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ACTIVE NOT RECRUITING
NCT03541083
PHASE2

Blinatumomab Added to Prephase and Consolidation Therapy in Precursor B-acute Lymphoblastic Leukemia in Adults.

Sponsor: Stichting Hemato-Oncologie voor Volwassenen Nederland

View on ClinicalTrials.gov

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

DRUG

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