Isatuximab as Upfront Therapy for the Treatment of High Risk AL Amyloidosis (NCT04754945) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Isatuximab as Upfront Therapy for the Treatment of High Risk AL Amyloidosis
United States11 participantsStarted 2021-04-28
Plain-language summary
This phase I trial studies the side effects of isatuximab and to see how well it works in treating patients with high risk immunoglobulin light chain amyloidosis (AL amyloidosis). Isatuximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histopathological diagnosis of amyloidosis based on detection by immunohistochemistry (IHC) and polarizing light microscopy of green birefringent material in Congo red-stained tissue specimens in an organ other than bone marrow, characteristic electron microscopy appearance, or mass spectrometry. Specifically for male subjects 70 years of age or older who have cardiac involvement only and subjects of African descent, mass spectrometry typing of AL amyloid in a tissue biopsy is recommended to rule out other types of amyloidosis such as age-related amyloidosis or hereditary amyloidosis (ATTR mutation)
* Must have evidence of high risk AL amyloidosis defined as one of the following any time within the 6 months prior to consent:
* Biomarker-based indicators of severe disease: NT-proBNP \> 8500 ng/L OR hs-cTnT \>= 50 ng/L
* BUMC 2019 stage 3b requiring both TnI \> 0.1 ng/mL and BNP \> 700 pg/mL
* Mayo 2012 stage 4 that includes each of the following a) cTnT \>= 0.025 ng/mL or hs-cTnT \>= 40 ng/mL; b) NT-proBNP \>= 1800 pg/mL; and c) dFLC \>= 180 mg/L
* Significant AL amyloid related hypotension (systolic blood pressure \[SBP\] \< 100 mm Hg or symptomatic orthostatic hypotension defined as a decrease in systolic blood pressure upon standing of \> 20 mm Hg despite medical management \[fludrocortisone, midodrine, etc\] in the absence of volume depletion)
* Absolute neutrophil count (ANC) \>= 1000/uL
* Platelet count \>= 50,000 and platelet transfusion …