Total Therapy XVII for Newly Diagnosed Children with Acute Lymphoblastic Leukemia and Lymphoma
Sponsor: St. Jude Children's Research Hospital
ClinicalTrials ID:NCT03117751
This study aims to improve treatment outcomes and quality of life for children with acute lymphoblastic leukemia (ALL) and lymphoma (LLy) using personalized medicine strategies based on genetic features of the cancer.
Patient Parameters
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Program Overview
The main goal of this study is to use new personalized medicine techniques to improve the cure rate and quality of life for children with acute lymphoblastic leukemia (ALL) and lymphoma (LLy). The study will focus on using genetic information from the cancer to guide treatment decisions and introduce targeted therapies to improve outcomes. Researchers will also explore ways to reduce side effects and improve the overall treatment experience for children.
Description
Participants in this study will be grouped into low-, standard-, or high-risk categories based on factors like age, white blood cell count, and genetic features of the cancer. Treatment will have three main phases: Remission Induction, Consolidation, and Continuation. Some patients may receive additional Early Intensification therapy if needed.
During Remission Induction, patients will receive a combination of medications to help reduce cancer cells. This includes prednisone, vincristine, daunorubicin, and pegaspargase. Additional drugs like dasatinib or bortezomib may be added based on specific genetic features of the cancer.
Early Intensification therapy may be given to certain patients before moving to the Consolidation phase. This phase includes high-dose methotrexate and other medications to further reduce cancer cells.
Immunotherapy options like CAR T-cell therapy or blinatumomab may be considered for patients with specific types of leukemia or lymphoma.
The Continuation phase involves ongoing treatment for up to 120 weeks, with adjustments based on the patient's risk group and response to earlier treatments. Some patients may receive additional medications like dasatinib, ruxolitinib, or nelarabine based on their specific cancer type and genetic features.
Throughout the study, patients will receive supportive care to monitor and manage side effects, including neurocognitive assessments and bone health evaluations.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with B- or T-cell acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LLy).
- LLy patients must have less than 25% tumor cells in bone marrow and blood.
- Age between 1 and 18 years.
- Limited or no prior therapy, except for specific emergency treatments.
- Written informed consent from the patient or guardian.
Exclusion Criteria
- Pregnant or breastfeeding participants.
- Participants must agree to use effective birth control during the study.
- Inability or unwillingness to provide written informed consent.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Lucile Packard Children's Hospital Stanford University | 94305 | Palo Alto | California |
| Rady Children's Hospital San Diego | 92123 | San Diego | California |
| Children's Hospital of Illinois at OSF-Saint Francis Medical Center (St. Jude Midwest Affiliate - Peoria) | 61637 | Peoria | Illinois |
| Children's Hospital of Michigan | 48201 | Detroit | Michigan |
| St. Jude Affiliate Clinic - Novant Health Hemby Children's Hospital | 28204 | Charlotte | North Carolina |
| St. Jude Children's Research Hospital | 38105 | Memphis | Tennessee |
| Cook Children's Medical Center | 76104 | Fort Worth | Texas |
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