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

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
gemcitabine hydrochloride
Sponsored by
Swiss Group for Clinical Cancer Research
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring recurrent mantle cell lymphoma, stage I mantle cell lymphoma, contiguous stage II mantle cell lymphoma, noncontiguous stage II mantle cell lymphoma, stage III mantle cell lymphoma, stage IV mantle cell lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed mantle cell lymphoma meeting 1 of the following criteria: Newly diagnosed Chemotherapy resistant Relapsed disease after no more than 2 prior lines of chemotherapy Measurable disease At least 1 unidimensionally measurable lesion ≥ 11 mm by CT scan No prior or current CNS lymphoma or lymphomatous meningosis PATIENT CHARACTERISTICS: Age 18 and over Performance status WHO 0-1 Life expectancy Not specified Hematopoietic Neutrophil count ≥ 1,500/mm^3 (1,000/mm^3 in case of bone marrow infiltration) Platelet count ≥ 100,000/mm^3 (75,000/mm^3 in case of bone marrow infiltration) Hepatic Bilirubin ≤ 2 times upper limit of normal (ULN) Alkaline phosphatase ≤ 2 times ULN AST and ALT ≤ 2 times ULN No active hepatitis Renal Creatinine clearance ≥ 50 mL/min Cardiovascular No congestive heart failure No New York Heart Association class III or IV heart disease No unstable angina pectoris No significant cardiac arrhythmia or arrhythmia requiring chronic treatment No myocardial infarction within the past 3 months Immunologic No active autoimmune disease No ongoing infection (e.g., HIV) Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 12 months after study participation No other malignancy within the past 5 years except nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix No uncontrolled diabetes mellitus No gastric ulcers No other uncontrolled medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent thalidomide Chemotherapy See Disease Characteristics Endocrine therapy Not specified Radiotherapy Prior radiotherapy allowed provided indicator lesions were not in the irradiated field No concurrent radiotherapy to the lungs or mediastinum Surgery Not specified Other More than 30 days since prior systemic anticancer treatment More than 30 days since prior clinical trial participation No other concurrent anticancer drugs No other concurrent experimental drugs

Sites / Locations

  • Kantonspital Aarau
  • Kantonsspital Baden
  • Oncology Institute of Southern Switzerland
  • Spital Buelach
  • Spital Limmattal
  • Kantonsspital - St. Gallen
  • Spital Uster
  • Kantonsspital Winterthur
  • Onkozentrum - Klinik im Park
  • City Hospital Triemli
  • Klinik Hirslanden
  • Stadtspital Waid
  • UniversitaetsSpital Zuerich

Outcomes

Primary Outcome Measures

Objective response at end of study treatment

Secondary Outcome Measures

Adverse reactions at end of study treatment
Time to progression
Response duration
Time to treatment failure at end of study treatment

Full Information

First Posted
October 5, 2005
Last Updated
June 4, 2012
Sponsor
Swiss Group for Clinical Cancer Research
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1. Study Identification

Unique Protocol Identification Number
NCT00234026
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 Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Group for Clinical Cancer Research

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
recurrent mantle cell lymphoma, stage I mantle cell lymphoma, contiguous stage II mantle cell lymphoma, noncontiguous stage II mantle cell lymphoma, stage III mantle cell lymphoma, stage IV mantle cell lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Primary Outcome Measure Information:
Title
Objective response at end of study treatment
Secondary Outcome Measure Information:
Title
Adverse reactions at end of study treatment
Title
Time to progression
Title
Response duration
Title
Time to treatment failure at end of study treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed mantle cell lymphoma meeting 1 of the following criteria: Newly diagnosed Chemotherapy resistant Relapsed disease after no more than 2 prior lines of chemotherapy Measurable disease At least 1 unidimensionally measurable lesion ≥ 11 mm by CT scan No prior or current CNS lymphoma or lymphomatous meningosis PATIENT CHARACTERISTICS: Age 18 and over Performance status WHO 0-1 Life expectancy Not specified Hematopoietic Neutrophil count ≥ 1,500/mm^3 (1,000/mm^3 in case of bone marrow infiltration) Platelet count ≥ 100,000/mm^3 (75,000/mm^3 in case of bone marrow infiltration) Hepatic Bilirubin ≤ 2 times upper limit of normal (ULN) Alkaline phosphatase ≤ 2 times ULN AST and ALT ≤ 2 times ULN No active hepatitis Renal Creatinine clearance ≥ 50 mL/min Cardiovascular No congestive heart failure No New York Heart Association class III or IV heart disease No unstable angina pectoris No significant cardiac arrhythmia or arrhythmia requiring chronic treatment No myocardial infarction within the past 3 months Immunologic No active autoimmune disease No ongoing infection (e.g., HIV) Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 12 months after study participation No other malignancy within the past 5 years except nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix No uncontrolled diabetes mellitus No gastric ulcers No other uncontrolled medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent thalidomide Chemotherapy See Disease Characteristics Endocrine therapy Not specified Radiotherapy Prior radiotherapy allowed provided indicator lesions were not in the irradiated field No concurrent radiotherapy to the lungs or mediastinum Surgery Not specified Other More than 30 days since prior systemic anticancer treatment More than 30 days since prior clinical trial participation No other concurrent anticancer drugs No other concurrent experimental drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felicitas Hitz, MD
Organizational Affiliation
Cantonal Hospital of St. Gallen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lucas Widmer, MD
Organizational Affiliation
City Hospital Triemli
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kantonspital Aarau
City
Aarau
ZIP/Postal Code
5001
Country
Switzerland
City
Baden
ZIP/Postal Code
5404
Country
Switzerland
Facility Name
Kantonsspital Baden
City
Baden
ZIP/Postal Code
CH-5404
Country
Switzerland
Facility Name
Oncology Institute of Southern Switzerland
City
Bellinzona
ZIP/Postal Code
6500
Country
Switzerland
Facility Name
Spital Buelach
City
Bulach
ZIP/Postal Code
CH-8180
Country
Switzerland
Facility Name
Spital Limmattal
City
Schlieren
ZIP/Postal Code
8952
Country
Switzerland
Facility Name
Kantonsspital - St. Gallen
City
St. Gallen
ZIP/Postal Code
CH-9007
Country
Switzerland
Facility Name
Spital Uster
City
Uster
ZIP/Postal Code
8610
Country
Switzerland
Facility Name
Kantonsspital Winterthur
City
Winterthur
ZIP/Postal Code
CH-8400
Country
Switzerland
City
Zurich
ZIP/Postal Code
8001
Country
Switzerland
Facility Name
Onkozentrum - Klinik im Park
City
Zurich
ZIP/Postal Code
8002
Country
Switzerland
Facility Name
City Hospital Triemli
City
Zurich
ZIP/Postal Code
8063
Country
Switzerland
Facility Name
Klinik Hirslanden
City
Zurich
ZIP/Postal Code
CH-8008
Country
Switzerland
Facility Name
Stadtspital Waid
City
Zurich
ZIP/Postal Code
CH-8037
Country
Switzerland
City
Zurich
ZIP/Postal Code
CH-8044
Country
Switzerland
Facility Name
UniversitaetsSpital Zuerich
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
19274614
Citation
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.
Results Reference
result

Learn more about this trial

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

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