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

Phase 2

Active, not recruiting

Conditions: Precursor B-acute lymphoblastic leukemia

Registration Number: 2024-511050-44-00

Lead Sponsor: Hemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting

Brief Summary: To assess the proportion of patients that achieve MRD negative response after the first consolidation phase including blinatumomab

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing, recruitment ended

Sex: Not specified

Target Recruitment: 71

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

Exclusion Criteria

Mature B-cell leukemia/lymphoma, B-lymphoblastic lymphoma, isolated extramedullary 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: - Basal or squamous cell carcinoma of the skin, - Carcinoma in situ of the cervix, - Carcinoma in situ of the breast, - 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

Clinically overt central nervous system 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

Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease)

Severe pulmonary dysfunction (CTCAE grade III-IV)

Severe neurological or psychiatric disease

Active, uncontrolled infection

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of MRD negative response by PCR/FCM after the first blinatumomab consolidation course. MRD negative response is defined as MRD <10^-4 by PCR or FCM		Proportion of MRD negative response by PCR/FCM after the first blinatumomab consolidation course. MRD negative response is defined as MRD <10^-4 by PCR or FCM

Secondary Outcome Measures

Name	Time	Method
MRD level following induction chemotherapy		MRD level following induction chemotherapy
MRD level after second blinatumomab consolidation		MRD level after second blinatumomab consolidation
Hematological response after induction, blinatumomab consolidation I and blinatumomab consolidation II		Hematological response after induction, blinatumomab consolidation I and blinatumomab consolidation II
Event-free survival, i.e. time from registration until no CR on protocol, 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.		Event-free survival, i.e. time from registration until no CR on protocol, 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.		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.		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		Adverse events
RFS and OS from start allogeneic transplantation and from start maintenance RFS, whichever is applicable		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		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)		Comparison of the results of molecular and flowcytometric MRD measurements at the same timepoints (sidestudy)

Trial Locations

Locations (14): Algemeen Ziekenhuis Delta
🇧🇪
Roeselare, Belgium
Ziekenhuis Aan De Stroom
🇧🇪
Antwerp, Belgium
Az St-Jan Brugge-Oostende A.V.
🇧🇪
Brugge, Belgium
Antwerp University Hospital
🇧🇪
Edegem, Belgium
Universitair Ziekenhuis Gent
🇧🇪
Gent, Belgium
Universitair Medisch Centrum Utrecht
🇳🇱
Utrecht, Netherlands
Universitair Medisch Centrum Groningen
🇳🇱
Groningen, Netherlands
Amsterdam UMC Stichting
🇳🇱
Amsterdam, Netherlands
Leids Universitair Medisch Centrum (LUMC)
🇳🇱
Leiden, Netherlands
Meander Medisch Centrum
🇳🇱
Amersfoort, Netherlands
Scroll for more (4 remaining)
Algemeen Ziekenhuis Delta
🇧🇪Roeselare, Belgium
D. Deeren
Site contact
+31107041560
hovon@erasmusmc.nl

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