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

ConditionCD20-positive Acute Lymphoblastic Leukemia
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Obinutuzumab

    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

    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.)

Treatment groups

124 Participants
are divided into 2 treatment groups
Group A: ObinutuzumabExperimental treatment 1 intervention
Group B: RituximabActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of patients achieving complete remission with Minimal Residual Disease level <0.1% of bone marrow cells after one course of induction treatment.

Time frame
assessed between days 33-34 since start of Induction I

Secondary outcomes

1

The proportion of patients achieving complete remission with Minimal Residual Disease level <0.01% of bone marrow cells after consolidation.

Time frame
assessed between days 20-28 since start of last course of consolidation
2

complete remission rate after Induction I

Time frame
assessed between days 33-34 since start of Induction I
3

Overall complete remission

Time frame
in 24month follow up
4

Probability of overall survival

Time frame
in 24 month follow up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Maria Sklodowska-Curie National Research Institute of Oncology

Lead sponsor

KCRI

Collaborator

Source ClinicalTrials.gov
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