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NCT00852709 · ClinicalTrials.gov registry record · Phase 1
Phase I Dose-Escalation Trial of Clofarabine Followed by Escalating Doses of Fractionated Cyclophosphamide in Children With Relapsed or Refractory Acute Leukemias
A Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Terminated
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
NCT00852709: Clinical Trial Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT00852709 is a Phase 1 study that was terminated before completion, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 35 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00852709, a Phase 1 study, was terminated before completion, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
Study Summary
This is a Phase I study designed to determine the MTD and assess the toxicity associated with clofarabine followed by fractionated cyclophosphamide in patients \> 1 year of age or \< 21 years of age with relapsed or refractory acute leukemias. There will be 25 to 35 patients enrolled. Cohorts of 3 to 6 patients each will receive escalated doses of clofarabine followed by fractionated cyclophosphamide until the MTD is reached. There will be no intra-patient dose escalation. Single-agent cyclophosphamide will be administered by 2-hour IVI on Day 0 of cycle 1. On Days 1, 2, and 3 and Days 8, 9, and 10 clofarabine will be administered by IVI 2 hours before each dose of cyclophosphamide (see the treatment schema below). A cycle is defined as 28 days.
Interventions
- DRUG Cyclophosphamide
- DRUG Clofarabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2007-09-01 |
| Est. Completion | 2009-11-20 |
| Phase | Phase 1 |
Why NCT00852709 stopped before completion
NCT00852709 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 2 interventions - of which Cyclophosphamide is the first listed.
NCT00852709 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00852709 about?
NCT00852709 is a clinical study titled "Phase I Dose-Escalation Trial of Clofarabine Followed by Escalating Doses of Fractionated Cyclophosphamide in Children With Relapsed or Refractory Acute Leukemias". This is a Phase I study designed to determine the MTD and assess the toxicity associated with clofarabine followed by fractionated cyclophosphamide in patients \> 1 year of age or \< 21 years of age with relapsed or refractory acute leukemias. There will be 25 to 35 patients enrolled. Cohorts of 3 t...
What is the current status of trial NCT00852709?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2007-09-01. Estimated completion is 2009-11-20.
What interventions are being tested in trial NCT00852709?
The interventions under investigation include: Cyclophosphamide (DRUG), Clofarabine (DRUG).
Who is sponsoring clinical trial NCT00852709?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00852709's enrollment target sits among peer trials
35 1258th of 2000 higher than 728 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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