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NCT00103285 · ClinicalTrials.gov registry record · Phase 3
Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
A Phase 3 study of Acute Lymphoblastic Leukemia and Childhood B Acute Lymphoblastic Leukemia, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 5,377
- Enrollment target
- 20
- Study locations
NCT00103285: Completed Phase 3 study of Acute Lymphoblastic Leukemia and Childhood B Acute Lymphoblastic Leukemia, sponsored by Children's Oncology Group.
NCT00103285 is a Phase 3 study of Acute Lymphoblastic Leukemia and Childhood B Acute Lymphoblastic Leukemia that has completed, run by Children's Oncology Group. The registered enrollment target is 5,377 participants, above the 341-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (1477% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00103285, a Phase 3 study of Acute Lymphoblastic Leukemia and Childhood B Acute Lymphoblastic Leukemia, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 5,377 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase III trial is studying different combination chemotherapy regimens and comparing how well they work in treating patients with newly diagnosed acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
Primary Outcome
EFS for SR-Average with standard and Intensified Consolidation. Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Doxorubicin Hydrochloride
- DRUG Dexamethasone
- DRUG Cytarabine
- RADIATION 3-Dimensional Conformal Radiation Therapy
Study Locations (20)
California
- Kaiser Permanente Downey Medical Center - Downey
- City of Hope Comprehensive Cancer Center - Duarte
- Loma Linda University Medical Center - Loma Linda
- Miller Children's and Women's Hospital Long Beach - Long Beach
- Children's Hospital Los Angeles - Los Angeles
- Cedars Sinai Medical Center - Los Angeles
- Mattel Children's Hospital UCLA - Los Angeles
- UCLA / Jonsson Comprehensive Cancer Center - Los Angeles
- Valley Children's Hospital - Madera
- UCSF Benioff Children's Hospital Oakland - Oakland
- Kaiser Permanente-Oakland - Oakland
- Children's Hospital of Orange County - Orange
Alabama
- Children's Hospital of Alabama - Birmingham
- University of Alabama at Birmingham Cancer Center - Birmingham
- USA Health Strada Patient Care Center - Mobile
Arizona
- Banner Children's at Desert - Mesa
- Phoenix Childrens Hospital - Phoenix
- Banner University Medical Center - Tucson - Tucson
Arkansas
- Arkansas Children's Hospital - Little Rock
- University of Arkansas for Medical Sciences - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,377 participants |
| Start Date | 2005-04-11 |
| Est. Completion | 2021-03-31 |
| Phase | Phase 3 |
What the finished NCT00103285 record still lists
NCT00103285 is an interventional study that assigns participants to a tested intervention. Its 5,377 participants enrollment target places it among the larger protocols in the corpus, above the 341-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (1477% higher).
The record links to 2 conditions, with Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT00103285 names 20 study sites across 4 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT00103285 about?
NCT00103285 is a clinical study titled "Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia". This randomized phase III trial is studying different combination chemotherapy regimens and comparing how well they work in treating patients with newly diagnosed acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the...
What is the current status of trial NCT00103285?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 5,377 participants. The study started on 2005-04-11. Estimated completion is 2021-03-31.
What conditions does trial NCT00103285 study?
This clinical trial studies the following conditions: Acute Lymphoblastic Leukemia, Childhood B Acute Lymphoblastic Leukemia.
What interventions are being tested in trial NCT00103285?
The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin Hydrochloride (DRUG), Dexamethasone (DRUG), Cytarabine (DRUG), 3-Dimensional Conformal Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT00103285?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00103285 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for 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 NCT00103285's enrollment target sits among peer trials
5,377 3rd of 131 higher than 129 of 131 other Acute Lymphoblastic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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