Non-Hodgkin's LymphomaPhase 2NCT00163761
Efficacy Study of Outpatient Therapy for Lymphoma
A Phase 2 study testing gemcitabine, vinorelbine, ifosfamide, filgastrim and gemcitabine, vinorelbine, filgastrim in people with Non-Hodgkin's Lymphoma and Hodgkin's Disease, run by Bayside Health at 10 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma, Hodgkin's Disease
- What is being tested?
- gemcitabine, vinorelbine, ifosfamide, filgastrim and gemcitabine, vinorelbine, filgastrim
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 10 sitesAustralia
- Study dates
- Dec 2002to Feb 2008
- 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
Who may be able to join
- age > 18 years
- relapsed or primary refractory non-Hodgkin's lymphoma (NHL) or Hodgkin's Disease (HD)
- ECOG 0 - 2
- written informed consent
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Australia10 sites
Canberra Hospital
Canberra, Australian Capital Territory, 2605
Fremantle Hospital
Fremantle, Western Australia, 6160
Royal Hobart Hospital
Hobart, Tasmania, 7001
The Alfred Hospital
Melbourne, Victoria, 3004
The Royal Melbourne Hospital
Melbourne, Victoria, 3050
Frankston Hospital
Melbourne, Victoria, 3199
Monash Medical Centre
Melbourne, Victoria, 3199
Mater Adult Hospital
South Brisbane, Queensland, 4101
Royal North Shore Hospital
Sydney, New South Wales, 2065
Border Medical Oncology
Wodonga, Victoria, 3690
About this study
Official title: A Multicentre Phase II Study of Risk-adjusted Outpatient-based Salvage Therapy for Patients With Relapsed and Refractory Lymphoma
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.
Read the 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.
- Conditions
- Non-Hodgkin's Lymphoma, Hodgkin's Disease
- Being tested
- gemcitabine, vinorelbine, ifosfamide, filgastrim, gemcitabine, vinorelbine, filgastrim
- Keywords
- Lymphoma
- Medical subject headings
- Lymphoma, Non-Hodgkin, Hodgkin Disease, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gemcitabine, vinorelbine, ifosfamide, filgastrimDrug
Drug
gemcitabine, vinorelbine, filgastrimDrug
Drug
| Study group | Role | What they receive |
|---|---|---|
| Commence VGF treatment | Active comparator | Drug. Vinorelbine, gemcitabine and filgrastim 21 day cycle Receives: Drug: gemcitabine, vinorelbine, filgastrim |
| Commence F-GIV treatment | Active comparator | Drug. Gemcitabine, ifosfamide, Vinorelbine and filgrastim 21 day cycle Receives: Drug: gemcitabine, vinorelbine, ifosfamide, filgastrim |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: After two cycles and after four cycles
Secondary outcomes (4)
To evaluate safety,
Measured: Days 1 and 8 for every cycle, days 10,12,14, and 16 for first cycle.
relapse free survival,
Measured: After 2 cycles, 4 cyles and every 3 or 4 months for 12 months. Then every 6 months until disease progression
overall survival,
Measured: every 3 or 4 months for 12 months. Then every 6 months.
and planned dose-on-time.
Measured: After two cycles and after four cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startDec 2002
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Andrew Spencer, Assoc. Prof, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00163761
- Sponsor's protocol ID
- AH226/02
- Status last verified
- Jan 2016
- First submitted
- 11 Sep 2005
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Phase II Study of Risk-adjusted Outpatient-based Salvage Therapy for Patients With Relapsed and Refractory Lymphoma
- ClinicalTrials.gov ID
- NCT00163761
- Acronym / sponsor ID
- AH226/02
- Conditions
- Non-Hodgkin's Lymphoma, Hodgkin's Disease
- Keywords
- Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Bayside HealthOther government
- Study start
- Dec 2002
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Commence VGF treatment | Active comparator | Drug: gemcitabine, vinorelbine, filgastrimDrug. Vinorelbine, gemcitabine and filgrastim 21 day cycle |
| Commence F-GIV treatment | Active comparator | Drug: gemcitabine, vinorelbine, ifosfamide, filgastrimDrug. Gemcitabine, ifosfamide, Vinorelbine and filgrastim 21 day cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age > 18 years
- relapsed or primary refractory non-Hodgkin's lymphoma (NHL) or Hodgkin's Disease (HD)
- ECOG 0 - 2
- written informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gemcitabine, vinorelbine, ifosfamide, filgastrimDrug | Drug | Commence F-GIV treatment |
| gemcitabine, vinorelbine, filgastrimDrug | Drug | Commence VGF treatment |
Primary outcome
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).
Time frame: After two cycles and after four cycles
4 secondary outcomes
To evaluate safety,
Time frame: Days 1 and 8 for every cycle, days 10,12,14, and 16 for first cycle.
relapse free survival,
Time frame: After 2 cycles, 4 cyles and every 3 or 4 months for 12 months. Then every 6 months until disease progression
overall survival,
Time frame: every 3 or 4 months for 12 months. Then every 6 months.
and planned dose-on-time.
Time frame: After two cycles and after four cycles
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Spencer, Assoc. Prof study chair
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing gemcitabine, vinorelbine, ifosfamide, filgastrim and gemcitabine, vinorelbine, filgastrim in people with Non-Hodgkin's Lymphoma and Hodgkin's Disease, run by Bayside Health at 10 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. 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 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Australia. 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?
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). (time frame: After two cycles and after four cycles). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jan 2016.