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Diagnosis | ALL, Acute Lymphoblastic Leukaemia | Study Status | Closed to enrollment |
Phase | I/II |
Age | Child - up to 365 days | Randomisation | NO |
Line of treatment | First line treatment |
Routes of Treatment Administration | Bortezomib: intravenous: Vorinostat: orally; Other drugs are given as usually administered for ALL therapy |
Last Posted Update | 2022-04-19 |
ClinicalTrials.gov # | NCT02553460 |
International Sponsor
St. Jude Children's Research HospitalPrincipal Investigators for Canadian Sites
BC Children's Hospital - Dr. Kirk R. Schultz
Alberta Children's Hospital - Dr. Victor A. Lewis
Hamilton Health Sciences Centre, McMaster University - Dr. Uma Athale
CHU Ste-Justine - Dr. Thai Hoa Tran
CHU de Quebec - Dr. Bruno Michon
Montreal Children's Hospital - Dr. Catherine Vezina
Stollery Children's Hospital - Dr. Sunil DesaiCentres
Medical contact
Rebecca Deyell
Social worker/patient navigator contact
Ilana Katz
Clinical research contact
Hem/Onc/BMT Clinical Trials Unit
Medical contact
Dr. Victor Lewis
Social worker/patient navigator contact
Wendy Pelletier
Clinical research contact
Debra Rich
Medical contact
Dr. Sarah McKillop
Dr. Sunil Desai
Social worker/patient navigator contact
Danielle Sikora
Michelle Woytiuk
Jaime Hobbs
Clinical research contact
Amanda Perreault
Medical contact
Dr. Carol Portwine
Social worker/patient navigator contact
Jane Cassano
Clinical research contact
Sabrina Millson
Medical contact
Raoul Santiago
Social worker/patient navigator contact
Isabelle Audet
Clinical research contact
Barbara Desbiens
Medical contact
Clinical Research Unit
Social worker/patient navigator contact
Clinical Research Unit
Clinical research contact
Stephanie Badour
Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
Social worker/patient navigator contact
Marie-Claude Charrette
Clinical research contact
Marie Saint-Jacques
Study Description
This study is to assess the effectiveness of two drugs (bortezomib and vorinostat) in addition to standard therapy, for the treatment of infants with a new diagnosis of acute lymphoblastic leukemia.
The study also looks at the side effects associated with these medications.
Bortezomib is a drug called a "proteasome inhibitor" while vorinostat is a drug called an "HDAC inhibitor".
Inclusion Criteria
- Children younger than 365 days of age with a new diagnosis of acute lymphoblastic leukemia
- They cannot have had prior treatment with other chemotherapies (with exception of a few medications, with limited amount of doses given).
- Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team