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

Официальное название

Efficacy and Safety of Obinutuzumab Versus Rituximab in Combination With Chemotherapy for Adult Patients With Newly Diagnosed CD20-positive Acute Lymphoblastic Leukemia

Обзор

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).

Вмешательства

• Препарат Obinutuzumab
  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).
• Препарат Rituximab
  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.)

Первичные конечные точки

• Proportion of patients achieving complete remission with Minimal Residual Disease level <0.1% of bone marrow cells after one course of induction treatment. [Срок оценки: assessed between days 33-34 since start of Induction I]

Вторичные конечные точки (8)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Польша · 19 центров

• Klinika Hematologii z Pododziałem Chorób Naczyń Uniwersyteckiego — Bialystok
• Oddział Hematologii Onkologicznej Podkarpacki Ośrodek Onkologiczny — Brzozów
• Klinika Transplantacji Szpiku i Onkohematologii Narodowy Instytut Onkologii im. Marii Skło — Gliwice
• Klinika Hematologii i Transplantacji Szpiku, Samodzielny Publiczny Szpital Kliniczny — Katowice
• Klinika Hematologii i Transplantacji Szpiku, Świętokrzyskie Centrum Onkologii — Kielce
• Oddział Hematologii i Chorób Wewnętrznych z Pododdziałem Dziennym Szpital Specjalistyczny — Krakow
• Oddział Hematologiczny Wojewódzkiego Szpitala Specjalistycznego w Legnicy — Legnica
• Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodz — Lodz
• … и ещё 11 центров

Идентификаторы

NCT: NCT04920968 · 20-NIO-0002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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