A Phase II Study of IGEV +/- Bortezomib Before Hign Dose Consolidation in Relapsed/Refractory Hodgkin's Lymphoma

Sponsor
Istituto Clinico Humanitas
Study ID
NCT00636311
Phase
PHASE2
Status
Completed

Conditions

  • Hodgkin Disease

Eligibility Criteria

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

Interventions

  • Ifosfamide, Gemcitabine, Vinorelbine — DRUG
    Ifosfamide 2000 mg/sqm, day 1-4 (plus MESNA); Gemcitabine 800 mg/sqm, day 1 and 4; Vinorelbine 20 mg/sqm, day 1; Prednisone 100 mg, day 1-4; G-CSF 1 vial sc, day 7-12 of each 21-day course.
  • Bortezomib + IGEV — DRUG
    Bortezomib 1,3 mg/sqm, day 1, 4, 8; Ifosfamide 2000 mg/sqm, day 1-4 (plus MESNA); Gemcitabine 800 mg/sqm, day 1 and 4; Vinorelbine 20 mg/sqm, day 1; Prednisone 100 mg, day 1-4; G-CSF 1 vial sc, day 7-12 of each 21-day course.

Study Details

The purpose of this study is to evaluate if the addition of Bortezomib (Velcade) to IGEV combination (Ifosfamide, Gemcitabine and Vinorelbine) in patients with relapsed/refractory Hodgkin's lymphoma increases the rate of complete remission (PET negativity) at transplantation.

Key Dates

Start date
Feb 29, 2008
Status verified
Sep 2010
Primary completion
Apr 30, 2008
Completion
Feb 28, 2010

Study Design

Enrollment
13 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 1
    IGEV regimen (Ifosfamide, Gemcitabine, Vinorelbine)
  • Experimental: 2
    B-IGEV (Bortezomib + IGEV)

Primary Outcome Measure

PET negativity rate obtained with IGEV or B-IGEV will be compared [ Time Frame: PET negativity after 4 courses of induction (IGEV or B-IGEV) ]

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