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NCT01319864 · ClinicalTrials.gov registry record · Phase 1
POETIC Plerixafor as a Chemosensitizing Agent for Relapsed Acute Leukemia and MDS in Pediatric Patients
A Phase 1 study, sponsored by Seattle Children's Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT01319864: Completed Phase 1 study, sponsored by Seattle Children's Hospital.
NCT01319864 is a Phase 1 study that has completed, run by Seattle Children's Hospital. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01319864, a Phase 1 study, has completed, sponsored by Seattle Children's Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
In this Phase I study, we will test the safety of the drug plerixafor (MOBOZIL) at different dose levels, used together with other anti-cancer drugs-cytarabine and etoposide. We want to find out what effects, good and /or bad, this combination of drugs has on leukemia. Plerixafor is a drug that blocks a receptor on the leukemia cell, which prevents it from staying in the bone marrow where it can be resistant to chemotherapy. Plerixafor is FDA approved for mobilizing stem cells from the bone marrow in preparation for an autologous stem cell transplant. Cytarabine and etoposide have been used as part of standard chemotherapy for ALL and AML. However, the use of plerixafor with cytarabine and etoposide in pediatric patients with relapsed or refractory ALL, AML and MDS is considered experimental.
Primary Outcome
To determine the safety and tolerability of plerixafor in combination with reinduction chemotherapy in pediatric and young adult patients with relapsed/refractory acute leukemia (AML/MDS and ALL)
Interventions
- DRUG Plerixafor Dose Escalation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2011-03 |
| Est. Completion | 2016-06-28 |
| Phase | Phase 1 |
What the finished NCT01319864 record still lists
NCT01319864 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 1 intervention - of which Plerixafor Dose Escalation is the first listed.
NCT01319864 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01319864 about?
NCT01319864 is a clinical study titled "POETIC Plerixafor as a Chemosensitizing Agent for Relapsed Acute Leukemia and MDS in Pediatric Patients". In this Phase I study, we will test the safety of the drug plerixafor (MOBOZIL) at different dose levels, used together with other anti-cancer drugs-cytarabine and etoposide. We want to find out what effects, good and /or bad, this combination of drugs has on leukemia. Plerixafor is a drug that bloc...
What is the current status of trial NCT01319864?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2011-03. Estimated completion is 2016-06-28.
What interventions are being tested in trial NCT01319864?
The interventions under investigation include: Plerixafor Dose Escalation (DRUG).
Who is sponsoring clinical trial NCT01319864?
This trial is sponsored by Seattle Children's Hospital, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01319864's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 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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