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Blinatumomab Added to Prephase and Consolidation Therapy in Precursor B-acute Lymphoblastic Leukemia in Adults.
Sponsor: Stichting Hemato-Oncologie voor Volwassenen Nederland
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.
Official title: Blinatumomab Added to Prephase and Consolidation Therapy in Precursor B-acute Lymphoblastic Leukemia in Adults. A Phase II Trial
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
71
Start Date
2018-06-04
Completion Date
2026-12-15
Last Updated
2024-09-19
Healthy Volunteers
No
Conditions
Interventions
Blinatumomab
prephase and consolidation (I and II)
Locations (18)
BE-Antwerpen Edegem-UZA
Antwerp, Belgium
BE-Antwerpen-ZNASTUIVENBERG
Antwerp, Belgium
BE-Brugge-AZBRUGGE
Bruges, Belgium
BE-Gent-UZGENT
Ghent, Belgium
BE-Leuven-UZLEUVEN
Leuven, Belgium
BE-Roeselare-AZDELTA
Roeselare, Belgium
NL-Amersfoort-MEANDERMC
Amersfoort, Netherlands
NL-Amsterdam-AMC
Amsterdam, Netherlands
NL-Amsterdam-VUMC
Amsterdam, Netherlands
NL-Enschede-MST
Enschede, Netherlands
NL-Groningen-UMCG
Groningen, Netherlands
NL-Leiden-LUMC
Leiden, Netherlands
NL-Maastricht-MUMC
Maastricht, Netherlands
NL-Nieuwegein-ANTONIUS
Nieuwegein, Netherlands
NL-Rotterdam-ERASMUSMC
Rotterdam, Netherlands
NL-Den Haag-HAGA
The Hague, Netherlands
NL-Utrecht-UMCUTRECHT
Utrecht, Netherlands
NL-Zwolle-ISALA
Zwolle, Netherlands