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Panobinostat Plus Ifosfamide, Carboplatin, and Etoposide (ICE) Compared With ICE For Relapsed Hodgkin Lymphoma

NCT01169636 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2021-01-06

Study results available
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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

Conditions

  • Hodgkin's Lymphoma

Interventions

DRUG

Panobinostat

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.

DRUG

Ifosfamide

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

DRUG

Mesna

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

DRUG

Carboplatin

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

DRUG

Etoposide

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

DRUG

Pegfilgrastim

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

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Yasuhiro Oki, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2017-05-17
Completion
2017-05-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01169636 on ClinicalTrials.gov