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NCT00098839 · ClinicalTrials.gov registry record · Phase 1
Chemoimmunotherapy With Epratuzumab in Relapsed Acute Lymphoblastic Leukemia (ALL)
A Phase 1 study of Recurrent Childhood Acute Lymphoblastic Leukemia, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 1
- Development phase
- 134
- Enrollment target
- 20
- Study locations
NCT00098839 is a Phase 1 study of Recurrent Childhood Acute Lymphoblastic Leukemia that has completed, run by Children's Oncology Group. The registered enrollment target is 134 participants, above the 115-participant average among 11 other Recurrent Childhood Acute Lymphoblastic Leukemia trials with a reported enrollment target (17% higher). The trial reports 20 study locations across 12 states.
The verdict
NCT00098839, a Phase 1 study of Recurrent Childhood Acute Lymphoblastic Leukemia, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 134 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 2005-02 |
| Est. Completion | 2011-04 |
| Phase | Phase 1 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 134 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 115-participant average among 11 other Recurrent Childhood Acute Lymphoblastic Leukemia trials with a reported enrollment target (17% higher). The listed sponsor is Children's Oncology Group, which has 342 total studies on file at ClinicalTrials.gov.
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.
NCT00098839 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Alabama, Colorado.
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.
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).
Who is sponsoring clinical trial NCT00098839?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
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.
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