Panobinostat Plus Ifosfamide, Carboplatin, and Etoposide (ICE) Compared With ICE For Relapsed Hodgkin Lymphoma
Status:
Completed
Trial end date:
2017-05-17
Target enrollment:
Participant gender:
Summary
Objectives:
Primary objective:
- Phase-I: To determine the maximal tolerated dose (MTD) of panobinostat (LBH589) +
Ifosfamide + Mesna, Carboplatin and Etoposide (ICE) combination
- Randomized Phase-II: To estimate the complete response (CR) rate in patients with
relapsed and refractory classical Hodgkins Lymphoma (HL) receiving ICE versus
PANOBINOSTAT plus ICE therapy
Secondary Objectives:
- To assess the safety and tolerability of the novel combination of PANOBINOSTAT (LBH589)
plus ICE versus ICE in patients with relapsed and refractory HL
- To estimate the overall response rate (CR + partial response PR)
- To estimate the success rate of stem cell collection in patients eligible for stem cell
transplant
- To estimate the percentage of patients who subsequently undergo autologous stem cell
transplantation (ASCT)
- To estimate the event free survival (EFS) at 1 year after randomization
- To determine pretreatment expression level of histone deacetylases (HDAC1), HDAC2, and
pSTAT3 and Signal transducer and activator of transcription protein (pSTAT6) by
Immunohistochemistry (IHC) and correlate the results with treatment response