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Recruiting NCT04920968

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

Phase II Interventional CD20-positive Acute Lymphoblastic Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Obinutuzumab, Rituximab.
Who it may be relevant to
Registry conditions: CD20-positive Acute Lymphoblastic Leukemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • Drug 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).
  • Drug 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.)

Primary outcome measures

  • Proportion of patients achieving complete remission with Minimal Residual Disease level <0.1% of bone marrow cells after one course of induction treatment. [Time frame: assessed between days 33-34 since start of Induction I]
Secondary outcome measures (8)
  • The proportion of patients achieving complete remission with Minimal Residual Disease level <0.01% of bone marrow cells after consolidation. [Time frame: assessed between days 20-28 since start of last course of consolidation]
  • complete remission rate after Induction I [Time frame: assessed between days 33-34 since start of Induction I]
  • Overall complete remission [Time frame: in 24month follow up]
  • Probability of overall survival [Time frame: in 24 month follow up]
  • Probability of relapse-free survival [Time frame: in 24 month follow up]
  • Probability of event-free survival [Time frame: in 24 month follow up]
  • Cumulative incidence of relapse [Time frame: in 24 month follow up]
  • Rate of adverse events [Time frame: in 24 month follow up]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Poland · 19 centers
  • 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
  • … and 11 more centers

Identifiers

NCT: NCT04920968 · 20-NIO-0002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗