OncoMatch/Clinical Trials/NCT06533748
Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma
Is NCT06533748 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments for acute lymphoblastic leukemia.
Treatment: Dexamethasone · Vincristine · Inotuzumab · Blinatumomab · Dasatinib · Cyclophosphamide · Cytarabine · Methotrexate · 6-Mercaptopurine · Calaspargase · Daunorubicin · Thioguanine — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Chemotherapy
Other
Cancer type
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Biomarker criteria
Excluded: ETV6 etv6::runx1 fusion
Disease stage
Required: Stage STAGE 3, STAGE 4
For lymphoblastic lymphoma, Stage 3-4 disease OR Stage 1-2 disease in patient ages ≥10 years OR HR clinical feature as defined above.
Demographics
Prior therapy
Cannot have received: chemotherapy
Exception: therapy given on or allowed by INITIALL
No prior chemotherapy excluding therapy given on or allowed by INITIALL.
Lab requirements
Kidney function
Calculated GFR ≥ 50 mL/min/1.73m^2 using Bedside Schwartz equation OR creatinine below or equal to age/sex-specific maximum.
Liver function
Total bilirubin ≤ 1.5x ULN for age and ALT ≤ 5x ULN for age. Patients with elevated total bilirubin due to hemolysis eligible if direct bilirubin <1.5x ULN.
Cardiac function
Unstable cardiac disease including QTc >500msec [excluded]
Adequate liver function defined as: Total bilirubin ≤ 1.5x ULN for age and ALT ≤ 5x ULN for age. Patients with an elevated total bilirubin due to hemolysis are eligible if they have a direct bilirubin <1.5x ULN. Adequate renal function defined as: Calculated GFR ≥ 50 mL/min/1.73m^2 using the Bedside Schwartz equation OR creatinine below or equal to the maximum defined below. Unstable cardiac disease including QTc >500msec [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Saint Francis Children's Hospital · Tulsa, Oklahoma
- St. Jude Children's Research Hospital · Memphis, Tennessee
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06533748 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Are patients with ETV6 alterations eligible?
No. ETV6 etv6::runx1 fusion is an exclusion criterion.
What disease stage is eligible?
Stage STAGE 3 or STAGE 4 is required.
Is there an age limit?
Yes. Patients must be 18 years or younger and at least 1 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify