 |
| other | Blurred vision | Eye disorders | Rituximab, High-Dose Methotrexate & Leucovorin Treatment | 1 | 12 | 2 |
1 to 10 of 111Source ClinicalTrials.gov
See all 111 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rituximab, High-Dose Methotrexate & Leucovorin Treatment | 3 | 12 |
| Total, other adverse events | Rituximab, High-Dose Methotrexate & Leucovorin Treatment | 11 | 12 |
| Total, serious adverse events | Rituximab, High-Dose Methotrexate & Leucovorin Treatment | 3 | 12 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00267865
GET https://conductscience.org/api/trials/v1/NCT00267865/events?page=2