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

NCT01884428 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2014-01-29

No results posted yet for this study

Summary

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

Conditions

  • Hodgkin's Lymphoma

Interventions

DRUG

panobinostat

Dose excalation oral panobinostat 3 days a week for a maximum of 4 cycles of three weeks duration

DRUG

Ifosfamide

Ifosfamide 2000 mg/m2 on days 1 to 4 as a 2-hour infusion for a maximum of 4 cycles of three weeks duration

DRUG

Gemcitabine

Gemcitabine 800 mg/m2 on days 1 and 4 for a maximum of 4 cycles of three weeks duration

DRUG

Vinorelbine

Vinorelbine 20 mg/m2 on day 1 for a maximum of 4 cycles of three weeks duration

DRUG

Prednisolone

Prednisolone 100 mg on days 1 to 4 for a maximum of 4 cycles of three weeks duration

Sponsors & Collaborators

  • Armando Santoro, MD

    lead OTHER

Principal Investigators

  • Armando Santoro, MD · Istituto Clinico Humanitas

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2014-03-31
Completion
2015-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

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 NCT01884428 on ClinicalTrials.gov