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


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Sponsored by:	Spectrum Pharmaceuticals, Inc
Information provided by:	Spectrum Pharmaceuticals, Inc

Condition	Treatment or Intervention	Phase
B-Cell Lymphoma T-Cell Lymphoma	Drug: Elsamitrucin	Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both

Inclusion Criteria:

Relapsed or Refractory B-cell (includes CLL/SLL) or T-cell non-hodgkin's lymphoma, except Burkitt's, Burkitt's like or HIV-associated lymphoma
at least two 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

Rosemarie Rosales, M.D. 949-743-9266 rrosales@spectrumpharm.com
Spectrum Information 949-788-6700 info@spectrumpharm.com

California
USC Norris Cancer Center, Los Angeles, California, 90033, United States; Recruiting

Christine Duran, Data Manager 323-226-4578 marquezc@usc.edu
Ann Mohrbacher, M.D., Principal Investigator

Providence Saint Joseph Medical Center, Burbank, California, 91505, United States; Recruiting

Evelyn Dizon, Data Manager 818-847-3218 evelyn.dizon@providence.org
Raul Mena, M.D., Principal Investigator

North Valley Hematology Oncology Medical Group, Mission Hills, California, 91343, United States; Recruiting

Catherine Madrid, LVN 818-365-3099 cathymh@covad.net
Shamel Sanani, M.D., Principal Investigator

Alta Bates Cancer Center, Berkeley, California, 94704, United States; Recruiting

Beth Davis 510-204-3428 bdavis@salick.com
David Irwin, M.D., Principal Investigator

Tower Hematology Oncology Medical Group, Los Angeles, California, 90048, United States; Recruiting

Marie Fuerst, RN 310-854-9269 fuerstm@toweroncology.com
Fred Rosenfelt, M.D., Principal Investigator

Cancer and Blood Institute Medical Group, Rancho Mirage, California, 92270, United States; Recruiting

Theresa Fox 760-568-4461 tfox@cbirm.com
Davood Vafai, M.D., Principal Investigator

New York
North Shores University Hospital, Manhasset, New York, 11021, United States; Recruiting

Marjorie Fricano, RN 516-562-8942
Steven Allen, M.D, Principal Investigator