Donor Umbilical Cord Blood Stem Cell Transplant in Treating Patients With 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. 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

Number of participants alive at 180 days post engraftment.

All participants that went on study, whether completing engraftment or not.

→

secondary · POSTED

Number of participants that were able to complete engraftment by day 42.

Participants that went on study.

→

secondary · POSTED

Number of participants that were alive.

Participants that completed engraftment. 10 participants completed engraftment by day 42 and 1 participant completed engraftment by day 46.

→

secondary · POSTED

Number of participants that were alive.

Participants that completed engraftment. 10 participants completed engraftment by day 42 and 1 participant completed engraftment by day 46.

→

secondary · POSTED

Number of participants that were disease free

Participants that completed engraftment. 10 participants completed engraftment by day 42 and 1 participant completed engraftment by day 46.

→

secondary · POSTED

Number of participants that were disease free

Participants that completed engraftment. 10 participants completed engraftment by day 42 and 1 participant completed engraftment by day 46.

→

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-t-cell-large-granular-lymphocyte-leukemia
nct id: NCT01093586
trial label: Donor Umbilical Cord Blood Stem Cell Transplant in Treating Patients With 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. 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-t-cell-large-granular-lymphocyte-leukemia
nct id
NCT01093586
outcome key
om-0000
source section id
NCT01093586-om-0000
source outcome index
0
endpoint
Overall Survival
endpoint definition
Number of participants alive at 180 days post engraftment.
time origin
On day +180
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All participants that went on study, whether completing engraftment or not.
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-t-cell-large-granular-lymphocyte-leukemia
nct id
NCT01093586
outcome key
om-0001
source section id
NCT01093586-om-0001
source outcome index
1
endpoint
Hematologic Engraftment
endpoint definition
Number of participants that were able to complete engraftment by day 42.
time origin
On day +42
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Participants that went on study.
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-t-cell-large-granular-lymphocyte-leukemia
nct id
NCT01093586
outcome key
om-0002
source section id
NCT01093586-om-0002
source outcome index
2
endpoint
Overall Survival
endpoint definition
Number of participants that were alive.
time origin
At 1 year
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Participants that completed engraftment. 10 participants completed engraftment by day 42 and 1 participant completed engraftment by day 46.
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-t-cell-large-granular-lymphocyte-leukemia
nct id
NCT01093586
outcome key
om-0003
source section id
NCT01093586-om-0003
source outcome index
3
endpoint
Overall Survival
endpoint definition
Number of participants that were alive.
time origin
At 2 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Participants that completed engraftment. 10 participants completed engraftment by day 42 and 1 participant completed engraftment by day 46.
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-t-cell-large-granular-lymphocyte-leukemia
nct id
NCT01093586
outcome key
om-0004
source section id
NCT01093586-om-0004
source outcome index
4
endpoint
Disease Free
endpoint definition
Number of participants that were disease free
time origin
At 1 year
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Participants that completed engraftment. 10 participants completed engraftment by day 42 and 1 participant completed engraftment by day 46.
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-t-cell-large-granular-lymphocyte-leukemia
nct id
NCT01093586
outcome key
om-0005
source section id
NCT01093586-om-0005
source outcome index
5
endpoint
Disease Free
endpoint definition
Number of participants that were disease free
time origin
At 2 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Participants that completed engraftment. 10 participants completed engraftment by day 42 and 1 participant completed engraftment by day 46.
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-t-cell-large-granular-lymphocyte-leukemia
nct id
NCT01093586
outcome key
om-0000
arm key
OG000
arm label
Arm I
regimen
PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45.
analyzed count
14
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01093586-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-t-cell-large-granular-lymphocyte-leukemia
nct id
NCT01093586
outcome key
om-0001
arm key
OG000
arm label
Arm I
regimen
PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45.
analyzed count
14
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01093586-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-t-cell-large-granular-lymphocyte-leukemia
nct id
NCT01093586
outcome key
om-0002
arm key
OG000
arm label
Arm I
regimen
PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45.
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01093586-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-t-cell-large-granular-lymphocyte-leukemia
nct id
NCT01093586
outcome key
om-0003
arm key
OG000
arm label
Arm I
regimen
PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45.
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01093586-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-t-cell-large-granular-lymphocyte-leukemia
nct id
NCT01093586
outcome key
om-0004
arm key
OG000
arm label
Arm I
regimen
PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45.
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01093586-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-t-cell-large-granular-lymphocyte-leukemia
nct id
NCT01093586
outcome key
om-0005
arm key
OG000
arm label
Arm I
regimen
PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45.
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01093586-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-t-cell-large-granular-lymphocyte-leukemia
nct id
NCT01093586
harm key
EG000
source section id
NCT01093586-ae
event group key
EG000
event group label
Arm I
serious affected
9
serious at risk
14
other affected
0
other at risk
0
frequency threshold
5
collection period
Adverse Events were collected from participant start on study to going off study up to a period of 2 years.
event definition
Non serious events were not collected. The protocol was assessing efficacy of cord blood in transplants, therefore the research was only gathering SAEs of grade 3 or 4.
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