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 (Jun 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
Treatments studied
Targeted therapy
Chemotherapy
Other
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)
Demographics
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.
Frequently asked questions
Is NCT05751044 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior dasatinib and venetoclax in combination disqualifies patients from enrollment.
Does this trial require ABL1?
Yes, ABL1 NUP214-ABL1 fusion is a required biomarker for enrollment.
Does this trial require ABL1?
Yes, ABL1 other ABL1 fusion, activating the kinase domain is a required biomarker for enrollment.
Does this trial require ABL1?
Yes, ABL1 amplification is a required biomarker for enrollment.
Are patients with BCL2 alterations eligible?
No. BCL2 mutations of venetoclax binding-site (Gly101Val mutation, Phe104Leu/Cys mutations) is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 21 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.
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