Gemcitabine in Treating Patients With Newly Diagnosed, Relapsed, or Chemotherapy-Resistant Mantle Cell Lymphoma
|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
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|