Efficacy and Treatment Related Toxicity Study of a New Regimen for Lymphoma

NCT ID: NCT00163748

Last Updated: 2016-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-02-28
• Study Completion Date: 2003-11-30

Brief Summary

This is an open label pilot study of 40 evaluable patients receiving vinorelbine-gemcitabine combination chemotherapy with filgrastim support in an outpatient setting. Participating patients at the time of registration will have measurable relapsed or primary refractory lymphoma.

Detailed Description

Patients suffering from lymphoma (a type of cancer of the white blood cells called lymphocytes) have less chance of cure if they are refractory to initial chemotherapy or relapse after receiving initial chemotherapy when compared to patients who are responsive to and do not relapse following initial chemotherapy. The standard of care, therefore, for these patients is to undergo some form of bone marrow transplant procedure. However, before this can be considered most patients require chemotherapy to control the lymphoma and to determine whether the lymphoma is still sensitive to alternative types of chemotherapy (salvage chemotherapy). Currently used types of salvage chemotherapy require significant periods of inpatient hospitalisation and are associated with significant haematological toxicities (low blood counts with the associated risks of infection and bleeding and the need for blood and platelet transfusions). Two new chemotherapy drugs, vinorelbine and gemcitabine, have both shown encouraging efficacy against lymphoma when used alone for patients with heavily pretreated lymphoma. Furthermore, they can be given in an outpatient setting and are usually not associated with significant haematological toxicity. All the patients participating in this study have been diagnosed with relapsed or refractory lymphoma and have been offered treatment with vinorelbine and gemcitabine as an alternative to inpatient salvage chemotherapy.

Conditions

Non-Hodgkin's Lymphoma; Hodgkin's Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

gemcitabine, vinorelbine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• age 18 to 70 years
• relapsed or primary refractory non-Hodgkin's lymphoma (NHL) or Hodgkin's Disease (HD)
• measurable disease (clinically or radiologically)
• ECOG 0 - 2
• written informed consent

Exclusion Criteria

• bilirubin > 50μmol/litre unless secondary to lymphoma
• creatinine > 2 x upper limit of normal unless secondary to lymphoma,
• absolute neutrophil count <0.5 x 109/litre and / or platelets < 50 x 109/litre unless secondary to lymphoma
• isolated bone marrow disease
• known sensitivity to E coli derived preparations

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayside Health

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Spencer, Assoc. Prof

Role: STUDY_CHAIR

Locations

Royal North Shore Hospital

Sydney, New South Wales, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

AH152/00

Identifier Type: -

Identifier Source: org_study_id