Non-Hodgkin's LymphomaPhase 2NCT00163748
Efficacy and Treatment Related Toxicity Study of a New Regimen for Lymphoma
A Phase 2 study testing gemcitabine, vinorelbine in people with Non-Hodgkin's Lymphoma and Hodgkin's Disease, run by Bayside Health at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-Hodgkin's Lymphoma, Hodgkin's Disease
- What is being tested?
- gemcitabine, vinorelbine
- How many people
- 40 participants
- Where
- 2 sitesAustralia
- Study dates
- Feb 2001to Nov 2003
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
The Alfred Hospital
Melbourne, Victoria, 3004
Royal North Shore Hospital
Sydney, New South Wales, 2065
About this study
Official title: A Pilot Study of Outpatient Vinorelbine and Gemcitabine With Filgrastim Support for Patients With Relapsed or Refractory Lymphoma.
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.
Read the 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
- Being tested
- gemcitabine, vinorelbine
- 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, vinorelbineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy and regimen related toxicity of the study treatment (vinorelbine and gemcitabine with filgrastim support).
Secondary outcomes (1)
To evaluate the requirement for inpatient admission and / or parenteral antibiotic therapy following study treatment in an outpatient setting.
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 startFeb 2001
- Primary completionNov 2003
- Study completionNov 2003
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
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
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
- NCT00163748
- Sponsor's protocol ID
- AH152/00
- Status last verified
- Jan 2016
- First submitted
- 12 Sep 2005
- Last updated
- 8 Jan 2016
- Results posted
- 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 Pilot Study of Outpatient Vinorelbine and Gemcitabine With Filgrastim Support for Patients With Relapsed or Refractory Lymphoma.
- ClinicalTrials.gov ID
- NCT00163748
- Acronym / sponsor ID
- AH152/00
- Conditions
- Non-Hodgkin's Lymphoma, Hodgkin's Disease
- Keywords
- Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Bayside HealthOther government
- Study start
- Feb 2001
- Primary completion
- Nov 2003 (actual)
- Study completion
- Nov 2003 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 | Drug | – |
Primary outcome
To evaluate the efficacy and regimen related toxicity of the study treatment (vinorelbine and gemcitabine with filgrastim support).
1 secondary outcome
To evaluate the requirement for inpatient admission and / or parenteral antibiotic therapy following study treatment in an outpatient setting.
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
2 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 in people with Non-Hodgkin's Lymphoma and Hodgkin's Disease, run by Bayside Health at 2 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 5 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 2 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 and regimen related toxicity of the study treatment (vinorelbine and gemcitabine with filgrastim support).. 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.