CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 62 enrolled
Drug / intervention
Panobinostat +5 moredrug
Likely dose
Panobinostat 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01169636
NCT01169636Phase 2Completed
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Phase I Study of Panobinostat Plus ICE Chemotherapy Followed by a Randomized Phase-II Study of ICE Compared With Panobinostat Plus ICE for Patients With Relapsed and Refractory Classical Hodgkin Lymphoma

M.D. Anderson Cancer Center·interventional·Posted Jul 26, 2010·Updated Jan 6, 2021

In Brief

A Phase 2 clinical trial evaluating Panobinostat, Ifosfamide, and 4 other interventions for Hodgkin's Lymphoma. Completed, enrolled 62 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHodgkin's Lymphoma
CountriesUnited States
CollaboratorsNovartis

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 26, 2010
Enrollment StartJan 31, 2011
Primary CompletionMay 17, 2017
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 15.9 years ago

Interventions

Panobinostatdrug

Starting Day -6 of Cycle 1, 20 mg orally on Monday, Wednesday, and Friday during Cycles 1 and 2 (Days -6, -4, and -2 of Cycle 1 and Days 1, 3, 5, 8, 10, and 12 of Cycles 1 and 2); MTD found in Phase 1 used for same schedule in Phase 2.

Ifosfamidedrug

Day 1 of Cycles 1-3, 5 grams/m2 by vein over 24 hours.

Mesnadrug

On Day 1 of Cycles 1-3, 2 grams/m2 by vein over 12 hours.

Carboplatindrug

On Day 1 of Cycles 1-3, Standard Dose (Target area under curve (AUC) = 5mg/ml/min) by vein over 1 hour.

Etoposidedrug

On Days 1-3 of Cycles 1-3, 100 mg/m2 by vein over 2 hours.

Pegfilgrastimdrug

Beginning Day 4 of Cycles 1-3, 6 mg under the skin.