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NCT00611247 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Study of Temozolomide to Treat Poor Risk / Refractory Acute Myeloid Leukemia
A Phase 2 study of Leukemia, Myeloid, sponsored by Bruno C. Medeiros.
- Completed
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
- 1
- Study location
NCT00611247: Completed Phase 2 study of Leukemia, Myeloid, sponsored by Bruno C. Medeiros.
NCT00611247 is a Phase 2 study of Leukemia, Myeloid that has completed, run by Bruno C. Medeiros. The registered enrollment target is 42 participants, below the 390-participant average among 8 other Leukemia, Myeloid trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00611247, a Phase 2 study of Leukemia, Myeloid, has completed, sponsored by Bruno C. Medeiros.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
- 1
- Study location
Study Summary
Open-label, non-randomized, parallel assignment, phase 2 trial assessing the safety and efficacy of distinct temozolomide treatment regimens for patients with AML and poor prognosis
Primary Outcome
Response determined per European LeukemiaNet response criteria: CR = bone marrow blasts \<5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \> 1.0 x 10e9/L; platelet count \> 100 x 10e9/L; and independence of red cell transfusions. CRi = all CR criteria except for residual neutropenia (\< 1.0 x 10e9/L) or thrombocytopenia (\< 100 x 10e9/L)\]. Morphologic leukemia-free state (LFS) = bone marrow blasts \<5%; absence of blasts with Auer rods; abse
Conditions Studied
Interventions
- DRUG Temozolomide
Study Locations (1)
California
- Stanford University School of Medicine - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2007-12 |
| Est. Completion | 2010-01 |
| Phase | Phase 2 |
What the finished NCT00611247 record still lists
NCT00611247 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 390-participant average among 8 other Leukemia, Myeloid trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Leukemia, Myeloid appearing as the primary indexed condition, and to 1 intervention - of which Temozolomide is the first listed.
NCT00611247 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT00611247 about?
NCT00611247 is a clinical study titled "Phase 2 Study of Temozolomide to Treat Poor Risk / Refractory Acute Myeloid Leukemia". Open-label, non-randomized, parallel assignment, phase 2 trial assessing the safety and efficacy of distinct temozolomide treatment regimens for patients with AML and poor prognosis
What is the current status of trial NCT00611247?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2007-12. Estimated completion is 2010-01.
What conditions does trial NCT00611247 study?
This clinical trial studies the following conditions: Leukemia, Myeloid.
What interventions are being tested in trial NCT00611247?
The interventions under investigation include: Temozolomide (DRUG).
Who is sponsoring clinical trial NCT00611247?
This trial is sponsored by Bruno C. Medeiros, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00611247 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00611247's enrollment target sits among peer trials
42 6th of 8 higher than 3 of 8 other Leukemia, Myeloid trials
participants (enrollment target), bucketed by value
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