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Blinatumomab added to prephase and consolidation therapy in precursor B-acute lymphoblastic leukemia in adults.
EU CTIS ID: 2024-511050-44-00
What this study is testing
To assess the proportion of patients that achieve MRD negative response after the first consolidation phase including blinatumomab
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.