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NCT01523977 · ClinicalTrials.gov registry record · Phase 1
Everolimus With Multiagent Re-Induction Chemotherapy in Pediatric Patients With ALL
A Phase 1 study, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT01523977: Completed Phase 1 study, sponsored by Dana-Farber Cancer Institute.
NCT01523977 is a Phase 1 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01523977, a Phase 1 study, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
Laboratory and other studies suggest that, the study drug, Everolimus (RAD001), may prevent tumor cell growth and also may increase the efficacy of other chemotherapy drugs. Everolimus is approved for use in the United States for certain types of cancer, such as kidney cancer. It has been extensively studied in people with various types of cancer as a single agent (a drug that is used alone to treat the cancer) or in combination with a number of other drugs. Studies in adults with cancer have also evaluated Everolimus in combination with other anti-tumor drugs. Information from lab studies and some other clinical trials suggests that Everolimus may kill leukemia cells on its own, and also make it more likely that steroids (such as prednisone) are able to kill leukemia cells. In this research study, we are looking to learn more about how Everolimus works in combination with other drugs which are commonly used to treat relapsed acute lymphoblastic leukemia (prednisone, vincristine, PEG-asparaginase, and doxorubicin). The main goal of the study is to evaluate the side effects of this treatment combination in order to determine a safe dose of Everolimus which can be given with these other 4 drugs.
Primary Outcome
To determine the safety and feasibility of treatment with everolimus in combination with vincristine, prednisone, PEG-asparaginase and doxorubicin in patients with relapsed acute lymphoblastic leukemia (ALL)
Interventions
- DRUG Doxorubicin
- DRUG Everolimus
- DRUG Vincristine
- DRUG Prednisone
- DRUG PEG-Asparaginase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2011-11 |
| Est. Completion | 2018-11 |
| Phase | Phase 1 |
What the finished NCT01523977 record still lists
NCT01523977 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 5 interventions - of which Doxorubicin is the first listed.
NCT01523977 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01523977 about?
NCT01523977 is a clinical study titled "Everolimus With Multiagent Re-Induction Chemotherapy in Pediatric Patients With ALL". Laboratory and other studies suggest that, the study drug, Everolimus (RAD001), may prevent tumor cell growth and also may increase the efficacy of other chemotherapy drugs. Everolimus is approved for use in the United States for certain types of cancer, such as kidney cancer. It has been extensivel...
What is the current status of trial NCT01523977?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2011-11. Estimated completion is 2018-11.
What interventions are being tested in trial NCT01523977?
The interventions under investigation include: Doxorubicin (DRUG), Everolimus (DRUG), Vincristine (DRUG), Prednisone (DRUG), PEG-Asparaginase (DRUG).
Who is sponsoring clinical trial NCT01523977?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01523977's enrollment target sits among peer trials
22 1601st of 2000 higher than 386 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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