Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 382-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (87% lower). The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
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 reports 15 study locations spanning 10 distinct geographic areas - top geographies include 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.
-
The Pediatric Acute Leukemia (PedAL) Screening Trial - A Study to Test Bone Marrow and Blood in Children With Leukemia That Has Come Back After Treatment or Is Difficult to Treat - A Leukemia & Lymphoma Society and Children's Oncology Group Study
RECRUITING · Phase 1
-
Alpha/Beta CD19+ Depleted Haploidentical Transplantation + Zometa for Pediatric Hematologic Malignancies and Solid Tumors
RECRUITING · Phase 1
-
UCD19 CAR T Therapy in Adults With B-ALL and MRD Positivity in CR1
RECRUITING · Phase 1
-
A Phase 1 Study of Orca-Q in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies
RECRUITING · Phase 1
-
225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody With Fludarabine, Melphalan and Total Marrow and Lymphoid Irradiation as Conditioning Treatment for Donor Stem Cell Transplant in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome
RECRUITING · Phase 1
-
211^At-BC8-B10 Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, or Mixed-Phenotype Acute Leukemia
RECRUITING · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.