Trial · NCT00577993
Fludarabine, Mitoxantrone, and Dexamethasone (FND) Plus Rituximab for Lymphoma Patients
NCT00577993, Phase 3, Completed, M.D. Anderson Cancer Center; results first posted 2020-11-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Fludarabine, Mitoxantrone, and Dexamethasone (FND) Plus Rituximab for Lymphoma Patients. Trials, record NCT00577993. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00577993
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fludarabine, Mitoxantrone, and Dexamethasone (FND) Plus Rituximab for Lymphoma Patients
- NCT number
- NCT00577993
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 210 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Lymphoma
- Interventions
- Fludarabine, Novantrone, Decadron, Rituximab, Interferon, Doxorubicin, Vincristine, Bleomycin, Cyclophosphamide, Etoposide, Cisplatin, Ara-C, Methyl-Prednisolone, Procarbazine, Prednisone
- First posted
- 2007-12-20
- Last updated
- 2020-11-16
- Results first posted
- 2020-11-16
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Overall Survival (10 Years) by Treatment | 10 Years | Overall Survival is the time from date of treatment start until date of death due to any cause or last Follow-up within 10 years. |
| Secondary | Number of Participants With Progression Free Survival (10 Years) by Treatment | 10 years | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Overall Survival (10 Years) by Treatment | 10 Years | The outcome measures were only being analyzed for the two randomized arms Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab and Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Progression Free Survival (10 Years) by Treatment | 10 years | The outcome measures were only being analyzed for the two randomized arms Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab and Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Overall Survival (10 Years) by Treatment | Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab | 59 | Participants | ||
| Number of Participants With Overall Survival (10 Years) by Treatment | Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND) | 58 | Participants | ||
| Number of Participants With Progression Free Survival (10 Years) by Treatment | Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab | 59 | Participants | ||
| Number of Participants With Progression Free Survival (10 Years) by Treatment | Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND) | 58 | Participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab | 85 | |
| Overall Study | STARTED | Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND) | 90 | |
| Overall Study | STARTED | Patients Without Bcl Gene Rearrangement | 35 | |
| Overall Study | COMPLETED | Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab | 78 | |
| Overall Study | COMPLETED | Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND) | 80 | |
| Overall Study | COMPLETED | Patients Without Bcl Gene Rearrangement | 32 | |
| Overall Study | NOT COMPLETED | Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab | 7 | |
| Overall Study | NOT COMPLETED | Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND) | 10 | |
| Overall Study | NOT COMPLETED | Patients Without Bcl Gene Rearrangement | 3 |
Source ClinicalTrials.gov
Adverse events42
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 | Abdominal Pain | Gastrointestinal disorders | Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab | 21 | 78 | |
| other | Abdominal Pain | Gastrointestinal disorders | Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND) | 16 | 80 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab | 26 | 78 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND) | 35 | 80 | |
| other | Fatigue | General disorders | Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab | 44 | 78 | |
| other | Fatigue | General disorders | Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND) | 48 | 80 | |
| other | Fever | General disorders | Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab | 14 | 78 | |
| other | Fever | General disorders | Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND) | 20 | 80 | |
| other | Neutropenic Fever | Blood and lymphatic system disorders | Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab | 14 | 78 | |
| other | Neutropenic Fever | Blood and lymphatic system disorders | Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND) | 9 | 80 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab | 19 | 78 |
| Total, all-cause mortality | Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND) | 22 | 80 |
| Total, other adverse events | Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab | 67 | 78 |
| Total, other adverse events | Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND) | 77 | 80 |
| Total, serious adverse events | Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab | 67 | 78 |
| Total, serious adverse events | Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND) | 77 | 80 |
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab vs Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND): Number of Participants With Overall Survival (10 Years) by Treatment | Trial comparisons |
Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab vs Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND): Number of Participants With Progression Free Survival (10 Years) by Treatment | Trial comparisons |
| Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab vs Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND): deaths from any cause | Trial comparisons |
| Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab vs Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND): serious adverse events | Trial comparisons |
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/NCT00577993
GET https://conductscience.org/api/trials/v1/NCT00577993/events?page=2