HEM-iSMART-C: Ruxolitinib + Venetoclax + Dexamethasone + Cyclophosphamide and Cytarabine in Pediatric Patients With Relapsed or Refractory Hematological Malignancies
NCT05745714 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 26
Last updated 2025-09-16
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.
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
Interventions
- DRUG
-
oral
- DRUG
-
oral
- DRUG
-
oral/intravenous
- DRUG
-
intravenous
- DRUG
-
intravenous
- DRUG
-
intrathecal chemotherapy
IT: Methotrexate +/- prednisone/hydrocortisone/cytarabine according to the degree of central nervous involvement
Sponsors & Collaborators
-
IBFM
collaborator INDUSTRY -
Innovative Therapies For Children with Cancer Consortium
collaborator OTHER -
Fight Kids Cancer
collaborator OTHER -
Princess Maxima Center for Pediatric Oncology
lead OTHER
Principal Investigators
-
Michel Zwaan, Prof. Dr. · Princess Máxima Center
-
Paco Bautista, MD PhD · Princess Máxima Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 1 Year
- Max Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-01
- Primary Completion
- 2032-02-01
- Completion
- 2032-02-02
Countries
- Austria
- Belgium
- Denmark
- Finland
- France
- Germany
- Ireland
- Israel
- Italy
- Netherlands
- Norway
- Spain
- Sweden
- United Kingdom
Study Locations
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