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NCT02518750 · ClinicalTrials.gov registry record · Phase 2
Re-Induction Therapy for Relapsed Pediatric T-Cell Acute Lymphoblastic Leukemia or Lymphoma
A Phase 2 study, sponsored by St. Jude Children's Research Hospital.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT02518750: Clinical Trial Phase 2 study, sponsored by St. Jude Children's Research Hospital.
NCT02518750 is a Phase 2 study that was terminated before completion, run by St. Jude Children's Research Hospital. The registered enrollment target is 3 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
NCT02518750, a Phase 2 study, was terminated before completion, sponsored by St. Jude Children's Research Hospital.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
This is a phase-II study to evaluate the efficacy of a salvage regimen in children with relapsed T-cell ALL or lymphoma. Peg-asparaginase, mitoxantrone, intrathecal triples (IT) (intrathecal methotrexate/hydrocortisone/cytarabine) (ITMHA) and dexamethasone are commonly used drugs to treat relapsed or refractory acute lymphocytic leukemia or lymphoma (ALL). In this study, the investigators want to know if adding three drugs called panobinostat, bortezomib and liposomal vincristine (VSLI) to this regimen will result in remission (no signs or symptoms of leukemia or lymphoma). * Panobinostat has been approved by the FDA for treating adults with multiple myeloma, but it has not been approved for use in children and has not been given together with the other drugs used in this study. It has not been widely studied in children. * VSLI has been approved by the FDA for adults with relapsed or refractory ALL, but has not yet been approved for treating children with leukemia or lymphoma. * Bortezomib has been approved by the FDA for treating adults with a cancer called multiple myeloma and adults with relapsed mantle cell lymphoma; it has not been approved for treating children. PRIMARY OBJECTIVE: * To estimate the complete remission (CR) rate for patients with T-cell lymphoblastic leukemia and lymphoma in first relapse. SECONDARY OBJECTIVES: * To evaluate minimal residual disease (MRD) levels at end of each block of therapy. * To describe the toxicities of vincristine sulfate liposome injection (VSLI) when used in combination with chemotherapy and bortezomib.
Primary Outcome
All participants who start re-induction Block A therapy are considered evaluable. Any patient who at any time point achieves CR and goes to transplant is considered as a success; or any patient who successfully reaches the end of block C and achieves/remains in CR is considered a success; all other cases are considered as failure.
Interventions
- DRUG Dexamethasone
- DRUG Mitoxantrone
- DRUG Panobinostat
- DRUG Liposomal vincristine
- DRUG Peg-asparaginase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2016-11-23 |
| Est. Completion | 2018-03-11 |
| Phase | Phase 2 |
Why NCT02518750 stopped before completion
NCT02518750 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 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.
NCT02518750 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02518750 about?
NCT02518750 is a clinical study titled "Re-Induction Therapy for Relapsed Pediatric T-Cell Acute Lymphoblastic Leukemia or Lymphoma". This is a phase-II study to evaluate the efficacy of a salvage regimen in children with relapsed T-cell ALL or lymphoma. Peg-asparaginase, mitoxantrone, intrathecal triples (IT) (intrathecal methotrexate/hydrocortisone/cytarabine) (ITMHA) and dexamethasone are commonly used drugs to treat relapsed o...
What is the current status of trial NCT02518750?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2016-11-23. Estimated completion is 2018-03-11.
What interventions are being tested in trial NCT02518750?
The interventions under investigation include: Dexamethasone (DRUG), Mitoxantrone (DRUG), Panobinostat (DRUG), Liposomal vincristine (DRUG), Peg-asparaginase (DRUG).
Who is sponsoring clinical trial NCT02518750?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02518750's enrollment target sits among peer trials
3 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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