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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02518750
The ClinicalTrials.gov registry entry for NCT02518750 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Dexamethasone is the first listed.
NCT02518750 reports 0 study locations.
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.
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