Busulfan, Etoposide, and Intensity-Modulated Radiation Therapy Followed By Donor Stem Cell Transplant in Treating Patients With Advanced Myeloid Cancer

Draft scope assessment: unclear. Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

6 patients treated at dose level one (1200cGy) are evaluable for dose limiting evaluable in Phase I.

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-acute-myeloid-leukemia-revuforj-1c689def
nct id: NCT00540995
trial label: Busulfan, Etoposide, and Intensity-Modulated Radiation Therapy Followed By Donor Stem Cell Transplant in Treating Patients With Advanced Myeloid Cancer
applicability: unclear
applicability note: Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 1
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-revuforj-1c689def
nct id
NCT00540995
outcome key
om-0000
source section id
NCT00540995-om-0000
source outcome index
0
endpoint
Maximum Tolerated Dose (MTD) of Intensity-modulated Radiation Therapy (Phase I)
endpoint definition
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.
time origin
from initial treatment date to Day 30 post-transplant
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
6 patients treated at dose level one (1200cGy) are evaluable for dose limiting evaluable in Phase I.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-revuforj-1c689def
nct id
NCT00540995
outcome key
om-0000
arm key
OG000
arm label
Arm I: 1200cGy
regimen
1200cGy = 150cGy x 8 doses: Patients receive busulfan IV once daily over 2 hours on days -15 and -13 and then every 6 hours on days -12 to -9. Patients also receive etoposide IV on day -3. Patients undergo image-guided intensity-modulated radiation therapy using helical tomotherapy on days -8 to -5. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GRAFT-VS-HOST DISEASE (GVHD) PROPHYLAXIS: Patients receive GVHD prophylaxis that excludes methotrexate. busulfan: Given IV etoposide: Given IV intensity-modulated radiation therapy: Initially 150 cGy X 8 doses with gradual dose escalation to 200 cGy X 10 doses allogeneic hematopoietic stem cell transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy allogeneic bone marrow transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy peripheral blood stem cell transplantation: Stem cell transplantation occurs on Day 0 after High Dose Therapy tomotherapy: Initially 150 cGy X 8 doses with gradual dose escalation to 200 cGy X 10 doses
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00540995-om-0000#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-revuforj-1c689def
nct id
NCT00540995
harm key
EG000
source section id
NCT00540995-ae
event group key
EG000
event group label
Arm I: 1200cGy
serious affected
7
serious at risk
23
other affected
23
other at risk
23
frequency threshold
0
collection period
Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-revuforj-1c689def
nct id
NCT00540995
harm key
EG001
source section id
NCT00540995-ae
event group key
EG001
event group label
Arm II: 1350cGy
serious affected
2
serious at risk
2
other affected
2
other at risk
2
frequency threshold
0
collection period
Adverse events were captured from initial treatment to Day 180 post-transplant. Vital Statuses were captured from the initial treatment to death.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice