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Platinum-based Chemotherapy

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

Phase 1 & 2
Waitlist Available
Led By Yasuhiro Oki, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed after 3 cycles of ice (2 months)
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

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

Eligible Conditions
  • Hodgkin's Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed after 3 cycles of ice (2 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed after 3 cycles of ice (2 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum Tolerated Dose (MTD) of Panobinostat + ICE
Number of Participants With Complete Remission (CR)
Secondary study objectives
Percentage of Participants With Failure Free Survival (FFS)

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Panobinostat MTD + ICEExperimental Treatment5 Interventions
Phase 1: Escalating Panobinostat dose with routine ICE Chemotherapy
Group II: Panobinostat + ICEExperimental Treatment6 Interventions
Phase 2: Panobinostat with ICE Chemotherapy
Group III: ICE ChemotherapyExperimental Treatment5 Interventions
Phase 2: Routine ICE Chemotherapy (Ifosfamide, Carboplatin, + Etoposide)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etoposide
FDA approved
Panobinostat
FDA approved
Ifosfamide
FDA approved
Coenzyme M
FDA approved
Carboplatin
FDA approved
Pegfilgrastim
FDA approved

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,483 Total Patients Enrolled
NovartisIndustry Sponsor
1,639 Previous Clinical Trials
2,774,241 Total Patients Enrolled
Yasuhiro Oki, MDPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
121 Total Patients Enrolled
~4 spots leftby Dec 2025
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