Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01034163 | A Phase III Randomized, Double Blind, Placebo Controlled Multi-center Study of Panobinostat for Maintenance of Response in Patients With Hodgkin's Lymphoma (HL) | PHASE3 | COMPLETED | 41 | — | — | Jun 1, 2010 | May 1, 2012 | Jul 7, 2016 | 35 | United States, Australia +12 |
| NCT01169636 | Panobinostat Plus Ifosfamide, Carboplatin, and Etoposide (ICE) Compared With ICE For Relapsed Hodgkin Lymphoma | PHASE1 | COMPLETED | 62 | — | — | Jan 31, 2011 | May 17, 2017 | Jan 6, 2021 | 1 | United States |
Safety monitoring was conducted throughout the study.
Will be assessed by Kaplan-Meier methods.
| Arm | Type | Description |
|---|---|---|
| Panobinostat (PAN) | EXPERIMENTAL | Participants received 45 mg orally 3 times a week (TIW), every other week (QOW), |
| Placebo | PLACEBO_COMPARATOR | Participants received matching placebo to PAN TIW, QOW. |
| Panobinostat MTD + ICE | EXPERIMENTAL | Phase 1: Escalating Panobinostat dose with routine ICE Chemotherapy |
| ICE Chemotherapy | EXPERIMENTAL | Phase 2: Routine ICE Chemotherapy (Ifosfamide, Carboplatin, + Etoposide) |
| Panobinostat + ICE | EXPERIMENTAL | Phase 2: Panobinostat with ICE Chemotherapy |
| Name | Type | Description |
|---|---|---|
| Panobinostat | DRUG | - |
| Placebo | DRUG | Placebo |
| Ifosfamide | DRUG | Day 1 of Cycles 1-3, 5 grams/m2 by vein over 24 hours. |
| Mesna | DRUG | On Day 1 of Cycles 1-3, 2 grams/m2 by vein over 12 hours. |
| Carboplatin | DRUG | On Day 1 of Cycles 1-3, Standard Dose (Target area under curve (AUC) = 5mg/ml/min) by vein over 1 hour. |
| Etoposide | DRUG | On Days 1-3 of Cycles 1-3, 100 mg/m2 by vein over 2 hours. |
| Pegfilgrastim | DRUG | Beginning Day 4 of Cycles 1-3, 6 mg under the skin. |
Inclusion Criteria: 1. Patient age is greater than or equal to 18 years 2. Patient has a history of histologically confirmed classical HL (i.e. Nodular sclerosing (NSHL), Mixed-cellularity (MCHL), Lymphocyte-rich (LRHL), Lymphocyte depleted (LDHL)) 3. Patient has achieved a complete response by CT/...