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NCT03236792 · ClinicalTrials.gov registry record · Phase 1
Ixazomib In Combination With Cyclophosphamide And Dexamethasone for Newly Diagnosed AL Amyloidosis
A Phase 1 study, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT03236792: Completed Phase 1 study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT03236792 is a Phase 1 study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03236792, a Phase 1 study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
Light chain (AL) amyloidosis is a bone marrow disorder that affects a wide range of organs that can lead to organ dysfunction and death. Amyloid is an abnormal protein that is produced in your bone marrow and cannot be broken down. It builds up in different organs preventing them from working well. The most commonly affected organs are the kidneys, heart, liver, spleen, nervous system, and digestive tract. Treatment with chemotherapy can stop the growth of abnormal cells that produce this abnormal protein. Decrease in amyloid protein in the body improves the function of the affected organs. The primary purpose of this study is to determine the safest dose of the medications and how well you tolerate them or the "maximum tolerated dose" (MTD). The study uses Ixazomib in combination with cyclophosphamide and dexamethasone to treat people with newly diagnosed AL amyloidosis. This combination of medications is an oral regimen that is taken over 6 cycles. The first part of study will determine the safety of this regimen and the second part of the study will determine how effective this combination of drugs is to treat your disease.
Primary Outcome
The MTD of ixazomib given in combination with cyclophosphamide and dexamethasone, 3 + 3 design in Phase 1 of this study
Interventions
- DRUG Cyclophosphamide
- DRUG Dexamethasone
- DRUG Ixazomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2017-06-12 |
| Est. Completion | 2022-09-20 |
| Phase | Phase 1 |
What the finished NCT03236792 record still lists
NCT03236792 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT03236792 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03236792 about?
NCT03236792 is a clinical study titled "Ixazomib In Combination With Cyclophosphamide And Dexamethasone for Newly Diagnosed AL Amyloidosis". Light chain (AL) amyloidosis is a bone marrow disorder that affects a wide range of organs that can lead to organ dysfunction and death. Amyloid is an abnormal protein that is produced in your bone marrow and cannot be broken down. It builds up in different organs preventing them from working well. ...
What is the current status of trial NCT03236792?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2017-06-12. Estimated completion is 2022-09-20.
What interventions are being tested in trial NCT03236792?
The interventions under investigation include: Cyclophosphamide (DRUG), Dexamethasone (DRUG), Ixazomib (DRUG).
Who is sponsoring clinical trial NCT03236792?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03236792's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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