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NCT01960387 · ClinicalTrials.gov registry record · Phase 2
Phase II Clofarabine and Cytarabine for Newly Diagnosed Acute Myeloid Leukemia
A Phase 2 study, sponsored by University of Pittsburgh.
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT01960387: Clinical Trial Phase 2 study, sponsored by University of Pittsburgh.
NCT01960387 is a Phase 2 study that was terminated before completion, run by University of Pittsburgh. The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01960387, a Phase 2 study, was terminated before completion, sponsored by University of Pittsburgh.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
The combination of clofarabine and cytarabine is an effective and reasonably well-tolerated treatment regimen in patients with either relapsed/refractory or newly diagnosed AML. For this prospective study, we propose the use of clofarabine and cytarabine for second course induction therapy for patients with persistent AML after treatment with an anthracycline and cytarabine.
Primary Outcome
Number of patients with newly diagnosed Acute Myeloid Leukemia who achieved Complete Response to therapy as determined by bone marrow biopsy evaluation. A CR designation required that the patient achieved a morphologic leukemia-free state and an absolute neutrophil count greater than or equal to 1.0 x 10\^9/l, a platelet count greater than or equal to 100 x 10\^9/l, and no evidence of extramedullary disease.
Interventions
- DRUG Cytarabine
- DRUG Clofarabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2013-10 |
| Est. Completion | 2015-03 |
| Phase | Phase 2 |
Why NCT01960387 stopped before completion
NCT01960387 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Cytarabine is the first listed.
NCT01960387 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01960387 about?
NCT01960387 is a clinical study titled "Phase II Clofarabine and Cytarabine for Newly Diagnosed Acute Myeloid Leukemia". The combination of clofarabine and cytarabine is an effective and reasonably well-tolerated treatment regimen in patients with either relapsed/refractory or newly diagnosed AML. For this prospective study, we propose the use of clofarabine and cytarabine for second course induction therapy for patie...
What is the current status of trial NCT01960387?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2013-10. Estimated completion is 2015-03.
What interventions are being tested in trial NCT01960387?
The interventions under investigation include: Cytarabine (DRUG), Clofarabine (DRUG).
Who is sponsoring clinical trial NCT01960387?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01960387's enrollment target sits among peer trials
2 2001st of 2000 the lowest 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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