Trials / Completed
CompletedNCT01851551
Phase 1/2 Study of VSLI Plus Rituximab in Patients With Relapsed and/or Refractory NHL
A Phase I/II Study of Rituximab Plus Vincristine Sulfate Liposomes Injection in the Treatment of Relapsed or Refractory Aggressive Non Hodgkin's Lymphoma
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- Acrotech Biopharma Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Vincristine Sulfate Liposome Injection plus rituximab |
Timeline
- Start date
- 2001-09-01
- Primary completion
- 2004-04-01
- Completion
- 2005-04-01
- First posted
- 2013-05-10
- Last updated
- 2020-01-03
Locations
2 sites across 2 countries: United States, United Kingdom
Source: ClinicalTrials.gov record NCT01851551. Inclusion in this directory is not an endorsement.