Status and phase
Conditions
Treatments
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Additional exclusion criteria for blinatumomab:
If exclusion criteria for blinatumomab are met, the patient should be treated according to the protocol but without blinatumomab.
Primary purpose
Allocation
Interventional model
Masking
160 participants in 2 patient groups
Loading...
Central trial contact
Lieke van den Wildenberg; Peggy Scholte-Van Houtem
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal