Recruiting Phase 2

Obinutuzumab Versus Rituximab for Acute Lymphoblastic Leukemia/PALG ALL7 "OVERALL"

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About this study

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 (62 in each study group).

Condition: CD20-positive Acute Lymphoblastic Leukemia
Tested: Obinutuzumab, Rituximab
Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology

Who can join

Age: 18 years and older
Sex: All sexes
Healthy volunteers: Not accepted

Inclusion 6

Minimum age: 18 years
Study condition: CD20-positive Acute Lymphoblastic Leukemia
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 12

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.

Where

19 sites, 19 recruiting

Klinika Hematologii z Pododziałem Chorób Naczyń Uniwersyteckiego

Bialystok, Poland

Recruiting

Oddział Hematologii Onkologicznej Podkarpacki Ośrodek Onkologiczny

Brzozów, Poland

Recruiting

Klinika Transplantacji Szpiku i Onkohematologii Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy, Oddział w Gliwicach

Gliwice, Poland

Recruiting

Klinika Hematologii i Transplantacji Szpiku, Samodzielny Publiczny Szpital Kliniczny

Katowice, Poland

Recruiting

Klinika Hematologii i Transplantacji Szpiku, Świętokrzyskie Centrum Onkologii

Kielce, Poland

Recruiting

Oddział Hematologii i Chorób Wewnętrznych z Pododdziałem Dziennym Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o.

Krakow, Poland

Recruiting

and 13 more sites on ClinicalTrials.gov

Contact

Sebastian Giebel, prof. dr n.med.

32 278 85 23 Sebastian.Giebel@io.gliwice.pl

Potential match only. Final eligibility is determined by the study team.