Obinutuzumab Versus Rituximab for Acute Lymphoblastic Leukemia/PALG ALL7 "OVERALL"
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMaria Sklodowska-Curie National Research Institute of Oncology
About this trial
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).
Eligibility criteria
Qualifiers
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
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Obinutuzumab
- Rituximab
Treatment groups
124 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov