NCT00134017 · STUDY IN CONTEXT

Combination Chemotherapy, Bone Marrow Transplant, and Post Transplant Cyclophosphamide for 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

Percentage of participants who developed grades II-IV and grades III-IV acute GVHD. Acute GVHD is defined by the Przepiorka criteria, which stages the degree of organ involvement in the skin, liver, and gastrointestinal (GI) tract, based on severity, with Stage 1+ being least severe and stage 4+ being the most severe. Grading of acute GVHD is as follows: Grade I (skin involvement stages 1+ to 2+, with no liver or GI involvement), Grade II (skin involvement stages 1+ to 3+, liver 1+, GI tract 1+), Grade III (skin involvement stages 2+ to 3+, liver 1+, GI tract 2+ to 4+), Grade IV (skin involvement stages 4+, Liver 4+).

The study data was analyzed early after 117 participants had been treated. This was done in order to publish the data and establish a new local standard of care at our institution. GVHD data was collected on 15 additional participants for a total of 132. GVHD data was not collected on the remaining 10 participants.

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secondary · POSTED

Median number of days to neutrophil and platelet engraftment.

The study data was analyzed early after 117 participants had been treated. This was done in order to publish the data and establish a new local standard of care at our institution. Engraftment data was not collected on the remaining 25 participants. Recipients of related-donor (n=78) and unrelated-donor (n=39) transplants were reported separately.

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secondary · POSTED

Number of patients who achieved 100% donor chimerism.

The study data was analyzed early after 117 participants had been treated. This was done in order to publish the data and establish a new local standard of care at our institution. Chimerism data was not collected on the remaining 25 participants. One participant died prior to Day 30 and was not analyzed for this outcome.

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secondary · POSTED

Percentage of participants who died for BMT-related reasons.

The study data was analyzed early after 117 participants had been treated. This was done in order to publish the data and establish a new local standard of care at our institution. NRM data was not collected on the remaining 25 participants.

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secondary · POSTED

Percentage of participants who developed relapse or progressive disease.

The study data was analyzed early after 117 participants had been treated. This was done in order to publish the data and establish a new local standard of care at our institution. Relapse data was not collected on the remaining 25 participants.

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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-myeloproliferative-neoplasms
nct id: NCT00134017
trial label: Combination Chemotherapy, Bone Marrow Transplant, and Post Transplant Cyclophosphamide for 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: 5
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-myeloproliferative-neoplasms
nct id
NCT00134017
outcome key
om-0000
source section id
NCT00134017-om-0000
source outcome index
0
endpoint
Percentage of Participants Who Develop Acute Graft-versus-host Disease (GVHD)
endpoint definition
Percentage of participants who developed grades II-IV and grades III-IV acute GVHD. Acute GVHD is defined by the Przepiorka criteria, which stages the degree of organ involvement in the skin, liver, and gastrointestinal (GI) tract, based on severity, with Stage 1+ being least severe and stage 4+ being the most severe. Grading of acute GVHD is as follows: Grade I (skin involvement stages 1+ to 2+, with no liver or GI involvement), Grade II (skin involvement stages 1+ to 3+, liver 1+, GI tract 1+), Grade III (skin involvement stages 2+ to 3+, liver 1+, GI tract 2+ to 4+), Grade IV (skin involvement stages 4+, Liver 4+).
time origin
Day 100
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The study data was analyzed early after 117 participants had been treated. This was done in order to publish the data and establish a new local standard of care at our institution. GVHD data was collected on 15 additional participants for a total of 132. GVHD data was not collected on the remaining 10 participants.
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-myeloproliferative-neoplasms
nct id
NCT00134017
outcome key
om-0001
source section id
NCT00134017-om-0001
source outcome index
1
endpoint
Days to Engraftment
endpoint definition
Median number of days to neutrophil and platelet engraftment.
time origin
Up to one year
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The study data was analyzed early after 117 participants had been treated. This was done in order to publish the data and establish a new local standard of care at our institution. Engraftment data was not collected on the remaining 25 participants. Recipients of related-donor (n=78) and unrelated-donor (n=39) transplants were reported separately.
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-myeloproliferative-neoplasms
nct id
NCT00134017
outcome key
om-0002
source section id
NCT00134017-om-0002
source outcome index
2
endpoint
Chimerism
endpoint definition
Number of patients who achieved 100% donor chimerism.
time origin
Day 30, Day 60
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The study data was analyzed early after 117 participants had been treated. This was done in order to publish the data and establish a new local standard of care at our institution. Chimerism data was not collected on the remaining 25 participants. One participant died prior to Day 30 and was not analyzed for this outcome.
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-myeloproliferative-neoplasms
nct id
NCT00134017
outcome key
om-0003
source section id
NCT00134017-om-0003
source outcome index
3
endpoint
Non-relapse Mortality
endpoint definition
Percentage of participants who died for BMT-related reasons.
time origin
Day 100, 2 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The study data was analyzed early after 117 participants had been treated. This was done in order to publish the data and establish a new local standard of care at our institution. NRM data was not collected on the remaining 25 participants.
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-myeloproliferative-neoplasms
nct id
NCT00134017
outcome key
om-0004
source section id
NCT00134017-om-0004
source outcome index
4
endpoint
Relapse
endpoint definition
Percentage of participants who developed relapse or progressive disease.
time origin
2 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The study data was analyzed early after 117 participants had been treated. This was done in order to publish the data and establish a new local standard of care at our institution. Relapse data was not collected on the remaining 25 participants.
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-myeloproliferative-neoplasms
nct id
NCT00134017
outcome key
om-0000
arm key
OG000
arm label
Bone Marrow Transplant
regimen
Myeloablative bone marrow transplant with a busulfan (Bu), cyclophosphamide (Cy), preparative regimen and post-transplant cyclophosphamide (PTCy) as GVHD prophylaxis.
analyzed count
132
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00134017-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-myeloproliferative-neoplasms
nct id
NCT00134017
outcome key
om-0001
arm key
OG000
arm label
Bone Marrow Transplant
regimen
Myeloablative bone marrow transplant with a busulfan (Bu), cyclophosphamide (Cy), preparative regimen and post-transplant cyclophosphamide (PTCy) as GVHD prophylaxis.
analyzed count
117
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00134017-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-myeloproliferative-neoplasms
nct id
NCT00134017
outcome key
om-0002
arm key
OG000
arm label
Bone Marrow Transplant
regimen
Myeloablative bone marrow transplant with a busulfan (Bu), cyclophosphamide (Cy), preparative regimen and post-transplant cyclophosphamide (PTCy) as GVHD prophylaxis.
analyzed count
116
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00134017-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-myeloproliferative-neoplasms
nct id
NCT00134017
outcome key
om-0003
arm key
OG000
arm label
Bone Marrow Transplant
regimen
Myeloablative bone marrow transplant with a busulfan (Bu), cyclophosphamide (Cy), preparative regimen and post-transplant cyclophosphamide (PTCy) as GVHD prophylaxis.
analyzed count
117
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00134017-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-myeloproliferative-neoplasms
nct id
NCT00134017
outcome key
om-0004
arm key
OG000
arm label
Bone Marrow Transplant
regimen
Myeloablative bone marrow transplant with a busulfan (Bu), cyclophosphamide (Cy), preparative regimen and post-transplant cyclophosphamide (PTCy) as GVHD prophylaxis.
analyzed count
117
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00134017-om-0004#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-myeloproliferative-neoplasms
nct id
NCT00134017
harm key
EG000
source section id
NCT00134017-ae
event group key
EG000
event group label
Bone Marrow Transplant
serious affected
20
serious at risk
142
other affected
0
other at risk
142
frequency threshold
5
collection period
Up to one year
event definition
Adverse events were tracked systematically for 30-60 days depending on exact discharge date from the initial hospitalization. Only the following adverse events were collected: all graft failures; deaths in the first sixty days; unexpected grade 4-5 events.
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