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Phase 2 N=129 Treatment

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

Classical Hodgkin's Lymphoma

Enrolled (actual)
129
Serious AEs
39.5%
Results posted
Jun 2021
Primary outcome: Primary: Objective Response Rate (ORR) as Assessed by the Investigator Based on Cheson Response Criteria — 5; 30; 71; 14 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Panobinostat (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Novartis Pharmaceuticals
Primary completion
Aug 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Objective Response Rate (ORR) as Assessed by the Investigator Based on Cheson Response Criteria
5; 30; 71; 14; 9
SECONDARY
Response Rate Based on Central Review of Computed Tomography (CT) Scan/Magnetic Resonance Imaging (MRI)
0.8; 20.9; 56.6; 15.5; 6.2
SECONDARY
Time To Overall Disease Response in Responders
9.9
SECONDARY
Duration of Overall Disease Response
30.1
SECONDARY
Progression Free Survival (PFS)
6.1
SECONDARY
The Overall Survival (OS)
34.9
SECONDARY
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), And Deaths as a Measure of Safety and Tolerability of Panobinostat
100; 39.5; 45.0
SECONDARY
Maximum Observed Concentration (Cmax) of Panobinostat
41.88
SECONDARY
The Time to Reach Maximum Plasma Concentration (Tmax) of Panobinostat
1.1
SECONDARY
Area Under the Plasma Concentration-Time Curve From Time Zero to 28 Hours (AUC0-28) for Panobinostat
233.38
SECONDARY
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-∞) for Panobinostat
239.36

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.

Eligibility Criteria

Inclusion Criteria

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

  • 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.

  • 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 5 prior systemic lines of treatment (see Post-text supplement 2 for definitions and examples).

  • 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.
  • Participant is using any anti-cancer therapy concomitantly.
  • 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).
  • 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.
  • Participant has a history of central nervous system (CNS) involvement with lymphoma.
  • 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 ( 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%.
  • Participant has any other clinically significant heart disease (e.g., uncontrolled hypertension).
  • 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).
  • Participant has unresolved diarrhea ≥ grade 2.
  • Participant has any other concurrent
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00742027). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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