NCT01499147 · STUDY IN CONTEXT

Fludarabine Based Conditioning for Allogeneic Transplantation for Advanced 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

Median time to ANC engraftment and platelet engraftment in both groups as well as the transfusion requirements measured within 30 days after transplant.

Source null

→

secondary · POSTED

Day 100 transplant-related mortality was measured in both groups.

Source null

→

secondary · POSTED

Days to ANC or platelet engraftment

Source null

→

secondary · POSTED

Acute GVHD grade 2-4 was assessed in patients in the FluBU and FluMel groups up to 100 days after transplant.

Source null

→

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-lymphoid-leukemia
nct id: NCT01499147
trial label: Fludarabine Based Conditioning for Allogeneic Transplantation for Advanced 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: 4
harms Count: 3
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-lymphoid-leukemia
nct id
NCT01499147
outcome key
om-0000
source section id
NCT01499147-om-0000
source outcome index
0
endpoint
Number of Participants With Engraftment.
endpoint definition
Median time to ANC engraftment and platelet engraftment in both groups as well as the transfusion requirements measured within 30 days after transplant.
time origin
Up to 30 days 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-lymphoid-leukemia
nct id
NCT01499147
outcome key
om-0001
source section id
NCT01499147-om-0001
source outcome index
1
endpoint
Participants With 100 Day Transplant-related Mortality.
endpoint definition
Day 100 transplant-related mortality was measured in both groups.
time origin
Up to 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-lymphoid-leukemia
nct id
NCT01499147
outcome key
om-0002
source section id
NCT01499147-om-0002
source outcome index
2
endpoint
Time to ANC and Platelet Engraftment
endpoint definition
Days to ANC or platelet engraftment
time origin
Up to 30 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-lymphoid-leukemia
nct id
NCT01499147
outcome key
om-0003
source section id
NCT01499147-om-0003
source outcome index
3
endpoint
Number of Participants With Moderate to Severe (Grade 2-4) Acute Graft Versus Host Disease (GVHD).
endpoint definition
Acute GVHD grade 2-4 was assessed in patients in the FluBU and FluMel groups up to 100 days after transplant.
time origin
Up to 100 days post-transplant (acute GVHD).
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-lymphoid-leukemia
nct id
NCT01499147
outcome key
om-0000
arm key
OG000
arm label
Fludarabine/Busulfan + ATG
regimen
All patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor. fludarabine/busulfan: All patients below age 55, should receive fludarabine/busulfan, and ATG in case of unrelated or mismatched donor, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 \<40%, DLCO\<50%, LVEF\<40, Serum bilirubin \>1.5 mg% or serum transaminases \> 2x nl) and/or specific medical conditions such as preventing a standard myeloablative treatment, as per discussion with the PI.
analyzed count
18
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01499147-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-lymphoid-leukemia
nct id
NCT01499147
outcome key
om-0000
arm key
OG001
arm label
Fludarabine/Melphalan + ATG
regimen
All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG. fludarabine/ melphalan: All patients above age 55 or below age 65, should receive fludarabine/melphalan, and ATG, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 \<40%, DLCO\<50%, LVEF\<40, Serum bilirubin \>1.5 mg% or serum transaminases \> 2x nl).
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01499147-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-lymphoid-leukemia
nct id
NCT01499147
outcome key
om-0001
arm key
OG000
arm label
Fludarabine/Busulfan + ATG
regimen
All patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor. fludarabine/busulfan: All patients below age 55, should receive fludarabine/busulfan, and ATG in case of unrelated or mismatched donor, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 \<40%, DLCO\<50%, LVEF\<40, Serum bilirubin \>1.5 mg% or serum transaminases \> 2x nl) and/or specific medical conditions such as preventing a standard myeloablative treatment, as per discussion with the PI.
analyzed count
18
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01499147-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-lymphoid-leukemia
nct id
NCT01499147
outcome key
om-0001
arm key
OG001
arm label
Fludarabine/Melphalan + ATG
regimen
All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG. fludarabine/ melphalan: All patients above age 55 or below age 65, should receive fludarabine/melphalan, and ATG, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 \<40%, DLCO\<50%, LVEF\<40, Serum bilirubin \>1.5 mg% or serum transaminases \> 2x nl).
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01499147-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-lymphoid-leukemia
nct id
NCT01499147
outcome key
om-0002
arm key
OG000
arm label
Fludarabine/Busulfan + ATG
regimen
All patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor. fludarabine/busulfan: All patients below age 55, should receive fludarabine/busulfan, and ATG in case of unrelated or mismatched donor, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 \<40%, DLCO\<50%, LVEF\<40, Serum bilirubin \>1.5 mg% or serum transaminases \> 2x nl) and/or specific medical conditions such as preventing a standard myeloablative treatment, as per discussion with the PI. ATG: Patients receiving a transplant from a matched unrelated or mismatched related/unrelated donor would receive ATG in the conditioning regimen.
analyzed count
18
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01499147-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-lymphoid-leukemia
nct id
NCT01499147
outcome key
om-0002
arm key
OG001
arm label
Fludarabine/Melphalan + ATG
regimen
All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG. fludarabine/ melphalan: All patients above age 55 or below age 65, should receive fludarabine/melphalan, and ATG, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 \<40%, DLCO\<50%, LVEF\<40, Serum bilirubin \>1.5 mg% or serum transaminases \> 2x nl). ATG: Patients receiving a transplant from a matched unrelated or mismatched related/unrelated donor would receive ATG in the conditioning regimen.
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01499147-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-lymphoid-leukemia
nct id
NCT01499147
outcome key
om-0003
arm key
OG000
arm label
Fludarabine/Busulfan + ATG
regimen
All patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor. fludarabine/busulfan: All patients below age 55, should receive fludarabine/busulfan, and ATG in case of unrelated or mismatched donor, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 \<40%, DLCO\<50%, LVEF\<40, Serum bilirubin \>1.5 mg% or serum transaminases \> 2x nl) and/or specific medical conditions such as preventing a standard myeloablative treatment, as per discussion with the PI.
analyzed count
18
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01499147-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-lymphoid-leukemia
nct id
NCT01499147
outcome key
om-0003
arm key
OG001
arm label
Fludarabine/Melphalan +ATG
regimen
All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG. fludarabine/ melphalan: All patients above age 55 or below age 65, should receive fludarabine/melphalan, and ATG, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 \<40%, DLCO\<50%, LVEF\<40, Serum bilirubin \>1.5 mg% or serum transaminases \> 2x nl).
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01499147-om-0003#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-lymphoid-leukemia
nct id
NCT01499147
harm key
EG000
source section id
NCT01499147-ae
event group key
EG000
event group label
Participants With Extra-hematological Toxicities
serious affected
8
serious at risk
30
other affected
0
other at risk
30
frequency threshold
0
collection period
365 days post-transplant
event definition
REGIMEN-RELATED TOXICITY ACCORDING TO ORGAN SYSTEM (ref: Bearman et al: J Clin Oncol vol 6, 1988, 1562-1568)
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-lymphoid-leukemia
nct id
NCT01499147
harm key
EG001
source section id
NCT01499147-ae
event group key
EG001
event group label
FluBu Participants With Extra-hematological Toxicities
serious affected
5
serious at risk
18
other affected
0
other at risk
18
frequency threshold
0
collection period
365 days post-transplant
event definition
REGIMEN-RELATED TOXICITY ACCORDING TO ORGAN SYSTEM (ref: Bearman et al: J Clin Oncol vol 6, 1988, 1562-1568)
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-lymphoid-leukemia
nct id
NCT01499147
harm key
EG002
source section id
NCT01499147-ae
event group key
EG002
event group label
FluMel Participants With Extra-hematological Toxicities
serious affected
3
serious at risk
12
other affected
0
other at risk
12
frequency threshold
0
collection period
365 days post-transplant
event definition
REGIMEN-RELATED TOXICITY ACCORDING TO ORGAN SYSTEM (ref: Bearman et al: J Clin Oncol vol 6, 1988, 1562-1568)
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