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

Phase 2

Completed

• Conditions: Lymphoma

• Registration Number: NCT00234026
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-10-05
• Study First Submitted QC: 2005-10-05
• Study First Posted: 2005-10-06
• Primary Completion: 2006-03
• Study Completion: 2006-03
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-04
• Last Update Posted: 2012-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective response at end of study treatment

Secondary Outcome Measures

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

Trial Locations

Locations (13)

Kantonsspital Baden; 🇨🇭 Baden, Switzerland

Spital Uster; 🇨🇭 Uster, Switzerland

Kantonsspital Winterthur; 🇨🇭 Winterthur, Switzerland

City Hospital Triemli; 🇨🇭 Zurich, Switzerland

Spital Buelach; 🇨🇭 Bulach, Switzerland

Stadtspital Waid; 🇨🇭 Zurich, Switzerland

UniversitaetsSpital Zuerich; 🇨🇭 Zurich, Switzerland

Kantonspital Aarau; 🇨🇭 Aarau, Switzerland

Kantonsspital - St. Gallen; 🇨🇭 St. Gallen, Switzerland

Onkozentrum - Klinik im Park; 🇨🇭 Zurich, Switzerland

Oncology Institute of Southern Switzerland; 🇨🇭 Bellinzona, Switzerland

Spital Limmattal; 🇨🇭 Schlieren, Switzerland

Klinik Hirslanden; 🇨🇭 Zurich, Switzerland