Phase II Study of Oral Panobinostat in Adult Participants With Relapsed/Refractory Classical Hodgkin's Lymphoma
Classical Hodgkin's Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00742027 ↗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
| Outcome | Result | p-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
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
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.