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NCT00795002 · ClinicalTrials.gov registry record · Phase 2
Alvocidib, Cytarabine, and Mitoxantrone in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 78
- Enrollment target
NCT00795002: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00795002 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 78 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00795002, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 78 participants
- Enrollment target
Study Summary
This randomized phase II trial is studying two different schedules of alvocidib to compare how well they work when given together with cytarabine and mitoxantrone in treating patients with newly diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as alvocidib, cytarabine, and mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known which schedule of alvocidib is more effective when given together with cytarabine and mitoxantrone in treating patients with acute myeloid leukemia.
Primary Outcome
Bone marrow showing less than 5% leukemic blasts with normal maturation of all cell lines, an ANC of at least 1000/uL and a platelet count of 100,000/uL, absence of blast in peripheral blood, absence of identifiable leukemic cells in the bone marrow, clearance of disease-associated cytogenetic abnormalities, and clearance of any previously existing extramedullary disease. Repeat marrow confirmation 4-6 weeks following the marrow documenting CR is not required due to the need for continued treatm
Interventions
- OTHER laboratory biomarker analysis
- OTHER pharmacological study
- DRUG cytarabine
- DRUG alvocidib
- DRUG mitoxantrone hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2008-11 |
| Est. Completion | 2012-09 |
| Phase | Phase 2 |
What the finished NCT00795002 record still lists
NCT00795002 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower).
The record links to 0 conditions, and to 5 interventions - of which laboratory biomarker analysis is the first listed.
NCT00795002 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00795002 about?
NCT00795002 is a clinical study titled "Alvocidib, Cytarabine, and Mitoxantrone in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia". This randomized phase II trial is studying two different schedules of alvocidib to compare how well they work when given together with cytarabine and mitoxantrone in treating patients with newly diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as alvocidib, cytarabine, and mitoxant...
What is the current status of trial NCT00795002?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 78 participants. The study started on 2008-11. Estimated completion is 2012-09.
What interventions are being tested in trial NCT00795002?
The interventions under investigation include: laboratory biomarker analysis (OTHER), pharmacological study (OTHER), cytarabine (DRUG), alvocidib (DRUG), mitoxantrone hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00795002?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00795002's enrollment target sits among peer trials
78 884th of 2000 higher than 1,110 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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