Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-24 @ 6:28 PM
NCT ID:
NCT04920968
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥18 years.
2. Newly diagnosed Acute lymphoblastic leukemia with CD20 expression on at least 20% of blasts.
3. Signed written informed consent.
4. Adequate contraception in case of women with child-bearing potential
Exclusion Criteria:
1. Lymphoblastic lymphoma with bone marrow blasts\<20%.
2. Patients with a history of chronic myeloid leukemia or other myeloproliferative disease.
3. Major surgery within 4 weeks before enrollment.
4. Impaired cardiac function: ejection fraction \<40% on echocardiography, QTc interval \> 450 ms on baseline electrocardiogram. Myocardial infarction within 6 months prior to starting study; other clinically significant heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension, uncontrolled arrhythmias).
5. Active infection e.g. hepatitis B virus, hepatitis C virus, human immunodeficiency virus
6. Other concurrent severe and/or uncontrolled medical conditions: patients with another primary malignant disease, except those that do not currently require treatment; acute or chronic liver, pancreatic or severe renal disease; another severe and/or life-threatening medical disease.
7. Serum creatinine \> 2 times the upper normal limit of the laboratory, total bilirubin\> 2.5 upper normal limit unless related to Acute lymphoblastic leukemia, aspartate aminotransferase or alanine aminotransferase \> 5 upper normal limit, unless related to Acute lymphoblastic leukemia
8. Intolerance to treatment with monoclonal antibody.
9. Positive pregnancy test (beta human chorionic gonadotropin) for women of childbearing age.
10. Inability to obtain written informed consent.
11. Inability to comply with regular monitoring.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04920968
Study Brief:
Protocol Section:
NCT04920968