Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (NCT03007147)

🧪 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)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. For patients enrolled on APEC14B1 prior to enrollment on AALL1631, the required diagnostic bone marrow sample has been fulfilled
2. For patients who have not previously enrolled on APEC14B1 prior to enrollment on AALL1631, a baseline diagnostic sample (or peripheral blood sample with blasts if marrow sample unavailable) must be available to develop an MRD probe
3. In addition, laboratory reports detailing evidence of BCR::ABL1 fusion or ABL-class fusion must be submitted for rapid central review within 72 hours of study enrollment
4. \>= 1 year (365 days) and =\< 21 years at ALL diagnosis
5. Ph+ (BCR::ABL1 fusion): newly diagnosed de novo ALL (B-ALL or T-ALL) or mixed phenotypic acute leukemia (MPAL meeting 2016 World Health Organization \[WHO\] definition) with definitive evidence of BCR::ABL1 fusion by karyotype, fluorescence in situ hybridization (FISH) and/or molecular methodologies
6. ABL-class fusion: newly diagnosed B-ALL with definitive evidence of ABL-class fusions. ABL-class fusions are defined as those involving the following genes: ABL1, ABL2, CSF1R, PDGFRB, PDGFRA. Methods of detection include fluorescence in-situ hybridization (\[FISH\], e.g. using break-apart or colocalization signals probes), multiplex or singleplex reverse-transcription polymerase chain reaction (RT-PCR), whole transcriptome or panel-based RNA-sequencing (e.g. TruSight RNA Pan-Cancer Panel; Illumina, San Diego, California \[CA\], United States of America \[USA\] or similar)
7. Ph+ patients must have previously started Induction therapy, which includes vincristine, a corticosteroid, pegaspargase, with or without anthracycline, and/or other standard cytotoxic chemotherapy
8. Ph+ patients have not received more than 14 days of multiagent Induction therapy beginning with the first dose of vinCRIStine
9. Ph+ patients may have started imatinib prior to study entry but have not received more than 14 days of imatinib
10. ABL-class fusion patients must have previously completed the 4 or 5 weeks of multiagent Induction chemotherapy (Induction IA phase)
11. ABL-class fusion patients may have started imatinib during Induction IA, at the same time of or after the first vinCRIStine dose
12. Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 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

• Ruxolitinib and Chemotherapy in Adolescents and Young Adults With Ph-like Acute Lymphoblastic Leukemia — Chicago, Illinois
• Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia — Birmingham, Alabama
• Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma — Charlotte, North Carolina
• European Prospective Investigation Into Childhood Cancer — New York, New York
• CD22 CAR T-cells to Extend Remission Following Commercial CD19 CAR T-cells in Children, Adolescents, and Adults With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia — Bethesda, Maryland

Explore by condition: All Acute Lymphoblastic Leukemia clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.