Obinutuzumab Versus Rituximab for Acute Lymphoblastic Leukemia/PALG ALL7 "OVERALL" (NCT04920968) | Clinical Trial Compass
RecruitingPhase 2
Obinutuzumab Versus Rituximab for Acute Lymphoblastic Leukemia/PALG ALL7 "OVERALL"
Poland124 participantsStarted 2021-10-05
Plain-language 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
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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
What they're measuring
1
Proportion of patients achieving complete remission with Minimal Residual Disease level <0.1% of bone marrow cells after one course of induction treatment.
Timeframe: assessed between days 33-34 since start of Induction I
Trial details
NCT IDNCT04920968
SponsorMaria Sklodowska-Curie National Research Institute of Oncology