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Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma

StatusRecruiting
PhasePhase 2
Started2025-01-23
View on ClinicalTrials.gov ↗

Amendment history

2026-07-15
Study Status, Contacts/Locations v12
Study sites2→3
2026-04-29
Study Status, Contacts/Locations v11
Study sitescontacts updated at 1 of 2 sites
2026-02-09
Study Status, Study Description v10
Study description+6 characters
[...] phosphamide intravenous (IV), cytarabine IV, inotuzumab IV, intrathecal (IT) MHA, and dasatinib PO for patients with ABL-class fusion. Patient [...] py at the end of Consolidation. Blinatumomab 1 will be given with IT MHA for four weeks to all patients after recovery from Consolid [...] ry two weeks for four cycles. Patients will also receive an intrathecalIT chemotherapy treatmentMHA with each of the 2 week cycles and will take oral mercaptop [...]
2025-09-03
Study Status, Eligibility v9
Eligibility criteria+6 characters
[...] ature as defined above. Adequate liver function defined as: BilirubinTotal bilirubin ≤ 1.5x the upper limit of normal for age and alanine transa [...]
2025-08-19
Study Status, Contacts/Locations v8
Study sites1→2
Show 7 earlier versions
2025-08-14
Study Status, Study Description, Arms and Interventions, Eligibility v7
Eligibility criteria+165 characters
[...] ature as defined above. Adequate liver function defined as: Direct bilirubinBilirubin ≤ 1.5x the upper limit of normal for age and alanine transa [...] (ALT) ≤ 5x the upper limit of normal for age. Patients with ALTan orelevated aspartatetotal transferasebilirubin (AST)due 2to hemolysis are eligible if they have a direct bilirubin <1.5-5x the upper limit of normal for age are ineligible unless the increase is attributable to hemolysis. Adequate renal function defined as: Calculated glomerular [...] others with ALL) OR HR genetics as defined in the protocol. These patients may receive no more than 2 weeks o [...] [...]
Study description+247 characters
[...] e (MRD ≥5% disease) will proceed directly to consolidation. Patients unable to receive inotuzumab by day 3 receive cyclophosphamide IV on days 3-4. Early Post Induction: Consolidation will be given following [...] ne. Blinatumomab 2 will be given for four weeks to patients without clonal IgH rearrangements, those with elevated end of inductionInduction MRD, those in whom next-generation based sequencing MRD andis unavailable, patients who did not receive blinatumomab during induction, or patients with Down syndrome after Reconsolidation. Maintena [...]
2025-03-21
Study Status v6
Re-verified, no change to tracked fields
2025-01-23
Study Status v5
Start dateestimated 2025-02→confirmed 2025-01-23
2025-01-08
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Start date2024-12→2025-02
Study sitesdetails revised at 1 of 1 site
2024-11-07
Study Status v3
Start date2024-11→2024-12
2024-10-08
Study Status v2
Start date2024-10→2024-11
2024-08-16
Study Status v1
Start date2024-08→2024-10
2024-07-30
Original filing
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.
Trial Details
NCT Number NCT06533748
Lead Sponsor St. Jude Children's Research Hospital
Collaborators: Pfizer, Amgen
Conditions Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma
Enrollment 128 participants
Start Date 2025-01-23
Primary Completion 2028-05 (estimated)
Study Completion 2034-05 (estimated)
Updated on ClinicalTrials.gov 2026-07-16