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ACTIVE NOT RECRUITING Phase 3

Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children and Adolescents

NCT03020030 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 560 participants
Start Date 2017-03-03
Est. Completion 2034-11
Phase Phase 3

Sponsor

Dana-Farber Cancer Institute

819 total trials

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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. It is categorized as Phase 3, 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 560 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dana-Farber Cancer Institute, which has 819 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, Pediatric appearing as the primary indexed condition, and to 5 interventions — of which Cyclophosphamide 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: NCT03020030 reports 9 study locations spanning 5 distinct geographic areas — top geographies include New York, Massachusetts, Quebec. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03020030?

The interventions under investigation include: Cyclophosphamide (DRUG), Pegaspargase (DRUG), Erwinia asparaginase (DRUG), CYTARABINE (DRUG), DASATINIB (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03020030?

This trial is sponsored by Dana-Farber Cancer Institute, which has 819 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial