Trial of Venetoclax (ABT-199) and Dexamethasone for Relapsed or Refractory Systemic AL Amyloidosis (NCT03000660) | Clinical Trial Compass
TerminatedPhase 1
Trial of Venetoclax (ABT-199) and Dexamethasone for Relapsed or Refractory Systemic AL Amyloidosis
Stopped: partial clinical hold per FDA
United States3 participantsStarted 2017-01
Plain-language summary
This is a study to determine the safety, tolerability and maximum tolerated dose of Venetoclax (ABT-199) and dexamethasone in relapsed or refractory amyloid light chain (AL) amyloidosis patients.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Renal: albuminuria higher than 0.5 g/day in a 24-hour urine collection.
✓. Cardiac: involvement is defined as the presence of a mean left ventricular wall thickness on echocardiogram more than 12 mm in the absence of a history of hypertension or valvular heart disease, or unexplained low voltage (\< 0.5 mV) on electrocardiogram; or an NT-proBNP \> 332 ng/L in CKD 1 or 2 patients or a BNP \> 100ng/L in those who are CKD3.
✓. Hepatic: hepatomegaly on physical examination with alkaline phosphatase \> 1.5 X the upper limit of normal (ULN).
✓. Autonomic or peripheral neuropathy: based on clinical history, autonomic dysfunction with orthostasis, symptoms of nausea or dysgeusia, gastric atony by gastric emptying scan, diarrhea or constipation, or abnormal sensory and/or motor findings on neurologic examination.
✓. Stage I, both under threshold;
✓. Stage II, either troponin or NT-proBNP \[but not both\] over threshold;
✓. Stage III, both over threshold;
✓. Stage IIIa, both over threshold but NT-proBNP \< 8500 pg/ml.
Exclusion criteria
✕. QTc \> 470 milliseconds (msec) on a 12 lead ECG obtained during the Screening period. If a machine reading is above this value, the ECG should be reviewed by a qualified reader and confirmed on a subsequent ECG.
✕. AL Amyloidosis Risk Stage IIIb disease. Stage IIIb is defined by NT-proBNP \> 8500 pg/mL and troponin I \> 0.10 ng/mL.
What they're measuring
1
Participants with treatment related adverse events using NCI CTCAE version 4.03.
Timeframe: Up to 8 months after beginning study drug
✕. New York Heart Association (NYHA) classification III or IV.
✕. Enzyme-documented myocardial infarction within 6 months before enrollment.
✕. Chronic atrial fibrillation.
✕. Grade 2 or 3 atrioventricular (AV) block (Mobitz, Type I permitted).
✕. Supine systolic blood pressure \< 90 mmHg, or symptomatic orthostatic hypotension, or a decrease in systolic blood pressure on standing of \> 20 mm Hg in spite of being treated for orthostatic hypotension.
✕. History of a bleeding diathesis or currently receiving treatment with warfarin. Patients are allowed to take aspirin.