Clinical trial NCT00280878: Rituximab in Combination With Outpatient Therapy for CD20+ Lymphoma
Official title: A Pilot Study of Rituximab in Combination With Out-patient Based VGF/F-GIV Salvage Therapies for Relapsed/Refractory CD20+ Lymphomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Hodgkin's Lymphoma (CD20+)
Keywords: Lymphoma
CD20+
Lead sponsor: Bayside Health
Sponsor class: OTHER_GOV
First posted: 2006-01-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a Phase II pilot study evaluating the safety of a risk-adjusted outpatient-based approach to lymphoma salvage therapy with VGF (vinorelbine, gemcitabine and pegfilgrastim) and/or F-GIV (gemcitabine, Ifosfamide, vinorelbine and pegfilgrastim) in combination with Rituximab (R-VGF/R-F-GIV).

Detailed description: Recent epidemiologic surveys have demonstrated a dramatic increase in the incidence of non-Hodgkin's lymphoma (NHL). NHL is now one of the most rapidly increasing malignancies in the industrial world.

The purpose of this project is to evaluate the efficacy and safety of an outpatient treatment for relapsed or treatment resistant (refractory) CD20+ lymphoma. Two combinations of chemotherapy drugs will be tested depending on the patients prior therapy and response - rituximab, vinorelbine and gemcitabine (R-VGF) OR rituximab, vinorelbine, gemcitabine and ifosfamide (R-FGIV).

Previous experience, including a recently completed study using combinations of vinorelbine, gemcitabine and ifosfamide has demonstrated that such an outpatient approach is safe and of similar efficacy to presently available alternative inpatient chemotherapy approaches. This study is expanding on the findings from the previous study by adding rituximab.

Rituximab is being increasingly and successfully used in the therapy of CD20+ NHL. It is a specific protein (antibody) that is directed against the surface protein (CD20 antigen) found on CD20+ lymphoma cells and can therefore lead to the destruction of these cells. Rituximab also has a highly favourable toxicity profile enabling outpatient treatment.

All of these factors provide a strong rationale for the combination of rituximab and the novel outpatient-based salvage approaches VGF and F-GIV that we have recently evaluated. This pilot study of 12 patients will test the feasibility of this combination approach in patients with relapsed/refractory CD20+ NHL.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Relapsed or primary refractory CD20+ NHL
* ECOG 0 - 2
* Written informed consent

Exclusion Criteria:

* Intention to proceed with any form of transplant therapy following fewer than 2 cycles of protocol salvage therapy.
* 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
* Relapse within 6 months of a prior transplant procedure (autologous or allogeneic).
* Known sensitivity to E coli derived preparations

Primary outcomes:
measure: To evaluate the safety of a risk-adjusted outpatient-based approach to lymphoma salvage therapy with VGF and/or F-GIV in combination with Rituximab.
Secondary outcomes:
measure: To determine point estimates of the response rates achieved with R-VGF or R-F-GIV in previously treated patients with relapsed/refractory CD20+ B-cell NHL.
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Frankston Hospital
state: Victoria
Study officials:
name: Andrew Spencer, Assoc.Prof
role: STUDY_CHAIR
References: