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

Part of paid clinical trials in San Francisco, California.

Sponsor
Acrotech Biopharma Inc.
Study ID
NCT01851551
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Sep 30, 2001
Status verified
Dec 2019
Primary completion
Apr 30, 2004
Completion
Apr 30, 2005

Study Design

Enrollment
22 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: VSLI plus rituximab
    VSLI (vincristine sulfate liposome injection) plus rituximab

Primary Outcome Measure

Objective response rate [ Time Frame: Assessed prior to each cycle for up to 12 cycles (24 weeks). For patients achieving a complete or partial response, follow-up assessments were to be made 2, 8, 16, and 24 weeks after treatment was discontinued (up to ~48 wks). ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of CaliforniaSan FranciscoCalifornia94110-

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