Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-18
SponsorSt. Jude Children's Research Hospital
About this trial
This is a Phase II clinical trial testing the use of two antigen-directed therapies, inotuzumab and blinatumomab, as part of induction therapy for children and young adults with newly diagnosed B-cell precursor acute lymphoblastic leukemia and lymphoma.
Primary Objective
* To assess if the flow-cytometry assessed MRD-negative remission rate following an immunotherapy-based Induction in NCI-high risk patients without favorable genetic features is higher than the results of similar patients treated on AALL1131.
Secondary Objectives
* To compare flow-cytometry assessed MRD-negative rates at the end of Induction for patients treated with this therapy compared to similar patients treated on TOT17. * To compare the rate of significant toxicities in patients treated with this therapy to those treated with standard-risk therapy on TOT17. * To assess the event free and overall survival of patients treated with this therapy.
Eligibility criteria
Qualifiers
Enrollment on INITIALL.
Age 1-18.99 years at the time of enrollment on INITIALL.
B-Acute lymphoblastic leukemia or lymphoblastic lymphoma.
No prior chemotherapy excluding therapy given on or allowed by INITIALL.
Disqualifiers
Presence of ETV6::RUNX1 fusion unless also having a HR clinical feature OR slow response to induction therapy.
History or presence of clinically relevant central nervous system (CNS) pathology or event such as epilepsy, childhood or adult non-febrile seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis. History of simple febrile seizure during childhood and presence of CNS leukemia at diagnosis are not exclusions to participation.
Active uncontrolled infection.
Current active autoimmune disease or history of autoimmune disease with the potential for CNS involvement.
Trial design
Treatments tested in this trial
- Dexamethasone
- Vincristine
- Inotuzumab
- Blinatumomab
- Dasatinib
- IT MHA
- Cyclophosphamide
- Cytarabine
- Methotrexate
- 6-Mercaptopurine
- Calaspargase
- Daunorubicin
- Thioguanine
Treatment groups
128 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov