NCT00644189 · STUDY IN CONTEXT

Oral Clofarabine for Relapsed/Refractory Non-Hodgkin Lymphoma

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

Determine the efficacy of oral clofarabine (any of the 4 dose levels: 1mg, 2mg, 4mg, and 3mg) in all phase I-II trial patients with relapsed/refractory non-Hodgkin lymphomas. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

all participants from phase I-II trial who are treated with any of the 4 dose levels of oral clofarabine

→

primary · POSTED

Determine the efficacy of oral clofarabine (any of the 4 dose levels: 1mg, 2mg, 4mg, and 3mg) in all phase I trial patients with relapsed/refractory non-Hodgkin lymphomas. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Phase I participants only

→

secondary · POSTED

To determine the efficacy of oral clofarabine (3mg) in patients with relapsed/refractory non-Hodgkin lymphoma. The 3mg dose was declared the recommended phase 2 dose (RP2D) from phase I. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

only participants from phase I-II trial who were treated at the RP2D (3mg)

→

secondary · POSTED

Determine the progression-free survival rate among all phase I-II trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

all participants from phase I-II trial who are treated with any of the 4 dose levels of oral clofarabine

→

secondary · POSTED

Determine the overall survival rate among all phase I-II trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg)

all participants from phase I-II trial who are treated with any of the 4 dose levels of oral clofarabine

→

secondary · POSTED

Grade 3-4 toxicities among all phase I-II trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg)

all phase I-II trial participants who are treated with any of the 4 dose levels of oral clofarabine

→

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-mantle-cell-lymphoma-recurrent-52761bc3
nct id: NCT00644189
trial label: Oral Clofarabine for Relapsed/Refractory Non-Hodgkin Lymphoma
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: 6
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-mantle-cell-lymphoma-recurrent-52761bc3
nct id
NCT00644189
outcome key
om-0000
source section id
NCT00644189-om-0000
source outcome index
0
endpoint
All Phase I-II Participants: Overall Response Rate (ORR)
endpoint definition
Determine the efficacy of oral clofarabine (any of the 4 dose levels: 1mg, 2mg, 4mg, and 3mg) in all phase I-II trial patients with relapsed/refractory non-Hodgkin lymphomas. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
time origin
after at most 6 28-day cycles
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
all participants from phase I-II trial who are treated with any of the 4 dose levels of oral clofarabine
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-mantle-cell-lymphoma-recurrent-52761bc3
nct id
NCT00644189
outcome key
om-0001
source section id
NCT00644189-om-0001
source outcome index
1
endpoint
Phase I Participants Only: Overall Response Rate (ORR)
endpoint definition
Determine the efficacy of oral clofarabine (any of the 4 dose levels: 1mg, 2mg, 4mg, and 3mg) in all phase I trial patients with relapsed/refractory non-Hodgkin lymphomas. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
time origin
after at most 6 28-day cycles
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Phase I participants only
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-mantle-cell-lymphoma-recurrent-52761bc3
nct id
NCT00644189
outcome key
om-0002
source section id
NCT00644189-om-0002
source outcome index
2
endpoint
Phase I-II Participants Treated at the RP2D (3mg): Overall Response Rate (ORR)
endpoint definition
To determine the efficacy of oral clofarabine (3mg) in patients with relapsed/refractory non-Hodgkin lymphoma. The 3mg dose was declared the recommended phase 2 dose (RP2D) from phase I. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
time origin
after at most 6 28-day cycles
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
only participants from phase I-II trial who were treated at the RP2D (3mg)
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-mantle-cell-lymphoma-recurrent-52761bc3
nct id
NCT00644189
outcome key
om-0003
source section id
NCT00644189-om-0003
source outcome index
3
endpoint
All Phase I-II Participants: Progression-free Survival (PFS)
endpoint definition
Determine the progression-free survival rate among all phase I-II trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
time origin
at 1 and 2 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
all participants from phase I-II trial who are treated with any of the 4 dose levels of oral clofarabine
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-mantle-cell-lymphoma-recurrent-52761bc3
nct id
NCT00644189
outcome key
om-0004
source section id
NCT00644189-om-0004
source outcome index
4
endpoint
All Phase I-II Participants: Overall Survival (OS)
endpoint definition
Determine the overall survival rate among all phase I-II trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg)
time origin
3 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
all participants from phase I-II trial who are treated with any of the 4 dose levels of oral clofarabine
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-mantle-cell-lymphoma-recurrent-52761bc3
nct id
NCT00644189
outcome key
om-0005
source section id
NCT00644189-om-0005
source outcome index
5
endpoint
All Phase I-II Participants: Safety
endpoint definition
Grade 3-4 toxicities among all phase I-II trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg)
time origin
during 6 28-day cycles and 90 days out
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
all phase I-II trial participants who are treated with any of the 4 dose levels of oral clofarabine
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-mantle-cell-lymphoma-recurrent-52761bc3
nct id
NCT00644189
outcome key
om-0000
arm key
OG000
arm label
Phase I-II
regimen
Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
analyzed count
50
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00644189-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-mantle-cell-lymphoma-recurrent-52761bc3
nct id
NCT00644189
outcome key
om-0001
arm key
OG000
arm label
Phase I
regimen
Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
analyzed count
30
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00644189-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-mantle-cell-lymphoma-recurrent-52761bc3
nct id
NCT00644189
outcome key
om-0002
arm key
OG000
arm label
Clofarabine
regimen
Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles. Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
analyzed count
36
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00644189-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-mantle-cell-lymphoma-recurrent-52761bc3
nct id
NCT00644189
outcome key
om-0003
arm key
OG000
arm label
Clofarabine
regimen
Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles. Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
analyzed count
50
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00644189-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-mantle-cell-lymphoma-recurrent-52761bc3
nct id
NCT00644189
outcome key
om-0004
arm key
OG000
arm label
Clofarabine
regimen
Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles. Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
analyzed count
50
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00644189-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-mantle-cell-lymphoma-recurrent-52761bc3
nct id
NCT00644189
outcome key
om-0005
arm key
OG000
arm label
Clofarabine
regimen
Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles. Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
analyzed count
50
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00644189-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-mantle-cell-lymphoma-recurrent-52761bc3
nct id
NCT00644189
harm key
EG000
source section id
NCT00644189-ae
event group key
EG000
event group label
Clofarabine
serious affected
15
serious at risk
50
other affected
50
other at risk
50
frequency threshold
5
collection period
Source null
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