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Phase 1/2 Study of VSLI Plus Rituximab in Patients With Relapsed and/or Refractory NHL

Non-Hodgkin's Lymphoma Clinical Trial

Official title:
A Phase I/II Study of Rituximab Plus Vincristine Sulfate Liposomes Injection in the Treatment of Relapsed or Refractory Aggressive Non Hodgkin's Lymphoma

Clinical Trial Summary

This was a Phase 1/2 study performed at two clinical centers in the US and UK. It was a single arm, open label study evaluating VSLI plus rituximab in adults with aggressive relapsed or refractory non-Hodgkin's lymphoma.

Clinical Trial Description

The primary efficacy endpoint was objective response rate, defined as the proportion of patients with a response of CR + PR.

Duration of response, time to progression, and overall survival were analyzed. Descriptive statistics were used for demographics, disease characteristics, treatment exposures, efficacy, and safety variables. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01851551
Study type Interventional
Source Acrotech Biopharma LLC
Contact
Status Completed
Phase Phase 1/Phase 2
Start date September 2001
Completion date April 2005
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