Trial · NCT00098774
Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Primary CNS Lymphoma
NCT00098774, Phase 2, Completed, Alliance for Clinical Trials in Oncology; results first posted 2014-09-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Primary CNS Lymphoma. Trials, record NCT00098774. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00098774
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Primary CNS Lymphoma
- NCT number
- NCT00098774
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 47 participants, actual
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Conditions
- Lymphoma
- Interventions
- filgrastim, rituximab, cytarabine, etoposide, leucovorin calcium, methotrexate, temozolomide
- First posted
- 2004-12-09
- Last updated
- 2016-07-06
- Results first posted
- 2014-09-12
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Response Rate After Remission Induction | 4 months | Response is assessed by investigator according to Revised Response Criteria for Malignant Lymphoma. Complete response requires disappearance of all evidence of disease. |
| Secondary | 4 Year Progression Free Rate | 4 years | Percentage of patients who were progression free at 4 years. The 4-year progression free rate was estimated using the Kaplan Meier method. Relapse was assessed by investigator according to Revised Response Criteria for Malignant Lymphoma. Progression required a 25% increase of previous area of gadolinium enhancement, appearance of new areas of T1 gadolinium enhancement or new appearance of malignant cells in the spinal fluid or new tumor appearance in other sites of the body |
| Secondary | Change From Baseline in Mini-Mental Status Evaluation at 4 Months | Baseline & month 4 | Neurologic functioning will be assessed using the Mini-Mental Status Evaluation (MMSE), a standardized, bedside tool for evaluation of higher mental function. This assessment is based on a 30-point scale (0-30) with higher scores associated with better performance. |
| Secondary | 4 Year Overall Survival Rate | 4 years | Percentage of patients who were alive at 4 years. The 4-year survival rate was estimated using the Kaplan Meier method. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Complete Response Rate After Remission Induction | 4 months | percentage of participants | NUMBER | |
| SECONDARY | 4 Year Progression Free Rate | 4 years | percentage of participants | NUMBER | |
| SECONDARY | Change From Baseline in Mini-Mental Status Evaluation at 4 Months | Baseline & month 4 | Only 14 participants had both baseline and 4 month MMSE evaluations reported. | units on a scale | MEDIAN |
| SECONDARY | 4 Year Overall Survival Rate | 4 years | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Response Rate After Remission Induction | Intensive Combination Chemo & Immunotherapy | 66 | 95% Confidence Interval 50 to 80 | percentage of participants | |
| 4 Year Progression Free Rate | Intensive Combination Chemo & Immunotherapy | 48 | 95% Confidence Interval 33 to 63 | percentage of participants | |
| Change From Baseline in Mini-Mental Status Evaluation at 4 Months | Intensive Combination Chemo & Immunotherapy | Baseline Score | 27 | Full Range 7 to 30 | units on a scale |
| Change From Baseline in Mini-Mental Status Evaluation at 4 Months | Intensive Combination Chemo & Immunotherapy | 4 month Score | 28 | Full Range 22 to 30 | units on a scale |
| Change From Baseline in Mini-Mental Status Evaluation at 4 Months | Intensive Combination Chemo & Immunotherapy | Change from Baseline | 1 | Full Range -1 to 18 | units on a scale |
| 4 Year Overall Survival Rate | Intensive Combination Chemo & Immunotherapy | 65 | 95% Confidence Interval 49 to 77 | percentage of participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Intensive Combination Chemo & Immunotherapy | 44 | |
| Overall Study | COMPLETED | Intensive Combination Chemo & Immunotherapy | 26 | |
| Overall Study | NOT COMPLETED | Intensive Combination Chemo & Immunotherapy | 18 |
Source ClinicalTrials.gov
Adverse events266
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 | Febrile neutropenia | Blood and lymphatic system disorders | Intensive Combination Chemo & Immunotherapy | 7 | 44 | 7 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Intensive Combination Chemo & Immunotherapy | 30 | 44 | 90 |
| other | Arrhythmia | Cardiac disorders | Intensive Combination Chemo & Immunotherapy | 1 | 44 | 1 |
| other | Atrial fibrillation | Cardiac disorders | Intensive Combination Chemo & Immunotherapy | 1 | 44 | 1 |
| other | Atrial tachycardia | Cardiac disorders | Intensive Combination Chemo & Immunotherapy | 1 | 44 | 1 |
| other | Cardiac disorder | Cardiac disorders | Intensive Combination Chemo & Immunotherapy | 2 | 44 | 4 |
| other | Edema | Cardiac disorders | Intensive Combination Chemo & Immunotherapy | 1 | 44 | 3 |
| other | Palpitations | Cardiac disorders | Intensive Combination Chemo & Immunotherapy | 2 | 44 | 3 |
| other | Sinus bradycardia | Cardiac disorders | Intensive Combination Chemo & Immunotherapy | 3 | 44 | 4 |
| other | Sinus tachycardia | Cardiac disorders | Intensive Combination Chemo & Immunotherapy | 1 | 44 | 1 |
1 to 10 of 266Source ClinicalTrials.gov
See all 266 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intensive Combination Chemo & Immunotherapy | ||
| Total, other adverse events | Intensive Combination Chemo & Immunotherapy | 43 | 44 |
| Total, serious adverse events | Intensive Combination Chemo & Immunotherapy | 15 | 44 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23569323 | RESULT |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA031946 | Cancer and Leukemia Group B | BERTAGNOLLI, MONICA M | BRIGHAM AND WOMEN'S HOSPITAL | NATIONAL CANCER INSTITUTE | 1985 to 2013 |
Source NIH RePORTER
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/NCT00098774
GET https://conductscience.org/api/trials/v1/NCT00098774/events?page=2