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Spots Global Cancer Trial Database for Gemcitabine in Treating Patients With Newly Diagnosed, Relapsed, or Chemotherapy-Resistant Mantle Cell Lymphoma

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Trial Identification

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

Conditions

Lymphoma

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Felicitas Hitz, MD

Affiliation: Cantonal Hospital of St. Gallen

Role: STUDY_CHAIR

Name: Lucas Widmer, MD

Affiliation: City Hospital Triemli

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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