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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 January 2016 |
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Main ID: |
NCT00280878 |
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Date of registration:
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22/01/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Rituximab in Combination With Outpatient Therapy for CD20+ Lymphoma
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Scientific title:
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A Pilot Study of Rituximab in Combination With Out-patient Based VGF/F-GIV Salvage Therapies for Relapsed/Refractory CD20+ Lymphomas |
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Date of first enrolment:
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January 2006 |
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Target sample size:
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12 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00280878 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Australia
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Contacts
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Name:
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Andrew Spencer, Assoc.Prof |
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Address:
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Non-Hodgkin's Lymphoma (CD20+)
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Intervention(s)
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Drug: ifosfamide
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Drug: rituximab
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Drug: gemcitabine
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Drug: vinorelbine
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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.
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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