Trial · NCT00117156
Fludarabine and Rituximab for the Treatment of Marginal Zone Non-Hodgkin's Lymphoma
NCT00117156, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2014-10-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Fludarabine and Rituximab for the Treatment of Marginal Zone Non-Hodgkin's Lymphoma. Trials, record NCT00117156. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00117156
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fludarabine and Rituximab for the Treatment of Marginal Zone Non-Hodgkin's Lymphoma
- NCT number
- NCT00117156
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 26 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Lymphoma, Non-Hodgkin, MALT Lymphoma
- Interventions
- Fludarabine, Rituximab
- First posted
- 2005-07-04
- Last updated
- 2016-08-01
- Results first posted
- 2014-10-06
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate | Assessed after three- and six-cycles of therapy. | Objective response rate is defined as the proportion of patients who achieve complete remission (CR), complete remission/unconfirmed (CRu) or partial remission (PR) based on Cheson criteria (1999). |
| Secondary | 3.1-Year Progression-Free Survival | Assessed after 3- and 6-cycles of therapy, every 6 months for 2 years and then annually up to 4 years | 3.1-year progression-free survival is the probability of patients remaining alive and progression-free at 3.1 years from study entry estimated using Kaplan-Meier methods. Disease progression was assessed per Cheson criteria (1999). |
| Secondary | 3.1-Year Overall Survival | Assessed after 3- and 6-cycles of therapy, every 6 months for 2 years and then annually up to 4 years | 3.1-year overall survival is the probability of patients remaining alive 3.1 years from study entry. |
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 | Objective Response Rate | Assessed after three- and six-cycles of therapy. | The analysis dataset is comprised of all treated patients. | proportion of patients | NUMBER |
| SECONDARY | 3.1-Year Progression-Free Survival | Assessed after 3- and 6-cycles of therapy, every 6 months for 2 years and then annually up to 4 years | The analysis dataset is comprised of all treated patients. | probability | NUMBER |
| SECONDARY | 3.1-Year Overall Survival | Assessed after 3- and 6-cycles of therapy, every 6 months for 2 years and then annually up to 4 years | The analysis dataset is comprised of all treated patients. | probability | NUMBER |
| POST_HOC | Delayed Bone Marrow Toxicity Rate | Assessed after therapy completion incidentally or at a minimum every 6 months for 2 years and then annually up to 4 years. | The analysis dataset is comprised of all treated patients. | proportion of patients | NUMBER |
| POST_HOC | Delayed Pneumonia Toxicity Rate | Assessed after therapy completion incidentally or at a minimum every 6 months for 2 years and then annually up to 4 years. | The analysis dataset is comprised of all treated patients. | proportion of patients | NUMBER |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate | Fludarabine and Rituximab | .85 | 95% Confidence Interval .65 to .96 | proportion of patients | |
| 3.1-Year Progression-Free Survival | Fludarabine and Rituximab | 0.795 | 95% Confidence Interval 0.634 to 0.956 | probability | |
| 3.1-Year Overall Survival | Fludarabine and Rituximab | 0.874 | 95% Confidence Interval 0.74 to .99 | probability | |
| Delayed Bone Marrow Toxicity Rate | Fludarabine and Rituximab | 0.154 | 95% Confidence Interval 0.043 to 0.349 | proportion of patients | |
| Delayed Pneumonia Toxicity Rate | Fludarabine and Rituximab | 0.115 | 95% Confidence Interval 0.024 to 0.301 | proportion of patients |
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 | Fludarabine and Rituximab | 26 | |
| Overall Study | COMPLETED | Fludarabine and Rituximab | 15 | |
| Overall Study | NOT COMPLETED | Fludarabine and Rituximab | 11 |
Source ClinicalTrials.gov
Adverse events60
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 | Hemoglobin | Blood and lymphatic system disorders | Fludarabine and Rituximab | 15 | 26 | |
| other | Sinus tachycardia | Cardiac disorders | Fludarabine and Rituximab | 1 | 26 | |
| other | Constipation | Gastrointestinal disorders | Fludarabine and Rituximab | 2 | 26 | |
| other | Diarrhea w/o prior colostomy | Gastrointestinal disorders | Fludarabine and Rituximab | 5 | 26 | |
| other | Dysphagia | Gastrointestinal disorders | Fludarabine and Rituximab | 1 | 26 | |
| other | Nausea | Gastrointestinal disorders | Fludarabine and Rituximab | 9 | 26 | |
| other | Vomiting | Gastrointestinal disorders | Fludarabine and Rituximab | 1 | 26 | |
| other | Fatigue | General disorders | Fludarabine and Rituximab | 16 | 26 | |
| other | Fever w/o neutropenia | General disorders | Fludarabine and Rituximab | 5 | 26 | |
| other | Rigors/chills | General disorders | Fludarabine and Rituximab | 3 | 26 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fludarabine and Rituximab | ||
| Total, other adverse events | Fludarabine and Rituximab | 25 | 26 |
| Total, serious adverse events | Fludarabine and Rituximab | 20 | 26 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19344412 | RESULT |
Source PubMed
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/NCT00117156
GET https://conductscience.org/api/trials/v1/NCT00117156/events?page=2