This is a multicenter Phase 2 randomized parallel-group study to determine the effect of Telintra treatment on severe chronic neutropenia. Patients will be randomized to Telintra or enter an observation period with an option to crossover to Telintra treatment in a 1:1 allocation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Starting Dose 2000 mg orally per day in two divided doses with dose to increase or decrease to achieve target median ANC (Range 1,500-10,000 cells/uL)
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
University of Michigan Hospital
Ann Arbor, Michigan, United States
Cancer Care Centers of South Texas
San Antonio, Texas, United States
University of Washington Medical Center
Seattle, Washington, United States
Objective absolute neutrophil count (ANC) response rate
Time frame: 18 Months
Incidence of infections, oropharyngeal ulcers and antibiotic use
Time frame: 18 Months
Incidence and duration of hospitalizations
Time frame: 18 Months
FACT-N quality of life assessment
Time frame: 18 Months
Safety assessments
Time frame: 18 Months
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