Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (NCT03007147)
International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL) Testing Imatinib in Combination With Two Different Cytotoxic Chemotherapy Backbones
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Children's Hospital of Alabama — Birmingham, Alabama
Age range: 1 Year to 21 Years
🧪 Interventions in This Study
- Calaspargase Pegol (DRUG)
- Cyclophosphamide (DRUG)
- Cytarabine (DRUG)
- Daunorubicin Hydrochloride (DRUG)
- Dexamethasone (DRUG)
- Dexrazoxane Hydrochloride (DRUG)
- Doxorubicin (DRUG)
- Etoposide (DRUG)
- Filgrastim (BIOLOGICAL)
- Ifosfamide (DRUG)
- Imatinib Mesylate (DRUG)
- Leucovorin Calcium (DRUG)
- Levoleucovorin (DRUG)
- Mercaptopurine (DRUG)
- Mercaptopurine (DRUG)
- Methotrexate (DRUG)
- Methylprednisolone (DRUG)
- Pegaspargase (DRUG)
- Prednisolone (DRUG)
- Therapeutic Hydrocortisone (DRUG)
- Thioguanine (DRUG)
- Vincristine Sulfate (DRUG)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (226 Sites)
Showing the first 25 of 226 sites.
- Children's Hospital of Alabama — Birmingham, Alabama
- USA Health Strada Patient Care Center — Mobile, Alabama
- Providence Alaska Medical Center — Anchorage, Alaska
- Banner Children's at Desert — Mesa, Arizona
- Phoenix Childrens Hospital — Phoenix, Arizona
- Banner University Medical Center - Tucson — Tucson, Arizona
- Arkansas Children's Hospital — Little Rock, Arkansas
- Kaiser Permanente Downey Medical Center — Downey, California
- City of Hope Comprehensive Cancer Center — Duarte, California
- Loma Linda University Medical Center — Loma Linda, California
- Miller Children's and Women's Hospital Long Beach — Long Beach, California
- Children's Hospital Los Angeles — Los Angeles, California
- Cedars-Sinai Medical Center — Los Angeles, California
- Valley Children's Hospital — Madera, California
- UCSF Benioff Children's Hospital Oakland — Oakland, California
- Kaiser Permanente-Oakland — Oakland, California
- Children's Hospital of Orange County — Orange, California
- Lucile Packard Children's Hospital Stanford University — Palo Alto, California
- University of California Davis Comprehensive Cancer Center — Sacramento, California
- Rady Children's Hospital - San Diego — San Diego, California
- UCSF Medical Center-Mission Bay — San Francisco, California
- Children's Hospital Colorado — Aurora, Colorado
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center — Denver, Colorado
- Connecticut Children's Medical Center — Hartford, Connecticut
- Yale University — New Haven, Connecticut
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Acute Lymphoblastic Leukemia
- Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia — Birmingham, Alabama
- Total Marrow and Lymphoid Irradiation as Conditioning Regimen Before Hematopoietic Cell Transplantation in Patients With Myelodysplastic Syndrome or Acute Leukemia — Duarte, California
- Transcranial Direct Current Stimulation of the Temporal Cortex in Survivors of Childhood Acute Lymphoblastic Leukemia (ALL) — Memphis, Tennessee
- Multi-modality Imaging and Collection of Biospecimen Samples in Understanding Bone Marrow Changes in Patients With Acute Myeloid Leukemia Undergoing TBI and Chemotherapy — Duarte, California
- Inotuzumab Ozogamicin in Treating Patients With B-cell Acute Lymphocytic Leukemia With Positive Minimal Residual Disease — Houston, Texas
Explore by condition: All Acute Lymphoblastic Leukemia clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.