Vorinostat, Tacrolimus, and Methotrexate in Preventing GVHD After Stem Cell Transplant in Patients With Hematological Malignancies

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

The incidence of grade 2-4 acute GVHD (Graft Versus Host Disease) by day 100 Grade 2 GVHD: Maculopapular rash covering 25-50% of BSA (Body Surface Area), bilirubin between 3.1-6 mg/dl, and/ or adult stool output between 1000-1500 ml/day (child between 20-30 ml/kg/day). Grade 3 GVHD: Maculopapular rash covering \>50% of BSA, bilirubin between 6.1-15 mg/dl, and/ or adult stool output \>1500 ml/day (child \>30 ml/kg/day). Grade 4 GVHD: Generalized erythroderma plus bullous formation and desquamation \>5% BSA, bilirubin \>15 mg/dl, and/ or severe abdominal pain with or without ileus, or grossly bloody stool.

Source null

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secondary · POSTED

The addition of vorinostat to tacrolimus and methotrexate for GVHD prophylaxis will be considered feasible if 60% or more of the planned doses are administered.

Source null

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secondary · POSTED

The percentage of patients alive without GVHD or use of steroids at 1 year.

This trial consisted of an initial pilot phase, funded by the NCI, that enrolled 12 patients (NCT01789255). The trial was extended to enroll an additional 25 patients. The results presented here include information for all 37 patients. The analysis population description for all 37 patients can be found under NCT01790568.

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secondary · POSTED

The percentage of patients alive at 1 year

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secondary · POSTED

The Percentage of Patients With Relapse at 1 Year

Source null

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secondary · POSTED

Median Ac-H3 levels ( depicted as a ratio of ac-H2 optical density (OD) and beta actin OD) were compared in patients treated with Vorinostat to patients not treated with Vorinostat. Optical Density is a dimensionless unit.

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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-primary-central-nervous-system-lymphoma
nct id: NCT01789255
trial label: Vorinostat, Tacrolimus, and Methotrexate in Preventing GVHD After Stem Cell Transplant in Patients With Hematological Malignancies
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: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-primary-central-nervous-system-lymphoma
nct id
NCT01789255
outcome key
om-0000
source section id
NCT01789255-om-0000
source outcome index
0
endpoint
The Number of Participants That Experience Grade 2-4 Acute GVHD (Graft Versus Host Disease) by Day 100
endpoint definition
The incidence of grade 2-4 acute GVHD (Graft Versus Host Disease) by day 100 Grade 2 GVHD: Maculopapular rash covering 25-50% of BSA (Body Surface Area), bilirubin between 3.1-6 mg/dl, and/ or adult stool output between 1000-1500 ml/day (child between 20-30 ml/kg/day). Grade 3 GVHD: Maculopapular rash covering \>50% of BSA, bilirubin between 6.1-15 mg/dl, and/ or adult stool output \>1500 ml/day (child \>30 ml/kg/day). Grade 4 GVHD: Generalized erythroderma plus bullous formation and desquamation \>5% BSA, bilirubin \>15 mg/dl, and/ or severe abdominal pain with or without ileus, or grossly bloody stool.
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-primary-central-nervous-system-lymphoma
nct id
NCT01789255
outcome key
om-0001
source section id
NCT01789255-om-0001
source outcome index
1
endpoint
Mean Percent of Planned Dose Administered
endpoint definition
The addition of vorinostat to tacrolimus and methotrexate for GVHD prophylaxis will be considered feasible if 60% or more of the planned doses are administered.
time origin
Up to day 30
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-primary-central-nervous-system-lymphoma
nct id
NCT01789255
outcome key
om-0002
source section id
NCT01789255-om-0002
source outcome index
2
endpoint
The Percentage of Patients Alive Without GVHD or Use of Steroids
endpoint definition
The percentage of patients alive without GVHD or use of steroids at 1 year.
time origin
Up to 1 year
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
This trial consisted of an initial pilot phase, funded by the NCI, that enrolled 12 patients (NCT01789255). The trial was extended to enroll an additional 25 patients. The results presented here include information for all 37 patients. The analysis population description for all 37 patients can be found under NCT01790568.
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-primary-central-nervous-system-lymphoma
nct id
NCT01789255
outcome key
om-0003
source section id
NCT01789255-om-0003
source outcome index
3
endpoint
The Percentage of Patients Alive at 1 Year
endpoint definition
The percentage of patients alive at 1 year
time origin
Up to 1 year
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
This trial consisted of an initial pilot phase, funded by the NCI, that enrolled 12 patients (NCT01789255). The trial was extended to enroll an additional 25 patients. The results presented here include information for all 37 patients. The analysis population description for all 37 patients can be found under NCT01790568.
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-primary-central-nervous-system-lymphoma
nct id
NCT01789255
outcome key
om-0004
source section id
NCT01789255-om-0004
source outcome index
4
endpoint
The Percentage of Patients With Relapse at 1 Year
endpoint definition
The Percentage of Patients With Relapse at 1 Year
time origin
Up to 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-primary-central-nervous-system-lymphoma
nct id
NCT01789255
outcome key
om-0005
source section id
NCT01789255-om-0005
source outcome index
5
endpoint
Median Ac-H3 Levels in Patients Treated With Vorinostat and Patients Not Treated With Vorinostat
endpoint definition
Median Ac-H3 levels ( depicted as a ratio of ac-H2 optical density (OD) and beta actin OD) were compared in patients treated with Vorinostat to patients not treated with Vorinostat. Optical Density is a dimensionless unit.
time origin
Up to day 100
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
This trial consisted of an initial pilot phase, funded by the NCI, that enrolled 12 patients (NCT01789255). The trial was extended to enroll an additional 25 patients. The results presented here include information for all 37 patients. The analysis population description for all 37 patients can be found under NCT01790568.
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-primary-central-nervous-system-lymphoma
nct id
NCT01789255
outcome key
om-0000
arm key
OG000
arm label
Supportive Care (Vorinostat, Tacrolimus, Methotrexate)
regimen
Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01789255-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-primary-central-nervous-system-lymphoma
nct id
NCT01789255
outcome key
om-0001
arm key
OG000
arm label
Supportive Care (Vorinostat, Tacrolimus, Methotrexate)
regimen
Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01789255-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-primary-central-nervous-system-lymphoma
nct id
NCT01789255
outcome key
om-0002
arm key
OG000
arm label
Supportive Care (Vorinostat, Tacrolimus, Methotrexate)
regimen
Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.
analyzed count
37
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01789255-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-primary-central-nervous-system-lymphoma
nct id
NCT01789255
outcome key
om-0003
arm key
OG000
arm label
Supportive Care (Vorinostat, Tacrolimus, Methotrexate)
regimen
Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.
analyzed count
37
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01789255-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-primary-central-nervous-system-lymphoma
nct id
NCT01789255
outcome key
om-0004
arm key
OG000
arm label
Supportive Care (Vorinostat, Tacrolimus, Methotrexate)
regimen
Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01789255-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-primary-central-nervous-system-lymphoma
nct id
NCT01789255
outcome key
om-0005
arm key
OG000
arm label
Supportive Care (Vorinostat, Tacrolimus, Methotrexate)
regimen
Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.
analyzed count
37
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01789255-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-primary-central-nervous-system-lymphoma
nct id
NCT01789255
harm key
EG000
source section id
NCT01789255-ae
event group key
EG000
event group label
Supportive Care (Vorinostat, Tacrolimus, Methotrexate)
serious affected
7
serious at risk
12
other affected
10
other at risk
12
frequency threshold
0
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