NCT05745714 - HEM-iSMART-C: Ruxolitinib + Venetoclax + Dexamethasone + Cyclophosphamide and Cytarabine in Pediatric Patients With Relapsed or Refractory Hematological Malignancies | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

October 1, 2025

Primary Completion Date

February 1, 2032

Study Completion Date

February 2, 2032

Conditions

Acute Lymphoblastic Leukemia, in RelapseLymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) RecurrentLymphoblastic Lymphoma (Precursor T-Lymphoblastic Lymphoma/Leukaemia) RecurrentLymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) RefractoryLymphoblastic Lymphoma (Precursor T-Lymphoblastic Lymphoma/Leukaemia) Refractory

Interventions

DRUG

Ruxolitinib

oral

DRUG

Venetoclax

oral

DRUG

Dexamethasone

oral/intravenous

DRUG

Cyclophosphamide

intravenous

DRUG

Cytarabine

intravenous

DRUG

intrathecal chemotherapy

IT: Methotrexate +/- prednisone/hydrocortisone/cytarabine according to the degree of central nervous involvement

Trial Locations (33)

1090

NOT_YET_RECRUITING

St. Anna Kinderspital, Vienna

9000

NOT_YET_RECRUITING

Universitair Ziekenhuis Gent, Ghent

10126

NOT_YET_RECRUITING

Ospedale Infantile Regina Margherita, Turin

13005

NOT_YET_RECRUITING

Hopital La Timone - Enfants, Marseille

13353

RECRUITING

Charité Universitätsmedizin Berlin, Berlin

16147

NOT_YET_RECRUITING

IRCCS Istituto Giannina Gaslini, Genova

20900

NOT_YET_RECRUITING

Fondazione MBBM c/o Centro ML Verga, Monza

28009

NOT_YET_RECRUITING

Hospital Infantil Universitario Niño Jesús, Madrid

33076

NOT_YET_RECRUITING

Hôpital des Enfants GH Pellegrin - CHU de Bordeaux, Bordeaux

35128

NOT_YET_RECRUITING

Padova Azienda Ospedaliera, Padua

44093

NOT_YET_RECRUITING

CHU Nantes Hôpital Mère-Enfant, Nantes

45147

NOT_YET_RECRUITING

Universitätsklinikum Essen, Essen

46026

NOT_YET_RECRUITING

La Fe, Valencia

48149

NOT_YET_RECRUITING

Universitätsklinikum Münster, Münster

52621

NOT_YET_RECRUITING

Sheba Medical Center Hospital, Ramat Gan

59037

NOT_YET_RECRUITING

CHRU Lille - Hôpital Jeanne de Flandre, Lille

60590

NOT_YET_RECRUITING

Universitätsklinikum Frankfurt, Frankfurt

75019

NOT_YET_RECRUITING

Hôpital Robert Debré, Paris

86156

NOT_YET_RECRUITING

Universitätsklinikum Augsburg, Augsburg

4920235

NOT_YET_RECRUITING

Schneider's Children's Medical Center, Petah Tikva

DK-2100

RECRUITING

Rigshospitalet Copenhagen, Copenhagen

FI00029

NOT_YET_RECRUITING

Helsinki University Hospital, New Children's Hospital, Helsinki

69 373

NOT_YET_RECRUITING

Centre Léon Bérard, Lyon

D12N512

NOT_YET_RECRUITING

Our Lady's Hospital for Sick Children, Dublin

0165

NOT_YET_RECRUITING

Ospedale Pediatrico Bambino Gesù, IRCCS, Roma

3584CS

NOT_YET_RECRUITING

Princess Máxima Center for Pediatric Oncology, Utrecht

0373

NOT_YET_RECRUITING

Oslo University Hospital, Oslo

08950

NOT_YET_RECRUITING

Hospital Sant Joan de Déu de Barcelona, Barcelona

171 76

RECRUITING

Karolinska university hospital, Stockholm

B52 8BJ

NOT_YET_RECRUITING

Bristol Royal Hospital for Children, Bristol

WC1N 2BH

NOT_YET_RECRUITING

Great Ormond Street Hospital for Children NHS Trust, London

NE1 4LP

NOT_YET_RECRUITING

Great North Children's Hospital, Newcastle

SM2 5PT

NOT_YET_RECRUITING

Royal Marsden NHS Trust, Sutton