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CompletedNCT00742027Updated Jul 28, 2021Results posted

Phase II Study of Oral Panobinostat in Adult Participants With Relapsed/Refractory Classical Hodgkin's Lymphoma

A Phase 2 interventional study of Panobinostat in Classical Hodgkin's Lymphoma, sponsored by Novartis Pharmaceuticals. Completed at 46 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-28.

Sponsored by Novartis Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
129
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This study evaluated the efficacy of oral panobinostat in participants with refractory/relapsed classical Hodgkins lymphoma (HL) who have received prior treatment with high dose chemotherapy and autologous stem cell transplant. Safety of panobinostat also was assessed. Other markers that may correlate with efficacy or safety were explored.

02

Conditions studied

  • Classical Hodgkin's Lymphoma

Keywords

  • Classical Hodgkin Lymphoma
  • Classical Hodgkin's Lymphoma
  • Hodgkin Lymphoma
  • Hodgkin's Lymphoma
  • Nodular sclerosing
  • Mixed-cellularity
  • Lymphocyte-rich
  • Lymphocyte depleted
  • HL
  • Classical HL
  • Refractory Hodgkin's Lymphoma
  • Refractory Hodgkin Lymphoma
  • Refractory HL
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 129 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Inclusion criteria

  1. Participant age is ≥ 18 years.
  2. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
  3. Participant has a history of classical Hodgkin's Lymphoma (HL) (i.e. Nodular sclerosing, Mixed-cellularity, Lymphocyte-rich, Lymphocyte depleted).

  4. Participant has progressive disease after receiving high dose chemotherapy with autologous hematopoietic stem cell transplant (AHSCT).

    Note: If last therapy was ≥ 18 months ago, then biopsy should be performed to confirm diagnosis.

    Note: Participant should have received ≤ 5 prior systemic treatment regimens (See Post-text supplement 2 for definitions and examples).

    Note: Participant will be allowed on study who have also received an allogeneic hematopoietic stem cell transplant, however this therapy alone is not sufficient for inclusion into this study.

  5. Participant has at least one site of measurable nodal disease at baseline ≥ 2.0 centimeter (cm) in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by computed tomography (CT) scan (magnetic resonance imaging [MRI] is allowed only if CT scan can not be performed).

    Note: Participant with bone marrow involvement are eligible, but this criteria alone should not be used for disease measurement.

  6. Participant has the following laboratory values (labs may be repeated, if needed, to obtain acceptable values before screen fail):

    • Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/liter (L) [International System of Units {SI} units 1.5 x 10\^9/L].
    • Platelet count ≥ 75 x 10\^9/L.
    • Serum potassium, magnesium, phosphorus, sodium, total calcium (corrected for serum albumin) or ionized calcium within normal limits (WNL) for the institution.

    Note: Potassium, calcium, magnesium, sodium, and/or phosphorus supplements may be given to correct values that are \< lower limits of normal (LLN). Post-correction values must not be deemed to be a clinically significant abnormality prior to participant being dosed.

    • Serum creatinine ≤ 1.5 x upper limits of normal (ULN).
    • Serum bilirubin ≤ 1.5 x ULN (or ≤ 3.0 x ULN, if participant has Gilbert syndrome).
    • Aspartate transaminase (AST)/ serum glutamic oxaloacetic transaminase (SGOT) and/or alanine transaminase (ALT)/ serum glutamic pyruvic transaminase (SGPT) ≤ 2.5 x ULN or ≤ 5.0 x ULN if the transaminase elevation is due to disease involvement.
  7. Clinically euthyroid. Note: Participants are permitted to receive thyroid hormone supplements to treat underlying hypothyroidism.
  8. Written informed consent was obtained from the participant prior to any study-specific screening procedures.
  9. Participant has the ability to swallow capsules or tablets.

Exclusion criteria

Exclusion Criteria:

  1. Participant has a history of prior treatment with a deacetylase (DAC) inhibitor including panobinostat.
  2. Participant will need valproic acid for any medical condition during the study or within 5 days prior to the first panobinostat treatment.
  3. Participant has been treated with monoclonal antibody therapy (e.g., rituximab or anti CD-30 antibody, etc.) within 4 weeks of start of study treatment.
  4. Participant has received chemotherapy or any investigational drug or undergone major surgery ≤ 2 weeks prior to starting study drug or whose side effects of such therapy have not resolved to ≤ grade 1.
  5. Participant has been treated with > 5 prior systemic lines of treatment (see Post-text supplement 2 for definitions and examples).
  6. Participant has received prior radiation therapy ≤ 4 weeks or limited field radiotherapy ≤ 2 weeks prior to start of study treatment or whose side effects of such therapy have not resolved to ≤ grade 1.
  7. Participant is using any anti-cancer therapy concomitantly.
  8. Participant treated with allogeneic hematopoietic stem cell transplant who is currently on or has received immunosuppressive therapy within 90 days prior to start of screening and/or have ≥ Grade 2 graft versus host disease (GvHD).
  9. Participant has a history of another primary malignancy ≤ 3 years before study entry, with the exception of non-melanoma skin cancer, and carcinoma in situ of uterine cervix.
  10. Participant has a history of central nervous system (CNS) involvement with lymphoma.

  11. Participant has impaired cardiac function including any of the following:

    • Complete left bundle branch block or use of a permanent cardiac pacemaker, congenital long QT syndrome, history or presence of ventricular tachyarrhythmias, clinically significant resting bradycardia (\<50 beats per minute [bpm]), QT interval (QTcF) > 450 milliseconds (msec) on screening electrocardiography (ECG), or right bundle branch block + left anterior hemiblock (bifascicular block).
    • Presence of atrial fibrillation (ventricular heart rate >100 bpm).
    • Previous history angina pectoris or acute myocardial infarction (MI) within 6 months.
    • Congestive heart failure (New York Heart Association functional classification III-IV) or baseline multigated acquisition (MUGA)/Echo shows left ventricular ejection fraction (LVEF) \< 45%.
  12. Participant has any other clinically significant heart disease (e.g., uncontrolled hypertension).
  13. Participant has an impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of panobinostat (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, obstruction, or stomach and/or small bowel resection).
  14. Participant has unresolved diarrhea ≥ grade 2.
  15. Participant has any other concurrent severe and/or uncontrolled medical condition(s) (e.g., uncontrolled diabetes mellitus, active or uncontrolled infection, chronic obstructive or chronic restrictive pulmonary disease including dyspnoea at rest from any cause) that could cause unacceptable safety risks or compromise compliance with the protocol.
  16. Participant has a known history of human immunodeficiency virus (HIV) seropositivity (screening HIV testing is not required).
  17. Participant is using medications that have a relative risk of prolonging the QT interval or of inducing Torsade de Pointes, where such treatment cannot be discontinued or switched to a different medication prior to starting study drug.
  18. Participant is a woman who is pregnant or breast feeding, or a women of childbearing potential (WOCBP) not willing to use a double method of contraception during the study through 3 months after the end of treatment. One of these methods of contraception must be a barrier method. WOCBP are defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months). WOCBP must have a negative serum pregnancy test at baseline.

  19. Male participant whose sexual partner(s) are WOCBP who are not willing to use a double method of contraception, one of which includes a condom, during the study and for 3 months after the end of treatment.

    Participants with any of the following contraindications to positron emission tomography (PET) are excluded from the [18F]- fludeoxyglucose (FDG) PET study (only applicable for centers participating in the PET study):

  20. Fasting blood glucose above 200 milligrams per deciliter (mg/dL), at time of PET scan.
  21. Inability to lay down for 60 minutes or has a history of claustrophobia.
  22. Participant not at a participating center.
05

Study design

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

Study arms

  • Experimental
    Panobinostat

    Participants received panobinostat 40 mg, capsules, orally, thrice every week (i.e. days 1, 3 and 5), in each cycle of 21 days until unacceptable toxicity, disease progression, start of new anti-cancer therapy or withdrawal of consent (up to approximately 48 months).

    Drug: Panobinostat

Interventions

  • DrugPanobinostat

    Panobinostat hard gelatin capsules.

    Also known as: LBH589, LBH

06

What researchers measure

Primary outcomes

  1. Objective Response Rate (ORR) as Assessed by the Investigator Based on Cheson Response Criteria

    ORR was number of participants with best overall disease response of complete response(CR)/partial response(PR).Best overall disease response was best disease response recorded from start of treatment until disease progression/recurrence.CR=complete normalization of all index nodal,extranodal lesions,complete disappearance of all extranodal lesions.PR=50% decrease in SPD for up to 6 identified dominant lesions (splenic,hepatic nodules) from baseline.Stable=neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease (PD), reference smallest sum diameters while on study.Progression=50% increase in sum of longest diameter of all target lesions,from smallest sum of longest diameter of all target lesions recorded at or after baseline/a new lesion/progression of non-target lesions.Unknown is progression not documented,one/more of index lesions not assessed or have been assessed using a different method than baseline at the time of radiologic evaluation.

    Time frame: From the start of the treatment of last participant up to 32 weeks

Secondary outcomes

  1. Response Rate Based on Central Review of Computed Tomography (CT) Scan/Magnetic Resonance Imaging (MRI)

    Best overall radiological response (CT/MRI) was recorded from start of treatment until progression/ recurrence. CR=complete normalization of all index nodal,extranodal lesions,complete disappearance of all extranodal lesions.PR=50% decrease in SPD for up to 6 identified dominant lesions (splenic,hepatic nodules) from baseline.Stable=neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease (PD), reference smallest sum diameters while on study.Progression=50% increase in sum of longest diameter of all target lesions,from smallest sum of longest diameter of all target lesions recorded at or after baseline/a new lesion/progression of non-target lesions.Unknown is progression not documented,one/more of index lesions not assessed or have been assessed using a different method than baseline at the time of radiologic evaluation.

    Time frame: From start of treatment until progression/recurrence or start of a new cancer therapy (up to approximately 5 years)

  2. Time To Overall Disease Response in Responders

    Time to overall disease response (CR or PR) was defined as the time from the date of randomization/start of treatment to the date of first documented disease response (PR or CR). Per Cheson response criteria, CR= is a complete normalization of all index nodal and extranodal lesions and complete disappearance of all extranodal lesions. PR= is a 50% decrease in the SPD for up to 6 identified dominant lesions, including splenic and hepatic nodules from baseline. Participants were considered responders if they had a partial or complete response to a treatment while in the study as per Investigator's assessment.

    Time frame: From the start of treatment up to approximately 5 years

  3. Duration of Overall Disease Response

    Duration of overall response (CR or PR) was defined as the time from the date of first documented disease response (CR or PR) to the date of first documented progression or death due to lymphoma. Per Cheson response criteria, CR= is a complete normalization of all index nodal and extranodal lesions and complete disappearance of all extranodal lesions. PR= is a 50% decrease in the SPD for up to 6 identified dominant lesions, including splenic and hepatic nodules from baseline. Participants were considered responders if they had a partial or complete response to a treatment while in the study.

    Time frame: From the start of treatment up to approximately 5 years

  4. Progression Free Survival (PFS)

    Progression-free survival (PFS) was defined as the time from the date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause. If a participant has not had an event, progression-free survival was censored at the date of the last adequate assessment.

    Time frame: From the start of treatment up to approximately 5 years

  5. The Overall Survival (OS)

    OS was the duration from date of randomization to date of death from any cause. If a participant has not had an event, overall survival was censored at the date of the last adequate assessment.

    Time frame: Baseline to date of death from any cause (up to approximately 5 years)

  6. Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), And Deaths as a Measure of Safety and Tolerability of Panobinostat

    An AE is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) occurring after signing the informed consent even if the event is not considered to be related to the study drug(s). SAEs are AEs leading to death, are life-threatening, require hospitalizations or prolongation of hospitalizations, represent an innate malformation or a congenital abnormality.

    Time frame: Up to approximately 5 years

  7. Maximum Observed Concentration (Cmax) of Panobinostat

    Time frame: Cycle 1, Day 1: Pre-dose, 0.25, 1, 3, 5, 7, 24, and 28 hours post-dose

  8. The Time to Reach Maximum Plasma Concentration (Tmax) of Panobinostat

    Time frame: Cycle 1, Day 1: Pre-dose, 0.25, 1, 3, 5, 7, 24, and 28 hours post-dose

  9. Area Under the Plasma Concentration-Time Curve From Time Zero to 28 Hours (AUC0-28) for Panobinostat

    Time frame: Cycle 1, Day 1: Pre-dose, 0.25, 1, 3, 5, 7, 24, and 28 hours post-dose

  10. Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-∞) for Panobinostat

    Time frame: Cycle 1, Day 1: Pre-dose, 0.25, 1, 3, 5, 7, 24, and 28 hours post-dose

07

Results

Posted Jun 3, 2021

Participant flow

Participants were enrolled at 45 sites in 13 countries from 16 September 2008 to 12 August 2013.

Participant flow — Overall Study
MilestonePanobinostat
Started129
Completed0
Not completed129
Withdrew: Disease progression76
Withdrew: New cancer therapy19
Withdrew: Withdrawal by subject18
Withdrew: Death7
Withdrew: Lost to follow-up4
Withdrew: Follow up phase completed as per protocol2
Withdrew: Missing2
Withdrew: Administrative problems1

Outcome measures

PrimaryObjective Response Rate (ORR) as Assessed by the Investigator Based on Cheson Response Criteria

ORR was number of participants with best overall disease response of complete response(CR)/partial response(PR).Best overall disease response was best disease response recorded from start of treatment until disease progression/recurrence.CR=complete normalization of all index nodal,extranodal lesions,complete disappearance of all extranodal lesions.PR=50% decrease in SPD for up to 6 identified dominant lesions (splenic,hepatic nodules) from baseline.Stable=neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease (PD), reference smallest sum diameters while on study.Progression=50% increase in sum of longest diameter of all target lesions,from smallest sum of longest diameter of all target lesions recorded at or after baseline/a new lesion/progression of non-target lesions.Unknown is progression not documented,one/more of index lesions not assessed or have been assessed using a different method than baseline at the time of radiologic evaluation.

Time frame:
From the start of the treatment of last participant up to 32 weeks
Reported as:
Count of participants · Participants
Objective Response Rate (ORR) as Assessed by the Investigator Based on Cheson Response Criteria
ParticipantsPanobinostat
Complete Response5
Partial Response30
Stable Disease71
Progressive Disease14
Unknown9
SecondaryResponse Rate Based on Central Review of Computed Tomography (CT) Scan/Magnetic Resonance Imaging (MRI)

Best overall radiological response (CT/MRI) was recorded from start of treatment until progression/ recurrence. CR=complete normalization of all index nodal,extranodal lesions,complete disappearance of all extranodal lesions.PR=50% decrease in SPD for up to 6 identified dominant lesions (splenic,hepatic nodules) from baseline.Stable=neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease (PD), reference smallest sum diameters while on study.Progression=50% increase in sum of longest diameter of all target lesions,from smallest sum of longest diameter of all target lesions recorded at or after baseline/a new lesion/progression of non-target lesions.Unknown is progression not documented,one/more of index lesions not assessed or have been assessed using a different method than baseline at the time of radiologic evaluation.

Time frame:
From start of treatment until progression/recurrence or start of a new cancer therapy (up to approximately 5 years)
Reported as:
Number · percentage of participants
Response Rate Based on Central Review of Computed Tomography (CT) Scan/Magnetic Resonance Imaging (MRI)
percentage of participantsPanobinostat
Complete Response0.8
Partial Response20.9
Stable Disease56.6
Progressive Disease15.5
Unknown6.2
SecondaryTime To Overall Disease Response in Responders

Time to overall disease response (CR or PR) was defined as the time from the date of randomization/start of treatment to the date of first documented disease response (PR or CR). Per Cheson response criteria, CR= is a complete normalization of all index nodal and extranodal lesions and complete disappearance of all extranodal lesions. PR= is a 50% decrease in the SPD for up to 6 identified dominant lesions, including splenic and hepatic nodules from baseline. Participants were considered responders if they had a partial or complete response to a treatment while in the study as per Investigator's assessment.

Time frame:
From the start of treatment up to approximately 5 years
Reported as:
Median · weeks
Time To Overall Disease Response in Responders
weeksPanobinostat
Time To Overall Disease Response in Responders9.9 (6.0 to 12.1)
SecondaryDuration of Overall Disease Response

Duration of overall response (CR or PR) was defined as the time from the date of first documented disease response (CR or PR) to the date of first documented progression or death due to lymphoma. Per Cheson response criteria, CR= is a complete normalization of all index nodal and extranodal lesions and complete disappearance of all extranodal lesions. PR= is a 50% decrease in the SPD for up to 6 identified dominant lesions, including splenic and hepatic nodules from baseline. Participants were considered responders if they had a partial or complete response to a treatment while in the study.

Time frame:
From the start of treatment up to approximately 5 years
Reported as:
Median · weeks
Duration of Overall Disease Response
weeksPanobinostat
Duration of Overall Disease Response30.1 (17.4 to 35.9)
SecondaryProgression Free Survival (PFS)

Progression-free survival (PFS) was defined as the time from the date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause. If a participant has not had an event, progression-free survival was censored at the date of the last adequate assessment.

Time frame:
From the start of treatment up to approximately 5 years
Reported as:
Median · months
Progression Free Survival (PFS)
monthsPanobinostat
Progression Free Survival (PFS)6.1 (5.4 to 8.3)
SecondaryThe Overall Survival (OS)

OS was the duration from date of randomization to date of death from any cause. If a participant has not had an event, overall survival was censored at the date of the last adequate assessment.

Time frame:
Baseline to date of death from any cause (up to approximately 5 years)
Reported as:
Median · months
The Overall Survival (OS)
monthsPanobinostat
The Overall Survival (OS)34.9 (0.7 to 53)
SecondaryPercentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), And Deaths as a Measure of Safety and Tolerability of Panobinostat

An AE is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) occurring after signing the informed consent even if the event is not considered to be related to the study drug(s). SAEs are AEs leading to death, are life-threatening, require hospitalizations or prolongation of hospitalizations, represent an innate malformation or a congenital abnormality.

Time frame:
Up to approximately 5 years
Reported as:
Number · percentage of participants
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), And Deaths as a Measure of Safety and Tolerability of Panobinostat
percentage of participantsPanobinostat
AEs100
SAEs39.5
Deaths45.0
SecondaryMaximum Observed Concentration (Cmax) of Panobinostat
Time frame:
Cycle 1, Day 1: Pre-dose, 0.25, 1, 3, 5, 7, 24, and 28 hours post-dose
Reported as:
Mean · nanograms per milliliter (ng/mL)
Maximum Observed Concentration (Cmax) of Panobinostat
nanograms per milliliter (ng/mL)Panobinostat
Maximum Observed Concentration (Cmax) of Panobinostat41.88 ± 22.165
SecondaryThe Time to Reach Maximum Plasma Concentration (Tmax) of Panobinostat
Time frame:
Cycle 1, Day 1: Pre-dose, 0.25, 1, 3, 5, 7, 24, and 28 hours post-dose
Reported as:
Median · hours
The Time to Reach Maximum Plasma Concentration (Tmax) of Panobinostat
hoursPanobinostat
The Time to Reach Maximum Plasma Concentration (Tmax) of Panobinostat1.1 (0.30 to 6.10)
SecondaryArea Under the Plasma Concentration-Time Curve From Time Zero to 28 Hours (AUC0-28) for Panobinostat
Time frame:
Cycle 1, Day 1: Pre-dose, 0.25, 1, 3, 5, 7, 24, and 28 hours post-dose
Reported as:
Mean · hour*nanograms per milliliter (h.ng/mL)
Area Under the Plasma Concentration-Time Curve From Time Zero to 28 Hours (AUC0-28) for Panobinostat
hour*nanograms per milliliter (h.ng/mL)Panobinostat
Area Under the Plasma Concentration-Time Curve From Time Zero to 28 Hours (AUC0-28) for Panobinostat233.38 ± 112.138
SecondaryArea Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-∞) for Panobinostat
Time frame:
Cycle 1, Day 1: Pre-dose, 0.25, 1, 3, 5, 7, 24, and 28 hours post-dose
Reported as:
Mean · h.ng/mL
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-∞) for Panobinostat
h.ng/mLPanobinostat
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-∞) for Panobinostat239.36 ± 104.263

Adverse events

Collected over Up to approximately 5 years. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Panobinostat—51/129 (39.5%)129/129 (100%)
Most frequent serious events
Showing 10 of 64
Most frequent serious events
EventPanobinostat
ThrombocytopeniaBlood and lymphatic system disorders12/129
AnaemiaBlood and lymphatic system disorders5/129
PneumoniaInfections and infestations5/129
SepsisInfections and infestations4/129
DyspnoeaRespiratory, thoracic and mediastinal disorders4/129
Atrial fibrillationCardiac disorders3/129
HypotensionVascular disorders3/129
NeutropeniaBlood and lymphatic system disorders2/129
DiarrhoeaGastrointestinal disorders2/129
VomitingGastrointestinal disorders2/129
Most frequent other events
Showing 10 of 126
Most frequent other events
EventPanobinostat
ThrombocytopeniaBlood and lymphatic system disorders109/129
DiarrhoeaGastrointestinal disorders96/129
NauseaGastrointestinal disorders87/129
FatigueGeneral disorders60/129
PyrexiaGeneral disorders56/129
VomitingGastrointestinal disorders55/129
AnaemiaBlood and lymphatic system disorders52/129
Decreased appetiteMetabolism and nutrition disorders48/129
NeutropeniaBlood and lymphatic system disorders36/129
CoughRespiratory, thoracic and mediastinal disorders36/129

Baseline characteristics

Full analysis set (FAS) included all participants who received at least one dose of study drug.

Age, Continuous
Age, Continuous(years)Panobinostat
Mean34.7 ± 12.24
Sex: Female, Male
Sex: Female, Male(Participants)Panobinostat
Female63
Male66
08

Study locations

46 sites
  • City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(2)
    Duarte, California 91010-3000, United States
  • Emory University School of Medicine/Winship Cancer Institute Dept. of Hematology (2)
    Atlanta, Georgia 30322, United States
  • Georgia Regents University Cancer Clinical Research Unit
    Augusta, Georgia 30912, United States
  • Rush University Medical Center Divisionof Hem/Onc Research(2)
    Chicago, Illinois 60612, United States
  • VA Maryland Health Care Dept.of GreenbaumCancerCent(5)
    Baltimore, Maryland 21201, United States
  • Dana Farber Cancer Institute Hematology / Oncology
    Boston, Massachusetts 02115, United States
  • Karmanos Cancer Institute Div.of Hematology/Oncology
    Detroit, Michigan 48201, United States
  • Mayo Clinic - Rochester Hematology
    Rochester, Minnesota 55905, United States
  • University of Pennsylvania Medical Center Dept of UPenn Med Ctr (3)
    Philadelphia, Pennsylvania 19104-4283, United States
  • University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(3)
    Houston, Texas 77030-4009, United States
  • The Methodist Hospital Cell & Gene Therapy Clinic
    Houston, Texas 77030, United States
  • Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(5)
    San Antonio, Texas 78229, United States
  • West Virginia University/ Mary Babb Randolph Cancer Center
    Morgantown, West Virginia 26506, United States
  • Novartis Investigative Site
    Herston, Queensland 4029, Australia
  • Novartis Investigative Site
    Malvern, Victoria 3144, Australia
  • Novartis Investigative Site
    Bruxelles, 1000, Belgium
  • Novartis Investigative Site
    Charleroi, 6000, Belgium
  • Novartis Investigative Site
    Leuven, 3000, Belgium
  • Novartis Investigative Site
    Rio de Janeiro, RJ 21941-913, Brazil
  • Novartis Investigative Site
    Campinas, SP 13083-970, Brazil
  • Novartis Investigative Site
    São Paulo, SP 01224-000, Brazil
  • Novartis Investigative Site
    São Paulo, SP 05403-000, Brazil
  • Novartis Investigative Site
    Dijon, 21034, France
  • Novartis Investigative Site
    Lille Cedex, 59 037, France
  • Novartis Investigative Site
    Lyon Cedex, 69373, France
  • Novartis Investigative Site
    Marseille, 13273, France
  • Novartis Investigative Site
    Rennes, 35019, France
  • Novartis Investigative Site
    Villejuif Cedex, 94805, France
  • Novartis Investigative Site
    Dresden, 01307, Germany
  • Novartis Investigative Site
    Göttingen, 37075, Germany
  • Novartis Investigative Site
    Köln, 50924, Germany
  • Novartis Investigative Site
    Be'er Sheva, 84101, Israel
  • Novartis Investigative Site
    Jerusalem, 91120, Israel
  • Novartis Investigative Site
    Ramat Gan, 52621, Israel
  • Novartis Investigative Site
    Bologna, BO 40138, Italy
  • Novartis Investigative Site
    Milano, MI 20162, Italy
  • Novartis Investigative Site
    Rozzano, MI 20089, Italy
  • Novartis Investigative Site
    Torino, TO 10126, Italy
  • Novartis Investigative Site
    Udine, UD 33100, Italy
  • Novartis Investigative Site
    Selangor, 68000, Malaysia
  • Novartis Investigative Site
    Auckland, New Zealand
  • Novartis Investigative Site
    Singapore, 169608, Singapore
  • Novartis Investigative Site
    Barcelona, Cataluña 08025, Spain
  • Novartis Investigative Site
    Madrid, 28006, Spain
  • Novartis Investigative Site
    Withington, Greater Manchester M20 4BX, United Kingdom
  • Novartis Investigative Site
    Southampton, United Kingdom
09

References and documents

Publications

  • Chari A, Cho HJ, Dhadwal A, Morgan G, La L, Zarychta K, Catamero D, Florendo E, Stevens N, Verina D, Chan E, Leshchenko V, Lagana A, Perumal D, Mei AH, Tung K, Fukui J, Jagannath S, Parekh S. A phase 2 study of panobinostat with lenalidomide and weekly dexamethasone in myeloma. Blood Adv. 2017 Aug 21;1(19):1575-1583. doi: 10.1182/bloodadvances.2017007427. eCollection 2017 Aug 22. PubMed 29296798 ↗
  • Harrison SJ, Hsu AK, Neeson P, Younes A, Sureda A, Engert A, Prince HM, Li M, Savage P, Bugarini R, Williams D, Squier M, Ritchie DS. Early thymus and activation-regulated chemokine (TARC) reduction and response following panobinostat treatment in patients with relapsed/refractory Hodgkin lymphoma following autologous stem cell transplant. Leuk Lymphoma. 2014 May;55(5):1053-60. doi: 10.3109/10428194.2013.820287. Epub 2013 Aug 5. PubMed 23822537 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00742027
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Aug 27, 2008
Start date
Sep 16, 2008
Primary completion
Aug 12, 2013
Completion
Aug 12, 2013
Results posted
Jun 3, 2021
Last update
Jul 28, 2021

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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