At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 43 enrolled
Drug / intervention
Isatuximab +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of Isatuximab (SAR650984) (NSC-795145) for Patients With Previously Treated AL Amyloidosis
In Brief
A Phase 2 clinical trial evaluating Isatuximab and Laboratory Biomarker Analysis for Amorphous, Eosinophilic, and Acellular Deposit and 12 related conditions. Completed, enrolled 43 participants across 345 sites.
Detailed Summary
This phase II trial studies how well isatuximab works in treating patients with primary amyloidosis that has come back or does not respond to treatment. Monoclonal antibodies, such as isatuximab, may interfere with the ability of cancer cells to grow and spread.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAmorphous, Eosinophilic, and Acellular Deposit, Constipation, Diarrhea, Early Satiety, Gastrointestinal Hemorrhage, Hepatomegaly, Lymphadenopathy, Macroglossia, Nausea, Primary Systemic Amyloidosis, Purpura, Recurrent Primary Amyloidosis, Refractory Primary Amyloidosis
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedApr 2018
Enrollment StartJun 2018
Primary CompletionAug 2023
Study CompletionSep 2023
TodayJul 2026
First PostedApr 17, 2018
Enrollment StartJun 6, 2018
Primary CompletionAug 30, 2023
Study CompletionSep 19, 2023
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 8.2 years ago
Interventions
Isatuximabbiological
Given IV
Laboratory Biomarker Analysisother
Correlative studies