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NCT00090090 Clinical Trial

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

Mantle Cell Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00090090
Other study ID # ELSA 2004-001
Secondary ID
Status Completed
Phase Phase 2
First received August 24, 2004
Last updated January 8, 2008
Start date April 2004
Est. completion date October 2006

Study information
Verified date January 2008
Source Spectrum Pharmaceuticals, Inc
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 114
Est. completion date October 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Elsamitrucin

Locations
Country Name City State
United States Alta Bates Cancer Center Berkeley California
United States Providence Saint Joseph Medical Center Burbank California
United States Tower Hematology Oncology Medical Group Los Angeles California
United States USC Norris Cancer Center Los Angeles California
United States North Shores University Hospital Manhasset New York
United States North Valley Hematology Oncology Medical Group Mission Hills California
United States Cancer and Blood Institute Medical Group Rancho Mirage California

Sponsors (1)
Lead Sponsor Collaborator
Spectrum Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

References & Publications (1)

Allen SL, Schacter LP, Lichtman SM, Bukowski R, Fusco D, Hensley M, O'Dwyer P, Mittelman A, Rosenbloom B, Huybensz S. Phase II study of elsamitrucin (BMY-28090) for the treatment of patients with refractory/relapsed non-Hodgkin's lymphoma. Invest New Drugs. 1996;14(2):213-7. — View Citation

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