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NCT03007147 · ClinicalTrials.gov registry record · Phase 3
Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
A Phase 3 study of Acute Lymphoblastic Leukemia and Mixed Phenotype Acute Leukemia, sponsored by Children's Oncology Group.
- Active
- Registry status
- Phase 3
- Development phase
- 475
- Enrollment target
- 20
- Study locations
NCT03007147: Active Phase 3 study of Acute Lymphoblastic Leukemia and Mixed Phenotype Acute Leukemia, sponsored by Children's Oncology Group.
NCT03007147 is a Phase 3 study of Acute Lymphoblastic Leukemia and Mixed Phenotype Acute Leukemia that is active but no longer recruiting, run by Children's Oncology Group. The registered enrollment target is 475 participants, above the 378-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (26% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03007147, a Phase 3 study of Acute Lymphoblastic Leukemia and Mixed Phenotype Acute Leukemia, is active but no longer recruiting, sponsored by Children's Oncology Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 475 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase III trial studies how well imatinib mesylate works in combination with two different chemotherapy regimens in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (ALL). Imatinib mesylate has been shown to improve outcomes in children and adolescents with Philadelphia chromosome positive (Ph+) ALL when given with strong chemotherapy, but the combination has many side effects. This trial is testing whether a different chemotherapy regimen may work as well as the stronger one but have fewer side effects when given with imatinib. The trial is also testing how well the combination of chemotherapy and imatinib works in another group of patients with a type of ALL that is similar to Ph+ ALL. This type of ALL is called "ABL-class fusion positive ALL", and because it is similar to Ph+ ALL, is thought it will respond well to the combination of agents used to treat Ph+ ALL.
Primary Outcome
Three-year DFS and 95% confidence intervals (CI) of SR Ph+ ALL patients treated continuous imatinib mesylate with high risk Children's Oncology Group (COG)-ALL chemotherapy backbone or more intensive European (Es)PhALL chemotherapy backbone.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Cytarabine
- DRUG Calaspargase Pegol
- DRUG Daunorubicin Hydrochloride
- PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation
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
- Valley Children's Hospital - Madera
- UCSF Benioff Children's Hospital Oakland - Oakland
- Kaiser Permanente-Oakland - Oakland
- Children's Hospital of Orange County - Orange
- Lucile Packard Children's Hospital Stanford University - Palo Alto
- University of California Davis Comprehensive Cancer Center - Sacramento
- Rady Children's Hospital - San Diego - San Diego
Arizona
- Banner Children's at Desert - Mesa
- Phoenix Childrens Hospital - Phoenix
- Banner University Medical Center - Tucson - Tucson
Alabama
- Children's Hospital of Alabama - Birmingham
- USA Health Strada Patient Care Center - Mobile
Alaska
- Providence Alaska Medical Center - Anchorage
Arkansas
- Arkansas Children's Hospital - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 475 participants |
| Start Date | 2017-08-08 |
| Est. Completion | 2027-09-30 |
| Phase | Phase 3 |
What the registry record for NCT03007147 still lists
NCT03007147 is an interventional study that assigns participants to a tested intervention. The registered 475 participants enrollment target is mid-sized for trials with a published cap, above the 378-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (26% higher).
The record links to 4 conditions, with Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT03007147 names 20 study sites across 5 states, led by California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT03007147 about?
NCT03007147 is a clinical study titled "Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia". This randomized phase III trial studies how well imatinib mesylate works in combination with two different chemotherapy regimens in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (ALL). Imatinib mesylate has been shown to improve outcomes in chil...
What is the current status of trial NCT03007147?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 475 participants. The study started on 2017-08-08. Estimated completion is 2027-09-30.
What conditions does trial NCT03007147 study?
This clinical trial studies the following conditions: Acute Lymphoblastic Leukemia, Mixed Phenotype Acute Leukemia, B Acute Lymphoblastic Leukemia, T Acute Lymphoblastic Leukemia.
What interventions are being tested in trial NCT03007147?
The interventions under investigation include: Cyclophosphamide (DRUG), Cytarabine (DRUG), Calaspargase Pegol (DRUG), Daunorubicin Hydrochloride (DRUG), Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT03007147?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03007147 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 NCT03007147's enrollment target sits among peer trials
475 15th of 131 higher than 117 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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