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

Phase 2

Recruiting

• Conditions: acute lymphoblastic leukemia; precursor B-acute lymphoblastic leukemia; 10024324

• Registration Number: NL-OMON50553
• Lead Sponsor: HOVO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 65

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;
- 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;
- 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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