Trial · NCT00208975
Phase II Study of Fludarabine and Mitoxantrone, Followed by GM-CSF(Granulocyte-macrophage Colony-stimulating Factor) and Rituximab
NCT00208975, Phase 2, Terminated, Emory University; results first posted 2012-06-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase II Study of Fludarabine and Mitoxantrone, Followed by GM-CSF(Granulocyte-macrophage Colony-stimulating Factor) and Rituximab. Trials, record NCT00208975. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00208975
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Study of Fludarabine and Mitoxantrone, Followed by GM-CSF(Granulocyte-macrophage Colony-stimulating Factor) and Rituximab
- NCT number
- NCT00208975
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- Emory University
- Conditions
- Lymphoma
- Interventions
- Mitoxantrone/Cyclophosphamide, Fludarabine, Rituximab and GM-CSF
- First posted
- 2005-09-21
- Last updated
- 2012-06-28
- Results first posted
- 2012-06-28
- Limitations and caveats
- The protocol was closed early due to slow and poor accrual.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients's Who Had Complete Response and Partial Response to the Treatment of Fludarabine and Cyclophosphamide Followed by GM-CSF and Rituximab. | 6 months | Complete Response (CR): Disappearance of all clinical evidence of active tumor for a minimum of eight weeks and absence of any symptoms related to the tumor. Partial Response (PR):50% decrease in the sum of the product diameters of all lesions that persist for at least four weeks. No lesion can increase in size and no new lesion can appear during this period. Stable disease (SD):A tumor that is neither growing nor shrinking.No new tumors have developed |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients's Who Had Complete Response and Partial Response to the Treatment of Fludarabine and Cyclophosphamide Followed by GM-CSF and Rituximab. | 6 months | 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 |
|---|---|---|---|---|---|
| Number of Patients's Who Had Complete Response and Partial Response to the Treatment of Fludarabine and Cyclophosphamide Followed by GM-CSF and Rituximab. | Chronic Lymphocytic Leukemia | Complete Response | 4 | participants | |
| Number of Patients's Who Had Complete Response and Partial Response to the Treatment of Fludarabine and Cyclophosphamide Followed by GM-CSF and Rituximab. | Non Hodgkin Lymphoma | Complete Response | 5 | participants | |
| Number of Patients's Who Had Complete Response and Partial Response to the Treatment of Fludarabine and Cyclophosphamide Followed by GM-CSF and Rituximab. | Chronic Lymphocytic Leukemia | Partial Response | 2 | participants | |
| Number of Patients's Who Had Complete Response and Partial Response to the Treatment of Fludarabine and Cyclophosphamide Followed by GM-CSF and Rituximab. | Non Hodgkin Lymphoma | Partial Response | 2 | participants | |
| Number of Patients's Who Had Complete Response and Partial Response to the Treatment of Fludarabine and Cyclophosphamide Followed by GM-CSF and Rituximab. | Chronic Lymphocytic Leukemia | Stable Disease | 1 | participants | |
| Number of Patients's Who Had Complete Response and Partial Response to the Treatment of Fludarabine and Cyclophosphamide Followed by GM-CSF and Rituximab. | Non Hodgkin Lymphoma | Stable Disease | 0 | 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 | Fludarabine and Cyclophosphamide With Sequential Administratio | 15 | |
| Overall Study | COMPLETED | Fludarabine and Cyclophosphamide With Sequential Administratio | 15 | |
| Overall Study | NOT COMPLETED | Fludarabine and Cyclophosphamide With Sequential Administratio | 0 |
Source ClinicalTrials.gov
Adverse events23
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 | Neutropenia | Blood and lymphatic system disorders | Fludarabine and Cyclophosphamide With Sequential Administratio | 10 | 15 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Fludarabine and Cyclophosphamide With Sequential Administratio | 7 | 15 | |
| other | Anemia | Blood and lymphatic system disorders | Fludarabine and Cyclophosphamide With Sequential Administratio | 9 | 15 | |
| other | Nausea | Gastrointestinal disorders | Fludarabine and Cyclophosphamide With Sequential Administratio | 9 | 15 | |
| other | Fatigue | General disorders | Fludarabine and Cyclophosphamide With Sequential Administratio | 7 | 15 | |
| other | Vomiting | Gastrointestinal disorders | Fludarabine and Cyclophosphamide With Sequential Administratio | 3 | 15 | |
| other | Arthritis | Musculoskeletal and connective tissue disorders | Fludarabine and Cyclophosphamide With Sequential Administratio | 2 | 15 | |
| other | Diarrhea | Gastrointestinal disorders | Fludarabine and Cyclophosphamide With Sequential Administratio | 1 | 15 | |
| other | Fever | General disorders | Fludarabine and Cyclophosphamide With Sequential Administratio | 3 | 15 | |
| other | Night Sweats | General disorders | Fludarabine and Cyclophosphamide With Sequential Administratio | 4 | 15 |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fludarabine and Cyclophosphamide With Sequential Administratio | ||
| Total, other adverse events | Fludarabine and Cyclophosphamide With Sequential Administratio | 15 | 15 |
| Total, serious adverse events | Fludarabine and Cyclophosphamide With Sequential Administratio | 0 | 15 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26297176 | DERIVED |
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/NCT00208975
GET https://conductscience.org/api/trials/v1/NCT00208975/events?page=2