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


Phase 2
18 Years
N/A
Not Enrolling
Both
Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Authority:

United States: Food and Drug Administration

Study ID:

ELSA 2004-001

NCT ID:

NCT00090090

Start Date:

April 2004

Completion Date:

October 2006

Related Keywords:

  • Mantle Cell Lymphoma
  • Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Mantle-Cell

Name

Location
Tower Hematology Oncology Medical Group Los Angeles, California  90048
USC Norris Cancer Center Los Angeles, California  90033
Providence Saint Joseph Medical Center Burbank, California  91505-4866
Alta Bates Cancer Center Berkeley, California  94704
North Valley Hematology Oncology Medical Group Mission Hills, California  91343
Cancer and Blood Institute Medical Group Rancho Mirage, California  92270
North Shores University Hospital Manhasset, New York  11021