OncoMatch/Clinical Trials/NCT05751044
HEM-iSMART-B: Dasatinib + Venetoclax + Dexamethasone + Cyclophosphamide and Cytarabine in Pediatric Patients With Relapsed or Refractory Hematological Malignancies
Is NCT05751044 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for acute lymphoblastic leukemia.
Treatment: Dasatinib · Venetoclax · Dexamethasone · Cyclophosphamide · Cytarabine · intrathecal chemotherapy — HEM-iSMART is a master protocol which investigates multiple investigational medicinal products in children, adolescents and young adults (AYA) with relapsed/refractory (R/R) ALL and LBL. Sub-protocol B is a phase I/II trial evaluating the safety and efficacy of dasatinib + venetocolax in combination with dexamethasone + Cyclophosphamide and cytarabine in children and AYA with R/R ped ALL/LBL whose tumor present with alterations in the MAPK/SRC pathway.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Biomarker criteria
Required: ABL1 NUP214-ABL1 fusion
NUP214-ABL1 fusion
Required: ABL1 other ABL1 fusion, activating the kinase domain
other ABL1 fusion, activating the kinase domain
Required: ABL1 amplification
ABL1 amplification
Required: PDGFRB fusion
PDGFRβ-fusion with various fusion partners including but not limited to: AGGF1, DOCK2, SATB1, ETV6
Excluded: BCL2 mutations of venetoclax binding-site (Gly101Val mutation, Phe104Leu/Cys mutations)
BCL2 mutations of venetoclax binding-site (Gly101Val mutation, Phe104Leu/Cys mutations)
Prior therapy
Cannot have received: dasatinib and venetoclax in combination (dasatinib, venetoclax)
Exception: Patients who have previously received any of these two drugs separately can be eligible for this sub-protocol
Previous treatment with dasatinib and venetoclax in combination
Lab requirements
Kidney function
Serum creatinine ≤ 1.5 x ULN for age or calculated creatinine clearance as per the Schwartz formula or radioisotope GFR ≥ 60 mL/min/1.73 m2
Liver function
Direct bilirubin ≤ 2 x ULN (≤ 3.0 × ULN for patients with Gilbert's syndrome); ALT/SGPT ≤ 5 x ULN; AST/SGOT ≤ 5 x ULN. Patients with hepatic dysfunction related to the underlying disease can be eligible after discussion with sponsor.
Cardiac function
Shortening fraction (SF) >29% (>35% for children < 3 years) and/or LVEF ≥50% at baseline; Absence of QTcF prolongation (>450 msec on baseline ECG, Friedericia correction), or other clinically significant ventricular or atrial arrhythmia
RENAL AND HEPATIC FUNCTION: Serum creatinine ≤ 1.5 x ULN for age or calculated creatinine clearance as per the Schwartz formula or radioisotope GFR ≥ 60 mL/min/1.73 m2. Direct bilirubin ≤ 2 x ULN (≤ 3.0 × ULN for patients with Gilbert's syndrome). ALT/SGPT ≤ 5 x ULN; AST/SGOT ≤ 5 x ULN. Patients with hepatic dysfunction related to the underlying disease can be eligible after discussion with sponsor. CARDIAC FUNCTION: Shortening fraction (SF) >29% (>35% for children < 3 years) and/or LVEF ≥50% at baseline; Absence of QTcF prolongation (>450 msec on baseline ECG, Friedericia correction), or other clinically significant ventricular or atrial arrhythmia.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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