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

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.

Trial Details

NCT ID

NCT05745714

Phase

PHASE1 / PHASE2

Sponsor

Princess Maxima Center for Pediatric Oncology

Status

RECRUITING

Cancer Type

Acute Lymphoblastic (ALL) Leukemia

Interventions

Ruxolitinib
Venetoclax
Dexamethasone
Cyclophosphamide
Cytarabine
intrathecal chemotherapy

Locations (sample)

Vienna, Austria|48.20849,16.37208
Ghent, Belgium|51.05,3.71667
Copenhagen, Denmark|55.67594,12.56553
Helsinki, Finland|60.16952,24.93545
Bordeaux, France|44.84124,-0.58046

Key Eligibility Criteria

Children between 1 year (≥ 12 months) and 18 years of age at the time of first diagnosis and less than 21 years at the time of inclusion
Performance status: Karnofsky performance status (for patients \>12 years of age) or Lansky Play score (for patients ≤12 years of age) ≥ 50% (Appen…
Written informed consent from parents/legal representative, patient, and age-appropriate assent before any study specific screening procedures are …
Patients must have had advanced molecular profiling and flow-cytometric analysis of their recurrent or refractory disease at a time-point before th…

For full eligibility, visit ClinicalTrials.gov.

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