A Multi-Center, Open-Label, Non-Randomized Phase II Study of Elsamitrucin (SPI 28090) In Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Data Collection
Chronic Disease+14
+ Hematologic Diseases
+ Immune System Diseases
Treatment Study
Summary
Study start date: April 1, 2004
Actual date on which the first participant was enrolled.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).
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.114 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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 Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 7 locations
Providence Saint Joseph Medical Center
Burbank, United StatesUSC Norris Cancer Center
Los Angeles, United StatesTower Hematology Oncology Medical Group
Los Angeles, United States