NCT00416351 · STUDY IN CONTEXT

Clofarabine in Treating Patients With T-Cell or Natural Killer-Cell Non-Hodgkin's Lymphoma That Has Relapsed or Not Responded to Previous Treatment

Draft scope assessment: unclear. Attached because the study's own record describes recurrent 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

Maximum Tolerated Dose

Source null

→

primary · POSTED

Response rate as defined by complete remission, complete remission unconfirmed, partial remission, positron emission tomography (PET)-negative partial remission, stable disease, and progressive disease (Phase II)

Evaluable participants with Non-Hodgkin's Lymphoma

→

secondary · POSTED

Toxicity as defined by NCI Common Terminology Criteria for Adverse Events v 3.0

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-small-intestine-cancer-recurrent-32754d2e
nct id: NCT00416351
trial label: Clofarabine in Treating Patients With T-Cell or Natural Killer-Cell Non-Hodgkin's Lymphoma That Has Relapsed or Not Responded to Previous Treatment
applicability: unclear
applicability note: Attached because the study's own record describes recurrent 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: 3
harms Count: 5
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-small-intestine-cancer-recurrent-32754d2e
nct id
NCT00416351
outcome key
om-0000
source section id
NCT00416351-om-0000
source outcome index
0
endpoint
Maximum Tolerated Dose
endpoint definition
Maximum Tolerated Dose
time origin
2 years
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-small-intestine-cancer-recurrent-32754d2e
nct id
NCT00416351
outcome key
om-0001
source section id
NCT00416351-om-0001
source outcome index
1
endpoint
Response Rate for Participants With Non-Hodgkin's Lymphoma
endpoint definition
Response rate as defined by complete remission, complete remission unconfirmed, partial remission, positron emission tomography (PET)-negative partial remission, stable disease, and progressive disease (Phase II)
time origin
2 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Evaluable participants with Non-Hodgkin's Lymphoma
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-small-intestine-cancer-recurrent-32754d2e
nct id
NCT00416351
outcome key
om-0002
source section id
NCT00416351-om-0002
source outcome index
2
endpoint
Participants Evaluated for Toxicity
endpoint definition
Toxicity as defined by NCI Common Terminology Criteria for Adverse Events v 3.0
time origin
2 years
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-small-intestine-cancer-recurrent-32754d2e
nct id
NCT00416351
outcome key
om-0000
arm key
OG000
arm label
Clofarabine
regimen
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels. clofarabine
analyzed count
29
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00416351-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-small-intestine-cancer-recurrent-32754d2e
nct id
NCT00416351
outcome key
om-0001
arm key
OG000
arm label
4 mg/m2/Day Clofarabine
regimen
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00416351-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-small-intestine-cancer-recurrent-32754d2e
nct id
NCT00416351
outcome key
om-0001
arm key
OG001
arm label
8 mg/m2/Day Clofarabine
regimen
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 8 mg/m2/day and will be escalated to higher dose levels.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00416351-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-small-intestine-cancer-recurrent-32754d2e
nct id
NCT00416351
outcome key
om-0001
arm key
OG002
arm label
13.2 mg/m2/Day Clofarabine
regimen
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 13.2 mg/m2/day and will be escalated to higher dose levels.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00416351-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-small-intestine-cancer-recurrent-32754d2e
nct id
NCT00416351
outcome key
om-0001
arm key
OG003
arm label
20 mg/m2/Day Clofarabine
regimen
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 20 mg/m2/day and will be escalated to higher dose levels.
analyzed count
17
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00416351-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-small-intestine-cancer-recurrent-32754d2e
nct id
NCT00416351
outcome key
om-0001
arm key
OG004
arm label
28 mg/m2/Day Clofarabine
regimen
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 28 mg/m2/day and will be escalated to higher dose levels.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00416351-om-0001#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-small-intestine-cancer-recurrent-32754d2e
nct id
NCT00416351
outcome key
om-0002
arm key
OG000
arm label
4 mg/m2/Day Clofarabine
regimen
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00416351-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-small-intestine-cancer-recurrent-32754d2e
nct id
NCT00416351
outcome key
om-0002
arm key
OG001
arm label
8 mg/m2/Day Clofarabine
regimen
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00416351-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-small-intestine-cancer-recurrent-32754d2e
nct id
NCT00416351
outcome key
om-0002
arm key
OG002
arm label
13.2 mg/m2/Day Clofarabine
regimen
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00416351-om-0002#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-small-intestine-cancer-recurrent-32754d2e
nct id
NCT00416351
outcome key
om-0002
arm key
OG003
arm label
20 mg/m2/Day Clofarabine
regimen
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
analyzed count
17
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00416351-om-0002#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-small-intestine-cancer-recurrent-32754d2e
nct id
NCT00416351
outcome key
om-0002
arm key
OG004
arm label
28 mg/m2/Day Clofarabine
regimen
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00416351-om-0002#groups/OG004

harms

release id
clinical-indications-draft-1
disease state id
ds-small-intestine-cancer-recurrent-32754d2e
nct id
NCT00416351
harm key
EG000
source section id
NCT00416351-ae
event group key
EG000
event group label
4 mg/m2/Day Clofarabine
serious affected
0
serious at risk
1
other affected
1
other at risk
1
frequency threshold
0
collection period
2 years
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
release id
clinical-indications-draft-1
disease state id
ds-small-intestine-cancer-recurrent-32754d2e
nct id
NCT00416351
harm key
EG001
source section id
NCT00416351-ae
event group key
EG001
event group label
8 mg/m2/Day Clofarabine
serious affected
1
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
2 years
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
release id
clinical-indications-draft-1
disease state id
ds-small-intestine-cancer-recurrent-32754d2e
nct id
NCT00416351
harm key
EG002
source section id
NCT00416351-ae
event group key
EG002
event group label
13.2 mg/m2/Day Clofarabine
serious affected
1
serious at risk
4
other affected
4
other at risk
4
frequency threshold
0
collection period
2 years
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
release id
clinical-indications-draft-1
disease state id
ds-small-intestine-cancer-recurrent-32754d2e
nct id
NCT00416351
harm key
EG003
source section id
NCT00416351-ae
event group key
EG003
event group label
20 mg/m2/Day Clofarabine
serious affected
13
serious at risk
17
other affected
17
other at risk
17
frequency threshold
0
collection period
2 years
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
release id
clinical-indications-draft-1
disease state id
ds-small-intestine-cancer-recurrent-32754d2e
nct id
NCT00416351
harm key
EG004
source section id
NCT00416351-ae
event group key
EG004
event group label
28 mg/m2/Day Clofarabine
serious affected
4
serious at risk
4
other affected
4
other at risk
4
frequency threshold
0
collection period
2 years
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