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COMPLETED Phase 1

Chemoimmunotherapy With Epratuzumab in Relapsed Acute Lymphoblastic Leukemia (ALL)

NCT00098839 · View on ClinicalTrials.gov ↗

Study Summary

This Phase II trial is studying how well giving epratuzumab together with an established chemotherapy platform works in treating young patients with relapsed acute lymphoblastic leukemia. Monoclonal antibodies, such as epratuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing them or by stopping them from dividing. Giving monoclonal antibody therapy in combination chemotherapy may kill cancer cells more effectively.

Interventions

  • DRUG doxorubicin hydrochloride
  • DRUG vincristine sulfate
  • DRUG therapeutic hydrocortisone
  • DRUG L-asparaginase
  • BIOLOGICAL epratuzumab

Study Locations (20)

California

  • Loma Linda University Medical Center — Loma Linda
  • Miller Children's Hospital — Long Beach
  • Children's Hospital Los Angeles — Los Angeles
  • David Geffen School of Medicine at UCLA — Los Angeles
  • Children's Hospital Central California — Madera
  • Kaiser Permanente-Oakland — Oakland
  • Childrens Hospital of Orange County — Orange
  • Lucile Packard Children's Hospital Stanford University — Palo Alto
  • University of California San Francisco Medical Center-Parnassus — San Francisco

Alabama

  • University of Alabama at Birmingham — Birmingham

Colorado

  • Children's Hospital Colorado — Aurora

District of Columbia

  • Children's National Medical Center — Washington D.C.

Florida

  • Saint Joseph Children's Hospital of Tampa — Tampa

Georgia

  • Children's Healthcare of Atlanta - Egleston — Atlanta

Indiana

  • Indiana University Medical Center — Indianapolis

Kentucky

  • University of Kentucky — Lexington

Trial Details

FieldValue
Enrollment Target 134 participants
Start Date 2005-02
Est. Completion 2011-04
Phase Phase 1

Sponsor

Children's Oncology Group

318 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00098839

The ClinicalTrials.gov registry entry for NCT00098839 describes a study currently listed as completed. 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 134 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Oncology Group, which has 318 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 Recurrent Childhood Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 5 interventions — of which doxorubicin hydrochloride 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: NCT00098839 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Alabama, Colorado. 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 NCT00098839 about?

NCT00098839 is a clinical study titled "Chemoimmunotherapy With Epratuzumab in Relapsed Acute Lymphoblastic Leukemia (ALL)". This Phase II trial is studying how well giving epratuzumab together with an established chemotherapy platform works in treating young patients with relapsed acute lymphoblastic leukemia. Monoclonal antibodies, such as epratuzumab, can block cancer growth in different ways. Some block the ability of...

What is the current status of trial NCT00098839?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 134 participants. The study started on 2005-02. Estimated completion is 2011-04.

What conditions does trial NCT00098839 study?

This clinical trial studies the following conditions: Recurrent Childhood 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 NCT00098839?

The interventions under investigation include: doxorubicin hydrochloride (DRUG), vincristine sulfate (DRUG), therapeutic hydrocortisone (DRUG), L-asparaginase (DRUG), epratuzumab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00098839?

This trial is sponsored by Children's Oncology Group, which has 318 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00098839 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, Florida. 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