NCT00448201 · STUDY IN CONTEXT

Reduced-Intensity Busulfan and Fludarabine With or Without Antithymocyte Globulin Followed by Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Disea

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

Treatment related mortality for first 6 months. Defined as the number of treatment related deaths excluding deaths due to disease relapse.

Source null

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secondary · POSTED

Complete Response at 6 and 12 Months Post-transplant

Complete response was not calculated at 6 and 12 months because the majority of patients had complete response at the time of transplant.

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secondary · POSTED

Complete chimerism is defined as 100% donor cells detected, suggesting complete hematopoietic replacement. Mixed donor chimerism means host cells are detected in particular cells like lymphocytes. Five to 90% donor cells set the criteria for mixed chimerism (MC). Chimerism was not tabulated on day 30.

Source null

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secondary · POSTED

The length of time post-transplant that the patient survives without any signs or symptoms of that cancer.

Source null

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secondary · POSTED

Graft-vs-host disease (GVHD) can be mild, moderate or severe depending on the differences in tissue type between patient and donor. Its symptoms can include: * Rashes, which include burning and redness, that erupt on the palms or soles and may spread to the trunk and eventually to the entire body * Blistering, causing the exposed skin surface to flake off in severe cases * Nausea, vomiting, abdominal cramps, diarrhea and loss of appetite, which can indicate that the gastrointestinal (digestive) tract is affected * Jaundice, or a yellowing of the skin, which can indicate liver damage * Excessive dryness of the mouth and throat, leading to ulcers * Dryness of the lungs, vagina and other surfaces Acute GVHD - Can occur soon after the transplanted cells begin to appear in the recipient. Acute GVHD ranges from mild, moderate or severe, and can be life-threatening if its effects are not controlled. Extensive chronic GVHD - Usually occurs at about three months post-transplant.

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-myeloproliferative-neoplasms
nct id: NCT00448201
trial label: Reduced-Intensity Busulfan and Fludarabine With or Without Antithymocyte Globulin Followed by Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Disea
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
NCT00448201
outcome key
om-0000
source section id
NCT00448201-om-0000
source outcome index
0
endpoint
Treatment-related Mortality
endpoint definition
Treatment related mortality for first 6 months. Defined as the number of treatment related deaths excluding deaths due to disease relapse.
time origin
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-myeloproliferative-neoplasms
nct id
NCT00448201
outcome key
om-0001
source section id
NCT00448201-om-0001
source outcome index
1
endpoint
Complete Response at 6 and 12 Months Post-transplant
endpoint definition
Complete Response at 6 and 12 Months Post-transplant
time origin
6 and 12 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Complete response was not calculated at 6 and 12 months because the majority of patients had complete response at the time of transplant.
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
NCT00448201
outcome key
om-0002
source section id
NCT00448201-om-0002
source outcome index
2
endpoint
Complete or Mixed Donor Chimerism at 30, 60, and 90 Days Post-transplant
endpoint definition
Complete chimerism is defined as 100% donor cells detected, suggesting complete hematopoietic replacement. Mixed donor chimerism means host cells are detected in particular cells like lymphocytes. Five to 90% donor cells set the criteria for mixed chimerism (MC). Chimerism was not tabulated on day 30.
time origin
Days 30, 60, and 90
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-myeloproliferative-neoplasms
nct id
NCT00448201
outcome key
om-0003
source section id
NCT00448201-om-0003
source outcome index
3
endpoint
5-year Disease-free Survival
endpoint definition
The length of time post-transplant that the patient survives without any signs or symptoms of that cancer.
time origin
Year 5
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-myeloproliferative-neoplasms
nct id
NCT00448201
outcome key
om-0004
source section id
NCT00448201-om-0004
source outcome index
4
endpoint
Graft-vs-host Disease at 6 Months Post-transplant
endpoint definition
Graft-vs-host disease (GVHD) can be mild, moderate or severe depending on the differences in tissue type between patient and donor. Its symptoms can include: * Rashes, which include burning and redness, that erupt on the palms or soles and may spread to the trunk and eventually to the entire body * Blistering, causing the exposed skin surface to flake off in severe cases * Nausea, vomiting, abdominal cramps, diarrhea and loss of appetite, which can indicate that the gastrointestinal (digestive) tract is affected * Jaundice, or a yellowing of the skin, which can indicate liver damage * Excessive dryness of the mouth and throat, leading to ulcers * Dryness of the lungs, vagina and other surfaces Acute GVHD - Can occur soon after the transplanted cells begin to appear in the recipient. Acute GVHD ranges from mild, moderate or severe, and can be life-threatening if its effects are not controlled. Extensive chronic GVHD - Usually occurs at about three months post-transplant.
time origin
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-myeloproliferative-neoplasms
nct id
NCT00448201
outcome key
om-0000
arm key
OG000
arm label
All Trial Participants
regimen
All patients received IV fludarabine 30 mg/m2/day on days -7 through -3; busulfan 6.4 mg/kg by continuous infusion over 48 hours on days -6 through -5 and tacrolimus from day -1. Throughout the study duration, 8 different GVHD regimens were investigated. In addition to tacrolimus, patients received combinations of 3 agents: methotrexate (5 mg/m2 D1, 3, 6), rabbit antithymocyte globulin (ATG, 3 mg/kg to- 6 mg/kg) or alemtuzumab (Campath, 30 mg to- 90 mg).
analyzed count
71
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00448201-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-myeloproliferative-neoplasms
nct id
NCT00448201
outcome key
om-0001
arm key
OG000
arm label
All Trial Participants
regimen
All patients received IV fludarabine 30 mg/m2/day on days -7 through -3; busulfan 6.4 mg/kg by continuous infusion over 48 hours on days -6 through -5 and tacrolimus from day -1. Throughout the study duration, 8 different GVHD regimens were investigated. In addition to tacrolimus, patients received combinations of 3 agents: methotrexate (5 mg/m2 D1, 3, 6), rabbit antithymocyte globulin (ATG, 3 mg/kg to- 6 mg/kg) or alemtuzumab (Campath, 30 mg to- 90 mg).
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00448201-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-myeloproliferative-neoplasms
nct id
NCT00448201
outcome key
om-0002
arm key
OG000
arm label
Day 60
regimen
60 days post-transplant
analyzed count
71
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00448201-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-myeloproliferative-neoplasms
nct id
NCT00448201
outcome key
om-0002
arm key
OG001
arm label
Day 90
regimen
90 days post-transplant
analyzed count
71
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00448201-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-myeloproliferative-neoplasms
nct id
NCT00448201
outcome key
om-0003
arm key
OG000
arm label
All Trial Participants
regimen
All patients received IV fludarabine 30 mg/m2/day on days -7 through -3; busulfan 6.4 mg/kg by continuous infusion over 48 hours on days -6 through -5 and tacrolimus from day -1. Throughout the study duration, 8 different GVHD regimens were investigated. In addition to tacrolimus, patients received combinations of 3 agents: methotrexate (5 mg/m2 D1, 3, 6), rabbit antithymocyte globulin (ATG, 3 mg/kg to- 6 mg/kg) or alemtuzumab (Campath, 30 mg to- 90 mg).
analyzed count
71
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00448201-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-myeloproliferative-neoplasms
nct id
NCT00448201
outcome key
om-0004
arm key
OG000
arm label
All Trial Participants
regimen
All patients received IV fludarabine 30 mg/m2/day on days -7 through -3; busulfan 6.4 mg/kg by continuous infusion over 48 hours on days -6 through -5 and tacrolimus from day -1. Throughout the study duration, 8 different GVHD regimens were investigated. In addition to tacrolimus, patients received combinations of 3 agents: methotrexate (5 mg/m2 D1, 3, 6), rabbit antithymocyte globulin (ATG, 3 mg/kg to- 6 mg/kg) or alemtuzumab (Campath, 30 mg to- 90 mg).
analyzed count
71
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00448201-om-0004#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-myeloproliferative-neoplasms
nct id
NCT00448201
harm key
EG000
source section id
NCT00448201-ae
event group key
EG000
event group label
All Trial Participants
serious affected
7
serious at risk
71
other affected
0
other at risk
0
frequency threshold
0
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