Trial · NCT00326417
Fludarabine-based Conditioning for Severe Aplastic Anemia (BMT CTN 0301)
NCT00326417, Phase 1, Phase 2, Completed, Medical College of Wisconsin; results first posted 2016-10-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Fludarabine-based Conditioning for Severe Aplastic Anemia (BMT CTN 0301). Trials, record NCT00326417. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00326417
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fludarabine-based Conditioning for Severe Aplastic Anemia (BMT CTN 0301)
- NCT number
- NCT00326417
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 97 participants, actual
- Lead sponsor
- Medical College of Wisconsin
- Conditions
- Anemia, Aplastic
- Interventions
- Fludarabine, Cyclophosphamide 150mg, Cyclophosphamide 100mg, Cyclophosphamide 50mg
- First posted
- 2006-05-16
- Last updated
- 2021-10-28
- Results first posted
- 2016-10-04
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease-free Survival (DFS) | Day 100 | DFS includes graft failure, regimen-related toxicity (RRT), and early death. Graft Failure is defined by lack of neutrophil engraftment (ANC less than 0.5 x 10\^9/L for 3 consecutive days on different days). Major RRT is defined as severity of grade 4 in any organ system or grade 3 for pulmonary, cardiac, renal, oral mucosal or hepatic. Early death is defined as death prior to Day 100 post-transplant. |
| Secondary | Cumulative Incidence of Graft Failure | Day 365 | Primary and secondary graft failure are included, secondary graft failure is defined by initial neutrophil engraftment followed by subsequent decline in the ANC to less than 0.5 x 10\^9/L for three consecutive measurements on different days, unresponsive to growth factor. |
| Secondary | Acute Graft vs Host Disease (GVHD) | Day 100 | All GVHD grades 2-4 will be graded according to the BMT CTN Manual of Procedures (MOP) |
| Secondary | Chronic GVHD | Day 365 | Chronic GVHD is scored according to the BMT CTN MOP. The first day of chronic GVHD onset will be used to calculate cumulative incidence curves. |
| Secondary | Overall Survival (OS) | Day 365 | OS is defined as alive at 1 year, the event is death from any cause. Patients alive at the time of last observation, for statistical purposes, will have a survival time which is censored. |
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 | Disease-free Survival (DFS) | Day 100 | participants | NUMBER | |
| SECONDARY | Cumulative Incidence of Graft Failure | Day 365 | percentage of participants | NUMBER | |
| SECONDARY | Acute Graft vs Host Disease (GVHD) | Day 100 | percentage of participants | NUMBER | |
| SECONDARY | Chronic GVHD | Day 365 | percentage of participants | NUMBER | |
| SECONDARY | Overall Survival (OS) | Day 365 | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease-free Survival (DFS) | Cyclophosphamide 100mg | Graft Failure | 6 | participants | |
| Disease-free Survival (DFS) | Cyclophosphamide 50mg | Graft Failure | 3 | participants | |
| Disease-free Survival (DFS) | Cyclophosphamide 100mg | Major RRT | 9 | participants | |
| Disease-free Survival (DFS) | Cyclophosphamide 50mg | Major RRT | 4 | participants | |
| Disease-free Survival (DFS) | Cyclophosphamide 100mg | Survival | 39 | participants | |
| Disease-free Survival (DFS) | Cyclophosphamide 50mg | Survival | 37 | participants | |
| Disease-free Survival (DFS) | Cyclophosphamide 100mg | Alive and engrafted | 35 | participants | |
| Disease-free Survival (DFS) | Cyclophosphamide 50mg | Alive and engrafted | 35 | participants | |
| Cumulative Incidence of Graft Failure | Cyclophosphamide 100mg | 14.6 | percentage of participants | ||
| Cumulative Incidence of Graft Failure | Cyclophosphamide 50mg | 11.7 | percentage of participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cyclophosphamide 150mg | 14 | |
| Overall Study | STARTED | Cyclophosphamide 100mg | 41 | |
| Overall Study | STARTED | Cyclophosphamide 50mg | 39 | |
| Overall Study | STARTED | Fludarabine | 3 | |
| Overall Study | Phase I | Cyclophosphamide 150mg | 6 | |
| Overall Study | Phase I | Cyclophosphamide 100mg | 6 | |
| Overall Study | Phase I | Cyclophosphamide 50mg | 6 | |
| Overall Study | Phase I | Fludarabine | 3 | |
| Overall Study | Phase II | Cyclophosphamide 150mg | 8 | |
| Overall Study | Phase II | Cyclophosphamide 100mg | 35 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events36
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 | Pericardial effusion | Cardiac disorders | Cyclophosphamide 150mg | 0 | 14 | 0 |
| other | Pericardial effusion | Cardiac disorders | Cyclophosphamide 100mg | 1 | 41 | 1 |
| other | Pericardial effusion | Cardiac disorders | Cyclophosphamide 50mg | 0 | 38 | 0 |
| other | Pericardial effusion | Cardiac disorders | Fludarabine | 0 | 3 | 0 |
| serious | Papilloedema | Eye disorders | Cyclophosphamide 150mg | 0 | 14 | 0 |
| serious | Papilloedema | Eye disorders | Cyclophosphamide 100mg | 0 | 41 | 0 |
| serious | Papilloedema | Eye disorders | Cyclophosphamide 50mg | 0 | 38 | 0 |
| serious | Papilloedema | Eye disorders | Fludarabine | 1 | 3 | 1 |
| serious | Metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Cyclophosphamide 150mg | 0 | 14 | 0 |
| serious | Metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Cyclophosphamide 100mg | 1 | 41 | 1 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cyclophosphamide 150mg | ||
| Total, all-cause mortality | Cyclophosphamide 100mg | ||
| Total, all-cause mortality | Cyclophosphamide 50mg | ||
| Total, all-cause mortality | Fludarabine | ||
| Total, other adverse events | Cyclophosphamide 150mg | 0 | 14 |
| Total, other adverse events | Cyclophosphamide 100mg | 1 | 41 |
| Total, other adverse events | Cyclophosphamide 50mg | 0 | 38 |
| Total, other adverse events | Fludarabine | 0 | 3 |
| Total, serious adverse events | Cyclophosphamide 150mg | 8 | 14 |
| Total, serious adverse events | Cyclophosphamide 100mg | 4 | 41 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
Grants2
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 | Source |
|---|---|---|---|---|---|---|
| U24CA076518 | A Data Resource for Blood and Marrow Transplants and Adoptive Cellular Therapy Research | SHAW, BRONWEN; MOSKOP, AMY M | MEDICAL COLLEGE OF WISCONSIN | NATIONAL CANCER INSTITUTE | 1998 to 2025 | NIH RePORTER |
| U01HL069294 | BMT Clinical Research Network Data Coordinating Center | HOROWITZ, MARY MARESCA | MEDICAL COLLEGE OF WISCONSIN | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2001 to 2010 | 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/NCT00326417
GET https://conductscience.org/api/trials/v1/NCT00326417/events?page=2