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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00234026
Recruitment Status : Completed
First Posted : October 6, 2005
Last Update Posted : June 5, 2012
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research

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.

Condition or disease Intervention/treatment Phase
Lymphoma Drug: gemcitabine hydrochloride Phase 2

Detailed Description:



  • 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.

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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
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

Primary Outcome Measures :
  1. Objective response at end of study treatment

Secondary Outcome Measures :
  1. Adverse reactions at end of study treatment
  2. Time to progression
  3. Response duration
  4. Time to treatment failure at end of study treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • WHO 0-1

Life expectancy

  • Not specified


  • 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)


  • Bilirubin ≤ 2 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2 times ULN
  • AST and ALT ≤ 2 times ULN
  • No active hepatitis


  • Creatinine clearance ≥ 50 mL/min


  • 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


  • No active autoimmune disease
  • No ongoing infection (e.g., HIV)


  • 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


Biologic therapy

  • No concurrent thalidomide


  • See Disease Characteristics

Endocrine therapy

  • Not specified


  • Prior radiotherapy allowed provided indicator lesions were not in the irradiated field
  • No concurrent radiotherapy to the lungs or mediastinum


  • Not specified


  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00234026

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Kantonspital Aarau
Aarau, Switzerland, 5001
Baden, Switzerland, 5404
Kantonsspital Baden
Baden, Switzerland, CH-5404
Oncology Institute of Southern Switzerland
Bellinzona, Switzerland, 6500
Spital Buelach
Bulach, Switzerland, CH-8180
Spital Limmattal
Schlieren, Switzerland, 8952
Kantonsspital - St. Gallen
St. Gallen, Switzerland, CH-9007
Spital Uster
Uster, Switzerland, 8610
Kantonsspital Winterthur
Winterthur, Switzerland, CH-8400
Zurich, Switzerland, 8001
Onkozentrum - Klinik im Park
Zurich, Switzerland, 8002
City Hospital Triemli
Zurich, Switzerland, 8063
Klinik Hirslanden
Zurich, Switzerland, CH-8008
Stadtspital Waid
Zurich, Switzerland, CH-8037
Zurich, Switzerland, CH-8044
UniversitaetsSpital Zuerich
Zurich, Switzerland, CH-8091
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
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Study Chair: Felicitas Hitz, MD Cantonal Hospital of St. Gallen
Principal Investigator: Lucas Widmer, MD City Hospital Triemli

Publications of Results:
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Responsible Party: Swiss Group for Clinical Cancer Research Identifier: NCT00234026     History of Changes
Other Study ID Numbers: SAKK 36/03
First Posted: October 6, 2005    Key Record Dates
Last Update Posted: June 5, 2012
Last Verified: June 2012
Keywords provided by Swiss Group for Clinical Cancer Research:
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
Additional relevant MeSH terms:
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Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs