Gemcitabine in Treating Patients With Newly Diagnosed, Relapsed, or Chemotherapy-Resistant Mantle Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT00234026|
Recruitment Status : Completed
First Posted : October 6, 2005
Last Update Posted : June 5, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: gemcitabine hydrochloride||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|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 Start Date :||June 2005|
|Actual Primary Completion Date :||March 2006|
|Actual Study Completion Date :||March 2006|
- Objective response at end of study treatment
- Adverse reactions at end of study treatment
- Time to progression
- Response duration
- Time to treatment failure at end of study treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00234026
|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, 8001|
|Onkozentrum - Klinik im Park|
|Zurich, Switzerland, 8002|
|City Hospital Triemli|
|Zurich, Switzerland, 8063|
|Zurich, Switzerland, CH-8008|
|Zurich, Switzerland, CH-8037|
|Zurich, Switzerland, CH-8044|
|Zurich, Switzerland, CH-8091|
|Study Chair:||Felicitas Hitz, MD||Cantonal Hospital of St. Gallen|
|Principal Investigator:||Lucas Widmer, MD||City Hospital Triemli|