Actively Recruiting
HEM-iSMART-C: Ruxolitinib + Venetoclax + Dexamethasone + Cyclophosphamide and Cytarabine in Pediatric Patients With Relapsed or Refractory Hematological Malignancies
Led by Princess Maxima Center for Pediatric Oncology · Updated on 2025-09-16
26
Participants Needed
33
Research Sites
330 weeks
Total Duration
On this page
Sponsors
P
Princess Maxima Center for Pediatric Oncology
Lead Sponsor
I
Innovative Therapies For Children with Cancer Consortium
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
HEM-iSMART-C: Ruxolitinib + Venetoclax + Dexamethasone + Cyclophosphamide and Cytarabine in Pediatric Patients With Relapsed or Refractory Hematological Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 1 year or older and less than 21 years at inclusion
- Karnofsky or Lansky performance status of 50% or higher
- Written informed consent and age-appropriate assent obtained
- Advanced molecular profiling and flow cytometry of recurrent or refractory disease done
- Tumors with alterations in IL-7R and/or JAK-STAT pathways, including specific mutations and rearrangements
- Adequate organ function: kidney, liver, and heart within specified limits
You will not qualify if you...
- Pregnancy or positive pregnancy test in females of childbearing potential
- Not willing to use effective contraception during and 6 months after therapy
- Breastfeeding
- Gastrointestinal issues affecting oral drug absorption
- Tumor mutations known to cause resistance to JAK inhibitors or venetoclax
- Known hypersensitivity to study drugs or related compounds
- Active viral hepatitis, HIV, or uncontrolled infections
- Severe diseases preventing protocol treatment
- Inability or unwillingness to comply with study procedures
- Prior combined treatment with ruxolitinib and venetoclax
- Use of prohibited medications affecting drug metabolism or QT interval
- Consumption of grapefruit or similar products within 72 hours before first dose
- Unresolved toxicities grade 2 or higher from prior therapies, except certain non-relevant ones
- Active graft versus host disease or recent immunosuppression post-transplant
- History of specific bone or endocrine disorders prior to diagnosis
- Evidence of active tuberculosis
- Required washout periods from prior chemotherapy, radiotherapy, stem cell transplant, immunotherapy, monoclonal antibodies, investigational drugs, or major surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 33 locations
1
St. Anna Kinderspital
Vienna, Austria, 1090
Not Yet Recruiting
2
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
Not Yet Recruiting
3
Rigshospitalet Copenhagen
Copenhagen, Denmark, DK-2100
Actively Recruiting
4
Helsinki University Hospital, New Children's Hospital
Helsinki, Finland, FI00029
Not Yet Recruiting
5
Hôpital des Enfants GH Pellegrin - CHU de Bordeaux
Bordeaux, France, 33076
Not Yet Recruiting
6
CHRU Lille - Hôpital Jeanne de Flandre
Lille, France, 59037
Not Yet Recruiting
7
Centre Léon Bérard
Lyon, France, 69 373
Not Yet Recruiting
8
Hopital La Timone - Enfants
Marseille, France, 13005
Not Yet Recruiting
9
CHU Nantes Hôpital Mère-Enfant
Nantes, France, 44093
Not Yet Recruiting
10
Hôpital Robert Debré
Paris, France, 75019
Not Yet Recruiting
11
Universitätsklinikum Augsburg
Augsburg, Germany, 86156
Not Yet Recruiting
12
Charité Universitätsmedizin Berlin
Berlin, Germany, 13353
Actively Recruiting
13
Universitätsklinikum Essen
Essen, Germany, 45147
Not Yet Recruiting
14
Universitätsklinikum Frankfurt
Frankfurt, Germany, 60590
Not Yet Recruiting
15
Universitätsklinikum Münster
Münster, Germany, 48149
Not Yet Recruiting
16
Our Lady's Hospital for Sick Children
Dublin, Ireland, D12N512
Not Yet Recruiting
17
Schneider's Children's Medical Center
Petah Tikva, Israel, 4920235
Not Yet Recruiting
18
Sheba Medical Center Hospital
Ramat Gan, Israel, 52621
Not Yet Recruiting
19
IRCCS Istituto Giannina Gaslini
Genova, Italy, 16147
Not Yet Recruiting
20
Fondazione MBBM c/o Centro ML Verga
Monza, Italy, 20900
Not Yet Recruiting
21
Padova Azienda Ospedaliera
Padova, Italy, 35128
Not Yet Recruiting
22
Ospedale Pediatrico Bambino Gesù, IRCCS
Roma, Italy, 0165
Not Yet Recruiting
23
Ospedale Infantile Regina Margherita
Turin, Italy, 10126
Not Yet Recruiting
24
Princess Máxima Center for Pediatric Oncology
Utrecht, Utrecht, Netherlands, 3584CS
Not Yet Recruiting
25
Oslo University Hospital
Oslo, Norway, 0373
Not Yet Recruiting
26
Hospital Sant Joan de Déu de Barcelona
Barcelona, Spain, 08950
Not Yet Recruiting
27
Hospital Infantil Universitario Niño Jesús
Madrid, Spain, 28009
Not Yet Recruiting
28
La Fe
Valencia, Spain, 46026
Not Yet Recruiting
29
Karolinska university hospital
Stockholm, Sweden, 171 76
Actively Recruiting
30
Bristol Royal Hospital for Children
Bristol, United Kingdom, B52 8BJ
Not Yet Recruiting
31
Great Ormond Street Hospital for Children NHS Trust
London, United Kingdom, WC1N 2BH
Not Yet Recruiting
32
Great North Children's Hospital
Newcastle, United Kingdom, NE1 4LP
Not Yet Recruiting
33
Royal Marsden NHS Trust
Sutton, United Kingdom, SM2 5PT
Not Yet Recruiting
Research Team
A
Anne Elsinghorst
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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