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

Phase 2

Recruiting

• Conditions: CD20-positive Acute Lymphoblastic Leukemia
• Interventions: Drug: Rituximab; Drug: Obinutuzumab

• Registration Number: NCT04920968
• Lead Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-25
• Study First Submitted QC: 2021-06-09
• Study First Posted: 2021-06-10
• Study Start: 2021-10-05
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-24
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 124

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rituximab	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.
Obinutuzumab	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.

Primary Outcome Measures

Name	Time	Method
Proportion of patients achieving complete remission with Minimal Residual Disease level <0.1% of bone marrow cells after one course of induction treatment.	assessed between days 33-34 since start of Induction I

Secondary Outcome Measures

Name	Time	Method
Probability of relapse-free survival	in 24 month follow up
Probability of event-free survival	in 24 month follow up
Cumulative incidence of relapse	in 24 month follow up
Rate of adverse events	in 24 month follow up
The proportion of patients achieving complete remission with Minimal Residual Disease level <0.01% of bone marrow cells after consolidation.	assessed between days 20-28 since start of last course of consolidation
complete remission rate after Induction I	assessed between days 33-34 since start of Induction I
Overall complete remission	in 24month follow up
Probability of overall survival	in 24 month follow up

Trial Locations

Locations (19)

Oddział Hematologii i Chorób Wewnętrznych z Pododdziałem Dziennym Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o.; 🇵🇱 Kraków, Poland

Oddział Hematologii i Transplantacji Szpiku Centrum Onkologii Ziemi Lubelskiej im. Św. Jana z Dukli w Lublinie; 🇵🇱 Lublin, Poland

Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi; 🇵🇱 Łódź, Poland

Klinika Hematologii z Pododziałem Chorób Naczyń Uniwersyteckiego; 🇵🇱 Białystok, Poland

Oddział Hematologii Onkologicznej Podkarpacki Ośrodek Onkologiczny; 🇵🇱 Brzozów, Poland

Klinika Transplantacji Szpiku i Onkohematologii Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy, Oddział w Gliwicach; 🇵🇱 Gliwice, Poland

Klinika Hematologii i Transplantacji Szpiku, Samodzielny Publiczny Szpital Kliniczny; 🇵🇱 Katowice, Poland

Klinika Hematologii i Transplantacji Szpiku, Świętokrzyskie Centrum Onkologii; 🇵🇱 Kielce, Poland

Oddział Hematologiczny Wojewódzkiego Szpitala Specjalistycznego w Legnicy; 🇵🇱 Legnica, Poland

Klinika Hematoonkologii I Transplantacji Szpiku, Uniwersytet Medyczny w Lublinie; 🇵🇱 Lublin, Poland

Oddział Kliniczny Hematologii Samodzielnego Publicznego Zakładu Opieki Zdrowotnej MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie; 🇵🇱 Olsztyn, Poland

Klinika Hematologii i Chorób Rozrostowych Układu Krwiotwórczego Uniwersytetu Medycznego w Poznaniu; 🇵🇱 Poznań, Poland

Klinika Hematologii Pomorskiego Uniwersytetu Medycznego; 🇵🇱 Szczecin, Poland

Oddział Hematologii, Specjalistyczny Szpital Miejski; 🇵🇱 Toruń, Poland

Klinika Chorób Wewnętrznych i Hematologii Wojskowy Instytut Medyczny; 🇵🇱 Warszawa, Poland

Klinika Hematologii, Instytut Hematologii i Transfuzjologii; 🇵🇱 Warszawa, Poland

Klinika Hematologii, Onkologii i Chorób Wewnętrznych Warszawskiego Uniwersytetu Medycznego; 🇵🇱 Warszawa, Poland

Katedra i Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku; 🇵🇱 Wrocław, Poland

Oddział Hematologiczny Z Oddziałem Nowotworów Krwi Dolnośląskie Centrum Transplantacji Komórkowych Z Krajowym Bankiem Dawców Szpiku; 🇵🇱 Wrocław, Poland