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NCT00439296 · ClinicalTrials.gov registry record · Phase 1
ABT-751 With Chemotherapy for Relapsed Pediatric ALL
A Phase 1 study, sponsored by Therapeutic Advances in Childhood Leukemia Consortium.
- Terminated
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT00439296: Clinical Trial Phase 1 study, sponsored by Therapeutic Advances in Childhood Leukemia Consortium.
NCT00439296 is a Phase 1 study that was terminated before completion, run by Therapeutic Advances in Childhood Leukemia Consortium. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00439296, a Phase 1 study, was terminated before completion, sponsored by Therapeutic Advances in Childhood Leukemia Consortium.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
This is a phase I/II study of an investigational drug called ABT-751, produced by Abbott Laboratories, given in combination with chemotherapy drugs used to treat acute lymphoblastic leukemia (ALL) that has come back (recurred). The phase I portion of this study is being done to find the highest dose of ABT-751 that can be given safely in combination with other chemotherapy drugs. A safe dose is one that does not result in unacceptable side effects. After a safe dose for ABT-751 given with chemotherapy has been found, the study will add additional patients to find out if ABT-751 (given at the maximal safe dose) when given with additional chemotherapy is an effective therapy for the treatment of children with relapsed ALL. It is expected that approximately 15-35 children and young adults will take part in this study.
Primary Outcome
ABT-751 was given daily for 21 days for a period of 28 day course in combination with dexamethasone, PEG-asparaginase, and doxorubicin. The occurrence of a dose limiting toxicity (DLT) was evaluated at the end of the 28 day course. DLT will be defined as any of the following events that are deemed by the investigator as probably or definitely attributable to ABT-751. Toxicity grade follows the CTCAE criteria, version 3.0. A copy of the CTCAE can be downloaded from the CTEP home page (http://cte
Interventions
- DRUG Doxorubicin
- DRUG Dexamethasone
- DRUG Cytarabine
- DRUG PEG-asparaginase
- DRUG ABT-751
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2006-05-22 |
| Est. Completion | 2009-09-23 |
| Phase | Phase 1 |
Why NCT00439296 stopped before completion
NCT00439296 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 5 interventions - of which Doxorubicin is the first listed.
NCT00439296 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00439296 about?
NCT00439296 is a clinical study titled "ABT-751 With Chemotherapy for Relapsed Pediatric ALL". This is a phase I/II study of an investigational drug called ABT-751, produced by Abbott Laboratories, given in combination with chemotherapy drugs used to treat acute lymphoblastic leukemia (ALL) that has come back (recurred). The phase I portion of this study is being done to find the highest dose...
What is the current status of trial NCT00439296?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2006-05-22. Estimated completion is 2009-09-23.
What interventions are being tested in trial NCT00439296?
The interventions under investigation include: Doxorubicin (DRUG), Dexamethasone (DRUG), Cytarabine (DRUG), PEG-asparaginase (DRUG), ABT-751 (DRUG).
Who is sponsoring clinical trial NCT00439296?
This trial is sponsored by Therapeutic Advances in Childhood Leukemia Consortium, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00439296's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 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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