18 and older, any sex, with Classical Hodgkin's Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Objective Response Rate (ORR) as Assessed by the Investigator Based on Cheson Response CriteriaPrimary· From the start of the treatment of last participant up to 32 weeks
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
Complete Response
Group
Value
95% CI
Panobinostat
5
Partial Response
Group
Value
95% CI
Panobinostat
30
Stable Disease
Group
Value
95% CI
Panobinostat
71
Progressive Disease
Group
Value
95% CI
Panobinostat
14
Unknown
Group
Value
95% CI
Panobinostat
9
Response Rate Based on Central Review of Computed Tomography (CT) Scan/Magnetic Resonance Imaging (MRI)Secondary· From start of treatment until progression/recurrence or start of a new cancer therapy (up to approximately 5 years)
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 a
Complete Response
Group
Value
95% CI
Panobinostat
0.8
Partial Response
Group
Value
95% CI
Panobinostat
20.9
Stable Disease
Group
Value
95% CI
Panobinostat
56.6
Progressive Disease
Group
Value
95% CI
Panobinostat
15.5
Unknown
Group
Value
95% CI
Panobinostat
6.2
Time To Overall Disease Response in RespondersSecondary· From the start of treatment up to approximately 5 years
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
Group
Value
95% CI
Panobinostat
9.9
6.0 – 12.1
Duration of Overall Disease ResponseSecondary· From the start of treatment up to approximately 5 years
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.
Group
Value
95% CI
Panobinostat
30.1
17.4 – 35.9
Progression Free Survival (PFS)Secondary· From the start of treatment up to approximately 5 years
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.
Group
Value
95% CI
Panobinostat
6.1
5.4 – 8.3
The Overall Survival (OS)Secondary· Baseline to date of death from any cause (up to approximately 5 years)
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.
Group
Value
95% CI
Panobinostat
34.9
0.7 – 53
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), And Deaths as a Measure of Safety and Tolerability of PanobinostatSecondary· Up to approximately 5 years
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.
AEs
Group
Value
95% CI
Panobinostat
100
SAEs
Group
Value
95% CI
Panobinostat
39.5
Deaths
Group
Value
95% CI
Panobinostat
45.0
Maximum Observed Concentration (Cmax) of PanobinostatSecondary· Cycle 1, Day 1: Pre-dose, 0.25, 1, 3, 5, 7, 24, and 28 hours post-dose
Group
Value
95% CI
Panobinostat
41.88
± 22.165
The Time to Reach Maximum Plasma Concentration (Tmax) of PanobinostatSecondary· Cycle 1, Day 1: Pre-dose, 0.25, 1, 3, 5, 7, 24, and 28 hours post-dose
Group
Value
95% CI
Panobinostat
1.1
0.30 – 6.10
Area Under the Plasma Concentration-Time Curve From Time Zero to 28 Hours (AUC0-28) for PanobinostatSecondary· Cycle 1, Day 1: Pre-dose, 0.25, 1, 3, 5, 7, 24, and 28 hours post-dose
Group
Value
95% CI
Panobinostat
233.38
± 112.138
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-∞) for PanobinostatSecondary· Cycle 1, Day 1: Pre-dose, 0.25, 1, 3, 5, 7, 24, and 28 hours post-dose
Group
Value
95% CI
Panobinostat
239.36
± 104.263
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to approximately 5 years.
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Panobinostat
Serious: 51/129 (40%)
Deaths: —
Serious adverse events (64 terms)
Reaction
System
Panobinostat
Thrombocytopenia
Blood and lymphatic system disorders
—
Anaemia
Blood and lymphatic system disorders
—
Pneumonia
Infections and infestations
—
Sepsis
Infections and infestations
—
Dyspnoea
Respiratory, thoracic and mediastinal disorders
—
Atrial fibrillation
Cardiac disorders
—
Hypotension
Vascular disorders
—
Neutropenia
Blood and lymphatic system disorders
—
Diarrhoea
Gastrointestinal disorders
—
Vomiting
Gastrointestinal disorders
—
Pyrexia
General disorders
—
Device related infection
Infections and infestations
—
Lower respiratory tract infection
Infections and infestations
—
Dehydration
Metabolism and nutrition disorders
—
Deep vein thrombosis
Vascular disorders
—
Febrile neutropenia
Blood and lymphatic system disorders
—
Haemorrhagic disorder
Blood and lymphatic system disorders
—
Idiopathic thrombocytopenic purpura
Blood and lymphatic system disorders
—
Pericardial effusion
Cardiac disorders
—
Sinus tachycardia
Cardiac disorders
—
Ventricular hypokinesia
Cardiac disorders
—
Abdominal pain
Gastrointestinal disorders
—
Colitis
Gastrointestinal disorders
—
Gastritis
Gastrointestinal disorders
—
Nausea
Gastrointestinal disorders
—
Other adverse events (126 terms — click to expand)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05725200 — Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer
· Phase 2
· recruiting
NCT04341311 — Phase I Study of Marizomib + Panobinostat for Children With DIPG
· Phase 1
· terminated
NCT03878524 — Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial
· Phase 1
· terminated
NCT04897880 — A Study of Panobinostat in Pediatric Patients With Solid Tumors Including MRT/ATRT
· Phase 2
· terminated
NCT04326764 — Panobinostat Maintenance After HSCT fo High-risk AML and MDS
· Phase 3
· terminated
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 28 July 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00742027.