ABC008 in Subjects With T-cell Large Granular Lymphocytic Leukemia (T-LGLL) (NCT05532722) | Clinical Trial Compass
CompletedPhase 1/2
ABC008 in Subjects With T-cell Large Granular Lymphocytic Leukemia (T-LGLL)
United States21 participantsStarted 2022-09-28
Plain-language summary
An open label, ascending dose study for adult subjects with T-cell Large Granular Lymphocytic Leukemia (T-LGLL)
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Is at least 18 years of age.
* Has body mass index (BMI) ≤35 kg/m2.
* Has a documented diagnosis of T LGLL.
* Has any 1 or more of the following at Screening:
* Absolute neutrophil count (ANC) \<0.5 x 109/L
* ANC ≥0.5 x 109/L and \<1.0 x 109/L associated with recurrent infection (≥2 or more infections requiring antimicrobial therapy within the previous 12 months)
* Hemoglobin (Hgb) \<8 g/dL or packed red blood cell transfusion frequency ≥1 time in the 4 weeks immediately prior to Screening
* Hgb ≥8 g/dL and \<10 g/dL accompanied by documented symptoms of anemia, e.g., fatigue, weakness, pale or yellowish skin, irregular heartbeat, shortness of breath, dizziness, or lightheadedness.
* Has adequate hepatic and renal function at Screening, as indicated by:
* Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST); \<2.5x the upper limit of normal (ULN)
* Total bilirubin ≤1.5 ULN; subjects with Gilbert syndrome must have a total bilirubin \<3.0x ULN with direct bilirubin \<1.0x ULN at time of Screening
* Estimated glomerular filtration rate (eGFR) ≥45 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) equation corrected for the body surface area of the subject calculated by the Mosteller equation and divided by 1.73
* Agrees to adhere to the current Centers for Disease Control advice regarding minimizing exposure to severe acute respiratory syndrome coronavirus 2 (SARS CoV 2) from the first Screen…
What they're measuring
1
Incidence, nature, and severity of treatment-emergent AEs and SAEs as determined by NCI CTCAE v5.0
Timeframe: Through Study Completion an average of 48 weeks