NCT05316701 · STUDY IN CONTEXT

Precision-T: A Randomized Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic 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. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

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

Event-free rate estimated at 12 months for cGFS per EAC, which is defined as the time from date of allogeneic hematopoietic cell transplantation (alloHCT) (ie, day 0) to date of death from any cause or first onset of moderate or severe chronic graft-versus-host disease (cGVHD) (graded per NIH consensus criteria), whichever was earliest, within 2 years after day 0. cGVHD was assessed and graded by EAC blinded to treatment assignment. Each participant in the study is followed for up to 730 days after transplant. Primary analysis was event driven (ie, when 56 participants had died or had moderate or severe cGVHD) and was not based on duration of follow-up. The analysis was conducted using all available data at the time that the 56th event occurred, and event-free rate at 12 months was estimated regardless of length of follow-up for individual participants. At the time of analysis, not all participants have reached 730 days of follow-up because they enrolled at different times.

ITT

→

secondary · POSTED

Event rate estimated at 12 months for time from alloHCT to first onset of moderate or severe cGVHD defined by NIH consensus criteria within 2 years after day 0. Death within 2 years after day 0 without prior moderate or severe cGVHD was considered a competing event. cGVHD was assessed and graded by an independent EAC. Each participant in the study is followed for up to 730 days after transplant. The primary analysis was triggered by the 56th cGFS event (ie, when 56 participants had died or had moderate or severe chronic GVHD) and was not based on the duration of follow-up. Therefore, the analysis was conducted using all available data at the time that the 56th cGFS event occurred, and the event rate of moderate or severe cGVHD at 12 months was estimated regardless of the length of follow-up for individual participants. At the time of analysis, not all participants have reached 730 days of follow-up because they enrolled at different times.

ITT

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secondary · POSTED

Event-free rate estimated at 12 months for OS, which is defined as time from randomization to death from any cause. Each participant in the study is followed for up to 730 days after transplant. The analysis was triggered by the 56th cGFS event (ie, when 56 participants had died or had moderate or severe chronic GVHD) and was not based on the duration of follow-up. Therefore, the analysis was conducted using all available data at the time that the 56th cGFS event occurred, and the event-free rate of OS at 12 months was estimated regardless of the length of follow-up for individual participants. At the time of analysis, not all participants have reached 730 days of follow-up because they enrolled at different times.

ITT

→

secondary · POSTED

Event-free rate estimated at 12 months for GRFS, which is defined as time from alloHCT to death from any cause, relapse, the first onset of grade 3 or 4 acute GVHD (graded per Mount Sinai aGVHD International Consortium \[MAGIC\] criteria), or the first onset of moderate or severe cGVHD (graded per NIH consensus criteria), whichever is earliest, within 2 years from day 0 as assessed by independent EAC. Each participant in the study is followed for up to 730 days after transplant. The analysis was triggered by the 56th cGFS event (ie, when 56 participants had died or had moderate or severe cGVHD) and not based on duration of follow-up. Therefore, analysis was conducted using all available data at the time that the 56th cGFS event occurred, and event-free rate of GRFS at 12 months was estimated regardless of length of follow-up for individual participants. At time of analysis, not all participants have reached 730 days of follow-up because they enrolled at different times.

ITT

→

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-mixed-phenotype-acute-leukemia
nct id: NCT05316701
trial label: Precision-T: A Randomized Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic 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.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 4
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-mixed-phenotype-acute-leukemia
nct id
NCT05316701
outcome key
om-0000
source section id
NCT05316701-om-0000
source outcome index
0
endpoint
Event-free at 12 Months for Moderate or Severe Chronic Graft-versus-Host-Disease-free Survival (cGFS) Per Endpoint Adjudication Committee (EAC)
endpoint definition
Event-free rate estimated at 12 months for cGFS per EAC, which is defined as the time from date of allogeneic hematopoietic cell transplantation (alloHCT) (ie, day 0) to date of death from any cause or first onset of moderate or severe chronic graft-versus-host disease (cGVHD) (graded per NIH consensus criteria), whichever was earliest, within 2 years after day 0. cGVHD was assessed and graded by EAC blinded to treatment assignment. Each participant in the study is followed for up to 730 days after transplant. Primary analysis was event driven (ie, when 56 participants had died or had moderate or severe cGVHD) and was not based on duration of follow-up. The analysis was conducted using all available data at the time that the 56th event occurred, and event-free rate at 12 months was estimated regardless of length of follow-up for individual participants. At the time of analysis, not all participants have reached 730 days of follow-up because they enrolled at different times.
time origin
Day 0 through 730 days after transplantation
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
ITT
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-mixed-phenotype-acute-leukemia
nct id
NCT05316701
outcome key
om-0001
source section id
NCT05316701-om-0001
source outcome index
1
endpoint
Event Rate at 12 Months for Time to Moderate or Severe cGVHD Per EAC
endpoint definition
Event rate estimated at 12 months for time from alloHCT to first onset of moderate or severe cGVHD defined by NIH consensus criteria within 2 years after day 0. Death within 2 years after day 0 without prior moderate or severe cGVHD was considered a competing event. cGVHD was assessed and graded by an independent EAC. Each participant in the study is followed for up to 730 days after transplant. The primary analysis was triggered by the 56th cGFS event (ie, when 56 participants had died or had moderate or severe chronic GVHD) and was not based on the duration of follow-up. Therefore, the analysis was conducted using all available data at the time that the 56th cGFS event occurred, and the event rate of moderate or severe cGVHD at 12 months was estimated regardless of the length of follow-up for individual participants. At the time of analysis, not all participants have reached 730 days of follow-up because they enrolled at different times.
time origin
Day 0 through 730 days after transplantation
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
ITT
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-mixed-phenotype-acute-leukemia
nct id
NCT05316701
outcome key
om-0002
source section id
NCT05316701-om-0002
source outcome index
2
endpoint
Event-free at 12 Months for Overall Survival (OS)
endpoint definition
Event-free rate estimated at 12 months for OS, which is defined as time from randomization to death from any cause. Each participant in the study is followed for up to 730 days after transplant. The analysis was triggered by the 56th cGFS event (ie, when 56 participants had died or had moderate or severe chronic GVHD) and was not based on the duration of follow-up. Therefore, the analysis was conducted using all available data at the time that the 56th cGFS event occurred, and the event-free rate of OS at 12 months was estimated regardless of the length of follow-up for individual participants. At the time of analysis, not all participants have reached 730 days of follow-up because they enrolled at different times.
time origin
Up to 730 days after end of enrollment
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
ITT
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-mixed-phenotype-acute-leukemia
nct id
NCT05316701
outcome key
om-0003
source section id
NCT05316701-om-0003
source outcome index
3
endpoint
Event-free Rate at 12 Months for Graft-versus-host Disease-free and Relapse-free Survival (GRFS) Per EAC
endpoint definition
Event-free rate estimated at 12 months for GRFS, which is defined as time from alloHCT to death from any cause, relapse, the first onset of grade 3 or 4 acute GVHD (graded per Mount Sinai aGVHD International Consortium \[MAGIC\] criteria), or the first onset of moderate or severe cGVHD (graded per NIH consensus criteria), whichever is earliest, within 2 years from day 0 as assessed by independent EAC. Each participant in the study is followed for up to 730 days after transplant. The analysis was triggered by the 56th cGFS event (ie, when 56 participants had died or had moderate or severe cGVHD) and not based on duration of follow-up. Therefore, analysis was conducted using all available data at the time that the 56th cGFS event occurred, and event-free rate of GRFS at 12 months was estimated regardless of length of follow-up for individual participants. At time of analysis, not all participants have reached 730 days of follow-up because they enrolled at different times.
time origin
Day 0 through 730 days after transplantation
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
ITT
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-mixed-phenotype-acute-leukemia
nct id
NCT05316701
outcome key
om-0000
arm key
OG000
arm label
Orca-T
regimen
Orca-T administered after myeloablative conditioning followed by single-agent tacrolimus
analyzed count
93
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05316701-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-mixed-phenotype-acute-leukemia
nct id
NCT05316701
outcome key
om-0000
arm key
OG001
arm label
Standard of Care
regimen
Unmanipulated allograft from peripheral blood of a matched donor after myeloablative conditioning followed by tacrolimus and methotrexate
analyzed count
94
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05316701-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-mixed-phenotype-acute-leukemia
nct id
NCT05316701
outcome key
om-0001
arm key
OG000
arm label
Orca-T
regimen
Orca-T administered after myeloablative conditioning followed by single-agent tacrolimus
analyzed count
93
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05316701-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-mixed-phenotype-acute-leukemia
nct id
NCT05316701
outcome key
om-0001
arm key
OG001
arm label
Standard of Care
regimen
Unmanipulated allograft from peripheral blood of a matched donor after myeloablative conditioning followed by tacrolimus and methotrexate
analyzed count
94
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05316701-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-mixed-phenotype-acute-leukemia
nct id
NCT05316701
outcome key
om-0002
arm key
OG000
arm label
Orca-T
regimen
Orca-T administered after myeloablative conditioning followed by single-agent tacrolimus
analyzed count
93
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05316701-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-mixed-phenotype-acute-leukemia
nct id
NCT05316701
outcome key
om-0002
arm key
OG001
arm label
Standard of Care
regimen
Unmanipulated allograft from peripheral blood of a matched donor after myeloablative conditioning followed by tacrolimus and methotrexate
analyzed count
94
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05316701-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-mixed-phenotype-acute-leukemia
nct id
NCT05316701
outcome key
om-0003
arm key
OG000
arm label
Orca-T
regimen
Orca-T administered after myeloablative conditioning followed by single-agent tacrolimus
analyzed count
93
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05316701-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-mixed-phenotype-acute-leukemia
nct id
NCT05316701
outcome key
om-0003
arm key
OG001
arm label
Standard of Care
regimen
Unmanipulated allograft from peripheral blood of a matched donor after myeloablative conditioning followed by tacrolimus and methotrexate
analyzed count
94
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05316701-om-0003#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-mixed-phenotype-acute-leukemia
nct id
NCT05316701
harm key
EG000
source section id
NCT05316701-ae
event group key
EG000
event group label
Orca-T
serious affected
34
serious at risk
88
other affected
88
other at risk
88
frequency threshold
5
collection period
A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
event definition
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
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-mixed-phenotype-acute-leukemia
nct id
NCT05316701
harm key
EG001
source section id
NCT05316701-ae
event group key
EG001
event group label
Standard of Care
serious affected
53
serious at risk
94
other affected
94
other at risk
94
frequency threshold
5
collection period
A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
event definition
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
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