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
- Diffuse Large B-cell Lymphoma
- Mantle Cell Lymphoma
- Non-Hodgkin's Lymphoma
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 rituximabVSLI (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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California | San Francisco | California | 94110 | - |
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