Elsamitrucin (SPI 28090) for Relapsed or Refractory Non-Hodgkin's Lymphoma

Spectrum Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Mantle Cell Lymphoma; Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Treatments: Drug: Elsamitrucin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00090090

ELSA 2004-001

Details and patient eligibility

About

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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)