Status:
RECRUITING
Obinutuzumab Versus Rituximab for Acute Lymphoblastic Leukemia/PALG ALL7 "OVERALL"
Lead Sponsor:
Maria Sklodowska-Curie National Research Institute of Oncology
Collaborating Sponsors:
KCRI
Conditions:
CD20-positive Acute Lymphoblastic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A multicenter, prospective, randomized and controlled study to compare the efficacy and safety of obinutuzumab and rituximab in adult ALL patients with CD20 expression.Study population is 124 patients...
Eligibility Criteria
Inclusion
- Age ≥18 years.
- Newly diagnosed Acute lymphoblastic leukemia with CD20 expression on at least 20% of blasts.
- Signed written informed consent.
- Adequate contraception in case of women with child-bearing potential
Exclusion
- Lymphoblastic lymphoma with bone marrow blasts\<20%.
- Patients with a history of chronic myeloid leukemia or other myeloproliferative disease.
- Major surgery within 4 weeks before enrollment.
- 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).
- Active infection e.g. hepatitis B virus, hepatitis C virus, human immunodeficiency virus
- 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.
- 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
- Intolerance to treatment with monoclonal antibody.
- Positive pregnancy test (beta human chorionic gonadotropin) for women of childbearing age.
- Inability to obtain written informed consent.
- Inability to comply with regular monitoring.
Key Trial Info
Start Date :
October 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT04920968
Start Date
October 5 2021
End Date
December 31 2025
Last Update
April 24 2025
Active Locations (19)
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1
Klinika Hematologii z Pododziałem Chorób Naczyń Uniwersyteckiego
Bialystok, Poland
2
Oddział Hematologii Onkologicznej Podkarpacki Ośrodek Onkologiczny
Brzozów, Poland
3
Klinika Transplantacji Szpiku i Onkohematologii Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy, Oddział w Gliwicach
Gliwice, Poland
4
Klinika Hematologii i Transplantacji Szpiku, Samodzielny Publiczny Szpital Kliniczny
Katowice, Poland