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Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I
NCT02553460 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to test the good and bad effects of the study drugs bortezomib and vorinostat when they are given in combination with chemotherapy commonly used to treat acute lymphoblastic leukemia (ALL) in infants. For example, adding these drugs could decrease the number of leukemia cells, but it could also cause additional side effects. Bortezomib and vorinostat have been approved by the US Food and Drug Administration (FDA) to treat other cancers in adults, but they have not been approved for treating children with leukemia. With this research, we plan to meet the following goals: PRIMARY OBJECTIVE: * Determine the tolerability of incorporating bortezomib and vorinostat into an ALL chemotherapy backbone for newly diagnosed infants with ALL. SECONDARY OBJECTIVES: * Estimate the event-free survival and overall survival of infants with ALL who are treated with bortezomib and vorinostat in combination with an ALL chemotherapy backbone. * Measure minimal residual disease (MRD) positivity using both flow cytometry and PCR. * Compare end of induction, end of consolidation, and end of reinduction MRD levels to Interfant99 (ClinicalTrials.gov registration ID number NCT00015873) participant outcomes.
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG Mitoxantrone
- DRUG Pegaspargase
- DRUG ITMHA
- DRUG Asparaginase Erwinia Chrysanthemi
Study Locations (15)
California
- Children's Hospital Los Angeles — Los Angeles
- Children's Hospital of Orange County — Orange
- Lucile Packard Children's Hospital Stanford University — Palo Alto
Quebec
- Centre Hospitalier Universitaire Sainte-Justine — Montreal
- The Montreal Children's Hospital (MUHC-McGill) — Montreal
- Centre Hospitalier Universitaire de Quebec — Québec
Alberta
- Alberta Children's Hospital — Calgary
- Stollery Children's Hospital — Edmonton
Minnesota
- Children's Hospital and Clinics of Minnesota — Minneapolis
North Carolina
- St. Jude Affiliate-Charlotte — Charlotte
Ohio
- Cincinnati Children's Hospital — Cincinnati
Oregon
- Oregon Health and Science University — Portland
Tennessee
- St. Jude Children's Research Hospital — Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2016-01-29 |
| Est. Completion | 2031-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02553460
The ClinicalTrials.gov registry entry for NCT02553460 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 50 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 441 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 5 interventions — of which Dexamethasone is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02553460 reports 15 study locations spanning 10 distinct geographic areas — top geographies include California, Quebec, Alberta. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02553460 about?
NCT02553460 is a clinical study titled "Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I". The purpose of this study is to test the good and bad effects of the study drugs bortezomib and vorinostat when they are given in combination with chemotherapy commonly used to treat acute lymphoblastic leukemia (ALL) in infants. For example, adding these drugs could decrease the number of leukemia ...
What is the current status of trial NCT02553460?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2016-01-29. Estimated completion is 2031-10.
What conditions does trial NCT02553460 study?
This clinical trial studies the following conditions: Acute Lymphoblastic Leukemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02553460?
The interventions under investigation include: Dexamethasone (DRUG), Mitoxantrone (DRUG), Pegaspargase (DRUG), ITMHA (DRUG), Asparaginase Erwinia Chrysanthemi (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02553460?
This trial is sponsored by St. Jude Children's Research Hospital, which has 441 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02553460 being conducted?
This trial has 15 study locations across California, Minnesota, North Carolina, Ohio, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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