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NCT03499808 · ClinicalTrials.gov registry record · Phase 2
S1702 Isatuximab in Treating Patients With Relapsed or Refractory Primary Amyloidosis
A Phase 2 study, sponsored by SWOG Cancer Research Network.
- Completed
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
NCT03499808: Completed Phase 2 study, sponsored by SWOG Cancer Research Network.
NCT03499808 is a Phase 2 study that has completed, run by SWOG Cancer Research Network. The registered enrollment target is 43 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03499808, a Phase 2 study, has completed, sponsored by SWOG Cancer Research Network.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
Study 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.
Primary Outcome
To assess the efficacy as measured by the confirmed overall hematologic response rate (partial response, very good partial response, complete response) of isatuximab in relapsed/ refractory systemic light chain (AL) amyloidosis. Measured as rate of partial response or better. Partial response is defined as a dFLC decrease of ≥ 50%, but remaining \> 4.0 mg/dL. Very good partial response is defined as the difference between involved and uninvolved FLCs \[dFLC\] \< 4.0 mg/dL. Complete response i
Interventions
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Isatuximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2018-06-06 |
| Est. Completion | 2023-09-19 |
| Phase | Phase 2 |
What the finished NCT03499808 record still lists
NCT03499808 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT03499808 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03499808 about?
NCT03499808 is a clinical study titled "S1702 Isatuximab in Treating Patients With Relapsed or Refractory Primary Amyloidosis". 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.
What is the current status of trial NCT03499808?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2018-06-06. Estimated completion is 2023-09-19.
What interventions are being tested in trial NCT03499808?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Isatuximab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03499808?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03499808's enrollment target sits among peer trials
43 1332nd of 2000 higher than 662 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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