NCT00594308 · STUDY IN CONTEXT

In-Vivo Activated T-Cell Depletion to Prevent GVHD

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 · NOT_STATED

Number of patients with Grade II-IV GVHD according to NMDP/CIBMTR GVHD severity scale. This scale measures the degree of GVHD involvement in the patient's skin (inflammatory skin disease), liver (bilirubin levels) and intestinal tract (amount of diarrhea) as well as the level of decline in a patient's activity and physical abilities.

All patient that received study drug

→

secondary · NOT_STATED

Number of Patients Engrafting at Day +30 by Short Tandem Repeat (STR) on Peripheral Blood Mononuclear Cells (PBMC's).

ITT population. All patient that received study drug

→

secondary · NOT_STATED

Average number of day per patient for absolute neutrophil count to recover(\> 500/mm3 for 3 consecutive days).

ITT: All patient that received study drug

→

secondary · NOT_STATED

Average number of days per patient for resolution of cytopenias.

IIT: All patients that received study drug.

→

secondary · NOT_STATED

Number of patients who died due to transplant related toxicities

Intent To Treat: All patients that received study drug

→

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-mantle-cell-lymphoma
nct id: NCT00594308
trial label: In-Vivo Activated T-Cell Depletion to Prevent GVHD
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-mantle-cell-lymphoma
nct id
NCT00594308
outcome key
om-0000
source section id
NCT00594308-om-0000
source outcome index
0
endpoint
Number of Patients With Acute Grade II-IV GVHD
endpoint definition
Number of patients with Grade II-IV GVHD according to NMDP/CIBMTR GVHD severity scale. This scale measures the degree of GVHD involvement in the patient's skin (inflammatory skin disease), liver (bilirubin levels) and intestinal tract (amount of diarrhea) as well as the level of decline in a patient's activity and physical abilities.
time origin
until 30 days after stem cell transplant
analysis role
primary
reporting status
NOT_STATED
data cutoff
Source null
population note
All patient that received study drug
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-mantle-cell-lymphoma
nct id
NCT00594308
outcome key
om-0001
source section id
NCT00594308-om-0001
source outcome index
1
endpoint
Number of Patients Engrafting at Day +30 by Short Tandem Repeat (STR) on Peripheral Blood Mononuclear Cells (PBMC's).
endpoint definition
Number of Patients Engrafting at Day +30 by Short Tandem Repeat (STR) on Peripheral Blood Mononuclear Cells (PBMC's).
time origin
until 30 days after stem cell transplant
analysis role
secondary
reporting status
NOT_STATED
data cutoff
Source null
population note
ITT population. All patient that received study drug
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-mantle-cell-lymphoma
nct id
NCT00594308
outcome key
om-0002
source section id
NCT00594308-om-0002
source outcome index
2
endpoint
Number of Days for Absolute Neutrophil Count to Recover
endpoint definition
Average number of day per patient for absolute neutrophil count to recover(\> 500/mm3 for 3 consecutive days).
time origin
From Day -1 (day before stem cell infusion) to Day+20 (20 days after stem cell infusion)
analysis role
secondary
reporting status
NOT_STATED
data cutoff
Source null
population note
ITT: All patient that received study drug
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-mantle-cell-lymphoma
nct id
NCT00594308
outcome key
om-0003
source section id
NCT00594308-om-0003
source outcome index
3
endpoint
Time to Resolution of Cytopenias: Platelet Transfusion Independence
endpoint definition
Average number of days per patient for resolution of cytopenias.
time origin
From Day -1 (day before stem cell infusion) to Day +20 (20 days after stem cell infusion)
analysis role
secondary
reporting status
NOT_STATED
data cutoff
Source null
population note
IIT: All patients that received study drug.
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-mantle-cell-lymphoma
nct id
NCT00594308
outcome key
om-0004
source section id
NCT00594308-om-0004
source outcome index
4
endpoint
Patients Who Experience Serious Transplant Related Toxicities as Evaluated by Bone Marrow Transplant-adjusted NCI Common Toxicity Criteria.
endpoint definition
Number of patients who died due to transplant related toxicities
time origin
up to 2 years after stem cell transplant
analysis role
secondary
reporting status
NOT_STATED
data cutoff
Source null
population note
Intent To Treat: All patients that received study drug
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-mantle-cell-lymphoma
nct id
NCT00594308
outcome key
om-0000
arm key
OG000
arm label
Basiliximab 20 mg
regimen
All patients that received Basiliximab 20 mg monoclonal therapy
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00594308-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-mantle-cell-lymphoma
nct id
NCT00594308
outcome key
om-0001
arm key
OG000
arm label
Basiliximab 20 mg
regimen
All patients that received Basiliximab 20 mg monoclonal therapy
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00594308-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-mantle-cell-lymphoma
nct id
NCT00594308
outcome key
om-0002
arm key
OG000
arm label
Basiliximab 20 mg
regimen
All patients that received Basiliximab 20 mg monoclonal therapy
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00594308-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-mantle-cell-lymphoma
nct id
NCT00594308
outcome key
om-0003
arm key
OG000
arm label
Basiliximab 20 mg
regimen
All patients that received Basiliximab 20 mg monoclonal therapy
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00594308-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-mantle-cell-lymphoma
nct id
NCT00594308
outcome key
om-0004
arm key
OG000
arm label
Basiliximab 20 mg
regimen
All patients that received Basiliximab 20 mg monoclonal therapy
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00594308-om-0004#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-mantle-cell-lymphoma
nct id
NCT00594308
harm key
EG000
source section id
NCT00594308-ae
event group key
EG000
event group label
Basiliximab 20 mg
serious affected
4
serious at risk
10
other affected
0
other at risk
10
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