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NCT Number: NCT04920968

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

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).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Klinika Hematologii z Pododziałem Chorób Naczyń Uniwersyteckiego, Bialystok, Poland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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.)

Other names: Activ comparator

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.

    Time frame: assessed between days 33-34 since start of Induction I

Secondary outcomes

  1. 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

  2. complete remission rate after Induction I

    Time frame: assessed between days 33-34 since start of Induction I

  3. Overall complete remission

    Time frame: in 24month follow up

  4. Probability of overall survival

    Time frame: in 24 month follow up

  5. Probability of relapse-free survival

    Time frame: in 24 month follow up

  6. Probability of event-free survival

    Time frame: in 24 month follow up

  7. Cumulative incidence of relapse

    Time frame: in 24 month follow up

  8. Rate of adverse events

    Time frame: in 24 month follow up

Study contacts

Contact information is provided by the study sponsor or research team.

Sebastian Giebel, prof. dr n.med.

CONTACT

[email protected]

32 278 85 23

Sponsors and collaborators

Lead sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Other

Collaborators

  • KCRI

Registry information

Official study title

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

Acronym: OVERALL

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jun 10, 2021
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.