Trial · NCT00517699
A Study of MabThera (Rituximab) in Primary Central Nervous System Lymphoma.
NCT00517699, Phase 2, Terminated, Hoffmann-La Roche; results first posted 2014-08-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of MabThera (Rituximab) in Primary Central Nervous System Lymphoma. Trials, record NCT00517699. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00517699
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of MabThera (Rituximab) in Primary Central Nervous System Lymphoma.
- NCT number
- NCT00517699
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 5 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Lymphoma
- Interventions
- rituximab [MabThera/Rituxan], Methotrexate, Cytarabine
- First posted
- 2007-08-17
- Last updated
- 2014-08-08
- Results first posted
- 2014-08-08
- Limitations and caveats
- The study was terminated early due to lack of enrollment.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With a Complete Response (CR) or Unconfirmed CR (CRu) | Week 24 | CR: complete disappearance of all enhancing abnormalities on contrast-enhanced cranial magnetic resonance imaging (MRI); no evidence of active ocular lymphoma as defined by absence of cells in the vitreous and resolution of any previously documented retinal or optic nerve infiltrates; negative cerebrospinal fluid (CSF) cytology; at the time of CR determination, participant had discontinued use of all corticosteroids for at least 2 weeks. CRu requires fulfillment of CR criteria but with these limitations: Fulfills CR criteria but had continued requirement for corticosteroid therapy at any dose; small but persistent enhancing abnormality on MRI related to biopsy or focal hemorrhage; persistent minor abnormality on follow-up ophthalmologic exam (related to persistent non-malignant cells in vitreous, or alterations in retina/optic nerve not consistent with tumor infiltration) if the abnormality is unlikely to represent ocular lymphoma. |
| Primary | Percentage of Participants With a CR, CRu or Partial Response (PR) | Week 24 | PR: greater than or equal to (≥) 50 percent (%) decrease in the contrast-enhancing lesion seen on MRI as compared with the baseline images; (2) Corticosteroid dose was irrelevant to the determination of PR; for participants with ocular disease, ophthalmologic exam must show a decrease in vitreous cell count or retina/optic nerve cellular infiltrate but may have continued to show persistent malignant or suspicious cells; for participants with CSF positive for neoplastic cells, CSF cytology may be negative or continue to show persistent malignant or suspicious cells in patients with ≥50% decrease in the primary brain lesions; no new sites of disease. |
| Secondary | Percentage of Participants With Initial CR or CRu and Subsequent Disease Relapse | Week 24 | |
| Secondary | Overall Survival | Time of last follow-up assessment between Day 1 and 3 years | Time from entry into trial until death of any cause. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last dose and participants with no post baseline information were censored at the baseline date. |
| Secondary | Progression-Free Survival (PFS) | Week 24 | PFS was defined as the time interval between the entry into trial and occurrence of one of the following events: progression of disease (PD) or death as a result of primary central nervous system lymphoma (PCNSL). Participants who were withdrawn from the study without documented progression and for whom there existed case report form (CRF) evidence that evaluations had been made, were censored at the date of last tumor assessment when participant was known to be progression free. Participants without postbaseline tumor assessments but known to be alive were censored at the time of randomization. PD required a ≥25% increase in the contrast-enhanced lesion seen on MRI as compared with baseline or best response (comparison should be made to the smallest of multiple lesions); progression of ocular disease as indicated by an increase in vitreous cell count or progressive retinal or optic nerve infiltration, appearance of any new lesion or site of disease during or at the end of therapy. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With a Complete Response (CR) or Unconfirmed CR (CRu) | Week 24 | Due to early study termination, all efficacy data were documented by data listings only, no data analysis was performed. | ||
| PRIMARY | Percentage of Participants With a CR, CRu or Partial Response (PR) | Week 24 | Due to early study termination, all efficacy data were documented by data listings only, no data analysis was performed. | ||
| SECONDARY | Percentage of Participants With Initial CR or CRu and Subsequent Disease Relapse | Week 24 | Due to early study termination, all efficacy data were documented by data listings only, no data analysis was performed. | ||
| SECONDARY | Overall Survival | Time of last follow-up assessment between Day 1 and 3 years | Due to early study termination, all efficacy data were documented by data listings only, no data analysis was performed. | ||
| SECONDARY | Progression-Free Survival (PFS) | Week 24 | Due to early study termination, all efficacy data were documented by data listings only, no data analysis was performed. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rituximab, Cytarabine, and Methotrexate (MTX) | 5 | |
| Overall Study | COMPLETED | Rituximab, Cytarabine, and Methotrexate (MTX) | 0 | |
| Overall Study | NOT COMPLETED | Rituximab, Cytarabine, and Methotrexate (MTX) | 5 |
Source ClinicalTrials.gov
Adverse events75
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 | Anaemia | Blood and lymphatic system disorders | Rituximab, Cytarabine, and MTX | 1 | 5 | |
| other | Leukopenia | Blood and lymphatic system disorders | Rituximab, Cytarabine, and MTX | 1 | 5 | |
| other | Neutropenia | Blood and lymphatic system disorders | Rituximab, Cytarabine, and MTX | 4 | 5 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Rituximab, Cytarabine, and MTX | 1 | 5 | |
| other | Eye allergy | Eye disorders | Rituximab, Cytarabine, and MTX | 1 | 5 | |
| other | Abdominal pain | Gastrointestinal disorders | Rituximab, Cytarabine, and MTX | 2 | 5 | |
| other | Constipation | Gastrointestinal disorders | Rituximab, Cytarabine, and MTX | 3 | 5 | |
| other | Diarrhoea | Gastrointestinal disorders | Rituximab, Cytarabine, and MTX | 1 | 5 | |
| other | Dyspepsia | Gastrointestinal disorders | Rituximab, Cytarabine, and MTX | 1 | 5 | |
| other | Gingival pain | Gastrointestinal disorders | Rituximab, Cytarabine, and MTX | 1 | 5 |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rituximab, Cytarabine, and MTX | ||
| Total, other adverse events | Rituximab, Cytarabine, and MTX | 5 | 5 |
| Total, serious adverse events | Rituximab, Cytarabine, and MTX | 0 | 5 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT00517699
GET https://conductscience.org/api/trials/v1/NCT00517699/events?page=2