Treosulfan, Fludarabine Phosphate, and Total-Body Irradiation Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Myelodysplastic Syndrome

Draft scope assessment: unclear. Attached because the study's own record describes recurrent 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

Relapse Incidence

Source null

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primary · POSTED

Cumulative incidence of NRM at 6 months. NRM includes all deaths without relapse or disease progression.

Source null

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secondary · POSTED

Non Relapse Mortality Incidence

Source null

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secondary · POSTED

Overall Survival (OS)

Source null

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secondary · POSTED

Relapse-free Survival

Source null

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secondary · POSTED

Incidence of Grades II-IV Acute GVHD

Source null

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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-chronic-myeloid-leukemia-pediatric-recurrent-61efaf08
nct id: NCT00860574
trial label: Treosulfan, Fludarabine Phosphate, and Total-Body Irradiation Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Myelodysplastic Syndrome
applicability: unclear
applicability note: Attached because the study's own record describes recurrent 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: 6
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia-pediatric-recurrent-61efaf08
nct id
NCT00860574
outcome key
om-0000
source section id
NCT00860574-om-0000
source outcome index
0
endpoint
Relapse Incidence
endpoint definition
Relapse Incidence
time origin
At 6 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population 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-chronic-myeloid-leukemia-pediatric-recurrent-61efaf08
nct id
NCT00860574
outcome key
om-0001
source section id
NCT00860574-om-0001
source outcome index
1
endpoint
Non Relapse Mortality (NRM) Incidence
endpoint definition
Cumulative incidence of NRM at 6 months. NRM includes all deaths without relapse or disease progression.
time origin
At 6 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population 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-chronic-myeloid-leukemia-pediatric-recurrent-61efaf08
nct id
NCT00860574
outcome key
om-0002
source section id
NCT00860574-om-0002
source outcome index
2
endpoint
Non Relapse Mortality Incidence
endpoint definition
Non Relapse Mortality Incidence
time origin
1 year after HCT
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population 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-chronic-myeloid-leukemia-pediatric-recurrent-61efaf08
nct id
NCT00860574
outcome key
om-0003
source section id
NCT00860574-om-0003
source outcome index
3
endpoint
Overall Survival (OS)
endpoint definition
Overall Survival (OS)
time origin
at 2 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population 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-chronic-myeloid-leukemia-pediatric-recurrent-61efaf08
nct id
NCT00860574
outcome key
om-0004
source section id
NCT00860574-om-0004
source outcome index
4
endpoint
Relapse-free Survival
endpoint definition
Relapse-free Survival
time origin
at 2 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population 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-chronic-myeloid-leukemia-pediatric-recurrent-61efaf08
nct id
NCT00860574
outcome key
om-0005
source section id
NCT00860574-om-0005
source outcome index
5
endpoint
Incidence of Grades II-IV Acute GVHD
endpoint definition
Incidence of Grades II-IV Acute GVHD
time origin
at 6 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
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-chronic-myeloid-leukemia-pediatric-recurrent-61efaf08
nct id
NCT00860574
outcome key
om-0000
arm key
OG000
arm label
Treatment (Allogeneic Transplantation)
regimen
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11. treosulfan: Given IV fludarabine phosphate: Given IV total-body irradiation: Low dose starting at 2Gy peripheral blood stem cell transplantation: Given IV per institutional standard practice tacrolimus: Given IV or PO allogeneic bone marrow transplantation: Given IV per institutional standard practice allogeneic hematopoietic stem cell transplantation: Given IV per institutional standard practice methotrexate: Given IV
analyzed count
96
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00860574-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia-pediatric-recurrent-61efaf08
nct id
NCT00860574
outcome key
om-0001
arm key
OG000
arm label
Treatment (Allogeneic Transplantation)
regimen
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11. treosulfan: Given IV fludarabine phosphate: Given IV total-body irradiation: Low dose starting at 2Gy peripheral blood stem cell transplantation: Given IV per institutional standard practice tacrolimus: Given IV or PO allogeneic bone marrow transplantation: Given IV per institutional standard practice allogeneic hematopoietic stem cell transplantation: Given IV per institutional standard practice methotrexate: Given IV
analyzed count
96
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00860574-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia-pediatric-recurrent-61efaf08
nct id
NCT00860574
outcome key
om-0002
arm key
OG000
arm label
Treatment (Allogeneic Transplantation)
regimen
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11. treosulfan: Given IV fludarabine phosphate: Given IV total-body irradiation: Low dose starting at 2Gy peripheral blood stem cell transplantation: Given IV per institutional standard practice tacrolimus: Given IV or PO allogeneic bone marrow transplantation: Given IV per institutional standard practice allogeneic hematopoietic stem cell transplantation: Given IV per institutional standard practice methotrexate: Given IV
analyzed count
96
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00860574-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia-pediatric-recurrent-61efaf08
nct id
NCT00860574
outcome key
om-0003
arm key
OG000
arm label
Treatment (Allogeneic Transplantation)
regimen
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11. treosulfan: Given IV fludarabine phosphate: Given IV total-body irradiation: Low dose starting at 2Gy peripheral blood stem cell transplantation: Given IV per institutional standard practice tacrolimus: Given IV or PO allogeneic bone marrow transplantation: Given IV per institutional standard practice allogeneic hematopoietic stem cell transplantation: Given IV per institutional standard practice methotrexate: Given IV
analyzed count
96
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00860574-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia-pediatric-recurrent-61efaf08
nct id
NCT00860574
outcome key
om-0004
arm key
OG000
arm label
Treatment (Allogeneic Transplantation)
regimen
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11. treosulfan: Given IV fludarabine phosphate: Given IV total-body irradiation: Low dose starting at 2Gy peripheral blood stem cell transplantation: Given IV per institutional standard practice tacrolimus: Given IV or PO allogeneic bone marrow transplantation: Given IV per institutional standard practice allogeneic hematopoietic stem cell transplantation: Given IV per institutional standard practice methotrexate: Given IV
analyzed count
96
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00860574-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia-pediatric-recurrent-61efaf08
nct id
NCT00860574
outcome key
om-0005
arm key
OG000
arm label
Treatment (Allogeneic Transplantation)
regimen
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11. treosulfan: Given IV fludarabine phosphate: Given IV total-body irradiation: Low dose starting at 2Gy peripheral blood stem cell transplantation: Given IV per institutional standard practice tacrolimus: Given IV or PO allogeneic bone marrow transplantation: Given IV per institutional standard practice allogeneic hematopoietic stem cell transplantation: Given IV per institutional standard practice methotrexate: Given IV
analyzed count
96
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00860574-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia-pediatric-recurrent-61efaf08
nct id
NCT00860574
harm key
EG000
source section id
NCT00860574-ae
event group key
EG000
event group label
Treatment (Allogeneic Transplantation)
serious affected
17
serious at risk
96
other affected
68
other at risk
96
frequency threshold
0
collection period
Toxicities Before Day 100
event definition
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
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