Master Protocol for Mantle Cell Lymphoma A Multicenter Phase II Trial Testing Gemcitabine for the Treatment of Patients With Newly Diagnosed, Relapsed or Chemotherapy Resistant Mantle Cell Lymphoma
- Determine the efficacy of gemcitabine, in terms of objective response and tolerability,
in patients with newly diagnosed, relapsed, or chemotherapy-resistant mantle cell
- Determine the time to progression and time to treatment failure in patients treated
with this drug.
- Determine the response duration in patients treated with this drug.
- Determine the adverse reactions in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 3
weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year, every
6 months for 1 year, and then annually for 3 years.
PROJECTED ACCRUAL: A total of 10-29 patients will be accrued for this study within 2 years.
Masking: Open Label, Primary Purpose: Treatment
Objective response at end of study treatment
Felicitas Hitz, MD
Kantonsspital St. Gallen