NCT01261247 · STUDY IN CONTEXT

Panobinostat in Treating Patients With Relapsed or Refractory Non-Hodgkin Lymphoma

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.

exploratory · NOT_POSTED

Pharmacokinetic/Pharmacodynamic of LBH589 and Correlation With Clinical Effects as Assessed by Immunoblotting, SNPs Analysis, Serum Cytokine Assays, and Flow Cytometry for Suppressive Monocytes (Correlative Studies)

Source null

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primary · POSTED

The primary endpoint of this phase II trial is the proportion of confirmed responses (complete response (CR) or partial response (PR)) noted as the objective status and will be considered synonymous with "success" for this study.Response will be evaluated using all cycles of treatment. A CR is defined using the Cheson et al. Revised Response Criteria for Malignant Lymphoma as Disappearance of all evidence of disease. A PR is defined as Regression of measurable disease and no new sites with ≥50% decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients.

Patients who completed the study were evaluable for the primary outcome. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.

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secondary · POSTED

The median overall survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.

Source null

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secondary · POSTED

The median progression-free survival time is defined as the time from registration to progression or death due to any cause. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier. Progression is defined using the Cheson et al. Revised Response Criteria for Malignant Lymphoma as: Any new lesion or increase by ≥50% of previously involved sites from nadir, Appearance of a new lesion(s) \> 1.5 cm in any axis, ≥50% increase from nadir in SPD of more than one node, or ≥50% increase in longest diameter of a previously identified node \> 1 cm in short axis, Lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy, \> 50% increase from nadir in the SPD of any previous lesions, New or recurrent involvement.

Source null

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secondary · POSTED

Duration of response is defined for all evaluable patients who have achieved a confirmed response as the date at which the patient's objective status is first noted to be a CR or PR to the earliest date progression (PD) is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by ≥50% of previously involved sites from nadir).

Patients who achieved a confirmed response were included in this analysis.

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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-small-intestinal-lymphoma
nct id: NCT01261247
trial label: Panobinostat in Treating Patients With Relapsed or Refractory Non-Hodgkin Lymphoma
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: 5
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-small-intestinal-lymphoma
nct id
NCT01261247
outcome key
om-0004
source section id
NCT01261247-om-0004
source outcome index
4
endpoint
Pharmacokinetic/Pharmacodynamic of LBH589 and Correlation With Clinical Effects as Assessed by Immunoblotting, SNPs Analysis, Serum Cytokine Assays, and Flow Cytometry for Suppressive Monocytes (Correlative Studies)
endpoint definition
Pharmacokinetic/Pharmacodynamic of LBH589 and Correlation With Clinical Effects as Assessed by Immunoblotting, SNPs Analysis, Serum Cytokine Assays, and Flow Cytometry for Suppressive Monocytes (Correlative Studies)
time origin
At baseline and day 1 of courses 3, 5, 7 and every three courses thereafter for up to 2 years
analysis role
exploratory
reporting status
NOT_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-intestinal-lymphoma
nct id
NCT01261247
outcome key
om-0000
source section id
NCT01261247-om-0000
source outcome index
0
endpoint
Proportion of Confirmed Responses Defined to be a CR or PR Noted as the Objective Status
endpoint definition
The primary endpoint of this phase II trial is the proportion of confirmed responses (complete response (CR) or partial response (PR)) noted as the objective status and will be considered synonymous with "success" for this study.Response will be evaluated using all cycles of treatment. A CR is defined using the Cheson et al. Revised Response Criteria for Malignant Lymphoma as Disappearance of all evidence of disease. A PR is defined as Regression of measurable disease and no new sites with ≥50% decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients.
time origin
Every 28 days for up to 2 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Patients who completed the study were evaluable for the primary outcome. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.
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-intestinal-lymphoma
nct id
NCT01261247
outcome key
om-0001
source section id
NCT01261247-om-0001
source outcome index
1
endpoint
Median Overall Survival Time
endpoint definition
The median overall survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.
time origin
Every 6 months for up to 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
release id
clinical-indications-draft-1
disease state id
ds-small-intestinal-lymphoma
nct id
NCT01261247
outcome key
om-0002
source section id
NCT01261247-om-0002
source outcome index
2
endpoint
Median Progression-free Survival Time
endpoint definition
The median progression-free survival time is defined as the time from registration to progression or death due to any cause. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier. Progression is defined using the Cheson et al. Revised Response Criteria for Malignant Lymphoma as: Any new lesion or increase by ≥50% of previously involved sites from nadir, Appearance of a new lesion(s) \> 1.5 cm in any axis, ≥50% increase from nadir in SPD of more than one node, or ≥50% increase in longest diameter of a previously identified node \> 1 cm in short axis, Lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy, \> 50% increase from nadir in the SPD of any previous lesions, New or recurrent involvement.
time origin
Every 6 months for up to 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
release id
clinical-indications-draft-1
disease state id
ds-small-intestinal-lymphoma
nct id
NCT01261247
outcome key
om-0003
source section id
NCT01261247-om-0003
source outcome index
3
endpoint
Duration of Response
endpoint definition
Duration of response is defined for all evaluable patients who have achieved a confirmed response as the date at which the patient's objective status is first noted to be a CR or PR to the earliest date progression (PD) is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by ≥50% of previously involved sites from nadir).
time origin
Every 6 months for up to 2 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Patients who achieved a confirmed response were included in this analysis.
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-intestinal-lymphoma
nct id
NCT01261247
outcome key
om-0000
arm key
OG000
arm label
Arm I (LBH589)
regimen
Patients receive oral 40 mg panobinostat 3 times weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
analyzed count
39
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01261247-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-small-intestinal-lymphoma
nct id
NCT01261247
outcome key
om-0001
arm key
OG000
arm label
Arm I (LBH589)
regimen
Patients receive oral 40 mg panobinostat 3 times weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
analyzed count
39
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01261247-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-small-intestinal-lymphoma
nct id
NCT01261247
outcome key
om-0002
arm key
OG000
arm label
Arm I (LBH589)
regimen
Patients receive oral 40 mg panobinostat 3 times weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
analyzed count
39
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01261247-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-small-intestinal-lymphoma
nct id
NCT01261247
outcome key
om-0003
arm key
OG000
arm label
Arm I (LBH589)
regimen
Patients receive oral 40 mg panobinostat 3 times weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01261247-om-0003#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-small-intestinal-lymphoma
nct id
NCT01261247
harm key
EG000
source section id
NCT01261247-ae
event group key
EG000
event group label
Arm I (LBH589)
serious affected
34
serious at risk
41
other affected
38
other at risk
41
frequency threshold
0
collection period
Up to 25 months
event definition
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
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