Trial Treating Relapsed Acute Lymphoblastic Leukemia With Venetoclax and Navitoclax
Status:
Not yet recruiting
Trial end date:
2029-07-01
Target enrollment:
Participant gender:
Summary
This is a phase I/II clinical trial evaluating the activity of combination chemotherapy with
venetoclax and navitoclax in children with relapsed or refractory acute lymphoblastic
leukemia or lymphoma (rALL) and assessing the combination dose of venetoclax combinations
with either blinatumomab for CD19-postive patients or navitoclax and high-dose cytarabine for
CD19-negative patients.
Primary Objectives
- To compare Minimal Residual Disease (MRD)-negative CR/CRi rate in children with relapsed
or refractory acute lymphoblastic leukemia or lymphoma (rALL) following Block 1 therapy
with venetoclax and navitoclax based reinduction to historical controls.
- To identify the recommended phase 2 combination dose (RP2D) of venetoclax based
consolidation in novel combinations with a) high-dose cytarabine and navitoclax or b)
blinatumomab.
Secondary Objectives
- To estimate the tolerability and activity of venetoclax based consolidation in novel
combinations with a) high-dose cytarabine and navitoclax or b) blinatumomab.
- To describe event-free and overall survival in patients treated with this regimen.
Exploratory Objectives
- To evaluate MRD-negative CR/CRi rates in each prespecified groups: late first relapse
B-ALL; early first relapse and second or greater relapse B-ALL; and relapsed T-ALL.
- To identify drug sensitivity patterns in patient samples prior to and after receiving
combination therapy and evaluate mechanisms of disease resistance/ escape.
- To explore immune subsets during and after this regimen.
- Evaluate response to therapy in rare relapse patient subsets.
- Explore breakthrough infections in children and young adults with relapsed or refractory
ALL