TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II
- Conditions
- Lymphoblastic Leukemia
- Interventions
- Registration Number
- NCT05848687
- Lead Sponsor
- Tanja Andrea Gruber
- Brief Summary
The purpose of this study is to improve upon the TINI study treatment. The study will test the ability of a type of immunotherapy called blinatumomab to clear persistent leukemia. Blinatumomab targets CD19 which is located on the leukemia cells outer membrane.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
- Patient is ≤ 365 days of age at the time of diagnosis.
- Patient has newly diagnosed CD19 positive acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia. Subjects with bilineage or biphenotypic acute leukemia are eligible provided they express CD19. Patients with CD19 positive mature B-cell ALL who carry a KMT2A rearrangement are eligible.
- Limited prior therapy, including hydroxyurea for 72 hours or less, systemic glucocorticoids for one week or less, cytarabine for 72 hours or less, one dose of vincristine, and one dose of intrathecal chemotherapy.
- Written informed consent following Institutional Review Board, NCI, FDA, and OHRP Guidelines.
- Patients with prior therapy, other than therapy specified in inclusion criteria.
- Patients with mature B-cell ALL that do not have a KMT2A rearrangement or patients with acute myelogenous (AML) or T-cell ALL.
- Patients with Down syndrome.
- Inability or unwillingness of legal guardian/representative to give written informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Ziftomenib Participants who meet eligibility criteria will receive remission induction, induction intensification, consolidation I, reinduction block I, reinduction block II, consolidation II, and Maintenance. Interventions: Dexamethasone, Mitoxantrone, PEG-asparaginase, Bortezomib, Vorinostat, Mercaptopurine, Methotrexate and Vincristine, Blinatumomab, Ziftomenib Treatment PEG asparaginase Participants who meet eligibility criteria will receive remission induction, induction intensification, consolidation I, reinduction block I, reinduction block II, consolidation II, and Maintenance. Interventions: Dexamethasone, Mitoxantrone, PEG-asparaginase, Bortezomib, Vorinostat, Mercaptopurine, Methotrexate and Vincristine, Blinatumomab, Ziftomenib Treatment Bortezomib Participants who meet eligibility criteria will receive remission induction, induction intensification, consolidation I, reinduction block I, reinduction block II, consolidation II, and Maintenance. Interventions: Dexamethasone, Mitoxantrone, PEG-asparaginase, Bortezomib, Vorinostat, Mercaptopurine, Methotrexate and Vincristine, Blinatumomab, Ziftomenib Treatment Methotrexate Participants who meet eligibility criteria will receive remission induction, induction intensification, consolidation I, reinduction block I, reinduction block II, consolidation II, and Maintenance. Interventions: Dexamethasone, Mitoxantrone, PEG-asparaginase, Bortezomib, Vorinostat, Mercaptopurine, Methotrexate and Vincristine, Blinatumomab, Ziftomenib Treatment Blinatumomab Participants who meet eligibility criteria will receive remission induction, induction intensification, consolidation I, reinduction block I, reinduction block II, consolidation II, and Maintenance. Interventions: Dexamethasone, Mitoxantrone, PEG-asparaginase, Bortezomib, Vorinostat, Mercaptopurine, Methotrexate and Vincristine, Blinatumomab, Ziftomenib Treatment Dexamethasone Participants who meet eligibility criteria will receive remission induction, induction intensification, consolidation I, reinduction block I, reinduction block II, consolidation II, and Maintenance. Interventions: Dexamethasone, Mitoxantrone, PEG-asparaginase, Bortezomib, Vorinostat, Mercaptopurine, Methotrexate and Vincristine, Blinatumomab, Ziftomenib Treatment Mitoxantrone Participants who meet eligibility criteria will receive remission induction, induction intensification, consolidation I, reinduction block I, reinduction block II, consolidation II, and Maintenance. Interventions: Dexamethasone, Mitoxantrone, PEG-asparaginase, Bortezomib, Vorinostat, Mercaptopurine, Methotrexate and Vincristine, Blinatumomab, Ziftomenib Treatment Vorinostat Participants who meet eligibility criteria will receive remission induction, induction intensification, consolidation I, reinduction block I, reinduction block II, consolidation II, and Maintenance. Interventions: Dexamethasone, Mitoxantrone, PEG-asparaginase, Bortezomib, Vorinostat, Mercaptopurine, Methotrexate and Vincristine, Blinatumomab, Ziftomenib Treatment Mercaptopurine Participants who meet eligibility criteria will receive remission induction, induction intensification, consolidation I, reinduction block I, reinduction block II, consolidation II, and Maintenance. Interventions: Dexamethasone, Mitoxantrone, PEG-asparaginase, Bortezomib, Vorinostat, Mercaptopurine, Methotrexate and Vincristine, Blinatumomab, Ziftomenib
- Primary Outcome Measures
Name Time Method Minimal Residual Disease 5 years and 2 months Proportion of patients who are minimal residual disease positive at the end of Induction Intensification
- Secondary Outcome Measures
Name Time Method Ziftomenib Minimum safe and Biologically-Effective Dose in Combination with Chemotherapy 5 years and 6 months To determine the estimated minimum safe and biologically-effective dose of Ziftomenib in combination with chemotherapy, on the basis of observed DLTs, MRD assessments, and pharmacokinetic studies
Event Free Survival 8 years To estimate the 3-year event-free survival for subjects treated on study
Overall Survival 8 years To estimate the 3-year overall survival for subjects treated on study
Trial Locations
- Locations (25)
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Arkansas Children's Hospital
🇺🇸Little Rock, Arkansas, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Valley Children's Hospital
🇺🇸Madera, California, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States
Stanford University
🇺🇸Palo Alto, California, United States
Rady Children's Hospital San Diego
🇺🇸San Diego, California, United States
Arnold Palmer Hospital for Children
🇺🇸Orlando, Florida, United States
Children's Hospital of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Novant Health - Hemby Children's Hospital
🇺🇸Charlotte, North Carolina, United States
Doernbecher Children's Hospital
🇺🇸Portland, Oregon, United States
Penn State Milton S Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
MD Anderson
🇺🇸Houston, Texas, United States
University of Texas Health Science Center San Antonio
🇺🇸San Antonio, Texas, United States
University of Utah Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Children's Hospital of The King's Daughters
🇺🇸Norfolk, Virginia, United States
University of Wisconsin Carbone Cancer Center
🇺🇸Madison, Wisconsin, United States
Alberta Children's Hospital
🇨🇦Calgary, Alberta, Canada
Stollery Children's Hospital
🇨🇦Edmonton, Alberta, Canada
BC Children's Hospital
🇨🇦Vancouver, British Columbia, Canada
McMaster Children's Hospital
🇨🇦Hamilton, Ontario, Canada
CHU Sainte-Justine
🇨🇦Montréal, Quebec, Canada
Montreal Children's Hospital
🇨🇦Montréal, Quebec, Canada
Chu De Quebec
🇨🇦Quebec City, Quebec, Canada