Fludarabine Phosphate, Melphalan, Total-Body Irradiation, Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Bone Marrow Failure Disorders

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

Day 100 Treatment Related Mortality An exact 95% confidence interval will be provided.

All treated and eligible patients

→

secondary · POSTED

Median Time to ANC Engraftment Summarized using standard descriptive statistics along with corresponding 95% confidence intervals.

All treated and eligible patients

→

secondary · POSTED

Median Time to Platelet Engraftment Summarized using standard descriptive statistics along with corresponding 95% confidence intervals.

All treated and eligible patients

→

secondary · POSTED

Rate of Complete Donor Chimerism - Blood Summarized using standard descriptive statistics.

All treated and eligible patients, who were able to complete testing

→

secondary · POSTED

Rate of Complete Donor Chimerism - Blood Summarized using standard descriptive statistics.

All treated and eligible patients, who were able to complete testing

→

secondary · POSTED

Acute GVHD grade III-IV Summarized using standard descriptive statistics along with corresponding 95% confidence intervals.

All treated and eligible patients

→

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-pediatric-recurrent-4479b980
nct id: NCT00856388
trial label: Fludarabine Phosphate, Melphalan, Total-Body Irradiation, Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Bone Marrow Failure Disorders
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-acute-myeloid-leukemia-pediatric-recurrent-4479b980
nct id
NCT00856388
outcome key
om-0000
source section id
NCT00856388-om-0000
source outcome index
0
endpoint
Day 100 TRM
endpoint definition
Day 100 Treatment Related Mortality An exact 95% confidence interval will be provided.
time origin
First 100 days
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All treated and eligible patients
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-pediatric-recurrent-4479b980
nct id
NCT00856388
outcome key
om-0001
source section id
NCT00856388-om-0001
source outcome index
1
endpoint
Median Time to ANC Engraftment
endpoint definition
Median Time to ANC Engraftment Summarized using standard descriptive statistics along with corresponding 95% confidence intervals.
time origin
Days 30
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All treated and eligible patients
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-pediatric-recurrent-4479b980
nct id
NCT00856388
outcome key
om-0002
source section id
NCT00856388-om-0002
source outcome index
2
endpoint
Median Time to Platelet Engraftment
endpoint definition
Median Time to Platelet Engraftment Summarized using standard descriptive statistics along with corresponding 95% confidence intervals.
time origin
Day 100
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All treated and eligible patients
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-pediatric-recurrent-4479b980
nct id
NCT00856388
outcome key
om-0003
source section id
NCT00856388-om-0003
source outcome index
3
endpoint
Rate of Complete Donor Chimerism - Blood
endpoint definition
Rate of Complete Donor Chimerism - Blood Summarized using standard descriptive statistics.
time origin
Day 30
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All treated and eligible patients, who were able to complete testing
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-pediatric-recurrent-4479b980
nct id
NCT00856388
outcome key
om-0004
source section id
NCT00856388-om-0004
source outcome index
4
endpoint
Rate of Complete Donor Chimerism - Blood
endpoint definition
Rate of Complete Donor Chimerism - Blood Summarized using standard descriptive statistics.
time origin
Day 100
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All treated and eligible patients, who were able to complete testing
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-pediatric-recurrent-4479b980
nct id
NCT00856388
outcome key
om-0005
source section id
NCT00856388-om-0005
source outcome index
5
endpoint
Acute GVHD Grade III-IV
endpoint definition
Acute GVHD grade III-IV Summarized using standard descriptive statistics along with corresponding 95% confidence intervals.
time origin
Up to day 100
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All treated and eligible patients
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-pediatric-recurrent-4479b980
nct id
NCT00856388
outcome key
om-0000
arm key
OG000
arm label
Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)
regimen
Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan\* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0. Note: \*Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan.
analyzed count
61
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00856388-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-pediatric-recurrent-4479b980
nct id
NCT00856388
outcome key
om-0001
arm key
OG000
arm label
Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)
regimen
Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan\* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0. Note: \*Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan.
analyzed count
61
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00856388-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-pediatric-recurrent-4479b980
nct id
NCT00856388
outcome key
om-0002
arm key
OG000
arm label
Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)
regimen
Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan\* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0. Note: \*Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan.
analyzed count
61
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00856388-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-pediatric-recurrent-4479b980
nct id
NCT00856388
outcome key
om-0003
arm key
OG000
arm label
Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)
regimen
Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan\* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0. Note: \*Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan.
analyzed count
44
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00856388-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-pediatric-recurrent-4479b980
nct id
NCT00856388
outcome key
om-0004
arm key
OG000
arm label
Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)
regimen
Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan\* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0. Note: \*Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan.
analyzed count
49
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00856388-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-pediatric-recurrent-4479b980
nct id
NCT00856388
outcome key
om-0005
arm key
OG000
arm label
Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)
regimen
Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan\* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0. Note: \*Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan.
analyzed count
61
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00856388-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-pediatric-recurrent-4479b980
nct id
NCT00856388
harm key
EG000
source section id
NCT00856388-ae
event group key
EG000
event group label
Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)
serious affected
34
serious at risk
62
other affected
0
other at risk
62
frequency threshold
0
collection period
Source null
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