Clinical Trial

HEM-iSMART-C: Ruxolitinib + Venetoclax + Dexamethasone + Cyclophosphamide and Cytarabine in Pediatric Patients With Relapsed or Refractory Hematological Malignancies

Study acronym: HEM-iSMART C
Recruiting Phase 1/2
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Summary
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 C is a phase I/II trial evaluating the safety and efficacy of ruxolitinib and venetoclax in combination with dexamethasone, cyclophosphamide and cytarabine in children and AYA with R/R ped ALL/LBL whose tumor present with alterations in the IL7R/JAK-STAT pathway.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-02-16; most recent amendment 2025-09-09.
Status change: Not Yet Recruiting → Recruiting 2025-09-09
Trial Details
NCT Number NCT05745714
Lead Sponsor Princess Maxima Center for Pediatric Oncology
Collaborators: Innovative Therapies For Children with Cancer Consortium, IBFM, Fight Kids Cancer
Conditions Acute Lymphoblastic Leukemia, in Relapse, Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Recurrent, Lymphoblastic Lymphoma (Precursor T-Lymphoblastic Lymphoma/Leukaemia) Recurrent, Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Refractory, Lymphoblastic Lymphoma (Precursor T-Lymphoblastic Lymphoma/Leukaemia) Refractory
Enrollment 26 participants
Start Date 2025-10-01
Primary Completion 2032-02-01 (estimated)
Study Completion 2032-02-02 (estimated)
Updated on ClinicalTrials.gov 2025-09-16