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Clinical Trials/NCT00090090
NCT00090090CompletedPhase 2

A Multi-Center, Open-Label, Non-Randomized Phase II Study of Elsamitrucin (SPI 28090) In Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Spectrum Pharmaceuticals, Inc7 sites in 1 country114 target enrollmentStarted: April 1, 2004Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
114
Locations
7
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

To determine the safety and efficacy of elsamitrucin in patients with relapsed or refractory non-Hodgkin's lymphoma (NHL). To determine if elsamitrucin is efficacious in a particular pathologic NHL subtype(s).

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Relapsed or Refractory mantle cell lymphoma and/or CLL/SLL except Burkitt's, Burkitt's like or HIV-associated lymphoma
  • •at least one prior cytotoxic chemotherapy regimens
  • •measurable disease
  • •adequate bone marrow, liver and kidney function
  • •ECOG PS 0-2

Exclusion Criteria

  • •prior treatment with elsamitrucin
  • •prior chemo, antibody or radiotherapy for NHL within 28 days prior to start to treatment
  • •HIV positive or known AIDS syndrome
  • •uncontrolled medical disease or psychiatric condition/s

Investigators

Sponsor Class
Industry

Study Sites (7)

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