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LymphomaPhase 2NCT00234026

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

A Phase 2 study testing gemcitabine hydrochloride in people with Lymphoma, run by Swiss Cancer Institute at 16 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
What is being tested?
gemcitabine hydrochloride
How many people
Not given
Where
16 sitesSwitzerland
Study dates
Jun 2005to Mar 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

Switzerland16 sites

  • Kantonspital Aarau

    Aarau, 5001

  • Study site

    Baden, 5404

  • Kantonsspital Baden

    Baden, CH-5404

  • Oncology Institute of Southern Switzerland

    Bellinzona, 6500

  • Spital Buelach

    Bülach, CH-8180

  • Kantonsspital - St. Gallen

    Sankt Gallen, CH-9007

  • Spital Limmattal

    Schlieren, 8952

  • Spital Uster

    Uster, 8610

  • Kantonsspital Winterthur

    Winterthur, CH-8400

  • Study site

    Zurich, 8001

  • Onkozentrum - Klinik im Park

    Zurich, 8002

  • City Hospital Triemli

    Zurich, 8063

  • Klinik Hirslanden

    Zurich, CH-8008

  • Stadtspital Waid

    Zurich, CH-8037

  • Study site

    Zurich, CH-8044

  • UniversitaetsSpital Zuerich

    Zurich, CH-8091

Other trials in Switzerland

About this study

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

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.

Read the 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.

Conditions
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
Medical subject headings
Lymphoma, Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response at end of study treatment

Secondary outcomes (4)

  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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2005 (estimated)
  2. Study startJun 2005
  3. Primary completionMar 2006
  4. Study completionMar 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00234026
Sponsor's protocol ID
SAKK 36/03
Other IDs
EU-20523
Status last verified
Jun 2012
First submitted
5 Oct 2005
Last updated
5 Jun 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 19274614

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing gemcitabine hydrochloride in people with Lymphoma, run by Swiss Cancer Institute at 16 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response at end of study treatment. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00234026, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2012.

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