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Efficacy and safety of obinutuzumab versus rituximab in combination with chemotherapy for adult patients with newly diagnosed CD20-positive acute lymphoblastic leukemia

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517389-40-00
Acronym
PALG ALL7 “OVERALL"
Enrollment
124
Registered
2024-10-07
Start date
2021-10-06
Completion date
Unknown
Last updated
2025-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute lymphoblastic leukemia

Brief summary

The proportion of patients achieving complete remission (CR) with MRD level <0.1% of bone marrow cells after one course of induction treatment

Detailed description

The proportion of patients achieving CR with MRD level <0.01% of bone marrow cells after consolidation., CR rate after Induction I., Overall CR rate in 24 month follow-up., Probability of overall survival (OS) in 24 month follow-up, Probability of relapse-free survival (RFS) in 24 month follow-up, Probability of event-free survival (EFS) in 24 month follow-up, Cumulative incidence of relapse in 24 month follow-up, Rate of adverse events in 24 month follow-up.

Interventions

DRUGOBINUTUZUMAB
DRUGRITUXIMAB

Sponsors

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The proportion of patients achieving complete remission (CR) with MRD level <0.1% of bone marrow cells after one course of induction treatment

Secondary

MeasureTime frame
The proportion of patients achieving CR with MRD level <0.01% of bone marrow cells after consolidation., CR rate after Induction I., Overall CR rate in 24 month follow-up., Probability of overall survival (OS) in 24 month follow-up, Probability of relapse-free survival (RFS) in 24 month follow-up, Probability of event-free survival (EFS) in 24 month follow-up, Cumulative incidence of relapse in 24 month follow-up, Rate of adverse events in 24 month follow-up.

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026