Tacrolimus and Mycophenolate Mofetil in Preventing Graft-Versus-Host Disease in Patients Who Have Undergone Total-Body Irradiation With or Without Fludarabine Phosphate Followed by

Draft scope assessment: unclear. Attached because the study's own record describes refractory 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

Number of patients who developed acute/chronic GVHD post-transplant. aGVHD Stages Skin: a maculopapular eruption involving \< 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation Liver: bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death

Source null

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primary · POSTED

Number of patients who developed chronic extensive GVHD post-transplant. The diagnosis of chronic GVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD.

Source null

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secondary · POSTED

Number of patients who rejected their graft. Rejection is defined as the inability to detect or loss of detection of greater than 5% donor T cells (CD3+) as a proportion of the total T cell population, respectively, after nonmyeloablative HCT.

Source null

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secondary · POSTED

Number of patients surviving post-transplant.

Source null

→

secondary · POSTED

Number of patients who developed acute/chronic GVHD post-transplant. aGVHD Stages Skin: a maculopapular eruption involving \< 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation Liver: bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade II: Stage 1 - 3 skin and/or stage 1 gut involvement and/or stage 1 liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death

Source null

→

secondary · POSTED

Relapse/Progression criteria: CML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever \>38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes \>20%. CMML, AML, ALL \>30% BM blasts w/ deteriorating performance status, or worsening of anemia, neutropenia, or thrombocytopenia. CLL ≥1 of: Physical exam/imaging studies ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation. NHL \>25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions. MM ≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ treatment; or definite increase in the size or number of plasmacytomas or lytic bone lesions.

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-acute-myeloid-leukemia-pediatric-refractory-7f79ecc8
nct id: NCT00089011
trial label: Tacrolimus and Mycophenolate Mofetil in Preventing Graft-Versus-Host Disease in Patients Who Have Undergone Total-Body Irradiation With or Without Fludarabine Phosphate Followed by
applicability: unclear
applicability note: Attached because the study's own record describes refractory 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: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-pediatric-refractory-7f79ecc8
nct id
NCT00089011
outcome key
om-0000
source section id
NCT00089011-om-0000
source outcome index
0
endpoint
Incidence of Grade III/IV GVHD
endpoint definition
Number of patients who developed acute/chronic GVHD post-transplant. aGVHD Stages Skin: a maculopapular eruption involving \< 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation Liver: bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death
time origin
Day 180 post-transplantation
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-acute-myeloid-leukemia-pediatric-refractory-7f79ecc8
nct id
NCT00089011
outcome key
om-0001
source section id
NCT00089011-om-0001
source outcome index
1
endpoint
Incidence of Chronic Extensive GVHD
endpoint definition
Number of patients who developed chronic extensive GVHD post-transplant. The diagnosis of chronic GVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD.
time origin
Day 180 post-transplantation
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-acute-myeloid-leukemia-pediatric-refractory-7f79ecc8
nct id
NCT00089011
outcome key
om-0002
source section id
NCT00089011-om-0002
source outcome index
2
endpoint
Incidences of Graft Rejection
endpoint definition
Number of patients who rejected their graft. Rejection is defined as the inability to detect or loss of detection of greater than 5% donor T cells (CD3+) as a proportion of the total T cell population, respectively, after nonmyeloablative HCT.
time origin
Day 180 post-transplantation
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-acute-myeloid-leukemia-pediatric-refractory-7f79ecc8
nct id
NCT00089011
outcome key
om-0003
source section id
NCT00089011-om-0003
source outcome index
3
endpoint
Overall Survival
endpoint definition
Number of patients surviving post-transplant.
time origin
At 1 year after conditioning
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-acute-myeloid-leukemia-pediatric-refractory-7f79ecc8
nct id
NCT00089011
outcome key
om-0004
source section id
NCT00089011-om-0004
source outcome index
4
endpoint
Incidences of Grades II-IV Acute GVHD
endpoint definition
Number of patients who developed acute/chronic GVHD post-transplant. aGVHD Stages Skin: a maculopapular eruption involving \< 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation Liver: bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade II: Stage 1 - 3 skin and/or stage 1 gut involvement and/or stage 1 liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death
time origin
Day 180 post-transplantation
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-acute-myeloid-leukemia-pediatric-refractory-7f79ecc8
nct id
NCT00089011
outcome key
om-0005
source section id
NCT00089011-om-0005
source outcome index
5
endpoint
Rates of Disease Progression
endpoint definition
Relapse/Progression criteria: CML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever \>38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes \>20%. CMML, AML, ALL \>30% BM blasts w/ deteriorating performance status, or worsening of anemia, neutropenia, or thrombocytopenia. CLL ≥1 of: Physical exam/imaging studies ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation. NHL \>25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions. MM ≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ treatment; or definite increase in the size or number of plasmacytomas or lytic bone lesions.
time origin
Up to 5 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-acute-myeloid-leukemia-pediatric-refractory-7f79ecc8
nct id
NCT00089011
outcome key
om-0000
arm key
OG000
arm label
Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)
regimen
Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. fludarabine phosphate: Given IV total-body irradiation: Undergo radiotherapy laboratory biomarker analysis: Correlative studies
analyzed count
100
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00089011-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-pediatric-refractory-7f79ecc8
nct id
NCT00089011
outcome key
om-0000
arm key
OG001
arm label
Arm II (Nonmyeloablative Conditioning With TBI)
regimen
Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO. total-body irradiation: Undergo radiotherapy mycophenolate mofetil: Given IV or PO tacrolimus: Given IV or PO peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant laboratory biomarker analysis: Correlative studies
analyzed count
50
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00089011-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-pediatric-refractory-7f79ecc8
nct id
NCT00089011
outcome key
om-0001
arm key
OG000
arm label
Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)
regimen
Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. fludarabine phosphate: Given IV total-body irradiation: Undergo radiotherapy laboratory biomarker analysis: Correlative studies
analyzed count
100
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00089011-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-pediatric-refractory-7f79ecc8
nct id
NCT00089011
outcome key
om-0001
arm key
OG001
arm label
Arm II (Nonmyeloablative Conditioning With TBI)
regimen
Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO. total-body irradiation: Undergo radiotherapy mycophenolate mofetil: Given IV or PO tacrolimus: Given IV or PO peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant laboratory biomarker analysis: Correlative studies
analyzed count
50
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00089011-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-pediatric-refractory-7f79ecc8
nct id
NCT00089011
outcome key
om-0002
arm key
OG000
arm label
Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)
regimen
Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. fludarabine phosphate: Given IV total-body irradiation: Undergo radiotherapy laboratory biomarker analysis: Correlative studies
analyzed count
100
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00089011-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-pediatric-refractory-7f79ecc8
nct id
NCT00089011
outcome key
om-0002
arm key
OG001
arm label
Arm II (Nonmyeloablative Conditioning With TBI)
regimen
Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO. total-body irradiation: Undergo radiotherapy mycophenolate mofetil: Given IV or PO tacrolimus: Given IV or PO peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant laboratory biomarker analysis: Correlative studies
analyzed count
50
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00089011-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-pediatric-refractory-7f79ecc8
nct id
NCT00089011
outcome key
om-0003
arm key
OG000
arm label
Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)
regimen
Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. fludarabine phosphate: Given IV total-body irradiation: Undergo radiotherapy laboratory biomarker analysis: Correlative studies
analyzed count
100
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00089011-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-pediatric-refractory-7f79ecc8
nct id
NCT00089011
outcome key
om-0003
arm key
OG001
arm label
Arm II (Nonmyeloablative Conditioning With TBI)
regimen
Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO. total-body irradiation: Undergo radiotherapy mycophenolate mofetil: Given IV or PO tacrolimus: Given IV or PO peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant laboratory biomarker analysis: Correlative studies
analyzed count
50
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00089011-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-pediatric-refractory-7f79ecc8
nct id
NCT00089011
outcome key
om-0004
arm key
OG000
arm label
Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)
regimen
Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. fludarabine phosphate: Given IV total-body irradiation: Undergo radiotherapy laboratory biomarker analysis: Correlative studies
analyzed count
100
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00089011-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-pediatric-refractory-7f79ecc8
nct id
NCT00089011
outcome key
om-0004
arm key
OG001
arm label
Arm II (Nonmyeloablative Conditioning With TBI)
regimen
Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO. total-body irradiation: Undergo radiotherapy mycophenolate mofetil: Given IV or PO tacrolimus: Given IV or PO peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant laboratory biomarker analysis: Correlative studies
analyzed count
50
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00089011-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-pediatric-refractory-7f79ecc8
nct id
NCT00089011
outcome key
om-0005
arm key
OG000
arm label
Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)
regimen
Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. fludarabine phosphate: Given IV total-body irradiation: Undergo radiotherapy laboratory biomarker analysis: Correlative studies
analyzed count
100
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00089011-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-pediatric-refractory-7f79ecc8
nct id
NCT00089011
outcome key
om-0005
arm key
OG001
arm label
Arm II (Nonmyeloablative Conditioning With TBI)
regimen
Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO. total-body irradiation: Undergo radiotherapy mycophenolate mofetil: Given IV or PO tacrolimus: Given IV or PO peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant laboratory biomarker analysis: Correlative studies
analyzed count
50
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00089011-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-pediatric-refractory-7f79ecc8
nct id
NCT00089011
harm key
EG000
source section id
NCT00089011-ae
event group key
EG000
event group label
Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)
serious affected
8
serious at risk
100
other affected
28
other at risk
100
frequency threshold
5
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
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-pediatric-refractory-7f79ecc8
nct id
NCT00089011
harm key
EG001
source section id
NCT00089011-ae
event group key
EG001
event group label
Arm II (Nonmyeloablative Conditioning With TBI)
serious affected
5
serious at risk
50
other affected
17
other at risk
50
frequency threshold
5
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