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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: Completed Phase 1 study of Recurrent Childhood Acute Lymphoblastic Leukemia, sponsored by Children's Oncology Group.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The proportion of patients who achieved complete response at the end Block 1 of re-induction therapy. Complete Remission (CR) - Attainment of M1 bone marrow (\<5% blasts) with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral counts (ANC \>1000/uL and platelet count \>100,000/uL). Partial Remission (PR) - Complete disappearance of circulating blasts and achievement of M2 marrow status (5% or \< 25% blast cells and adequate cellularity). Partial Remission
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 |
What the finished NCT00098839 record still lists
NCT00098839 is an interventional study that assigns participants to a tested intervention. The registered 134 participants enrollment target is mid-sized for trials with a published cap, above the 115-participant average among 11 other Recurrent Childhood Acute Lymphoblastic Leukemia trials with a reported enrollment target (17% higher).
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 names 20 study sites across 12 states, led by 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.
Learn More About Clinical Trials
Similar trials for Recurrent Childhood 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.
Where NCT00098839's enrollment target sits among peer trials
134 4th of 11 higher than 8 of 11 other Recurrent Childhood Acute Lymphoblastic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Childhood Acute Lymphoblastic Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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