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NCT02553460 · ClinicalTrials.gov registry record · Phase 1
Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I
A Phase 1 study of Acute Lymphoblastic Leukemia, sponsored by St. Jude Children's Research Hospital.
- Active
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 15
- Study locations
NCT02553460: Active Phase 1 study of Acute Lymphoblastic Leukemia, sponsored by St. Jude Children's Research Hospital.
NCT02553460 is a Phase 1 study of Acute Lymphoblastic Leukemia that is active but no longer recruiting, run by St. Jude Children's Research Hospital. The registered enrollment target is 50 participants, below the 382-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (87% lower). The trial reports 15 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02553460, a Phase 1 study of Acute Lymphoblastic Leukemia, is active but no longer recruiting, sponsored by St. Jude Children's Research Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 15
- Study locations
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.
Primary Outcome
Number of treatment related deaths divided by total number of patients during induction or reinduction therapy. Presented as percentage
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 |
What the registry record for NCT02553460 still lists
NCT02553460 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 382-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (87% lower).
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.
NCT02553460 lists 15 locations in 10 states (California, Quebec, Alberta).
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.
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).
Who is sponsoring clinical trial NCT02553460?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Acute Lymphoblastic Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02553460's enrollment target sits among peer trials
50 73rd of 131 higher than 57 of 131 other Acute Lymphoblastic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Lymphoblastic Leukemia 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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