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| ID | Type | Description | Link |
|---|---|---|---|
| EU-20523 |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gemcitabine hydrochloride | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response at end of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse reactions at end of study treatment | ||
| Time to progression | ||
| Response duration |
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DISEASE CHARACTERISTICS:
Histologically confirmed mantle cell lymphoma meeting 1 of the following criteria:
Measurable disease
No prior or current CNS lymphoma or lymphomatous meningosis
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Felicitas Hitz, MD | Cantonal Hospital of St. Gallen | Study Chair |
| Lucas Widmer, MD | City Hospital Triemli | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonspital Aarau | Aarau | 5001 | Switzerland | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19274614 | Result | Hitz F, Martinelli G, Zucca E, von Moos R, Mingrone W, Simcock M, Peterson J, Cogliatti SB, Bertoni F, Zimmermann DR, Ghielmini M; Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland. A multicentre phase II trial of gemcitabine for the treatment of patients with newly diagnosed, relapsed or chemotherapy resistant mantle cell lymphoma: SAKK 36/03. Hematol Oncol. 2009 Sep;27(3):154-9. doi: 10.1002/hon.891. |
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| Time to treatment failure at end of study treatment |
| Baden |
| 5404 |
| Switzerland |
| Kantonsspital Baden | Baden | CH-5404 | Switzerland |
| Oncology Institute of Southern Switzerland | Bellinzona | 6500 | Switzerland |
| Spital Buelach | Bülach | CH-8180 | Switzerland |
| Kantonsspital - St. Gallen | Sankt Gallen | CH-9007 | Switzerland |
| Spital Limmattal | Schlieren | 8952 | Switzerland |
| Spital Uster | Uster | 8610 | Switzerland |
| Kantonsspital Winterthur | Winterthur | CH-8400 | Switzerland |
| Zurich | 8001 | Switzerland |
| Onkozentrum - Klinik im Park | Zurich | 8002 | Switzerland |
| City Hospital Triemli | Zurich | 8063 | Switzerland |
| Klinik Hirslanden | Zurich | CH-8008 | Switzerland |
| Stadtspital Waid | Zurich | CH-8037 | Switzerland |
| Zurich | CH-8044 | Switzerland |
| UniversitaetsSpital Zuerich | Zurich | CH-8091 | Switzerland |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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