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NCT00440726 · ClinicalTrials.gov registry record · Phase 1
Bortezomib With Chemotherapy for Relapsed Pediatric Acute Lymphoblastic Leukemia (ALL)
A Phase 1 study, sponsored by Therapeutic Advances in Childhood Leukemia Consortium.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT00440726: Completed Phase 1 study, sponsored by Therapeutic Advances in Childhood Leukemia Consortium.
NCT00440726 is a Phase 1 study that has completed, run by Therapeutic Advances in Childhood Leukemia Consortium. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00440726, a Phase 1 study, has completed, sponsored by Therapeutic Advances in Childhood Leukemia Consortium.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
This is a Phase I/II study of a drug called bortezomib given in combination with chemotherapy drugs used to treat acute lymphoblastic leukemia (ALL) that has come back (recurred). Bortezomib is a drug that has been approved by the Food and Drug Administration (FDA) for treating adults with multiple myeloma which is a type of blood cancer. Bortezomib has been shown to cause cancer cells to die in studies done on animals (mice). Studies have been done that have shown that some adults and children with cancer have shown a response to bortezomib when it is used alone. Studies have also been done in adults to evaluate the dose of bortezomib that can be safely given in combination with other chemotherapy drugs.
Primary Outcome
Toxicity will be graded using the CTCAE criteria, version 3.0. Dose-limiting toxicity will be defined as any of the following events that are deemed by the investigator as possibly, probably or definitely attributable to bortezomib: Grade 3 or 4 Sensory Neuropathy; Grade 3 or 4 Neuropathic pain (Neuralgia or peripheral nerve) lasting longer than 24 hours despite medical intervention; Marrow hypoplasia, which continues 6 weeks from the start of each course (less than 10% cellularity); and Grade 4
Interventions
- DRUG Doxorubicin
- DRUG Dexamethasone
- DRUG Cytarabine
- DRUG Bortezomib
- DRUG PEG-asparaginase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2006-08-04 |
| Est. Completion | 2011-02-26 |
| Phase | Phase 1 |
What the finished NCT00440726 record still lists
NCT00440726 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 5 interventions - of which Doxorubicin is the first listed.
NCT00440726 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00440726 about?
NCT00440726 is a clinical study titled "Bortezomib With Chemotherapy for Relapsed Pediatric Acute Lymphoblastic Leukemia (ALL)". This is a Phase I/II study of a drug called bortezomib given in combination with chemotherapy drugs used to treat acute lymphoblastic leukemia (ALL) that has come back (recurred). Bortezomib is a drug that has been approved by the Food and Drug Administration (FDA) for treating adults with multiple ...
What is the current status of trial NCT00440726?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2006-08-04. Estimated completion is 2011-02-26.
What interventions are being tested in trial NCT00440726?
The interventions under investigation include: Doxorubicin (DRUG), Dexamethasone (DRUG), Cytarabine (DRUG), Bortezomib (DRUG), PEG-asparaginase (DRUG).
Who is sponsoring clinical trial NCT00440726?
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 NCT00440726's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 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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