Trial · NCT00540995
Busulfan, Etoposide, and Intensity-Modulated Radiation Therapy Followed By Donor Stem Cell Transplant in Treating Patients With Advanced Myeloid Cancer
NCT00540995, Phase 1, Phase 2, Terminated, City of Hope Medical Center; results first posted 2021-11-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Busulfan, Etoposide, and Intensity-Modulated Radiation Therapy Followed By Donor Stem Cell Transplant in Treating Patients With Advanced Myeloid Cancer. Trials, record NCT00540995. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00540995
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Busulfan, Etoposide, and Intensity-Modulated Radiation Therapy Followed By Donor Stem Cell Transplant in Treating Patients With Advanced Myeloid Cancer
- NCT number
- NCT00540995
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- City of Hope Medical Center
- Conditions
Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Blastic Phase Chronic Myelogenous Leukemia, Childhood Acute Myeloid Leukemia in Remission, Childhood Chronic Myelogenous Leukemia, Childhood Myelodysplastic Syndromes, Previously Treated Myelodysplastic Syndromes, Recurrent Adult Acute Myeloid Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Refractory Anemia With Excess Blasts
- Interventions
busulfan, etoposide, intensity-modulated radiation therapy, allogeneic hematopoietic stem cell transplantation, allogeneic bone marrow transplantation, peripheral blood stem cell transplantation, tomotherapy
- First posted
- 2007-10-08
- Last updated
- 2023-11-30
- Results first posted
- 2021-11-22
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of Intensity-modulated Radiation Therapy (Phase I) | from initial treatment date to Day 30 post-transplant | The highest dose tested in which fewer than 33% of patients experienced DLT attributable to the study treatment when at least six patients were treated at the dose and are evaluable for toxicity. The MDT is one dose level below the DLT level. At least six patients will be treated at the MTD. |
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 | Maximum Tolerated Dose (MTD) of Intensity-modulated Radiation Therapy (Phase I) | from initial treatment date to Day 30 post-transplant | 6 patients treated at dose level one (1200cGy) are evaluable for dose limiting evaluable in Phase I. | cGy | NUMBER |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) of Intensity-modulated Radiation Therapy (Phase I) | Arm I: 1200cGy | 1200 | cGy |
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 | Arm I: 1200cGy | 23 | |
| Overall Study | STARTED | Arm II: 1350cGy | 2 | |
| Overall Study | COMPLETED | Arm I: 1200cGy | 23 | |
| Overall Study | COMPLETED | Arm II: 1350cGy | 2 | |
| Overall Study | NOT COMPLETED | Arm I: 1200cGy | 0 | |
| Overall Study | NOT COMPLETED | Arm II: 1350cGy | 0 |
Source ClinicalTrials.gov
Adverse events320
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 | Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | Arm I: 1200cGy | 4 | 23 | 4 |
| other | Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | Arm II: 1350cGy | 1 | 2 | 1 |
| other | Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders | Arm I: 1200cGy | 4 | 23 | 4 |
| other | Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders | Arm II: 1350cGy | 0 | 2 | 0 |
| other | Veno-Occlusive Disease (VOD) | Investigations | Arm I: 1200cGy | 0 | 23 | 0 |
| other | Veno-Occlusive Disease (VOD) | Investigations | Arm II: 1350cGy | 1 | 2 | 1 |
| other | Hemoglobin | Blood and lymphatic system disorders | Arm I: 1200cGy | 22 | 23 | 22 |
| other | Hemoglobin | Blood and lymphatic system disorders | Arm II: 1350cGy | 1 | 2 | 1 |
| other | Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis) | Blood and lymphatic system disorders | Arm I: 1200cGy | 0 | 23 | 0 |
| other | Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis) | Blood and lymphatic system disorders | Arm II: 1350cGy | 1 | 2 | 1 |
1 to 10 of 320Source ClinicalTrials.gov
See all 320 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I: 1200cGy | 19 | 23 |
| Total, all-cause mortality | Arm II: 1350cGy | 2 | 2 |
| Total, other adverse events | Arm I: 1200cGy | 23 | 23 |
| Total, other adverse events | Arm II: 1350cGy | 2 | 2 |
| Total, serious adverse events | Arm I: 1200cGy | 7 | 23 |
| Total, serious adverse events | Arm II: 1350cGy | 2 | 2 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm I: 1200cGy vs Arm II: 1350cGy: deaths from any cause | Trial comparisons |
| Arm I: 1200cGy vs Arm II: 1350cGy: 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/NCT00540995
GET https://conductscience.org/api/trials/v1/NCT00540995/events?page=2