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

NCT04920968 | Recruiting Phase 2 DMC

• 1 other identifier: 20-NIO-0002
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 19

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).

Conditions

CD20-positive Acute Lymphoblastic Leukemia

Outcome Measures

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.

  assessed between days 33-34 since start of Induction I

Secondary Outcomes (8)

• 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

• Probability of relapse-free survival

  in 24 month follow up

Study Arms (2)

Obinutuzumab

EXPERIMENTAL

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.

Drug: Obinutuzumab

Rituximab

ACTIVE COMPARATOR

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.

Drug: Rituximab

Interventions

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).

Obinutuzumab

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.)

Also known as: Activ comparator

Rituximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Maria Sklodowska-Curie National Research Institute of Oncology: lead
• KCRI: collaborator

Study Sites (19)

Klinika Hematologii z Pododziałem Chorób Naczyń Uniwersyteckiego

Bialystok, Poland

RECRUITING

Oddział Hematologii Onkologicznej Podkarpacki Ośrodek Onkologiczny

Brzozów, Poland

RECRUITING

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

Gliwice, Poland

RECRUITING

Klinika Hematologii i Transplantacji Szpiku, Samodzielny Publiczny Szpital Kliniczny

Katowice, Poland

RECRUITING

Klinika Hematologii i Transplantacji Szpiku, Świętokrzyskie Centrum Onkologii

Kielce, Poland

RECRUITING

Oddział Hematologii i Chorób Wewnętrznych z Pododdziałem Dziennym Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o.

Krakow, Poland

RECRUITING

Oddział Hematologiczny Wojewódzkiego Szpitala Specjalistycznego w Legnicy

Legnica, Poland

RECRUITING

Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi

Lodz, Poland

RECRUITING

Klinika Hematoonkologii I Transplantacji Szpiku, Uniwersytet Medyczny w Lublinie

Lublin, Poland

RECRUITING

Oddział Hematologii i Transplantacji Szpiku Centrum Onkologii Ziemi Lubelskiej im. Św. Jana z Dukli w Lublinie

Lublin, Poland

RECRUITING

Oddział Kliniczny Hematologii Samodzielnego Publicznego Zakładu Opieki Zdrowotnej MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie

Olsztyn, Poland

RECRUITING

Klinika Hematologii i Chorób Rozrostowych Układu Krwiotwórczego Uniwersytetu Medycznego w Poznaniu

Poznan, Poland

RECRUITING

Klinika Hematologii Pomorskiego Uniwersytetu Medycznego

Szczecin, Poland

RECRUITING

Oddział Hematologii, Specjalistyczny Szpital Miejski

Torun, Poland

RECRUITING

Klinika Chorób Wewnętrznych i Hematologii Wojskowy Instytut Medyczny

Warsaw, Poland

RECRUITING

Klinika Hematologii, Instytut Hematologii i Transfuzjologii

Warsaw, Poland

RECRUITING

Klinika Hematologii, Onkologii i Chorób Wewnętrznych Warszawskiego Uniwersytetu Medycznego

Warsaw, Poland

RECRUITING

Katedra i Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku

Wroclaw, Poland

RECRUITING

Oddział Hematologiczny Z Oddziałem Nowotworów Krwi Dolnośląskie Centrum Transplantacji Komórkowych Z Krajowym Bankiem Dawców Szpiku

Wroclaw, Poland

RECRUITING

MeSH Terms

Interventions

obinutuzumab; Rituximab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Sebastian Giebel, prof. dr n.med.

CONTACT

32 278 85 23; Sebastian.Giebel@io.gliwice.pl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2021
• First Posted: June 10, 2021
• Study Start: October 5, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-04

Locations

PL (19)