NCT00003816 · STUDY IN CONTEXT

Combination Chemotherapy and Donor Stem Cell Transplant in Treating Patients With Aplastic Anemia or Hematologic Cancer

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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

Rate of Complete Remission by Day +100

Source null

→

secondary · POSTED

Death due to treatment related causes before day +100 after BMT

Source null

→

secondary · POSTED

progression free survival estimate at 4 years post BMT (events are disease progression/relapse and death due to any cause)

Source null

→

secondary · POSTED

Overall survival estimate at 4 years post BMT

Source null

→

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-myelodysplastic-syndromes
nct id: NCT00003816
trial label: Combination Chemotherapy and Donor Stem Cell Transplant in Treating Patients With Aplastic Anemia or Hematologic Cancer
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
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: 4
harms Count: 5
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00003816
outcome key
om-0000
source section id
NCT00003816-om-0000
source outcome index
0
endpoint
CR Rate
endpoint definition
Rate of Complete Remission by Day +100
time origin
day 100
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-myelodysplastic-syndromes
nct id
NCT00003816
outcome key
om-0001
source section id
NCT00003816-om-0001
source outcome index
1
endpoint
Toxicity/TRM at Day 100
endpoint definition
Death due to treatment related causes before day +100 after BMT
time origin
Day +100
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-myelodysplastic-syndromes
nct id
NCT00003816
outcome key
om-0002
source section id
NCT00003816-om-0002
source outcome index
2
endpoint
4 Year PFS
endpoint definition
progression free survival estimate at 4 years post BMT (events are disease progression/relapse and death due to any cause)
time origin
4 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-myelodysplastic-syndromes
nct id
NCT00003816
outcome key
om-0003
source section id
NCT00003816-om-0003
source outcome index
3
endpoint
4 yr OS
endpoint definition
Overall survival estimate at 4 years post BMT
time origin
4-year
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-myelodysplastic-syndromes
nct id
NCT00003816
outcome key
om-0000
arm key
OG000
arm label
BuCy
regimen
Patients receive busulfan IV over 2 hours every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. busulfan: Given IV cyclophosphamide: Given IV
analyzed count
55
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00003816-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00003816
outcome key
om-0000
arm key
OG001
arm label
CyTBI
regimen
Patients receive cyclophosphamide IV over 2 hours on days -5 and -4 and total-body irradiation (TBI) twice daily on days -3 to -1. cyclophosphamide: Given IV total-body irradiation: Given twice daily for 3 days
analyzed count
69
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00003816-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00003816
outcome key
om-0000
arm key
OG002
arm label
FluMel
regimen
Patients receive fludarabine IV over 30 minutes on days -6 to -2 and melphalan IV over 1 hour on days -3 and -2. fludarabine phosphate: Given IV melphalan: Given IV
analyzed count
199
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00003816-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00003816
outcome key
om-0000
arm key
OG003
arm label
VpCyTBI
regimen
Patients receive etoposide IV over 26 hours beginning on day -5, cyclophosphamide IV over 2 hours on day -4, and TBI twice daily on days -3 to -1. cyclophosphamide: Given IV etoposide: Given IV total-body irradiation: Given twice daily for 3 days
analyzed count
23
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00003816-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00003816
outcome key
om-0000
arm key
OG004
arm label
Other
regimen
Patients receive cyclophosphamide IV over 2 hours on days -5 and -4, TBI twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4-8 hours on days -3 to -1. OR Patients receive cyclophosphamide IV over 2 hours on days -5 to -2 and anti-thymocyte globulin IV over 4-8 hours on days -5 to -3. OR Patients receive cyclophosphamide IV over 24 hours, carboplatin IV over 24 hours, and thiotepa IV over 24 hours on days -7 to -4. OR Patients receive fludarabine IV over 30 minutes on days -5 to -1 and anti-thymocyte globulin IV over 4-8 hours on days -5 to -2. OR Patients receive busulfan IV over 2 hours every 6 hours and anti-thymocyte globulin IV over 4-8 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2.
analyzed count
15
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00003816-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00003816
outcome key
om-0001
arm key
OG000
arm label
BuCy
regimen
Patients receive busulfan IV over 2 hours every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. busulfan: Given IV cyclophosphamide: Given IV
analyzed count
55
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00003816-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00003816
outcome key
om-0001
arm key
OG001
arm label
CyTBI
regimen
Patients receive cyclophosphamide IV over 2 hours on days -5 and -4 and total-body irradiation (TBI) twice daily on days -3 to -1. cyclophosphamide: Given IV total-body irradiation: Given twice daily for 3 days
analyzed count
69
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00003816-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00003816
outcome key
om-0001
arm key
OG002
arm label
FluMel
regimen
Patients receive fludarabine IV over 30 minutes on days -6 to -2 and melphalan IV over 1 hour on days -3 and -2. fludarabine phosphate: Given IV melphalan: Given IV
analyzed count
199
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00003816-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00003816
outcome key
om-0001
arm key
OG003
arm label
VpCyTBI
regimen
Patients receive etoposide IV over 26 hours beginning on day -5, cyclophosphamide IV over 2 hours on day -4, and TBI twice daily on days -3 to -1. cyclophosphamide: Given IV etoposide: Given IV total-body irradiation: Given twice daily for 3 days
analyzed count
23
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00003816-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00003816
outcome key
om-0001
arm key
OG004
arm label
Other
regimen
Patients receive cyclophosphamide IV over 2 hours on days -5 and -4, TBI twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4-8 hours on days -3 to -1. OR Patients receive cyclophosphamide IV over 2 hours on days -5 to -2 and anti-thymocyte globulin IV over 4-8 hours on days -5 to -3. OR Patients receive cyclophosphamide IV over 24 hours, carboplatin IV over 24 hours, and thiotepa IV over 24 hours on days -7 to -4. OR Patients receive fludarabine IV over 30 minutes on days -5 to -1 and anti-thymocyte globulin IV over 4-8 hours on days -5 to -2. OR Patients receive busulfan IV over 2 hours every 6 hours and anti-thymocyte globulin IV over 4-8 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2.
analyzed count
15
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00003816-om-0001#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00003816
outcome key
om-0002
arm key
OG000
arm label
BuCy
regimen
Patients receive busulfan IV over 2 hours every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. busulfan: Given IV cyclophosphamide: Given IV
analyzed count
55
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00003816-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00003816
outcome key
om-0002
arm key
OG001
arm label
CyTBI
regimen
Patients receive cyclophosphamide IV over 2 hours on days -5 and -4 and total-body irradiation (TBI) twice daily on days -3 to -1. cyclophosphamide: Given IV total-body irradiation: Given twice daily for 3 days
analyzed count
69
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00003816-om-0002#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00003816
harm key
EG000
source section id
NCT00003816-ae
event group key
EG000
event group label
BuCy
serious affected
11
serious at risk
55
other affected
25
other at risk
55
frequency threshold
5
collection period
1 year
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-myelodysplastic-syndromes
nct id
NCT00003816
harm key
EG001
source section id
NCT00003816-ae
event group key
EG001
event group label
CyTBI
serious affected
10
serious at risk
69
other affected
35
other at risk
69
frequency threshold
5
collection period
1 year
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-myelodysplastic-syndromes
nct id
NCT00003816
harm key
EG002
source section id
NCT00003816-ae
event group key
EG002
event group label
FluMel
serious affected
62
serious at risk
199
other affected
100
other at risk
199
frequency threshold
5
collection period
1 year
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-myelodysplastic-syndromes
nct id
NCT00003816
harm key
EG003
source section id
NCT00003816-ae
event group key
EG003
event group label
VpCyTBI
serious affected
6
serious at risk
23
other affected
6
other at risk
23
frequency threshold
5
collection period
1 year
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-myelodysplastic-syndromes
nct id
NCT00003816
harm key
EG004
source section id
NCT00003816-ae
event group key
EG004
event group label
Other
serious affected
4
serious at risk
15
other affected
9
other at risk
15
frequency threshold
5
collection period
1 year
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