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Comparing obinutuzumab and rituximab for treating acute lymphoblastic leukemia

Efficacy and Safety of Obinutuzumab Versus Rituximab in Combination With Chemotherapy for Adult Patients With Newly Diagnosed CD20-positive Acute Lymphoblastic Leukemia

Phase 2 Interventional Maria Sklodowska-Curie National Research Institute of Oncology · NCT04920968

This study is testing whether obinutuzumab works better than rituximab for treating adults with a type of leukemia called CD20-positive acute lymphoblastic leukemia.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment124 (estimated)
Ages18 Years and up
SexAll
SponsorMaria Sklodowska-Curie National Research Institute of Oncology Academic / other
Drugs / interventionsobinutuzumab, rituximab
Locations19 sites (Bialystok and 18 other locations)
Trial IDNCT04920968 on ClinicalTrials.gov

What this trial studies

This clinical trial is a multicenter, prospective, randomized, and controlled study designed to compare the efficacy and safety of two monoclonal antibodies, obinutuzumab and rituximab, in adult patients diagnosed with CD20-positive acute lymphoblastic leukemia (ALL). The study will enroll 124 patients, with 62 participants receiving each treatment. The primary focus is to evaluate how well these treatments work in managing the disease and their safety profiles. Participants must meet specific eligibility criteria, including age and disease characteristics.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 years and older who have newly diagnosed acute lymphoblastic leukemia with at least 20% CD20 expression on their blasts.

Not a fit: Patients with lymphoblastic lymphoma, significant cardiac issues, or active infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with CD20-positive acute lymphoblastic leukemia.

How similar studies have performed: Other studies have shown promise in using monoclonal antibodies for treating similar conditions, but this specific comparison is novel.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Bialystok and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions CD20-positive Acute Lymphoblastic Leukemia
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.