Spots Global Cancer Trial Database for Phase 1/2 Study of VSLI Plus Rituximab in Patients With Relapsed and/or Refractory NHL
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Trial Identification
Brief Title: Phase 1/2 Study of VSLI Plus Rituximab in Patients With Relapsed and/or Refractory NHL
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
Study ID: NCT01851551
Study Description
Brief 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.
Detailed 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California, San Francisco, California, United States
Leeds General Infirmary, Leeds, West Yorkshire, United Kingdom
Contact Details
Name: Lawrence Kaplan, MD
Affiliation: University of California, San Francisco
Role: PRINCIPAL_INVESTIGATOR
Name: Gareth Morgan, Prof.
Affiliation: Leeds General Infirmary
Role: PRINCIPAL_INVESTIGATOR
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