Gemcitabine in Treating Patients With Newly Diagnosed, Relapsed, or Chemotherapy-Resistant Mantle Cell Lymphoma
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well gemcitabine works in treating patients with newly diagnosed, relapsed, or chemotherapy-resistant mantle cell lymphoma.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Objective response at end of study treatment [ Designated as safety issue: No ]
- Adverse reactions at end of study treatment [ Designated as safety issue: Yes ]
- Time to progression [ Designated as safety issue: No ]
- Response duration [ Designated as safety issue: No ]
- Time to treatment failure at end of study treatment [ Designated as safety issue: No ]
|Study Start Date:||June 2005|
|Study Completion Date:||March 2006|
|Primary Completion Date:||March 2006 (Final data collection date for primary outcome measure)|
- Determine the efficacy of gemcitabine, in terms of objective response and tolerability, in patients with newly diagnosed, relapsed, or chemotherapy-resistant mantle cell lymphoma.
- 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.
|Aarau, Switzerland, 5001|
|Baden, Switzerland, 5404|
|Baden, Switzerland, CH-5404|
|Oncology Institute of Southern Switzerland|
|Bellinzona, Switzerland, 6500|
|Bulach, Switzerland, CH-8180|
|Schlieren, Switzerland, 8952|
|Kantonsspital - St. Gallen|
|St. Gallen, Switzerland, CH-9007|
|Uster, Switzerland, 8610|
|Winterthur, Switzerland, CH-8400|
|Zurich, Switzerland, CH-8044|
|City Hospital Triemli|
|Zurich, Switzerland, 8063|
|Zurich, Switzerland, CH-8008|
|Onkozentrum - Klinik im Park|
|Zurich, Switzerland, 8002|
|Zurich, Switzerland, CH-8037|
|Zurich, Switzerland, CH-8091|
|Zurich, Switzerland, 8001|
|Study Chair:||Felicitas Hitz, MD||Kantonsspital St. Gallen|
|Principal Investigator:||Lucas Widmer, MD||City Hospital Triemli|