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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-05

Study Completion Date

2025-12-31

Brief Summary

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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).

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Detailed Description

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Conditions

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CD20-positive Acute Lymphoblastic Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Obinutuzumab

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.

Group Type EXPERIMENTAL

Obinutuzumab

Intervention Type DRUG

Chemotherapy will be conducted according to PALG ALL7 protocol, which is considered a standard of care in Poland. Patients in experimental arm will receive obinutuzumab .Obinutuzumab: 1000 mg i.v. (first infusion divided into 100 mg on d. 1 and 900 mg on d. 2).

Rituximab

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.

Group Type ACTIVE_COMPARATOR

Rituximab

Intervention Type DRUG

Chemotherapy will be conducted according to PALG ALL7 protocol, which is considered a standard of care in Poland.The protocol includes the use of rituximab in combination chemotherapy. Rituximab: 375 mg/m2 intravenously (i.v.)

Interventions

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Obinutuzumab

Chemotherapy will be conducted according to PALG ALL7 protocol, which is considered a standard of care in Poland. Patients in experimental arm will receive obinutuzumab .Obinutuzumab: 1000 mg i.v. (first infusion divided into 100 mg on d. 1 and 900 mg on d. 2).

Intervention Type DRUG

Rituximab

Chemotherapy will be conducted according to PALG ALL7 protocol, which is considered a standard of care in Poland.The protocol includes the use of rituximab in combination chemotherapy. Rituximab: 375 mg/m2 intravenously (i.v.)

Intervention Type DRUG

Other Intervention Names

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Activ comparator

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No