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

Maria Sklodowska-Curie National Research Institute of Oncology

Status and phase: Enrolling; Phase 2

Conditions: CD20-positive Acute Lymphoblastic Leukemia

Treatments: Drug: Obinutuzumab; Drug: Rituximab

Study type: Interventional

Funder types: Other

Identifiers

NCT04920968

20-NIO-0002

Details and patient eligibility

About

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).

Enrollment: 124 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).
5. Active infection e.g. hepatitis B virus, hepatitis C virus, human immunodeficiency virus
6. 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.
7. 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
8. Intolerance to treatment with monoclonal antibody.
9. Positive pregnancy test (beta human chorionic gonadotropin) for women of childbearing age.
10. Inability to obtain written informed consent.
11. Inability to comply with regular monitoring.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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124 participants in 2 patient groups

Obinutuzumab

Experimental group

Description:

Patients in reference arm (Arm A) will receive rituximab. Patients in experimental arm (Arm B) will receive obinutuzumab instead of rituximab in the same time-points.

Treatment:

Drug: Obinutuzumab

Rituximab

Active Comparator group

Description:

Patients in reference arm (Arm A) will receive rituximab. Patients in experimental arm (Arm B) will receive obinutuzumab instead of rituximab in the same time-points.

Treatment:

Drug: Rituximab