Clinical trial NCT00163761: Efficacy Study of Outpatient Therapy for Lymphoma
Official title: A Multicentre Phase II Study of Risk-adjusted Outpatient-based Salvage Therapy for Patients With Relapsed and Refractory Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Hodgkin's Lymphoma
Hodgkin's Disease
Keywords: Lymphoma
Lead sponsor: Bayside Health
Sponsor class: OTHER_GOV
First posted: 2005-09-14
Enrollment: 90
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 trial evaluating the efficacy (overall response rate) of a risk-adjusted outpatient based approach to lymphoma salvage therapy with vinorelbine, gemcitabine and pegfilgrastim and/or gemcitabine, ifosfamide, vinorelbine and pegfilgrastim.

Detailed description: Lymphoma has been increasing in incidence annually for the past several decades and the majority of patients relapse after first line therapy. A variety of 'salvage chemotherapy' treatments are available that are usually inpatient-based treatments associated with significant haematological toxicity. Furthermore, all patients are treated in the same manner despite the fact that some patients will do well irrespective of the type of salvage therapy whereas others will do badly no matter what is done. During 2001-2002 we undertook a pilot study in 40 such patients using an outpatient-based salvage therapy with 2 newer chemotherapy drugs, vinorelbine and gemcitabine. Over 75% of all treatments were successfully delivered on an outpatient basis with response rates similar to historical controls. We now propose to expand on these initial findings by modifying the outpatient approach for those patients with less favourable prognostic features, that is, patients will be stratified to differing therapies but with the majority still receiving the proven vinorelbine-gemcitabine combination.

Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* relapsed or primary refractory non-Hodgkin's lymphoma (NHL) or Hodgkin's Disease (HD)
* 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 efficacy (overall response rate) 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).
timeFrame: After two cycles and after four cycles
Secondary outcomes:
measure: To evaluate safety,
timeFrame: Days 1 and 8 for every cycle, days 10,12,14, and 16 for first cycle.
measure: relapse free survival,
timeFrame: After 2 cycles, 4 cyles and every 3 or 4 months for 12 months. Then every 6 months until disease progression
measure: overall survival,
timeFrame: every 3 or 4 months for 12 months. Then every 6 months.
measure: and planned dose-on-time.
timeFrame: After two cycles and after four cycles
Other outcomes:
Locations:
city: Canberra
country: Australia
facility: Canberra Hospital
state: Australian Capital Territory
city: Sydney
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: South Brisbane
country: Australia
facility: Mater Adult Hospital
state: Queensland
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Melbourne
country: Australia
facility: The Royal Melbourne Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Frankston Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Wodonga
country: Australia
facility: Border Medical Oncology
state: Victoria
city: Fremantle
country: Australia
facility: Fremantle Hospital
state: Western Australia
Study officials:
name: Andrew Spencer, Assoc. Prof
role: STUDY_CHAIR
References: