Efficacy and safety of obinutuzumab versus rituximab in combination with chemotherapy for adult patients with newly diagnosed CD20-positive acute lymphoblastic leukemia
Key facts
- Where
- Bialystok, Brzozów, Cracow, Gliwice, Katowice, Kielce, Legnica, Lodz, Lublin, Olsztyn, Poznan, Szczecin, Torun, Warsaw és Wroclaw, LengyelországSee the 19 sites
- Phase
- 2. fázis
Where in Lengyelország
- Uniwersytecki Szpital Kliniczny w BialymstokuBialystok, LengyelországNo longer taking part
- Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.MarkiewiczaBrzozów, LengyelországNo longer taking part
- Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.Cracow, LengyelországNo longer taking part
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut BadawczyGliwice, LengyelországNo longer taking part
- Samodzielny Publiczny Szpital Kliniczny Im.Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego W KatowicachKatowice, LengyelországNo longer taking part
- Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w KielcachKielce, LengyelországNo longer taking part
- Wojewodzki Szpital Specjalistyczny w LegnicyLegnica, LengyelországNo longer taking part
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w LodziLodz, LengyelországNo longer taking part
- Centrum Onkologii Ziemi Lubelskiej im sw Jana z DukliLublin, LengyelországNo longer taking part
- Uniwersytecki Szpital Kliniczny Nr 1 w LublinieLublin, LengyelországNo longer taking part
- Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji z Warmińsko - Mazurskim Centrum Onkologii w OlsztynieOlsztyn, LengyelországNo longer taking part
- Uniwersytecki Szpital Kliniczny w PoznaniuPoznan, LengyelországNo longer taking part
- Uniwersytecki Szpital Kliniczny Nr 1 Im. Prof. Tadeusza Sokolowskiego Pum W SzczecinieSzczecin, LengyelországNo longer taking part
- Wojewodzki Szpital Zespolony im. L. Rydygiera w ToruniuTorun, LengyelországNo longer taking part
- Instytut Hematologii I TransfuzjologiiWarsaw, LengyelországNo longer taking part
- Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu MedycznegoWarsaw, LengyelországNo longer taking part
- Wojskowy Instytut Medyczny Panstwowy Instytut BadawczyWarsaw, LengyelországNo longer taking part
- Dolnośląskie Centrum Onkologii, Pulmonologii i HematologiiWroclaw, LengyelországNo longer taking part
- Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we WroclawiuWroclaw, LengyelországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Trial code
- EU 2024-517389-40-00
- Record updated
- 2025. november 4.
- Original description
To compare efficacy of obinutuzumab and rituximab in adult patients with newly diagnosed CD20-positive ALL. The efficacy for this purpose is defined as the proportion of patients achieving complete remission (CR) with MRD level <0.1% of bone marrow cells after one course of induction treatmentRead full original descriptionShow less
To compare efficacy of obinutuzumab and rituximab in adult patients with newly diagnosed CD20-positive ALL. The efficacy for this purpose is defined as the proportion of patients achieving complete remission (CR) with MRD level <0.1% of bone marrow cells after one course of induction treatment
Inclusion: Age ≥18 years; Newly diagnosed ALL with CD20 expression on at least 20% of blasts; Signed written informed consent; Adequate contraception in case of women with child-bearing potential.
Exclusion: Major surgery within 4 weeks before enrollment; 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; Intolerance to treatment with monoclonal antibody; Patients with a history of chronic myeloid leukemia or other myeloproliferative disease; Active infection e.g. HBV, HCV, HIV; Impaired cardiac function: ejection fraction <40% on echocardiography, QTc interval >450 ms on baseline ECG. 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); Serum creatinine >2 times the upper normal limit (UNL) of the laboratory, total bilirubin> 2.5 UNL unless related to ALL, AST or ALT >5 UNL, unless related to ALL; Positive pregnancy test (β-HCG) for women of childbearing age; Lymphoblastic lymphoma with bone marrow blasts <20%; Inability to obtain written informed consent; Inability to comply with regular monitoring.