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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2006-10-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Mantle Cell Lymphoma Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Elsamitrucin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No