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Oral Clofarabine + Rituximab in Relapsed B Cell NHL
NCT00691652Phase 2
Key facts
- Status
- Terminated
- Start
- May 2008
- Primary completion
- Jan 2009
- Countries
- 1
- Sponsor
- OHSU Knight Cancer Institute
- Modality
- Orthosteric Ligands, Metabolically Activated Prodrugs
- Drugs
- clofarabine
- Conditions
- B-cell non-Hodgkin lymphoma
01
Overview
Phase 2, open-label, single-arm trial of clofarabine in B-cell non-Hodgkin lymphoma, sponsored by OHSU Knight Cancer Institute. Primary endpoints: Maximum Tolerated Dose and Objective Response Rate. Started May 2008; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Oral Clofarabine + Rituximab
Oral Clofarabine (dose escalation in Phase I, fixed in Phase II) + Rituximab IV
03
Who it enrols
Adult patients with relapsed CD20-positive B-cell non-Hodgkin lymphoma, adequate organ function, and no active infections or HIV.
04
Endpoints
Primary
Maximum Tolerated Dose
Objective Response Rate
Secondary
Progression-Free Survival
Safety and Efficacy
DNA Methylation Inhibition
DNA Methylation Correlation
Gene Activation
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