T-Cell Replete Haploidentical Donor Hematopoietic Stem Cell Plus Natural Killer (NK) Cell Transplantation in Patients With Hematologic Malignancies Relapsed or Refractory Despite P

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

Evaluate the number of participants alive at 1 year. The number of participants surviving to one-year post-transplantation is given.

Source null

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secondary · POSTED

Estimate the incidence of malignant relapse at one year post-transplant. The number of participants with malignant relapse or progressive disease is given. Relapse was evaluated using standard WHO criteria for each disease.

Source null

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secondary · POSTED

Estimate the EFS at one-year post-transplantation. The event is defined as relapse or death due to any cause. The number of participants who were alive without relapse at one year post-transplant is reported.

Source null

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secondary · POSTED

Estimate the DFS at one-year post-transplantation. The event is defined as relapse or death due to relapse. The number of participants who did not relapse up to one year post transplant is reported.

Source null

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secondary · POSTED

The number of participants with acute GVHD is given, organized by grade. Participants are graded on a scale from 1 to 4, with 1 being mild and 4 being severe.

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secondary · POSTED

The severity of chronic GVHD will be described. Chronic GVHD was evaluated using NIH Consensus Global Severity Scoring. The number of participants with chronic GVHD is given, organized by severity.

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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-juvenile-myelomonocytic-leukemia-refractory-33e0633a
nct id: NCT01621477
trial label: T-Cell Replete Haploidentical Donor Hematopoietic Stem Cell Plus Natural Killer (NK) Cell Transplantation in Patients With Hematologic Malignancies Relapsed or Refractory Despite P
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: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-juvenile-myelomonocytic-leukemia-refractory-33e0633a
nct id
NCT01621477
outcome key
om-0000
source section id
NCT01621477-om-0000
source outcome index
0
endpoint
One-year Survival (OS)
endpoint definition
Evaluate the number of participants alive at 1 year. The number of participants surviving to one-year post-transplantation is given.
time origin
One year post transplant
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-juvenile-myelomonocytic-leukemia-refractory-33e0633a
nct id
NCT01621477
outcome key
om-0001
source section id
NCT01621477-om-0001
source outcome index
1
endpoint
Incidence of Malignant Relapse
endpoint definition
Estimate the incidence of malignant relapse at one year post-transplant. The number of participants with malignant relapse or progressive disease is given. Relapse was evaluated using standard WHO criteria for each disease.
time origin
One year 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-juvenile-myelomonocytic-leukemia-refractory-33e0633a
nct id
NCT01621477
outcome key
om-0002
source section id
NCT01621477-om-0002
source outcome index
2
endpoint
Event-Free Survival (EFS)
endpoint definition
Estimate the EFS at one-year post-transplantation. The event is defined as relapse or death due to any cause. The number of participants who were alive without relapse at one year post-transplant is reported.
time origin
one year post transplant
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-juvenile-myelomonocytic-leukemia-refractory-33e0633a
nct id
NCT01621477
outcome key
om-0003
source section id
NCT01621477-om-0003
source outcome index
3
endpoint
Disease-Free Survival (DFS)
endpoint definition
Estimate the DFS at one-year post-transplantation. The event is defined as relapse or death due to relapse. The number of participants who did not relapse up to one year post transplant is reported.
time origin
one year post transplant
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-juvenile-myelomonocytic-leukemia-refractory-33e0633a
nct id
NCT01621477
outcome key
om-0004
source section id
NCT01621477-om-0004
source outcome index
4
endpoint
Incidence and Severity of Acute Graft Versus Host Disease (GVHD)
endpoint definition
The number of participants with acute GVHD is given, organized by grade. Participants are graded on a scale from 1 to 4, with 1 being mild and 4 being severe.
time origin
100 days post transplant
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-juvenile-myelomonocytic-leukemia-refractory-33e0633a
nct id
NCT01621477
outcome key
om-0005
source section id
NCT01621477-om-0005
source outcome index
5
endpoint
Incidence and Severity of Chronic Graft Versus Host Disease (GVHD)
endpoint definition
The severity of chronic GVHD will be described. Chronic GVHD was evaluated using NIH Consensus Global Severity Scoring. The number of participants with chronic GVHD is given, organized by severity.
time origin
100 days post transplant
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-juvenile-myelomonocytic-leukemia-refractory-33e0633a
nct id
NCT01621477
outcome key
om-0000
arm key
OG000
arm label
Treatment
regimen
Study participants (excluding donors) who were enrolled and underwent transplant.
analyzed count
17
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01621477-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-juvenile-myelomonocytic-leukemia-refractory-33e0633a
nct id
NCT01621477
outcome key
om-0001
arm key
OG000
arm label
Treatment
regimen
Study participants (excluding donors) who were enrolled and underwent transplant.
analyzed count
17
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01621477-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-juvenile-myelomonocytic-leukemia-refractory-33e0633a
nct id
NCT01621477
outcome key
om-0002
arm key
OG000
arm label
Treatment
regimen
Study participants (excluding donors) who were enrolled and underwent transplant.
analyzed count
17
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01621477-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-juvenile-myelomonocytic-leukemia-refractory-33e0633a
nct id
NCT01621477
outcome key
om-0003
arm key
OG000
arm label
Treatment
regimen
Study participants (excluding donors) who were enrolled and underwent transplant.
analyzed count
17
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01621477-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-juvenile-myelomonocytic-leukemia-refractory-33e0633a
nct id
NCT01621477
outcome key
om-0004
arm key
OG000
arm label
Treatment
regimen
Study participants (excluding donors) who were enrolled and underwent transplant.
analyzed count
17
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01621477-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-juvenile-myelomonocytic-leukemia-refractory-33e0633a
nct id
NCT01621477
outcome key
om-0005
arm key
OG000
arm label
Treatment
regimen
Study participants (excluding donors) who were enrolled and underwent transplant.
analyzed count
17
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01621477-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-juvenile-myelomonocytic-leukemia-refractory-33e0633a
nct id
NCT01621477
harm key
EG000
source section id
NCT01621477-ae
event group key
EG000
event group label
Treatment
serious affected
10
serious at risk
17
other affected
17
other at risk
17
frequency threshold
0
collection period
Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
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