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NCT02535806 · ClinicalTrials.gov registry record · Phase 2
Four Drug Reinduction With Bortezomib for Relapsed or Refractory ALL or LL in Children and Young Adults
A Phase 2 study, sponsored by Children's Mercy Hospital Kansas City.
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT02535806: Clinical Trial Phase 2 study, sponsored by Children's Mercy Hospital Kansas City.
NCT02535806 is a Phase 2 study that was terminated before completion, run by Children's Mercy Hospital Kansas City. 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
NCT02535806, a Phase 2 study, was terminated before completion, sponsored by Children's Mercy Hospital Kansas City.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
This is a phase II study designed to investigate the combination of bortezomib with the mitoxantrone reinduction regimen used in the ALL R3 trial. The study will enroll patients with high risk ALL relapse including early bone marrow relapse and second or greater relapse of any kind. Patients with relapsed LL will also be eligible. Bone marrow evaluation will be performed after blood counts recover to assess the rate of CR (\<5% bone marrow blasts) and MRD status in children following this regimen. Further treatment with or without HSCT will be at the discretion of the primary physician.
Primary Outcome
Toxicities were assessed and graded according to CTCAE v 4.0.
Interventions
- DRUG Dexamethasone
- DRUG Mitoxantrone
- DRUG Methotrexate
- DRUG Velcade
- DRUG Methotrexate / Hydrocortisone / Cytarabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2015-07 |
| Est. Completion | 2017-05-25 |
| Phase | Phase 2 |
Why NCT02535806 stopped before completion
NCT02535806 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 5 interventions - of which Dexamethasone is the first listed.
NCT02535806 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02535806 about?
NCT02535806 is a clinical study titled "Four Drug Reinduction With Bortezomib for Relapsed or Refractory ALL or LL in Children and Young Adults". This is a phase II study designed to investigate the combination of bortezomib with the mitoxantrone reinduction regimen used in the ALL R3 trial. The study will enroll patients with high risk ALL relapse including early bone marrow relapse and second or greater relapse of any kind. Patients with re...
What is the current status of trial NCT02535806?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2015-07. Estimated completion is 2017-05-25.
What interventions are being tested in trial NCT02535806?
The interventions under investigation include: Dexamethasone (DRUG), Mitoxantrone (DRUG), Methotrexate (DRUG), Velcade (DRUG), Methotrexate / Hydrocortisone / Cytarabine (DRUG).
Who is sponsoring clinical trial NCT02535806?
This trial is sponsored by Children's Mercy Hospital Kansas City, which has 184 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02535806'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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