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NCT00968253 · ClinicalTrials.gov registry record · Phase 1
RAD001 Study in Treatment of Relapsed or Refractory Acute Lymphocytic Leukemia
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT00968253: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00968253 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00968253, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
The goal of Phase I of this clinical research study is to find the highest tolerable dose of RAD001 (everolimus) when given in combination with the standard chemotherapy regimens to patients with ALL. The goal of Phase II of this study is to learn if the drug combinations can help to control ALL. The safety of these drug combinations will be also studied in both phases.
Primary Outcome
The Maximum tolerated dose (MTD) was the highest dose level at which fewer than 2 of 6 patients developed a dose limiting toxicity (DLT) in the first two cycles of therapy. A 3 by 3 design was used for dose escalation in the phase I portion of the study. A dose-limiting toxic effect (DLT) was defined as a clinically significant adverse event or abnormal laboratory value directly attributable to everolimus and assessed as unrelated to disease progression, intercurrent illness, or concomitant med
Interventions
- DRUG Cyclophosphamide
- DRUG Doxorubicin
- DRUG Dexamethasone
- DRUG Vincristine
- DRUG Everolimus (RAD001)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2009-11 |
| Est. Completion | 2015-12 |
| Phase | Phase 1 |
What the finished NCT00968253 record still lists
NCT00968253 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT00968253 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00968253 about?
NCT00968253 is a clinical study titled "RAD001 Study in Treatment of Relapsed or Refractory Acute Lymphocytic Leukemia". The goal of Phase I of this clinical research study is to find the highest tolerable dose of RAD001 (everolimus) when given in combination with the standard chemotherapy regimens to patients with ALL. The goal of Phase II of this study is to learn if the drug combinations can help to control ALL. T...
What is the current status of trial NCT00968253?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2009-11. Estimated completion is 2015-12.
What interventions are being tested in trial NCT00968253?
The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin (DRUG), Dexamethasone (DRUG), Vincristine (DRUG), Everolimus (RAD001) (DRUG).
Who is sponsoring clinical trial NCT00968253?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00968253's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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