Actively Recruiting
HEM iSMART-D: Trametinib + Dexamethasone + Chemotherapy in Children With Relapsed or Refractory Hematological Malignancies
Led by Princess Maxima Center for Pediatric Oncology · Updated on 2025-09-16
26
Participants Needed
36
Research Sites
280 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 D is a phase I/II trial evaluating the safety and efficacy of trametinib in combination with dexamethasone, cyclophosphamide and cytarabine in children and AYA with R/R ped ALL/LBL whose tumor present with alterations in the RAS-RAF-MAPK pathway.
CONDITIONS
Official Title
HEM iSMART-D: Trametinib + Dexamethasone + Chemotherapy in Children With Relapsed or Refractory Hematological Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 1 year (≥12 months) to less than 21 years at inclusion
- Patients must weigh at least 7 kg if under 6 years old or 10 kg if over 6 years old
- Karnofsky or Lansky performance status ≥ 50%
- Written informed consent and age-appropriate assent obtained
- Molecular profiling and flow cytometric analysis of relapse or refractory disease done before inclusion
- Tumors must have activating mutations in the RAS pathway (e.g., KRAS, NRAS, HRAS, FLT3, PTPN11, MAP2K1, cCBL, NF1 deletion)
- Adequate kidney, liver, and heart function as specified in the protocol
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 absorption of oral drugs
- Known allergy or hypersensitivity to study drugs or related substances
- Active viral hepatitis, HIV infection, or uncontrolled infections
- Severe other diseases preventing protocol treatment
- Unwilling or unable to comply with study procedures
- Previous treatment with trametinib
- Use of prohibited medications or herbal products during the study
- Unresolved toxicity ≥ grade 3 from previous therapies, except certain non-relevant effects
- Active graft versus host disease or recent treatment for it
- Recent immunosuppression after allogenic stem cell transplant
- History or evidence of retina vein occlusion or central serous retinopathy
- Insufficient washout periods from prior chemotherapy, radiotherapy, stem cell transplant, immunotherapy, monoclonal antibodies, or surgery as defined in the protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 36 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
Actively Recruiting
25
Oslo University Hospital
Oslo, Norway, 0373
Actively Recruiting
26
Hospital Vall d'Hebron
Barcelona, Spain, 08035
Not Yet Recruiting
27
Hospital Sant Joan de Déu de Barcelona
Barcelona, Spain, 08950
Not Yet Recruiting
28
Hospital Infantil Universitario Niño Jesús
Madrid, Spain, 28009
Not Yet Recruiting
29
La Fe
Valencia, Spain, 46026
Not Yet Recruiting
30
Karolinska university hospital
Stockholm, Sweden, 171 76
Actively Recruiting
31
University Children's Hospital Zürich
Zurich, Switzerland, CH-8032
Not Yet Recruiting
32
Bristol Royal Hospital for Children
Bristol, United Kingdom, B52 8BJ
Not Yet Recruiting
33
Great Ormond Street Hospital for Children NHS Trust
London, United Kingdom, WC1N 2BH
Not Yet Recruiting
34
Royal Manchester Children's Hospital
Manchester, United Kingdom, M13 9WL
Not Yet Recruiting
35
Great North Children's Hospital
Newcastle, United Kingdom, NE1 4LP
Not Yet Recruiting
36
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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