Study of Combination of PIGEV Before Autologous Stem Cell Transplant in Patients With Hodgkin's Lymphoma

Sponsor
Armando Santoro, MD
Study ID
NCT01884428
Phase
PHASE1
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • panobinostat — DRUG
    Dose excalation oral panobinostat 3 days a week for a maximum of 4 cycles of three weeks duration
  • Ifosfamide — DRUG
    Ifosfamide 2000 mg/m2 on days 1 to 4 as a 2-hour infusion for a maximum of 4 cycles of three weeks duration
  • Gemcitabine — DRUG
    Gemcitabine 800 mg/m2 on days 1 and 4 for a maximum of 4 cycles of three weeks duration
  • Vinorelbine — DRUG
    Vinorelbine 20 mg/m2 on day 1 for a maximum of 4 cycles of three weeks duration
  • Prednisolone — DRUG
    Prednisolone 100 mg on days 1 to 4 for a maximum of 4 cycles of three weeks duration

Study Details

study to assess maximum tolerated dose (MTD), safety, tolerability and activity of IGEV (Ifosfamide, Gemcitabine,Vinorelbine, Prednisolone) + Panobinostat new combination in order to determine the recommended phase II dose

Key Dates

Start date
Jul 31, 2011
Status verified
Jan 2014
Primary completion
Mar 31, 2014
Completion
Dec 31, 2015

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Panobinostat + IGEV
    Panobinostat + IGEV regimen (Ifosfamide, Gemcitabine, Vinorelbine, Prednisolone)

Primary Outcome Measure

Maximum Tolerated Dose (MTD) or the recommended phase II dose defined as the highest dosage cohort at which no more than one of six patients will experience a DLT in the first treatment cycle. [ Time Frame: 3 weeks ]

Central Contacts

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