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NCT03020030 · ClinicalTrials.gov registry record · Phase 3
Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children and Adolescents
A Phase 3 study of Acute Lymphoblastic Leukemia, Pediatric, sponsored by Dana-Farber Cancer Institute.
- Active
- Registry status
- Phase 3
- Development phase
- 560
- Enrollment target
- 9
- Study locations
NCT03020030 is a Phase 3 study of Acute Lymphoblastic Leukemia, Pediatric that is active but no longer recruiting, run by Dana-Farber Cancer Institute. The registered enrollment target is 560 participants, above the 54-participant average among 8 other Acute Lymphoblastic Leukemia, Pediatric trials with a reported enrollment target (937% higher). The trial reports 9 study locations across 5 states.
The verdict
NCT03020030, a Phase 3 study of Acute Lymphoblastic Leukemia, Pediatric, is active but no longer recruiting, sponsored by Dana-Farber Cancer Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 560 participants
- Enrollment target
- 9
- Study locations
Study Summary
Acute lymphoblastic leukemia (ALL) is the most common cancer diagnosed in children. The cancer comes from a cell in the blood called a lymphocyte. Normal lymphocytes are produced in the bone marrow (along with other blood cells) and help fight infections. In ALL, the cancerous lymphocytes are called lymphoblasts. They do not help fight infection and crowd out the normal blood cells in the bone marrow so that the body cannot make enough normal blood cells. ALL is always fatal if it is not treated. With current treatments, most children and adolescents with this disease will be cured. The standard treatment for ALL involves about 2 years of chemotherapy. The drugs that are used, and the doses of the drugs, are similar but not identical for all children and adolescents with ALL. Some children and adolescents receive stronger treatment, especially during the first several months. A number of factors are used to decide how strong the treatment should be to give the best chance for cure. These factors are called "risk factors". This trial is studying the use of a new, updated set of risk factors to decide how strong the treatment will be. The study also will test a new way of dosing a chemotherapy drug called pegaspargase (which is part of the standard treatment for ALL) based on checking levels of the drug in the blood and adjusting the dose based on the levels.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Pegaspargase
- DRUG Erwinia asparaginase
- DRUG CYTARABINE
- DRUG DASATINIB
Study Locations (9)
New York
- Roswell Park Cancer Institute - Buffalo
- Columbia University Medical Center, Morgan Stanley Children's Hospital of New York-Presbyterian - New York
- Montefiore Medical Center - The Bronx
Massachusetts
- Boston Children's Hospital - Boston
- Dana-Farber Cancer Institute - Boston
Quebec
- Hospital Sainte Justine, University of Montreal - Montreal
- Centre Hospitalier U. de Quebec - Québec
New Jersey
- Rutgers Cancer Institute of New Jersey - New Brunswick
Rhode Island
- Hasbro Children's Hospital / Rhode Island Hospital - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 560 participants |
| Start Date | 2017-03-03 |
| Est. Completion | 2034-11 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03020030
The ClinicalTrials.gov registry entry for NCT03020030 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 560 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 54-participant average among 8 other Acute Lymphoblastic Leukemia, Pediatric trials with a reported enrollment target (937% higher). The listed sponsor is Dana-Farber Cancer Institute, which has 781 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Acute Lymphoblastic Leukemia, Pediatric appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT03020030 reports 9 study locations spanning 5 distinct geographic areas - top geographies include New York, Massachusetts, Quebec.
Frequently Asked Questions
What is clinical trial NCT03020030 about?
NCT03020030 is a clinical study titled "Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children and Adolescents". Acute lymphoblastic leukemia (ALL) is the most common cancer diagnosed in children. The cancer comes from a cell in the blood called a lymphocyte. Normal lymphocytes are produced in the bone marrow (along with other blood cells) and help fight infections. In ALL, the cancerous lymphocytes are called...
What is the current status of trial NCT03020030?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 560 participants. The study started on 2017-03-03. Estimated completion is 2034-11.
What conditions does trial NCT03020030 study?
This clinical trial studies the following conditions: Acute Lymphoblastic Leukemia, Pediatric.
What interventions are being tested in trial NCT03020030?
The interventions under investigation include: Cyclophosphamide (DRUG), Pegaspargase (DRUG), Erwinia asparaginase (DRUG), CYTARABINE (DRUG), DASATINIB (DRUG).
Who is sponsoring clinical trial NCT03020030?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03020030 being conducted?
This trial has 9 study locations across Massachusetts, New Jersey, New York, Rhode Island, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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