ClinicalTrials.gg
CompletedNCT01261247Updated May 24, 2022Results posted

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

A Phase 2 interventional study of panobinostat and laboratory biomarker analysis in Adult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma and Angioimmunoblastic T-cell Lymphoma, sponsored by Mayo Clinic. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-24.

Sponsored by Mayo Clinic · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
41
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 11 studies in Lymphoma, Extranodal NK-T-Cell by Mayo Clinic — none open to participants now, 1 under way, none of them phase 3. Lymphoma, Extranodal NK-T-Cell · Mayo Clinic.

Enrollment
7th of 10
41 · median 91
Started
2011
with 1 other
Phase 2
4 of 11
none open now
Registered
8th of 11
by date

Among the 11 studies in Lymphoma, Extranodal NK-T-Cell by Mayo Clinic, this one is the 7th largest by enrollment of the 10 interventional ones that give a count, is one of 2 that started in 2011, is one of 4 in phase 2, and was the 8th registered.

Lymphoma, Extranodal NK-T-Cell

270 studies on the registry are indexed under Lymphoma, Extranodal NK-T-Cell; 36 are open to participants now.

Browse Lymphoma, Extranodal NK-T-Cell studies →

Open to participants now

None of the 11 studies in Lymphoma, Extranodal NK-T-Cell by Mayo Clinic is open now.

Where they have run

Who these studies take

Of the 20 Lymphoma, Extranodal NK-T-Cell studies recruiting now, 11 (55%) set no upper age limit and 8 (40%) stop at 75 or younger; 4 take children under 18; 1 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Download CSVNarrow it in search →With an account: the 11 studies in Lymphoma, Extranodal NK-T-Cell by Mayo Clinic as a file.
02

Study summary

Panobinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well panobinostat works in treating patients with relapsed or refractory non-Hodgkin lymphoma

Read the detailed description

PRIMARY OBJECTIVES: I. To evaluate the proportion of confirmed response of LBH589 in patients with relapsed or refractory non-Hodgkin lymphoma. SECONDARY OBJECTIVES: I. To describe the toxicities associated with LBH589 in patients with NHL. II. To evaluate overall survival, progression-free survival, and duration of response in patients treated with LBH589. TERTIARY OBJECTIVES: I. To evaluate the pharmacokinetics of LBH589. II. To assess the correlation between clinical (toxicity and/or tumor response or activity) effects with the pharmacologic (pharmacokinetic/pharmacodynamic) parameters, and/or biologic (correlative laboratory) results. OUTLINE: Patients receive oral panobinostat 3 times weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for up to 2 years.

03

Conditions studied

  • Adult Nasal Type Extranodal NK/T-cell Lymphoma
  • Anaplastic Large Cell Lymphoma
  • Angioimmunoblastic T-cell Lymphoma
  • Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
  • Hepatosplenic T-cell Lymphoma
  • Nodal Marginal Zone B-cell Lymphoma
  • Peripheral T-cell Lymphoma
  • Post-transplant Lymphoproliferative Disorder
  • Recurrent Adult Burkitt Lymphoma
  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Recurrent Adult Lymphoblastic Lymphoma
  • Recurrent Adult T-cell Leukemia/Lymphoma
  • Recurrent Grade 1 Follicular Lymphoma
  • Recurrent Grade 2 Follicular Lymphoma
  • Recurrent Grade 3 Follicular Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Mycosis Fungoides/Sezary Syndrome
  • Recurrent Small Lymphocytic Lymphoma
  • Small Intestine Lymphoma
  • Splenic Marginal Zone Lymphoma
  • Waldenstrom Macroglobulinemia
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • -proven non-Hodgkin lymphoma requiring treatment, who have failed, unable to tolerate, or refused other available active therapies; patients should not have other treatment options considered curative (NOTE: for patients with lymphoma without CNS involvement, a re-biopsy is necessary unless the patient has had a previous biopsy =\< 6 months prior to treatment on this protocol if there has been no intervening treatment; patients with biopsy-proven CNS lymphoma at any time are not required to have a rebiopsy to be eligible for this study); NOTE: relapsed NHL is defined as NHL that relapses after at least one prior therapy and does not have available curative therapy; refractory NHL is defined as NHL that has progressed or not responded to most recent therapy and has had at least one prior therapy and have no available curative therapies
  • by CT or MRI or the CT portion of the PET/CT: must have at least one lesion that has a single diameter of >= 2 cm or tumor cells in the blood >= 5 x 10\^9/L; skin lesions can be used if the area is >= 2 cm in at least one diameter and photographed with a ruler
  • The following disease types are eligible: transformed lymphomas: diffuse large B cell lymphoma, mantle cell lymphoma, follicular lymphoma grade III; precursor B lymphoblastic leukemia/lymphoma; mediastinal (thymic) large B-cell lymphoma; Burkitt lymphoma/leukemia; precursor T-lymphoblastic leukemia/lymphoma; primary cutaneous anaplastic large cell lymphoma; anaplastic large cell lymphoma - primary systemic type; small lymphocytic lymphoma/chronic lymphocytic leukemia; follicular lymphoma, grades 1, 2; extranodal marginal zone B-cell lymphoma of MALT type; nodal marginal zone B-cell lymphoma; splenic marginal zone B-cell lymphoma; peripheral T cell lymphoma, unspecified; anaplastic large cell lymphoma (T and null cell type); lymphoplasmacytic lymphoma (Waldenstrom Macroglobulinemia); CNS lymphoma; post transplant lymphoproliferative disorders; mycosis fungoides/Sezary syndrome; primary effusion lymphoma; blastic NK-cell lymphoma; adult T-cell leukemia/lymphoma; extranodal NK/T-cell lymphoma, nasal type; enteropathy-type T-cell lymphoma; hepatosplenic T-cell lymphoma; subcutaneous panniculitis-like T-cell lymphoma; angioimmunoblastic T-cell lymphoma; anaplastic large cell lymphoma - primary cutaneous type
  • For lymphoplasmacytic lymphoma patients without measurable lymphadenopathy, measurable disease can be defined by both of the following criteria: bone marrow lymphoplasmacytosis with > 10% lymphoplasmacytic cells or aggregates, sheets, lymphocytes, plasma cells, or lymphoplasmacytic cells on bone marrow biopsy and quantitative IgM monoclonal protein > 1,000 mg/dL
  • >= 1000/uL
  • >= 9 g/dl
  • >= 75,000/uL
  • Total =\< 1.5 x (ULN) or if total bilirubin is > 1.5 x ULN the direct bilirubin must be normal
  • =\< 3 x ULN
  • Albumin > 3.0 g/dl
  • Creatinine =\< 2.5 x ULN
  • Serum potassium, magnesium and phosphorus >= LLN and =\< 1.2 x ULN
  • Total serum calcium [corrected for serum albumin] or ionized calcium >= LLN
  • Clinically euthyroid; patients are permitted to receive thyroid hormone supplements to treat underlying hypothyroidism
  • Baseline or ECHO must demonstrate LVEF >= the lower limit of the institutional normal
  • Ability to understand and the willingness to sign a written document
  • Willingness to return to Mayo Clinic
  • >= 12 weeks
  • Willingness to provide blood and tissues samples for research studies as required by the protocol
  • Negative pregnancy test done =\< 7 days prior to registration, for women of only
  • performance status (PS) 0, 1 or 2

Exclusion criteria

Exclusion Criteria

  • Prior HDAC, DAC, HSP90 inhibitors or valproic acid for the treatment of cancer
  • Patients who will need valproic acid for any medical condition during the study or within 5 days prior to first panobinostat treatment
  • Candidate for known standard therapy for the patient's disease that is potentially curative
  • Uncontrolled infection requiring ongoing antibiotics
  • Any prior therapy for lymphoma within the previous 2 weeks for standard treatments and within 4 weeks for experimental therapies unless the patient has recovered from the nadir of the previous treatment to a level that meets the inclusion criteria
  • Receiving > 20mg of prednisone per day (or equivalent)
  • Persistent toxicities >= grade 2 from prior chemotherapy or biological therapy regardless of interval since last treatment
  • Patients with congenital long syndrome
  • History or presence of sustained ventricular tachyarrhythmia (patients with a history of atrial arrhythmia are eligible but should be discussed with the study PI prior to enrollment)
  • Any history of ventricular fibrillation or torsade de pointes
  • Bradycardia defined as HR \< 50 bpm; patients with pacemakers are eligible if HR >= 50 bpm
  • Screening with a QTcFredericia (QTcF) > 450 msec
  • Right bundle branch block + left anterior hemiblock (bifascicular block)
  • Patients with myocardial infarction or unstable angina =\< 6 months prior registration
  • Other heart disease (e.g. CHF NY Heart Association class III or IV, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen)
  • Pregnant women or women of reproductive ability who are unwilling to use effective during the study and for 3 months after stopping treatment
  • Nursing women
  • Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 3 months after stopping treatment
  • Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered (utilized for a non-FDA-approved indication and in the context of a research investigation); patients should have recovered from any immunotherapy, chemotherapy, or radiation therapy related toxicities
  • Known positivity for (HIV) or with uncontrolled disease; baseline testing for HIV and hepatitis C is not required
  • Active other requiring treatment that would interfere with the assessments of response of the lymphoma to protocol treatment
  • Inability to swallow or impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of the drugs (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea > Grade 2, malabsorption syndrome or small bowel resection) that would preclude use of oral medications
  • Thrombolic or embolic events such as a cerebrovascular accident including within the past 6 months
  • Any severe and/or uncontrolled medical conditions or other conditions that, in the treating physician's opinion, could adversely impact their ability to participate in the study; patients on chronic oxygen therapy, those with liver disease such as cirrhosis, chronic hepatitis or chronic persistent hepatitis, or uncontrolled infections will be excluded
  • Concomitant use of strong or moderate inhibitors
  • Using medications that have a relative risk of prolonging the QT interval or inducing torsade de pointes if treatment cannot be discontinued or switched to a different medication prior to starting study drug
  • Active bleeding tendency. NOTE: Patients on therapeutic anticoagulation should be monitored carefully to maintain therapeutic level of anticoagulation to avoid increased risk of bleeding due to concurrent drug induced thrombocytopenia. It is suggested that patients who require anticoagulation therapy while on therapy use low molecular weight heparin (LMWH).
  • Major surgery =\< 4 weeks prior to registration or have not recovered from side effects of such therapy
  • History of other prior malignancies except for properly treated basal cell or squamous cell carcinoma of skin, in situ cervical cancer, in situ breast cancer or early stage prostate cancer
Terms in these criteria, in plain language(26)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
41 participants (actual)

Study arms

  • Experimental
    Arm I

    Patients receive oral panobinostat 3 times weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

    Drug: panobinostat · Other: laboratory biomarker analysis · Genetic: western blotting · Genetic: DNA analysis · Other: flow cytometry · Other: pharmacological study · Other: immunohistochemistry staining method

Interventions

  • Given orally

    Also known as: Faridak, HDAC inhibitor LBH589, histone deacetylase inhibitor LBH589, LBH589

  • Otherlaboratory biomarker analysis

    Correlative studies

  • Geneticwestern blotting

    Correlative studies

    Also known as: Blotting, Western, Western Blot

  • GeneticDNA analysis

    Correlative studies

  • Otherflow cytometry

    Correlative studies

  • Otherpharmacological study

    Correlative studies

    Also known as: pharmacological studies

  • Otherimmunohistochemistry staining method

    Optional correlative studies

    Also known as: immunohistochemistry

06

What researchers measure

Primary outcomes

  1. Proportion of Confirmed Responses Defined to be a CR or PR Noted as the Objective Status

    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 frame: Every 28 days for up to 2 years

Secondary outcomes

  1. Median Overall Survival Time

    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 frame: Every 6 months for up to 2 years

  2. Median Progression-free Survival Time

    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 frame: Every 6 months for up to 2 years

  3. Duration of Response

    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 frame: Every 6 months for up to 2 years

Other outcomes

  1. 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 frame: At baseline and day 1 of courses 3, 5, 7 and every three courses thereafter for up to 2 years

07

Results

Posted May 17, 2018

Participant flow

Participant flow — Overall Study
MilestoneArm I (LBH589)
Started41
Completed39
Not completed2
Withdrew: Ineligible2

Outcome measures

PrimaryProportion of Confirmed Responses Defined to be a CR or PR Noted as the Objective Status

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 frame:
Every 28 days for up to 2 years
Reported as:
Number · proportion of CR or PR patients
Proportion of Confirmed Responses Defined to be a CR or PR Noted as the Objective Status
proportion of CR or PR patientsArm I (LBH589)
Proportion of Confirmed Responses Defined to be a CR or PR Noted as the Objective Status0.21 (0.07 to 0.38)
SecondaryMedian Overall Survival Time

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 frame:
Every 6 months for up to 2 years
Reported as:
Median · months
Median Overall Survival Time
monthsArm I (LBH589)
Median Overall Survival Time14.9 (8.8 to 46.4)
SecondaryMedian Progression-free Survival Time

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 frame:
Every 6 months for up to 2 years
Reported as:
Median · months
Median Progression-free Survival Time
monthsArm I (LBH589)
Median Progression-free Survival Time3.1 (2.0 to 8.4)
SecondaryDuration of Response

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 frame:
Every 6 months for up to 2 years
Reported as:
Median · months
Duration of Response
monthsArm I (LBH589)
Duration of Response19.7 (15.1 to 28.1)
Other pre-specifiedPharmacokinetic/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 frame:
At baseline and day 1 of courses 3, 5, 7 and every three courses thereafter for up to 2 years

Results for this outcome have not been posted.

Adverse events

Collected over Up to 25 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Arm I (LBH589)0/41 (0%)34/41 (82.9%)38/41 (92.7%)
Most frequent serious events
Showing 10 of 28
Most frequent serious events
EventArm I (LBH589)
Platelet count decreasedInvestigations33/41
Neutrophil count decreasedInvestigations12/41
White blood cell decreasedInvestigations8/41
AnemiaBlood and lymphatic system disorders6/41
FatigueGeneral disorders4/41
Lung infectionInfections and infestations3/41
Lymphocyte count decreasedInvestigations3/41
DiarrheaGastrointestinal disorders2/41
Upper respiratory infectionInfections and infestations2/41
HypophosphatemiaMetabolism and nutrition disorders2/41
Most frequent other events
Showing 10 of 32
Most frequent other events
EventArm I (LBH589)
FatigueGeneral disorders35/41
DiarrheaGastrointestinal disorders31/41
NauseaGastrointestinal disorders29/41
Platelet count decreasedInvestigations19/41
Neutrophil count decreasedInvestigations17/41
VomitingGastrointestinal disorders15/41
White blood cell decreasedInvestigations15/41
AnemiaBlood and lymphatic system disorders11/41
AnorexiaMetabolism and nutrition disorders8/41
Lymphocyte count decreasedInvestigations6/41

Baseline characteristics

Baseline characteristics are summarized for patients who completed the study.

Age, Continuous
Age, Continuous(years)Arm I (LBH589)
Median61.0 (37.0 to 86.0)
Sex: Female, Male
Sex: Female, Male(Participants)Arm I (LBH589)
Female12
Male27
Region of Enrollment
Region of Enrollment(Participants)Arm I (LBH589)
United States39
08

Study locations

2 sites
  • Mayo Clinic in Arizona
    Scottsdale, Arizona, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2011 to primary completion in May 2016, 63 months.

Results were first posted in May 2018, 2 years after primary completion.

Of 39 phase 2 interventional studies under Lymphoma, Extranodal NK-T-Cell, half reached primary completion within 64 months of starting (the median), counting those still running; a quarter within 45 and three quarters within 99. This study's 63 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 14, 2010
First posted
Dec 16, 2010
StartActual
Jan 17, 2011
Primary completionActual
May 9, 2016
CompletionActual
Dec 2, 2019
Results first posted
May 17, 2018
Last update
May 24, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01261247
Lead sponsor
Mayo Clinic
Responsible party
Sponsor
First posted
Dec 16, 2010
Start date
Jan 17, 2011
Primary completion
May 9, 2016
Completion
Dec 2, 2019
Results posted
May 17, 2018
Last update
May 24, 2022

Study contacts

Patrick Johnston, M.D.
study chair · Mayo Clinic

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Panobinostat

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