Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma
NCT Number: NCT06533748
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Acute Lymphoblastic Leukemia|Lymphoblastic Lymphoma
Interventions: DRUG: Dexamethasone|DRUG: Vincristine|DRUG: Inotuzumab|DRUG: Blinatumomab|DRUG: Dasatinib|PROCEDURE: IT MHA|DRUG: Cyclophosphamide|DRUG: Cytarabine|DRUG: Methotrexate|DRUG: 6-Mercaptopurine|DRUG: Calaspargase|DRUG: Daunorubicin|DRUG: Thioguanine
Sponsor: St. Jude Children's Research Hospital
Collaborators: Pfizer|Amgen
Sex: ALL
Age: CHILD, ADULT
Enrollment: 128
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2034-05
Locations: St. Jude Children's Research Hospital, Memphis, Tennessee, 38105, United States

Summary:
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.

Primary Outcome Measures: End of induction minimal residual disease negative remission, Flow cytometry (preferred) or next generation sequencing measurement of bone marrow with \<0.01% leukemia with resolution of extramedullary disease at the end of induction (approximately day 29) and will be analyzed within 6 months of the last participant reaching the timepoint., On treatment to end of induction, approximately 29 days
Secondary Outcome Measures: Comparison of MRD-negative rates to those on Total 17, Flow cytometry (preferred) or next generation sequencing measurement of bone marrow with \<0.01% leukemia with resolution of extramedullary disease will be compared between patients enrolled on this trial and patients with similar clinical features (age, WBC at diagnosis, CNS status, testicular involvement) enrolled on Total 17(NCT03117751)., On treatment to end of induction, approximately 29 days|Compare significant toxicities experienced to those on Total 17, We will compare CTCAE version 5 clinically significant, non-hematological grade 3 or any non-hematological grade 4-5 toxicities. This comparison will encompass 3 periods: induction/ consolidation, reinduction, and reconsolidation., On treatment to end of reconsolidation, approximately 56 days.|Event free survival (EFS), Kaplan-Meier estimates of the survival functions for event-free survival (EFS) will be calculated along with standard error. For EFS, death due to any cause, any relapse, consolidation failure, and second malignancy are considered as failure; patients remaining failure-free at the last follow up are censored., 3.5 years after enrollment.|Overall survival (OS), Kaplan-Meier estimates of the survival functions for overall survival (OS) will be calculated along with standard error. For OS, only death due to any cause is considered as failure and patients still alive at the last follow up are censored., 3.5 years after enrollment.