NCT00176930 · STUDY IN CONTEXT

Stem Cell Transplant for Hematological Malignancy

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

Disease-Free Survival is the length of time during and after medication or treatment during which the disease being treated (usually cancer) does not get worse. It is sometimes used as a metric to study the health of a person with a disease to try to determine how well a new treatment is working.

Source null

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primary · POSTED

Disease-Free Survival is the length of time during and after medication or treatment during which the disease being treated (usually cancer) does not get worse. It is sometimes used as a metric to study the health of a person with a disease to try to determine how well a new treatment is working.

Source null

→

secondary · POSTED

Neutrophil engraftment is defined as the first day of three consecutive days where the neutrophil count (absolute neutrophil count) is 500 cells/mm\^3 (0.5 x 10\^9/L) or greater.

Source null

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secondary · POSTED

Acute Graft-Versus-Host Disease (aGVHD) is a severe short-term complication created by infusion of donor cells into a foreign host. Determine the incidence of grade II-IV acute graft-versus-host disease (GVHD) at day 100 post transplant. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria used for staging. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level.

Source null

→

secondary · POSTED

Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host. Determine the incidence of chronic GVHD 1 year post transplant. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level.

Source null

→

secondary · POSTED

Defined as the return of disease after its apparent recovery/cessation. Patients with leukemia and lymphoma involving the BM and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated.

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
nct id: NCT00176930
trial label: Stem Cell Transplant for Hematological Malignancy
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: 6
harms Count: 8
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia
nct id
NCT00176930
outcome key
om-0000
source section id
NCT00176930-om-0000
source outcome index
0
endpoint
Number of Participants Experiencing Disease-Free Survival at 2 Years Post Transplant
endpoint definition
Disease-Free Survival is the length of time during and after medication or treatment during which the disease being treated (usually cancer) does not get worse. It is sometimes used as a metric to study the health of a person with a disease to try to determine how well a new treatment is working.
time origin
2 years
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
nct id
NCT00176930
outcome key
om-0001
source section id
NCT00176930-om-0001
source outcome index
1
endpoint
Number of Participants Experiencing Disease-Free Survival at 5 Years Post Transplant
endpoint definition
Disease-Free Survival is the length of time during and after medication or treatment during which the disease being treated (usually cancer) does not get worse. It is sometimes used as a metric to study the health of a person with a disease to try to determine how well a new treatment is working.
time origin
5 years
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
nct id
NCT00176930
outcome key
om-0002
source section id
NCT00176930-om-0002
source outcome index
2
endpoint
Number of Participants With Neutrophil Engraftment
endpoint definition
Neutrophil engraftment is defined as the first day of three consecutive days where the neutrophil count (absolute neutrophil count) is 500 cells/mm\^3 (0.5 x 10\^9/L) or greater.
time origin
Day 42
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
nct id
NCT00176930
outcome key
om-0003
source section id
NCT00176930-om-0003
source outcome index
3
endpoint
Number of Participants With Acute Graft-versus-host Disease (GVHD)
endpoint definition
Acute Graft-Versus-Host Disease (aGVHD) is a severe short-term complication created by infusion of donor cells into a foreign host. Determine the incidence of grade II-IV acute graft-versus-host disease (GVHD) at day 100 post transplant. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria used for staging. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level.
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-chronic-myeloid-leukemia
nct id
NCT00176930
outcome key
om-0004
source section id
NCT00176930-om-0004
source outcome index
4
endpoint
Number of Participants With Chronic Graft-Versus-Host Disease
endpoint definition
Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host. Determine the incidence of chronic GVHD 1 year post transplant. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level.
time origin
1 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
release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia
nct id
NCT00176930
outcome key
om-0005
source section id
NCT00176930-om-0005
source outcome index
5
endpoint
Number of Participants With Persistence or Relapse of Malignancy at 2 Years Post Transplant
endpoint definition
Defined as the return of disease after its apparent recovery/cessation. Patients with leukemia and lymphoma involving the BM and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated.
time origin
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

arms

release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia
nct id
NCT00176930
outcome key
om-0000
arm key
OG000
arm label
PBSC: No TBI
regimen
Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Peripheral Blood Stem Cells (PBSC) as a source of transplant
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00176930-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia
nct id
NCT00176930
outcome key
om-0000
arm key
OG001
arm label
Marrow : No TBI
regimen
Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Bone Marrow as a source of stem cell transplant
analyzed count
13
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00176930-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia
nct id
NCT00176930
outcome key
om-0000
arm key
OG002
arm label
UCB : No TBI
regimen
Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Umbilical Cord Blood (UCB) as a source of stem cell transplant
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00176930-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia
nct id
NCT00176930
outcome key
om-0000
arm key
OG003
arm label
UCB : No TBI/Bu/Cy/ATG
regimen
Patients who receives Umbilical Cord Blood (UCB) as a source of transplant and who have not had chemotherapy in the prior 3 months receives ATG in addition to cyclophosphamide, Busulfan preparative regimen
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00176930-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia
nct id
NCT00176930
outcome key
om-0000
arm key
OG004
arm label
PBSC
regimen
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant
analyzed count
213
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00176930-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia
nct id
NCT00176930
outcome key
om-0000
arm key
OG005
arm label
Marrow
regimen
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant
analyzed count
85
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00176930-om-0000#groups/OG005
release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia
nct id
NCT00176930
outcome key
om-0000
arm key
OG006
arm label
Umbilical Cord Blood
regimen
Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00176930-om-0000#groups/OG006
release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia
nct id
NCT00176930
outcome key
om-0000
arm key
OG007
arm label
Co-Enroll From MT0403
regimen
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) , CD4+CD25+ and Peripheral Blood Stem Cells (PBSC) as a source of transplant. These patients are co-enrolled on the MT2004-03 trial (NCT00725062)
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00176930-om-0000#groups/OG007
release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia
nct id
NCT00176930
outcome key
om-0001
arm key
OG000
arm label
PBSC: No TBI
regimen
Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Peripheral Blood Stem Cells (PBSC) as a source of transplant
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00176930-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia
nct id
NCT00176930
outcome key
om-0001
arm key
OG001
arm label
Marrow : No TBI
regimen
Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Bone Marrow as a source of stem cell transplant
analyzed count
13
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00176930-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia
nct id
NCT00176930
outcome key
om-0001
arm key
OG002
arm label
UCB : No TBI
regimen
Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Umbilical Cord Blood (UCB) as a source of stem cell transplant
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00176930-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia
nct id
NCT00176930
outcome key
om-0001
arm key
OG003
arm label
UCB : No TBI/Bu/Cy/ATG
regimen
Patients who receives Umbilical Cord Blood (UCB) as a source of transplant and who have not had chemotherapy in the prior 3 months receives ATG in addition to cyclophosphamide, Busulfan preparative regimen
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00176930-om-0001#groups/OG003

harms

release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia
nct id
NCT00176930
harm key
EG000
source section id
NCT00176930-ae
event group key
EG000
event group label
PBSC: No TBI
serious affected
3
serious at risk
12
other affected
12
other at risk
12
frequency threshold
5
collection period
5 years
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-chronic-myeloid-leukemia
nct id
NCT00176930
harm key
EG001
source section id
NCT00176930-ae
event group key
EG001
event group label
Marrow : No TBI
serious affected
0
serious at risk
13
other affected
10
other at risk
13
frequency threshold
5
collection period
5 years
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-chronic-myeloid-leukemia
nct id
NCT00176930
harm key
EG002
source section id
NCT00176930-ae
event group key
EG002
event group label
UCB : No TBI
serious affected
0
serious at risk
1
other affected
1
other at risk
1
frequency threshold
5
collection period
5 years
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-chronic-myeloid-leukemia
nct id
NCT00176930
harm key
EG003
source section id
NCT00176930-ae
event group key
EG003
event group label
UCB : No TBI/Bu/Cy/ATG
serious affected
0
serious at risk
1
other affected
1
other at risk
1
frequency threshold
5
collection period
5 years
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-chronic-myeloid-leukemia
nct id
NCT00176930
harm key
EG004
source section id
NCT00176930-ae
event group key
EG004
event group label
PBSC
serious affected
32
serious at risk
213
other affected
183
other at risk
213
frequency threshold
5
collection period
5 years
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-chronic-myeloid-leukemia
nct id
NCT00176930
harm key
EG005
source section id
NCT00176930-ae
event group key
EG005
event group label
Marrow
serious affected
10
serious at risk
85
other affected
71
other at risk
85
frequency threshold
5
collection period
5 years
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-chronic-myeloid-leukemia
nct id
NCT00176930
harm key
EG006
source section id
NCT00176930-ae
event group key
EG006
event group label
Umbilical Cord Blood
serious affected
0
serious at risk
2
other affected
2
other at risk
2
frequency threshold
5
collection period
5 years
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-chronic-myeloid-leukemia
nct id
NCT00176930
harm key
EG007
source section id
NCT00176930-ae
event group key
EG007
event group label
Co-Enroll From MT0403
serious affected
0
serious at risk
2
other affected
2
other at risk
2
frequency threshold
5
collection period
5 years
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