Clinical trial NCT04920968: Obinutuzumab Versus Rituximab for Acute Lymphoblastic Leukemia/PALG ALL7 "OVERALL"
Official title: Efficacy and Safety of Obinutuzumab Versus Rituximab in Combination With Chemotherapy for Adult Patients With Newly Diagnosed CD20-positive Acute Lymphoblastic Leukemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: CD20-positive Acute Lymphoblastic Leukemia
Lead sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
Sponsor class: OTHER
Collaborators: name: KCRI
First posted: 2021-06-10
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients achieving complete remission with Minimal Residual Disease level <0.1% of bone marrow cells after one course of induction treatment.
timeFrame: assessed between days 33-34 since start of Induction I
Secondary outcomes:
measure: The proportion of patients achieving complete remission with Minimal Residual Disease level <0.01% of bone marrow cells after consolidation.
timeFrame: assessed between days 20-28 since start of last course of consolidation
measure: complete remission rate after Induction I
timeFrame: assessed between days 33-34 since start of Induction I
measure: Overall complete remission
timeFrame: in 24month follow up
measure: Probability of overall survival
timeFrame: in 24 month follow up
measure: Probability of relapse-free survival
timeFrame: in 24 month follow up
measure: Probability of event-free survival
timeFrame: in 24 month follow up
measure: Cumulative incidence of relapse
timeFrame: in 24 month follow up
measure: Rate of adverse events
timeFrame: in 24 month follow up
Other outcomes:
Locations:
city: Białystok
country: Poland
facility: Klinika Hematologii z Pododziałem Chorób Naczyń Uniwersyteckiego
city: Brzozów
country: Poland
facility: Oddział Hematologii Onkologicznej Podkarpacki Ośrodek Onkologiczny
city: Gliwice
country: Poland
facility: Klinika Transplantacji Szpiku i Onkohematologii Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy, Oddział w Gliwicach
city: Katowice
country: Poland
facility: Klinika Hematologii i Transplantacji Szpiku, Samodzielny Publiczny Szpital Kliniczny
city: Kielce
country: Poland
facility: Klinika Hematologii i Transplantacji Szpiku, Świętokrzyskie Centrum Onkologii
city: Kraków
country: Poland
facility: Oddział Hematologii i Chorób Wewnętrznych z Pododdziałem Dziennym Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o.
city: Legnica
country: Poland
facility: Oddział Hematologiczny Wojewódzkiego Szpitala Specjalistycznego w Legnicy
city: Lublin
country: Poland
facility: Klinika Hematoonkologii I Transplantacji Szpiku, Uniwersytet Medyczny w Lublinie
city: Lublin
country: Poland
facility: Oddział Hematologii i Transplantacji Szpiku Centrum Onkologii Ziemi Lubelskiej im. Św. Jana z Dukli w Lublinie
city: Olsztyn
country: Poland
facility: Oddział Kliniczny Hematologii Samodzielnego Publicznego Zakładu Opieki Zdrowotnej MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie
city: Poznań
country: Poland
facility: Klinika Hematologii i Chorób Rozrostowych Układu Krwiotwórczego Uniwersytetu Medycznego w Poznaniu
city: Szczecin
country: Poland
facility: Klinika Hematologii Pomorskiego Uniwersytetu Medycznego
city: Toruń
country: Poland
facility: Oddział Hematologii, Specjalistyczny Szpital Miejski
city: Warszawa
country: Poland
facility: Klinika Chorób Wewnętrznych i Hematologii Wojskowy Instytut Medyczny
city: Warszawa
country: Poland
facility: Klinika Hematologii, Instytut Hematologii i Transfuzjologii
city: Warszawa
country: Poland
facility: Klinika Hematologii, Onkologii i Chorób Wewnętrznych Warszawskiego Uniwersytetu Medycznego
city: Wrocław
country: Poland
facility: Katedra i Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku
city: Wrocław
country: Poland
facility: Oddział Hematologiczny Z Oddziałem Nowotworów Krwi Dolnośląskie Centrum Transplantacji Komórkowych Z Krajowym Bankiem Dawców Szpiku
city: Łódź
country: Poland
facility: Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi
Study officials:
References: