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NCT01190930 · ClinicalTrials.gov registry record · Phase 3
Risk-Adapted Chemotherapy in Treating Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia or Localized B-Lineage Lymphoblastic Lymphoma
A Phase 3 study of Acute Lymphoblastic Leukemia and Down Syndrome, sponsored by Children's Oncology Group.
- Active
- Registry status
- Phase 3
- Development phase
- 9,350
- Enrollment target
- 20
- Study locations
NCT01190930: Active Phase 3 study of Acute Lymphoblastic Leukemia and Down Syndrome, sponsored by Children's Oncology Group.
NCT01190930 is a Phase 3 study of Acute Lymphoblastic Leukemia and Down Syndrome that is active but no longer recruiting, run by Children's Oncology Group. The registered enrollment target is 9,350 participants, above the 311-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (2906% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01190930, a Phase 3 study of Acute Lymphoblastic Leukemia and Down Syndrome, is active but no longer recruiting, sponsored by Children's Oncology Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 9,350 participants
- Enrollment target
- 20
- Study locations
Study Summary
This partially randomized phase III trial studies the side effects of different combinations of risk-adapted chemotherapy regimens and how well they work in treating younger patients with newly diagnosed standard-risk acute lymphoblastic leukemia or B-lineage lymphoblastic lymphoma that is found only in the tissue or organ where it began (localized). Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy), giving the drugs in different doses, and giving the drugs in different combinations may kill more cancer cells.
Primary Outcome
DFS is calculated as the time from randomization at the end of interim maintenance II to first event (relapse, second malignancy, remission death) or date of last contact. Five year DFS estimates will be calculated from the point of randomization for both groups. Two-sided 95% confidence intervals will be calculated.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- OTHER Laboratory Biomarker Analysis
- DRUG Doxorubicin Hydrochloride
- DRUG Dexamethasone
- DRUG Cytarabine
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
- 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
Alaska
- Providence Alaska Medical Center - Anchorage
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9,350 participants |
| Start Date | 2010-08-09 |
| Est. Completion | 2028-03-31 |
| Phase | Phase 3 |
What the registry record for NCT01190930 still lists
NCT01190930 is an interventional study that assigns participants to a tested intervention. Its 9,350 participants enrollment target places it among the larger protocols in the corpus, above the 311-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (2906% higher).
The record links to 10 conditions, with Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01190930 names 20 study sites across 5 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT01190930 about?
NCT01190930 is a clinical study titled "Risk-Adapted Chemotherapy in Treating Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia or Localized B-Lineage Lymphoblastic Lymphoma". This partially randomized phase III trial studies the side effects of different combinations of risk-adapted chemotherapy regimens and how well they work in treating younger patients with newly diagnosed standard-risk acute lymphoblastic leukemia or B-lineage lymphoblastic lymphoma that is found onl...
What is the current status of trial NCT01190930?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 9,350 participants. The study started on 2010-08-09. Estimated completion is 2028-03-31.
What conditions does trial NCT01190930 study?
This clinical trial studies the following conditions: Acute Lymphoblastic Leukemia, Down Syndrome, Philadelphia Chromosome Positive, Childhood B Acute Lymphoblastic Leukemia, Adult B Lymphoblastic Lymphoma.
What interventions are being tested in trial NCT01190930?
The interventions under investigation include: Cyclophosphamide (DRUG), Laboratory Biomarker Analysis (OTHER), Doxorubicin Hydrochloride (DRUG), Dexamethasone (DRUG), Cytarabine (DRUG).
Who is sponsoring clinical trial NCT01190930?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01190930 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT01190930's enrollment target sits among peer trials
9,350 1st of 131 higher than 131 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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