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NCT03318016 · ClinicalTrials.gov registry record · Phase 1
Arsenic Trioxide With Cyclophosphamide in Patients With Relapsed/Refractory Acute Myeloid Leukemia
A Phase 1 study, sponsored by University of Colorado, Denver.
- Terminated
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT03318016 is a Phase 1 study that was terminated before completion, run by University of Colorado, Denver. The registered enrollment target is 5 participants.
The verdict
NCT03318016, a Phase 1 study, was terminated before completion, sponsored by University of Colorado, Denver.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
Determine the maximum tolerated dose (MTD) and toxicity profile of the combination of cyclophosphamide and ATO (Arsenic Trioxide) in subjects with relapsed refractory AML. Determine the efficacy of ATO and cyclophosphamide in this population, as defined by response rate, response duration, event-free survival (EFS) and overall survival (OS). Determine the number of transplant-eligible subjects who are successfully bridged to stem cell transplantation or donor lymphocyte infusion.
Interventions
- DRUG Cyclophosphamide 500 MG
- DRUG Cyclophosphamide 1000 MG
- DRUG Cyclophosphamide 2000 MG
- DRUG Cyclophosphamide 3000 MG
- DRUG Cyclophosphamide 4000 MG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2017-12-15 |
| Est. Completion | 2021-01-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03318016
The ClinicalTrials.gov registry entry for NCT03318016 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide 500 MG is the first listed.
NCT03318016 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03318016 about?
NCT03318016 is a clinical study titled "Arsenic Trioxide With Cyclophosphamide in Patients With Relapsed/Refractory Acute Myeloid Leukemia". Determine the maximum tolerated dose (MTD) and toxicity profile of the combination of cyclophosphamide and ATO (Arsenic Trioxide) in subjects with relapsed refractory AML. Determine the efficacy of ATO and cyclophosphamide in this population, as defined by response rate, response duration, event-fr...
What is the current status of trial NCT03318016?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2017-12-15. Estimated completion is 2021-01-20.
What interventions are being tested in trial NCT03318016?
The interventions under investigation include: Cyclophosphamide 500 MG (DRUG), Cyclophosphamide 1000 MG (DRUG), Cyclophosphamide 2000 MG (DRUG), Cyclophosphamide 3000 MG (DRUG), Cyclophosphamide 4000 MG (DRUG).
Who is sponsoring clinical trial NCT03318016?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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