Trial · NCT00469144
IV Busulfan With Allo-BMT: Study for Patients With Acute Myelogenous Leukemia and Myelodysplastic Syndrome
NCT00469144, Phase 3, Completed, M.D. Anderson Cancer Center; results first posted 2021-01-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. IV Busulfan With Allo-BMT: Study for Patients With Acute Myelogenous Leukemia and Myelodysplastic Syndrome. Trials, record NCT00469144. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00469144
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- IV Busulfan With Allo-BMT: Study for Patients With Acute Myelogenous Leukemia and Myelodysplastic Syndrome
- NCT number
- NCT00469144
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 233 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Myelodysplastic Syndrome, Leukemia, Acute Myeloid Leukemia
- Interventions
- Busulfan, Fludarabine
- First posted
- 2007-05-04
- Last updated
- 2021-01-19
- Results first posted
- 2021-01-19
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment-related Mortality (TRM) | From transplant at Day 0 to Day 100 and 1 year following transplant | Time to failure (TTF) defined as either disease recurrence or death, from the time of bone marrow transplant (BMT) and reported as TRM at 100 days and 1 year. Treatment period defined as BMT Day -9 for patients treated on the PK-guided treatment arm, and day -7 for patients receiving the fixed-dose busulfan treatment through BMT Day +28. The post study surveillance period is defined as BMT Day +29 through BMT Day +100. Bone marrow aspirate with cytogenetics at approximately one (1) month and three (3) months, or as clinically indicated. Response Criteria is measured by the bone marrow aspirate to determine it has leukemic blast. Bone marrow blast less than 5% is considered to be a complete response. |
| Primary | 3 Year Progression Free Survival | 3 years | PFS defined as length of time either due to disease recurrence or death, from the time of stem cell infusion (Bone marrow or PBPC) to 3 years. Response Criteria is measured by the bone marrow aspirate to determine it has leukemic blast. Bone marrow blast less than 5% is considered to be a complete response. |
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 | Treatment-related Mortality (TRM) | From transplant at Day 0 to Day 100 and 1 year following transplant | Percentage of Participants | NUMBER | |
| PRIMARY | 3 Year Progression Free Survival | 3 years | Days | MEDIAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Treatment-related Mortality (TRM) | Fixed-Dose: Participants in CR | 100 Days | 3 | 90% Confidence Interval 1 to 11 | Percentage of Participants |
| Treatment-related Mortality (TRM) | Adjusted Dose: Participants in CR | 100 Days | 3 | 90% Confidence Interval 1 to 11 | Percentage of Participants |
| Treatment-related Mortality (TRM) | Fixed Dose: Participants Not in CR | 100 Days | 7 | 90% Confidence Interval 2 to 20 | Percentage of Participants |
| Treatment-related Mortality (TRM) | Adjusted Dose: Participants Not in CR | 100 Days | 3 | 90% Confidence Interval 0.5 to 17 | Percentage of Participants |
| Treatment-related Mortality (TRM) | Fixed-Dose: Participants in CR | 1 Year | 19 | 90% Confidence Interval 11 to 32 | Percentage of Participants |
| Treatment-related Mortality (TRM) | Adjusted Dose: Participants in CR | 1 Year | 17 | 90% Confidence Interval 10 to 29 | Percentage of Participants |
| Treatment-related Mortality (TRM) | Fixed Dose: Participants Not in CR | 1 Year | 18 | 90% Confidence Interval 10 to 34 | Percentage of Participants |
| Treatment-related Mortality (TRM) | Adjusted Dose: Participants Not in CR | 1 Year | 3 | 90% Confidence Interval 0.5 to 17 | Percentage of Participants |
| 3 Year Progression Free Survival | Fixed-Dose Busulfan + Fludarabine | 42 | Full Range 32 to 52 | Days | |
| 3 Year Progression Free Survival | Adjusted Dose Busulfan + Fludarabine | 56 | Full Range 45 to 66 | Days |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fixed-Dose Busulfan + Fludarabine | 114 | |
| Overall Study | STARTED | Adjusted Dose Busulfan + Fludarabine | 111 | |
| Overall Study | COMPLETED | Fixed-Dose Busulfan + Fludarabine | 108 | |
| Overall Study | COMPLETED | Adjusted Dose Busulfan + Fludarabine | 105 | |
| Overall Study | NOT COMPLETED | Fixed-Dose Busulfan + Fludarabine | 6 | |
| Overall Study | NOT COMPLETED | Adjusted Dose Busulfan + Fludarabine | 6 |
Source ClinicalTrials.gov
Adverse events160
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 | Chronic Oral GvHD | Gastrointestinal disorders | Fixed-Dose Busulfan + Fludarabine | 2 | 114 | 2 |
| other | Chronic Oral GvHD | Gastrointestinal disorders | Adjusted Dose Busulfan + Fludarabine | 1 | 111 | 1 |
| other | Renal Insufficiency | Renal and urinary disorders | Fixed-Dose Busulfan + Fludarabine | 1 | 114 | 1 |
| other | Renal Insufficiency | Renal and urinary disorders | Adjusted Dose Busulfan + Fludarabine | 0 | 111 | 0 |
| other | Beta Hemolytic Streptococcus Upper Respiratory Infection | Infections and infestations | Fixed-Dose Busulfan + Fludarabine | 1 | 114 | 1 |
| other | Beta Hemolytic Streptococcus Upper Respiratory Infection | Infections and infestations | Adjusted Dose Busulfan + Fludarabine | 0 | 111 | 0 |
| other | Streptococcus Pneumonia | Infections and infestations | Fixed-Dose Busulfan + Fludarabine | 1 | 114 | 1 |
| other | Streptococcus Pneumonia | Infections and infestations | Adjusted Dose Busulfan + Fludarabine | 0 | 111 | 0 |
| other | Cytomegalovirus Pneumonia | Infections and infestations | Fixed-Dose Busulfan + Fludarabine | 1 | 114 | 1 |
| other | Cytomegalovirus Pneumonia | Infections and infestations | Adjusted Dose Busulfan + Fludarabine | 0 | 111 | 0 |
1 to 10 of 160Source ClinicalTrials.gov
See all 160 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fixed-Dose Busulfan + Fludarabine | ||
| Total, all-cause mortality | Adjusted Dose Busulfan + Fludarabine | ||
| Total, other adverse events | Fixed-Dose Busulfan + Fludarabine | 29 | 114 |
| Total, other adverse events | Adjusted Dose Busulfan + Fludarabine | 26 | 111 |
| Total, serious adverse events | Fixed-Dose Busulfan + Fludarabine | 2 | 114 |
| Total, serious adverse events | Adjusted Dose Busulfan + Fludarabine | 3 | 111 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Fixed-Dose Busulfan + Fludarabine vs Adjusted Dose Busulfan + Fludarabine: serious adverse events |
Source 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/NCT00469144
GET https://conductscience.org/api/trials/v1/NCT00469144/events?page=2