Blinatumomab Added to Prephase and Consolidation Therapy in Precursor B-acute Lymphoblastic Leukemia in Adults.
Status:
Recruiting
Trial end date:
2026-12-15
Target enrollment:
Participant gender:
Summary
Blinatumomab is a new active bispecific monoclonal antibody for treatment of lymphoid
malignancies, including ALL (acute Lymphoblastic Leukemia ) whose activity for remission
induction needs to be explored in combination with standardized treatment in order to improve
outcome of this disease which is still lethal in most adult patients. Ultimate proof of
efficacy resides in an increase of reaching MRD ( minimal residual disease) negativity,
prolongation of that response, and long-term survival. Since hematological response rate in
adult ALL is high already and defining long-term survival in a large clinical trial takes
many years, this trial aims to improve the strength of the MRD response as defined by
achieving complete MRD negative response (ie, < 10^-4) after the first consolidation phase
including blinatumomab. This MRD response will be assessed by Real-Time Quantitative
Polymerase Chain Reaction (RQ-PCR) analysis of patient-specific Ig/TCR (T-cell receptor )
gene rearrangements. When MRD data are missing, MRD positivity will be assumed. Although
younger (up to 40 years of age) patients are treated more intensively than older patients
(older than 40 years of age), the investigational questions concerning blinatumomab can be
examined in both subgroups as both younger and older patients receive the same type of
chemotherapy courses with dose adjustments for chemotherapeutic agents only for patients
above 60 years of age.
Phase:
Phase 2
Details
Lead Sponsor:
Stichting Hemato-Oncologie voor Volwassenen Nederland