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Brief Title: Gemcitabine in Treating Patients With Newly Diagnosed, Relapsed, or Chemotherapy-Resistant Mantle Cell Lymphoma
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
Study ID: NCT00234026
Brief Summary: 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.
Detailed Description: OBJECTIVES: Primary * Determine the efficacy of gemcitabine, in terms of objective response and tolerability, in patients with newly diagnosed, relapsed, or chemotherapy-resistant mantle cell lymphoma. Secondary * 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Kantonspital Aarau, Aarau, , Switzerland
, Baden, , Switzerland
Kantonsspital Baden, Baden, , Switzerland
Oncology Institute of Southern Switzerland, Bellinzona, , Switzerland
Spital Buelach, Bulach, , Switzerland
Spital Limmattal, Schlieren, , Switzerland
Kantonsspital - St. Gallen, St. Gallen, , Switzerland
Spital Uster, Uster, , Switzerland
Kantonsspital Winterthur, Winterthur, , Switzerland
, Zurich, , Switzerland
Onkozentrum - Klinik im Park, Zurich, , Switzerland
City Hospital Triemli, Zurich, , Switzerland
Klinik Hirslanden, Zurich, , Switzerland
Stadtspital Waid, Zurich, , Switzerland
, Zurich, , Switzerland
UniversitaetsSpital Zuerich, Zurich, , Switzerland
Name: Felicitas Hitz, MD
Affiliation: Cantonal Hospital of St. Gallen
Role: STUDY_CHAIR
Name: Lucas Widmer, MD
Affiliation: City Hospital Triemli
Role: PRINCIPAL_INVESTIGATOR