Efficacy Study of Outpatient Therapy for Lymphoma

Sponsor
Bayside Health
Study ID
NCT00163761
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a Phase II trial evaluating the efficacy (overall response rate) of a risk-adjusted outpatient based approach to lymphoma salvage therapy with vinorelbine, gemcitabine and pegfilgrastim and/or gemcitabine, ifosfamide, vinorelbine and pegfilgrastim.

Key Dates

Start date
Dec 31, 2002
Status verified
Jan 2016
Primary completion
Feb 29, 2008
Completion
Feb 29, 2008

Study Design

Enrollment
90 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Commence VGF treatment
    Drug. Vinorelbine, gemcitabine and filgrastim 21 day cycle
  • Active Comparator: Commence F-GIV treatment
    Drug. Gemcitabine, ifosfamide, Vinorelbine and filgrastim 21 day cycle

Primary Outcome Measure

To evaluate the efficacy (overall response rate) of a risk-adjusted outpatient-based approach to lymphoma salvage therapy with VGF (vinorelbine, gemcitabine and pegfilgrastim) and/or F-GIV (gemcitabine, Ifosfamide, vinorelbine and pegfilgrastim). [ Time Frame: After two cycles and after four cycles ]

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