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NCT00814164 · ClinicalTrials.gov registry record · Phase 2
Clofarabine and Daunorubicin in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia
A Phase 2 study, sponsored by Roswell Park Cancer Institute.
- Terminated
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
NCT00814164: Clinical Trial Phase 2 study, sponsored by Roswell Park Cancer Institute.
NCT00814164 is a Phase 2 study that was terminated before completion, run by Roswell Park Cancer Institute. The registered enrollment target is 21 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00814164, a Phase 2 study, was terminated before completion, sponsored by Roswell Park Cancer Institute.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as clofarabine and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving clofarabine together with daunorubicin may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving clofarabine together with daunorubicin works in treating older patients with newly diagnosed acute myeloid leukemia.
Primary Outcome
Complete Response/Remission (CR) was defined on morphologic criteria at a single response assessment as follows: A bone marrow aspirate or biopsy of \< 5% blasts, with evidence of normal hematopoiesis; Absence of Auer rods in the blast that are present; Absence of extramedullary disease \[imaging required only if obtained pretreatment for known site(s) of disease\]; If applicable and available, absence of a unique phenotype determined at the pretreatment specimen, as assessed by immunophenotypin
Interventions
- GENETIC protein expression analysis
- DRUG clofarabine
- GENETIC cytogenetic analysis
- DRUG daunorubicin hydrochloride
- OTHER immunologic technique
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2008-12 |
| Est. Completion | 2013-08 |
| Phase | Phase 2 |
Why NCT00814164 stopped before completion
NCT00814164 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 5 interventions - of which protein expression analysis is the first listed.
NCT00814164 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00814164 about?
NCT00814164 is a clinical study titled "Clofarabine and Daunorubicin in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia". RATIONALE: Drugs used in chemotherapy, such as clofarabine and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving clofarabine together with daunorubicin may kill more cancer cells. PURPOSE: This phase II tri...
What is the current status of trial NCT00814164?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2008-12. Estimated completion is 2013-08.
What interventions are being tested in trial NCT00814164?
The interventions under investigation include: protein expression analysis (GENETIC), clofarabine (DRUG), cytogenetic analysis (GENETIC), daunorubicin hydrochloride (DRUG), immunologic technique (OTHER).
Who is sponsoring clinical trial NCT00814164?
This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00814164's enrollment target sits among peer trials
21 1794th of 2000 higher than 196 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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