Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

8mo left

Started Jun 2018

Longer than P75 for phase_2

Geographic Reach

2 countries

18 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

8.5 years study duration

Study Progress93%

Jun 2018Dec 2026

First Submitted

Initial submission to the registry

March 20, 2018

Completed

2 months until next milestone

First Posted

Study publicly available on registry

May 30, 2018

Completed

5 days until next milestone

Study Start

First participant enrolled

June 4, 2018

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed

6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Expected

Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

2.5 years

First QC Date

March 20, 2018

Last Update Submit

September 17, 2024

Conditions

ALL, Adult

Outcome Measures

Primary Outcomes (1)

The proportion of patients that achieve MRD ( minimal residual disease) negative response, measured by Polymerase Chain Reaction (PCR), after the first blinatumomab consolidation course. MRD negative response is defined as MRD <10-4
1 year after closure of study

Secondary Outcomes (7)

Complete and molecular response rate following induction and after blinatumomab consolidation ll by the addition of i.v. blinatumomab to standard prophase, consolidation and intensification therapy
1 year after closure of study
Event-free survival (EFS)
1 year after closure of study
Relapse-free survival (RFS)
1 year after closure of study
Overall survival (OS)
1 year after closure of study
Adverse events; assessing the safety and toxicity of adding blinatumomab to standard prophase and consolidation therapy (two times) in adult ALL
1 year after closure of study
+2 more secondary outcomes

Study Arms (1)

Blinatumomab

EXPERIMENTAL

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 therapy with 4 cycles of chemotherapy and two 4-week courses of blinatumomab will follow, and subsequently depending on risk group, eligibility and a suitable donor either allogeneic stem cell transplantation or 2 year maintenance treatment.

Drug: Blinatumomab

Interventions

BlinatumomabDRUG

prephase and consolidation (I and II)

Also known as: Blincyto

Blinatumomab

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Primary CD19 (cluster of differentiation antigen 19) positive precursor B-ALL (excluding mature B-cell ALL and B-lymphoblastic lymphoma, but including Philadelphia positive/BCR-ABL (Abelson murine leukemia viral oncogene homolog 1) positive ALL) and CD19 positive mixed phenotype acute lymphoblastic leukemia (MPAL);
Patients aged 18 to 70 years inclusive;
WHO ( World Health Organization) performance status 0-2;
Written informed consent;
Patient is capable of giving informed consent.

You may not qualify if:

Mature B-cell leukemia/lymphoma, B-lymphoblastic lymphoma, isolated extramedullary disease;
CML (Chronic myeloid leukemia) 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 (Upper Limit of Normal) despite steroid pre-treatment (see also 8.1.3.)
Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease);
Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix D);
Severe neurological or psychiatric disease;
Active, uncontrolled infection;
Clinically overt central nervous system disease;
History of active malignancy during the past 5 years with the exception of basal cell carcinoma of the skin or stage 0 cervical carcinoma;
Patient known to be HIV-positive;
Pregnant or breast-feeding female patients;
Unwilling or not capable to use effective means of birth control (all men, all premenopausal women under the age of 50 need contraception for two years after the last period, and women older than 50 years for at least one year);
Current participation in another clinical trial;
+1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Stichting Hemato-Oncologie voor Volwassenen Nederlandlead

Study Sites (18)

BE-Antwerpen Edegem-UZA

Antwerp, Belgium

Location

BE-Antwerpen-ZNASTUIVENBERG

Antwerp, Belgium

Location

BE-Brugge-AZBRUGGE

Bruges, Belgium

Location

BE-Gent-UZGENT

Ghent, Belgium

Location

BE-Leuven-UZLEUVEN

Leuven, Belgium

Location

BE-Roeselare-AZDELTA

Roeselare, Belgium

Location

NL-Amersfoort-MEANDERMC

Amersfoort, Netherlands

Location

NL-Amsterdam-AMC

Amsterdam, Netherlands

Location

NL-Amsterdam-VUMC

Amsterdam, Netherlands

Location

NL-Enschede-MST

Enschede, Netherlands

Location

NL-Groningen-UMCG

Groningen, Netherlands

Location

NL-Leiden-LUMC

Leiden, Netherlands

Location

NL-Maastricht-MUMC

Maastricht, Netherlands

Location

NL-Nieuwegein-ANTONIUS

Nieuwegein, Netherlands

Location

NL-Rotterdam-ERASMUSMC

Rotterdam, Netherlands

Location

NL-Den Haag-HAGA

The Hague, Netherlands

Location

NL-Utrecht-UMCUTRECHT

Utrecht, Netherlands

Location

NL-Zwolle-ISALA

Zwolle, Netherlands

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

blinatumomab

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

A.W. Rijneveld, Dr.
Erasmus MC, Rotterdam
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 20, 2018

First Posted

May 30, 2018

Study Start

June 4, 2018

Primary Completion

November 30, 2020

Study Completion (Estimated)

December 15, 2026

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing: Will not share

Locations

BE(6)NL(12)

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

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (1)

Blinatumomab

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (18)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (1)

Blinatumomab

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (18)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Locations