NCT01823198 · STUDY IN CONTEXT

Donor Natural Killer Cells and Donor Stem Cell Transplant in Treating Patients With High Risk Myeloid 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

Participants that experienced DLT related to the NK Cells post transplant at different dose levels.

Twenty one donor participants were not included in outcome analysis.

→

secondary · POSTED

Participants that survived between day of transplant and day of death on different dose levels.

Twenty one donor participants were not included in outcome analysis.

→

secondary · POSTED

Number of participants that had grade 3 toxicities up to day 42.

Twenty one donor participants were not included in outcome analysis.

→

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-myeloid-neoplasm
nct id: NCT01823198
trial label: Donor Natural Killer Cells and Donor Stem Cell Transplant in Treating Patients With High Risk Myeloid 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: 3
harms Count: 7
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-myeloid-neoplasm
nct id
NCT01823198
outcome key
om-0000
source section id
NCT01823198-om-0000
source outcome index
0
endpoint
Number of Participants Who Experienced Dose-limiting Toxicities (DLT)
endpoint definition
Participants that experienced DLT related to the NK Cells post transplant at different dose levels.
time origin
Up to 42 days
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Twenty one donor participants were not included in outcome analysis.
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-myeloid-neoplasm
nct id
NCT01823198
outcome key
om-0001
source section id
NCT01823198-om-0001
source outcome index
1
endpoint
Overall Survival
endpoint definition
Participants that survived between day of transplant and day of death on different dose levels.
time origin
Up to 2 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Twenty one donor participants were not included in outcome analysis.
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-myeloid-neoplasm
nct id
NCT01823198
outcome key
om-0002
source section id
NCT01823198-om-0002
source outcome index
2
endpoint
Number of Participants With Grade 3 Toxicities
endpoint definition
Number of participants that had grade 3 toxicities up to day 42.
time origin
Up to day 42
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Twenty one donor participants were not included in outcome analysis.
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-myeloid-neoplasm
nct id
NCT01823198
outcome key
om-0000
arm key
OG000
arm label
Phase I: NK Cell Dose Level 1_10^6
regimen
Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01823198-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-myeloid-neoplasm
nct id
NCT01823198
outcome key
om-0000
arm key
OG001
arm label
Phase I: NK Cell Dose Level 2_10^7
regimen
Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01823198-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-myeloid-neoplasm
nct id
NCT01823198
outcome key
om-0000
arm key
OG002
arm label
Phase I: NK Cell Dose Level 3_ 3x10^7
regimen
Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01823198-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-myeloid-neoplasm
nct id
NCT01823198
outcome key
om-0000
arm key
OG003
arm label
Phase I: NK Cell Dose Level 4_ 10^8
regimen
Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with phase I/II escalation ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01823198-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-myeloid-neoplasm
nct id
NCT01823198
outcome key
om-0000
arm key
OG004
arm label
Phase II: NK Cell Dose Level 3_3x10^7
regimen
Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with phase I/II escalation ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01823198-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-myeloid-neoplasm
nct id
NCT01823198
outcome key
om-0000
arm key
OG005
arm label
Phase II: NK Cell Dose Level 4_ 10^8
regimen
Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with phase I/II escalation ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood
analyzed count
21
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01823198-om-0000#groups/OG005
release id
clinical-indications-draft-1
disease state id
ds-myeloid-neoplasm
nct id
NCT01823198
outcome key
om-0001
arm key
OG000
arm label
Phase I: NK Cell Dose Level 1_10^6
regimen
Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01823198-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-myeloid-neoplasm
nct id
NCT01823198
outcome key
om-0001
arm key
OG001
arm label
Phase I: NK Cell Dose Level 2_10^7
regimen
Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01823198-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-myeloid-neoplasm
nct id
NCT01823198
outcome key
om-0001
arm key
OG002
arm label
Phase I: NK Cell Dose Level 3_ 3x10^7
regimen
Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01823198-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-myeloid-neoplasm
nct id
NCT01823198
outcome key
om-0001
arm key
OG003
arm label
Phase I: NK Cell Dose Level 4_ 10^8
regimen
Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with phase I/II escalation ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01823198-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-myeloid-neoplasm
nct id
NCT01823198
outcome key
om-0001
arm key
OG004
arm label
Phase II: NK Cell Dose Level 3_3x10^7
regimen
Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with phase I/II escalation ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01823198-om-0001#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-myeloid-neoplasm
nct id
NCT01823198
outcome key
om-0001
arm key
OG005
arm label
Phase II: NK Cell Dose Level 4_ 10^8
regimen
Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with phase I/II escalation ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood
analyzed count
21
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01823198-om-0001#groups/OG005

harms

release id
clinical-indications-draft-1
disease state id
ds-myeloid-neoplasm
nct id
NCT01823198
harm key
EG000
source section id
NCT01823198-ae
event group key
EG000
event group label
Phase I: NK Cell Dose Level 1_10^6
serious affected
1
serious at risk
6
other affected
6
other at risk
6
frequency threshold
5
collection period
Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years).
event definition
Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
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-myeloid-neoplasm
nct id
NCT01823198
harm key
EG001
source section id
NCT01823198-ae
event group key
EG001
event group label
Phase I: NK Cell Dose Level 2_10^7
serious affected
2
serious at risk
6
other affected
5
other at risk
6
frequency threshold
5
collection period
Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years).
event definition
Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
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-myeloid-neoplasm
nct id
NCT01823198
harm key
EG002
source section id
NCT01823198-ae
event group key
EG002
event group label
Phase I: NK Cell Dose Level 3_ 3x10^7
serious affected
1
serious at risk
4
other affected
4
other at risk
4
frequency threshold
5
collection period
Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years).
event definition
Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
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-myeloid-neoplasm
nct id
NCT01823198
harm key
EG003
source section id
NCT01823198-ae
event group key
EG003
event group label
Phase I: NK Cell Dose Level 4_ 10^8
serious affected
0
serious at risk
4
other affected
4
other at risk
4
frequency threshold
5
collection period
Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years).
event definition
Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
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-myeloid-neoplasm
nct id
NCT01823198
harm key
EG004
source section id
NCT01823198-ae
event group key
EG004
event group label
Phase II: NK Cell Dose Level 3_3x10^7
serious affected
1
serious at risk
1
other affected
1
other at risk
1
frequency threshold
5
collection period
Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years).
event definition
Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
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-myeloid-neoplasm
nct id
NCT01823198
harm key
EG005
source section id
NCT01823198-ae
event group key
EG005
event group label
Phase II: NK Cell Dose Level 4_ 10^8
serious affected
6
serious at risk
21
other affected
17
other at risk
21
frequency threshold
5
collection period
Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years).
event definition
Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
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-myeloid-neoplasm
nct id
NCT01823198
harm key
EG006
source section id
NCT01823198-ae
event group key
EG006
event group label
Donors
serious affected
0
serious at risk
0
other affected
0
other at risk
0
frequency threshold
5
collection period
Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years).
event definition
Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
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