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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: Clinical Trial Phase 1 study, sponsored by University of Colorado, Denver.
NCT03318016 is a Phase 1 study that was terminated before completion, run by University of Colorado, Denver. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of Participants that were treated in each Cohort in attempt to establish Maximally Tolerated Dose (MTD) of cyclophosphamide with ATO is defined as the highest dose level of 1000 mg/m2. MTD is established when at least 6 participants within a Cohort have responded without toxicity. The trial is organized in a standard, phase I, 3+3 design. The first 3 subjects will be assigned to cohort 1. Per standard trial design, if there are 0/3 dose-limiting toxicities (DLT) in this cohort, the next
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 |
Why NCT03318016 stopped before completion
NCT03318016 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide 500 MG is the first listed.
NCT03318016 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03318016's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 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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