Blinatumomab added to prephase and consolidation therapy in precursor B-acute lymphoblastic leukemia in adults. A phase II trial.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000766-30-NL

Enrollment

Registered

2017-12-14

Start date

2018-03-09

Completion date

Unknown

Last updated

2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Precursor B-acute lymphoblastic leukemia MedDRA version: 21.0 Level: LLT Classification code 10000845 Term: Acute lymphoblastic leukemia System Organ Class: 100000004864

Interventions

Trade Name: Blincyto Product Name: blinatumomab Pharmaceutical Form: Powder for concentrate and solution for solution for infusion INN or Proposed INN: blinatumomab CAS Number: 853426-35-4 Other descr

Eligibility

Sex/Gender

All

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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 11

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 (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; -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 < 30% risk of relapse within one year. However, patients with the following history/concurrent conditions are allowed: o Basal or squamous cell carcinoma of the skin o Carcinoma in situ of the cervix o Carcinoma in situ of the breast o Incidental histologic finding of prostate 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; -Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the proportion of patients that achieve MRD negative response by PCR/FCM after the first blinatumomab consolidation course. MRD negative response is defined as MRD <10-4;Secondary Objective: -To assess the 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 -To evaluate event-free survival (EFS) -To evaluate relapse-free survival (RFS) -To evaluate overall survival (OS) -To document safety and toxicity of adding blinatumomab to standard prophase and consolidation therapy (two times) in adult ALL -To assess clinical outcome of patients receiving maintenance or allogeneic SCT -To assess kinetics of T-cells and B-cells and their various subsets during treatment and assess their predictive value as regard to molecular response -To compare the results of molecular and flowcytometric MRD measurements at the same timepoints;Primary end point(s): -Proportion of MRD negative response by PCR/FCM after the first blinatumomab consolidation course. MRD negative response is defined as MRD <10^-4;Timepoint(s) of evaluation of this end point: This endpoint will be evaluated when the needed data is available for all patients.	—

Measure

Time frame

Main Objective: To assess the proportion of patients that achieve MRD negative response by PCR/FCM after the first blinatumomab consolidation course. MRD negative response is defined as MRD <10-4;Secondary Objective: -To assess the 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 -To evaluate event-free survival (EFS) -To evaluate relapse-free survival (RFS) -To evaluate overall survival (OS) -To document safety and toxicity of adding blinatumomab to standard prophase and consolidation therapy (two times) in adult ALL -To assess clinical outcome of patients receiving maintenance or allogeneic SCT -To assess kinetics of T-cells and B-cells and their various subsets during treatment and assess their predictive value as regard to molecular response -To compare the results of molecular and flowcytometric MRD measurements at the same timepoints;Primary end point(s): -Proportion of MRD negative response by PCR/FCM after the first blinatumomab consolidation course. MRD negative response is defined as MRD <10^-4;Timepoint(s) of evaluation of this end point: This endpoint will be evaluated when the needed data is available for all patients.

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Secondary

Measure	Time frame
Secondary end point(s): -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);Timepoint(s) of evaluation of this end point: These endpoints will be evaluated when the relevant data for all patients are available.	—

Measure

Time frame

Secondary end point(s): -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);Timepoint(s) of evaluation of this end point: These endpoints will be evaluated when the relevant data for all patients are available.

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Countries

Belgium, Netherlands

Contacts

Public ContactHOVON Data Center

HOVON

hdc@erasmusmc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026