acute lymphoblastic leukemia precursor B-acute lymphoblastic leukemia
Conditions
Interventions
After a 5-day steroid prephase patients will receive two weeks continuous
infusion of blinatumomab. Then the first remission-induction course will be
given after one week interruption. Subsequent th
Sponsors
HOVON
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Primary CD19 positive precursor B-ALL (excluding mature B-cell ALL and B-lymphoblastic lymphoma, but including Philadelphia positive/BCR-ABL positive ALL) and CD19 positive mixed phenotype acute lymphoblastic leukemia (MPAL); - Patients aged 18 to 70 years inclusive; - WHO performance status 0-2; - Negative pregnancy test at inclusion, if applicable; - Written informed consent; - Patient is capable of giving informed consent.
Exclusion criteria
Exclusion criteria: - Mature B-cell leukemia/lymphoma, B-lymphoblastic lymphoma, isolated extramedullary disease; - CML in blast crisis; - Acute undifferentiated leukemia; - Previous treatment with chemotherapy for precursor B-ALL (maximum 5 days of steroid treatment is allowed); - Persistent liver enzyme disorders (ASAT/ALAT) >5xULN despite steroid pre-treatment; - Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease); - Severe pulmonary dysfunction (CTCAE grade III-IV); - Severe neurological or psychiatric disease; - Active, uncontrolled infection; - Clinically overt central nervous system disease; - Patients with a currently active second malignancy. Patients are not considered to have a currently active malignancy if they have completed therapy and are considered by their physician to be at
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of MRD negative response by PCR/FCM after the first blinatumomab consolidation course. MRD negative response is defined as MRD | — |
Secondary
| Measure | Time frame |
|---|---|
| -MRD level following induction chemotherapy -MRD level after second blinatumomab consolidation -Hematological response after induction, blinatumomab consolidation I and blinatumomab consolidation II -Event free survival, i.e. time from registration until no CR on protocol (i.e. after prephase, induction, consolidation I, or blinatumomab after consolidation I), relapse or death from any cause, whichever comes first. EFS for patients without a CR on protocol will be set at 1 day; this also includes patients with a first CR only after start intensification 1. Patients still in first CR and alive are censored at the last day they were last known to be alive. -Relapse free survival (hematologically; i.e. time from CR on protocol until relapse or death from any cause, whichever comes first)).. Patients still in first CR and alive are censored at the last day they were last known to be alive. -Overall survival, measured from the time of registration until death from any cause. Patients still alive or lost to follow up are censored at the date they were last known to be alive. -Adverse events -RFS and OS from start allogeneic transplantation and from start maintenance RFS, whichever is applicable -T-cell and B-cell kinetics and assessment of predictive value -Comparison of the results of molecular and flowcytometric MRD measurements at the same timepoints (sidestudy) | — |
Countries
Netherlands
Outcome results
None listed