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← recurrent Cutaneous T-Cell Lymphomas

NCT00918333 · STUDY IN CONTEXT

Panobinostat and Everolimus in Treating Patients With Recurrent Multiple Myeloma, Non-Hodgkin Lymphoma, or 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.

exploratory · NOT_POSTED

Changes in parameters will be both graphically and quantitatively summarized and explored. Standard paired comparisons methodologies (paired t-tests, Wilcoxon signed rank tests and Fisher's exact tests for interval, ordinal and nominal level data, respectively) will be used to assess changes in these variables before and after therapy. In addition, these changes in pharmacologic markers and biological results will be explored in relation to clinical outcome to explore any differences between responders and non-responders.

Source null

→

primary · POSTED

The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Dose-limiting toxicities include non-hematologic events graded 3 or higher and deemed at least possibly related to treatment. A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD. The number of patients reporting a dose-limiting event are reported.

The overall number of participants analyzed noted above were enrolled in and completed Phase I of the study to determine the maximum tolerated dose (MTD).

→

primary · POSTED

For myeloma, a complete response(CR, defined as Negative immunofixation(IFE) of the serum and urine, \< 5% plasma cells in bone marrow(BM), Disappearance of plasmacytomas), stringent CR(sCR, defined as CR plus Normal serum FLC ratio, Absence of clonal cells in BM), very good partial response(VGPR, defined as PR plus Serum and urine M-component detectable by IFE but not on electrophoresis), partial response(PR, defined as a ≥ 50% reduction of serum M-protein and/or reduction in 24-h urinary M-protein by ≥ 90% or to \<200 mg per 24 h), or minor response(MR, defined as ≥25% but \< 49% reduction of serum M-protein and reduction in 24h urine M-protein by 50-89%) noted as the objective status. For lymphoma, a CR(defined as no evidence of measurable disease), or PR(defined as regression of measurable disease and no new sites of disease) noted as the objective status. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients.

Patients who were enrolled in and completed Phase II and treated at a starting dose of 20 mg or 30/40 mg LBH589 were evaluated in this analysis.

→

secondary · POSTED

Overall survival time is defined as the time from registration to death due to any cause. The median and 95% confidence intervals will be estimated using the method of Kaplan-Meier.

Patients who were enrolled in and completed Phase II and treated at a starting dose of 20 mg or 30/40 mg LBH589 were evaluated in this analysis.

→

secondary · POSTED

Progression-free survival time is defined as the time from registration to progression or death due to any cause. Progression is defined for myeloma as Any one or more of the following: Increase of 25% from lowest value in, Serum M-component (absolute increase must be ≥ 0.5 g/dl), Serum M-component increase ≥ 1 g/dl, if lowest M component was ≥ 5 g/dl,Urine M-component (absolute increase must be ≥ 200 mg/24 h), Bone marrow plasma cell percentage (absolute % must be ≥10%) Or any one or more of the following felt related to the underlying clonal plasma cell proliferative disorder: Development of new soft tissue plasmacytomas or bone lesions, Hypercalcemia (≥11.5 mg/dl) Decrease in hemoglobin of ≥2 g/dl, Serum creatinine level ≥2 mg/dl. Progression is defined for lymphoma as any new lesion or increase by ≥50% of previously involved sites from nadir. The median and 95% confidence intervals are estimated using the method of Kaplan-Meier.

Patients who were enrolled in and completed Phase II and treated at a starting dose of 20 mg or 30/40 mg LBH589 were evaluated in this analysis.

→

secondary · POSTED

Duration of response is defined as the time from the date at which the objective status is first noted to be (for myeloma) a complete response (CR, defined as Negative immunofixation(IFE) of the serum and urine, \< 5% plasma cells in bone marrow(BM), Disappearance of plasmacytomas), stringent CR(sCR, defined as CR plus Normal serum FLC ratio, Absence of clonal cells in BM), very good partial response(VGPR, defined as PR plus Serum and urine M-component detectable by IFE but not on electrophoresis), partial response(PR, defined as a ≥ 50% reduction of serum M-protein and/or reduction in 24-h urinary M-protein by ≥ 90% or to \<200 mg per 24 h) or minor response(MR, defined as ≥25% but \< 49% reduction of serum M-protein and reduction in 24h urine M-protein by 50-89%); (for lymphoma) a CR(defined as no evidence of measurable disease), or PR(defined as regression of measurable disease and no new sites of disease) noted as the objective status. Estimated using the method of Kaplan-Meier.

Patients who were enrolled in and completed Phase II and objective status are first noted to be CR, sCR, VGPR, PR or MR were evaluable for this endpoint.

→

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-cutaneous-t-cell-lymphomas-recurrent-c41d0ac8
nct id
NCT00918333
trial label
Panobinostat and Everolimus in Treating Patients With Recurrent Multiple Myeloma, Non-Hodgkin Lymphoma, or 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
2
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-recurrent-c41d0ac8
    nct id
    NCT00918333
    outcome key
    om-0005
    source section id
    NCT00918333-om-0005
    source outcome index
    5
    endpoint
    Change in Pharmacologic (Pharmacokinetic/Pharmacodynamic) Parameters
    endpoint definition
    Changes in parameters will be both graphically and quantitatively summarized and explored. Standard paired comparisons methodologies (paired t-tests, Wilcoxon signed rank tests and Fisher's exact tests for interval, ordinal and nominal level data, respectively) will be used to assess changes in these variables before and after therapy. In addition, these changes in pharmacologic markers and biological results will be explored in relation to clinical outcome to explore any differences between responders and non-responders.
    time origin
    Day 5 and 19 of the first course and then day 1 of each subsequent courses (courses 2-4) prior to the daily dose and 1 and 2 hours after each dose
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-recurrent-c41d0ac8
    nct id
    NCT00918333
    outcome key
    om-0000
    source section id
    NCT00918333-om-0000
    source outcome index
    0
    endpoint
    Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I)
    endpoint definition
    The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Dose-limiting toxicities include non-hematologic events graded 3 or higher and deemed at least possibly related to treatment. A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD. The number of patients reporting a dose-limiting event are reported.
    time origin
    4 weeks
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The overall number of participants analyzed noted above were enrolled in and completed Phase I of the study to determine the maximum tolerated dose (MTD).
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-recurrent-c41d0ac8
    nct id
    NCT00918333
    outcome key
    om-0001
    source section id
    NCT00918333-om-0001
    source outcome index
    1
    endpoint
    Overall Response Rate (Phase II)
    endpoint definition
    For myeloma, a complete response(CR, defined as Negative immunofixation(IFE) of the serum and urine, \< 5% plasma cells in bone marrow(BM), Disappearance of plasmacytomas), stringent CR(sCR, defined as CR plus Normal serum FLC ratio, Absence of clonal cells in BM), very good partial response(VGPR, defined as PR plus Serum and urine M-component detectable by IFE but not on electrophoresis), partial response(PR, defined as a ≥ 50% reduction of serum M-protein and/or reduction in 24-h urinary M-protein by ≥ 90% or to \<200 mg per 24 h), or minor response(MR, defined as ≥25% but \< 49% reduction of serum M-protein and reduction in 24h urine M-protein by 50-89%) noted as the objective status. For lymphoma, a CR(defined as no evidence of measurable disease), or PR(defined as regression of measurable disease and no new sites of disease) noted as the objective status. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients.
    time origin
    Up to 12 courses
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients who were enrolled in and completed Phase II and treated at a starting dose of 20 mg or 30/40 mg LBH589 were evaluated in this analysis.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-recurrent-c41d0ac8
    nct id
    NCT00918333
    outcome key
    om-0002
    source section id
    NCT00918333-om-0002
    source outcome index
    2
    endpoint
    Overall Survival Time (Phase II)
    endpoint definition
    Overall survival time is defined as the time from registration to death due to any cause. The median and 95% confidence intervals will be estimated using the method of Kaplan-Meier.
    time origin
    Time from registration to death due to any cause, assessed up to 2 years post-treatment
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients who were enrolled in and completed Phase II and treated at a starting dose of 20 mg or 30/40 mg LBH589 were evaluated in this analysis.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-recurrent-c41d0ac8
    nct id
    NCT00918333
    outcome key
    om-0003
    source section id
    NCT00918333-om-0003
    source outcome index
    3
    endpoint
    Progression-free Survival (Phase II)
    endpoint definition
    Progression-free survival time is defined as the time from registration to progression or death due to any cause. Progression is defined for myeloma as Any one or more of the following: Increase of 25% from lowest value in, Serum M-component (absolute increase must be ≥ 0.5 g/dl), Serum M-component increase ≥ 1 g/dl, if lowest M component was ≥ 5 g/dl,Urine M-component (absolute increase must be ≥ 200 mg/24 h), Bone marrow plasma cell percentage (absolute % must be ≥10%) Or any one or more of the following felt related to the underlying clonal plasma cell proliferative disorder: Development of new soft tissue plasmacytomas or bone lesions, Hypercalcemia (≥11.5 mg/dl) Decrease in hemoglobin of ≥2 g/dl, Serum creatinine level ≥2 mg/dl. Progression is defined for lymphoma as any new lesion or increase by ≥50% of previously involved sites from nadir. The median and 95% confidence intervals are estimated using the method of Kaplan-Meier.
    time origin
    Time from registration to progression or death due to any cause, assessed up to 2 years post-treatment
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients who were enrolled in and completed Phase II and treated at a starting dose of 20 mg or 30/40 mg LBH589 were evaluated in this analysis.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-recurrent-c41d0ac8
    nct id
    NCT00918333
    outcome key
    om-0004
    source section id
    NCT00918333-om-0004
    source outcome index
    4
    endpoint
    Duration of Response (Phase II)
    endpoint definition
    Duration of response is defined as the time from the date at which the objective status is first noted to be (for myeloma) a complete response (CR, defined as Negative immunofixation(IFE) of the serum and urine, \< 5% plasma cells in bone marrow(BM), Disappearance of plasmacytomas), stringent CR(sCR, defined as CR plus Normal serum FLC ratio, Absence of clonal cells in BM), very good partial response(VGPR, defined as PR plus Serum and urine M-component detectable by IFE but not on electrophoresis), partial response(PR, defined as a ≥ 50% reduction of serum M-protein and/or reduction in 24-h urinary M-protein by ≥ 90% or to \<200 mg per 24 h) or minor response(MR, defined as ≥25% but \< 49% reduction of serum M-protein and reduction in 24h urine M-protein by 50-89%); (for lymphoma) a CR(defined as no evidence of measurable disease), or PR(defined as regression of measurable disease and no new sites of disease) noted as the objective status. Estimated using the method of Kaplan-Meier.
    time origin
    The time from the date at which the patient's objective status is first noted to be a CR, sCR, VGPR, PR, or minor response to the earliest date progression is documented, assessed up to 2 years post-treatment
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients who were enrolled in and completed Phase II and objective status are first noted to be CR, sCR, VGPR, PR or MR were evaluable for this endpoint.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-recurrent-c41d0ac8
    nct id
    NCT00918333
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Phase I (Panobinostat + Everolimus)
    regimen
    Patients receive 10, 15, 20, 30 or 40 mg/day panobinostat PO 3 times/week or on days 1, 3, 5, 15, 17, and 19 and 5 or 10 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    analyzed count
    23
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00918333-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-recurrent-c41d0ac8
    nct id
    NCT00918333
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Phase II (Lymphoma Patients Receiving 20 mg LBL589)
    regimen
    Lymphoma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    analyzed count
    41
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00918333-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-recurrent-c41d0ac8
    nct id
    NCT00918333
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Phase II (Myeloma Patients Receiving 20 mg LBH589)
    regimen
    Myeloma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    analyzed count
    14
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00918333-om-0001#groups/OG001
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-recurrent-c41d0ac8
    nct id
    NCT00918333
    outcome key
    om-0001
    arm key
    OG002
    arm label
    Phase II (Lymphoma Patients Receiving 30/40 mg LBH589)
    regimen
    Lymphoma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    analyzed count
    20
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00918333-om-0001#groups/OG002
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-recurrent-c41d0ac8
    nct id
    NCT00918333
    outcome key
    om-0001
    arm key
    OG003
    arm label
    Phase II (Myeloma Patients Receiving 30/40 mg LBH589)
    regimen
    Myeloma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    analyzed count
    18
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00918333-om-0001#groups/OG003
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-recurrent-c41d0ac8
    nct id
    NCT00918333
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Phase II (Lymphoma Patients Receiving 20 mg LBL589)
    regimen
    Lymphoma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    analyzed count
    41
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00918333-om-0002#groups/OG000
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-recurrent-c41d0ac8
    nct id
    NCT00918333
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Phase II (Myeloma Patients Receiving 20 mg LBH589)
    regimen
    Myeloma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    analyzed count
    14
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00918333-om-0002#groups/OG001
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-recurrent-c41d0ac8
    nct id
    NCT00918333
    outcome key
    om-0002
    arm key
    OG002
    arm label
    Phase II (Lymphoma Patients Receiving 30/40 mg LBH589)
    regimen
    Lymphoma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    analyzed count
    20
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00918333-om-0002#groups/OG002
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-recurrent-c41d0ac8
    nct id
    NCT00918333
    outcome key
    om-0002
    arm key
    OG003
    arm label
    Phase II (Myeloma Patients Receiving 30/40 mg LBH589)
    regimen
    Myeloma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    analyzed count
    18
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00918333-om-0002#groups/OG003
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-recurrent-c41d0ac8
    nct id
    NCT00918333
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Phase II (Lymphoma Patients Receiving 20 mg LBL589)
    regimen
    Lymphoma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    analyzed count
    41
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00918333-om-0003#groups/OG000
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-recurrent-c41d0ac8
    nct id
    NCT00918333
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Phase II (Myeloma Patients Receiving 20 mg LBH589)
    regimen
    Myeloma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    analyzed count
    14
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00918333-om-0003#groups/OG001
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-recurrent-c41d0ac8
    nct id
    NCT00918333
    outcome key
    om-0003
    arm key
    OG002
    arm label
    Phase II (Lymphoma Patients Receiving 30/40 mg LBH589)
    regimen
    Lymphoma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    analyzed count
    20
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00918333-om-0003#groups/OG002
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-recurrent-c41d0ac8
    nct id
    NCT00918333
    harm key
    EG000
    source section id
    NCT00918333-ae
    event group key
    EG000
    event group label
    Phase I (Panobinostat + Everolimus)
    serious affected
    3
    serious at risk
    23
    other affected
    23
    other at risk
    23
    frequency threshold
    0
    collection period
    Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 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 3.0 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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-recurrent-c41d0ac8
    nct id
    NCT00918333
    harm key
    EG001
    source section id
    NCT00918333-ae
    event group key
    EG001
    event group label
    Phase II (Panobinostat + Everolimus)
    serious affected
    25
    serious at risk
    93
    other affected
    92
    other at risk
    93
    frequency threshold
    0
    collection period
    Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 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 3.0 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