Spots Global Cancer Trial Database for Interfant-21 Treatment Protocol for Infants Under 1 Year With KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia
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Trial Identification
Brief Title: Interfant-21 Treatment Protocol for Infants Under 1 Year With KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia
Official Title: Interfant-21 International Collaborative Treatment Protocol for Infants Under One Year With KMT2A-rearranged Acute Lymphoblastic Leukemia or Mixed Phenotype Acute Leukemia.
Study ID: NCT05327894
Study Description
Brief Summary: This study is a treatment protocol with blinatumomab for infants under 1 year old who are diagnosed with acute lymphoblastic leukemia with a specific unfavorable genetic alteration. The purpose of the study is to improve the outcome of this disease in infants.
Detailed Description: All infants that are eligible for this study and for whom the parents/legal representatives give informed consent will be enrolled in this study. All patients will receive one cycle of blinatumomab on top of the standard treatment backbone after induction therapy. Medium risk patients, that respond well to the 1st cycle will be treated with a 2nd cycle of blinatumomab replacing one chemo course after consolidation therapy. If they do not respond well enough they will be treated according to the current treatment standard. Minimal residual disease will be used to determine the response to blinatumomab. High risk patients will be eligible for allogeneic stem cell transplantation after the first blinatumomab cycle if they are Minimal Residual Disease (MRD) negative (defined as \< 0.01%). Also medium risk patients with insufficient MRD response after induction or after the 1st cycle of blinatumomab will be allocated to high risk treatment and will be eligible for allogeneic stem cell transplantation.
Eligibility
Minimum Age: 1 Day
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Locations
Hospital de Pediatría S.A.M.I.C. "Juan P. Garrahan", Buenos Aires, , Argentina
Australian and New Zealand Children's Haematology/Oncology Group, Clayton, Victoria, Australia
St. Anna Children's Hospital, Vienna, , Austria
Hôpital Universitaire des Enfants Reine Fabiola, Brussel, , Belgium
Hospital Motol V Uvalu 841, Prague, , Czechia
AUH Skejby, Aarhus, , Denmark
Copenhagen-Rigshospitalet, Copenhagen, , Denmark
Odense University Hospital, Odense, , Denmark
New Children's Hospital, Helsinki, , Finland
Kuopio University Hospital, Kuopio, , Finland
Oulu University Hospital, Oulu, , Finland
Tampere University Hospital, Tampere, , Finland
Hôpital Robert Debré, APHP, Paris, , France
Universtitätsklinikum Eppendorf, Hamburg, , Germany
University of Pécs, Pécs, , Hungary
National Children's Cancer Service, Dublin, , Ireland
IRCCS Ospedale Pediatrico Bambino Gesù, Roma, , Italy
Osaka University Graduate School of Medicine 2-2, Osaka, , Japan
Princess Máxima Center for pediatric oncology, Utrecht, , Netherlands
St. Olavs Hospital, Trondheim, , Norway
Instituto Portugues de Oncologica Lisboa, Lisboa, , Portugal
King Abdulaziz Medical City, King Abdullah International Medical Research Center, Riyadh, , Saudi Arabia
Childrens Cancer Center Queen Silvia Children´s Hospital, Sahlgrenska University Hospital, Gothenburg, , Sweden
Contact Details
Name: Janine Stutterheim, Dr
Affiliation: Princess Maxima Center for Pediatric Oncology in The Netherlands
Role: PRINCIPAL_INVESTIGATOR
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