Obinutuzumab Versus Rituximab for Acute Lymphoblastic Leukemia/PALG ALL7 "OVERALL"
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(s) | CD20-positive Acute Lymphoblastic Leukemia |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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 (62 in each study group). |
| Who can participate | 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). |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Maria Sklodowska-Curie National Research Institute of Oncology |
| Locations | Bialystok, Poland; Brzozów, Poland; Gliwice, Poland; Katowice, Poland; Kielce, Poland; Krakow, Poland (+13 more sites) |
| Start date | 2021-10-05 |
| NCT ID | NCT04920968 |
| Official listing | https://clinicaltrials.gov/study/NCT04920968 |