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NCT03328104 · ClinicalTrials.gov registry record · Phase 1
Everolimus in Combination With Nelarabine, Cyclophosphamide and Etoposide in Lymphoblastic Leukemia/Lymphoma
A Phase 1 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT03328104: Completed Phase 1 study, sponsored by Emory University.
NCT03328104 is a Phase 1 study that has completed, run by Emory University. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03328104, a Phase 1 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
T- cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LLy) has an increase in proteins in a specific pathway called the mTOR pathway within the cancer cells. In cancer cells it can encourage untimely cell growth, cell production, and cell survival. Everolimus is an inhibitor of the mTOR pathway and can decrease the growth and survival of cancer cells. It also prevents communication within cells and stops proteins from being made that may contribute to leukemia. The main purpose of the study is to find the maximum tolerated dose of everolimus when used together with standard chemotherapy.
Primary Outcome
Maximum Tolerated Dose (MTD) will be defined as the highest dose level tested at which 0/6 or 1/6 patients experience Dose Limiting Toxicity (DLT) with at least 2/3 or 2/6 patients encountering DLT at the next higher dose.
Interventions
- DRUG Cyclophosphamide
- DRUG Everolimus
- DRUG Etoposide
- DRUG Nelarabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2018-07-24 |
| Est. Completion | 2023-06-29 |
| Phase | Phase 1 |
What the finished NCT03328104 record still lists
NCT03328104 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT03328104 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03328104 about?
NCT03328104 is a clinical study titled "Everolimus in Combination With Nelarabine, Cyclophosphamide and Etoposide in Lymphoblastic Leukemia/Lymphoma". T- cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LLy) has an increase in proteins in a specific pathway called the mTOR pathway within the cancer cells. In cancer cells it can encourage untimely cell growth, cell production, and cell survival. Everolimus is an inhibit...
What is the current status of trial NCT03328104?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2018-07-24. Estimated completion is 2023-06-29.
What interventions are being tested in trial NCT03328104?
The interventions under investigation include: Cyclophosphamide (DRUG), Everolimus (DRUG), Etoposide (DRUG), Nelarabine (DRUG).
Who is sponsoring clinical trial NCT03328104?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03328104's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 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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