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Study on Obinutuzumab and Rituximab with Chemotherapy for Adults with Newly Diagnosed CD20-Positive Acute Lymphoblastic Leukemia

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What is this study about?

This clinical trial is focused on studying a type of blood cancer called acute lymphoblastic leukemia (ALL), specifically in adults who have a newly diagnosed form of this disease that is positive for a marker known as CD20. The study is comparing two treatments: obinutuzumab and rituximab, both of which are given in combination with chemotherapy. These treatments are solutions that are administered through an infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to evaluate how effective these treatments are in helping patients achieve complete remission, which means that signs of cancer are reduced or disappear. The study will monitor patients to see if they reach a state where less than 0.1% of their bone marrow cells show signs of the disease after the initial treatment phase. This is an important measure of success in treating ALL.

Participants in the study will receive one of the two treatments and will be observed over a period of time to assess their response to the treatment. The study will also track the overall health and survival of the participants, as well as any side effects they may experience. The goal is to determine which treatment is more effective and safer for patients with this type of leukemia.

1 joining the study

Participation begins after meeting the inclusion criteria, which include being 18 years or older, having newly diagnosed acute lymphoblastic leukemia (ALL) with CD20 expression on at least 20% of blasts, and providing signed written consent.

Women with child-bearing potential must use adequate contraception.

2 induction treatment

The initial phase involves receiving either obinutuzumab or rituximab in combination with chemotherapy.

Both medications are administered through intravenous use.

The goal is to achieve complete remission (CR) with minimal residual disease (MRD) level of less than 0.1% of bone marrow cells after one course.

3 consolidation treatment

Following successful induction, consolidation treatment aims to further reduce MRD levels to less than 0.01% of bone marrow cells.

This phase continues to use the assigned medication in combination with chemotherapy.

4 follow-up period

A 24-month follow-up period is conducted to monitor overall complete remission rates, survival probabilities, and relapse incidences.

The follow-up also assesses the rate of adverse events experienced during the trial.

Who Can Join the Study?

  • Must be at least 18 years old.
  • Must have been newly diagnosed with acute lymphoblastic leukemia (ALL), which is a type of blood cancer, and have CD20 expression on at least 20% of the cancer cells. CD20 is a protein found on the surface of some blood cells.
  • Must sign a written informed consent form, which means agreeing to participate in the study after being fully informed about it.
  • If a woman can have children, she must use adequate contraception to prevent pregnancy during the study.

Who Cannot Join the Study?

  • Patients who have a different type of cancer other than acute lymphoblastic leukemia (a type of blood cancer).
  • Patients who have already received treatment for their leukemia.
  • Patients who have a serious, uncontrolled medical condition that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a known allergy to the study drugs or similar medications.
  • Patients who are unable to follow the study procedures or attend the required visits.
  • Patients who have participated in another clinical trial recently.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Osrodek Badan Klinicznych Przy Szpitalu Specjalistycznym Im. Ludwika Rydygiera W Krakowie Sp. z o.o. Cracow Poland
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu Wroclaw Poland
Pomeranian Medical University Szczecin Poland

Other Sites

Site Name City Country Status
Instytut Hematologii I Transfuzjologii Warsaw Poland
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli Lublin Poland
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza Brzozow Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Warsaw Poland
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie Olsztyn Poland
Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu Torun Poland
Uniwersytecki Szpital Kliniczny W Bialymstoku Bialystok Poland
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy Warsaw Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie Lublin Poland
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach Kielce Poland
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Wojewodzki Szpital Specjalistyczny W Legnicy Legnica Poland
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Djbylwenxpwz Cjxukyp Oepdgijld Pbzjxiaibjzt I Heibiewrtet Wroclaw Poland
Nndxqghk Iakjlcxm Obvqsdcln Iej Mvizm Sxpmmuowqmmamblquxtyxlysoiyy Iqzbbqro Bnzcofix Cracow Poland
Sxcxqxrgqzm Peeitbnqh Sximypd Kzmuxyulj Ifjyezjjvfr Mrvsdbbbaxx Sqx W Kpvyzmpdfc Katowice Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Poland Poland
Not recruiting
01.03.2021

Trial locations

Investigated drugs:

Obinutuzumab is a medication used in this trial to treat adult patients with newly diagnosed CD20-positive acute lymphoblastic leukemia (ALL). It is a type of targeted therapy that works by attaching to a specific protein on the surface of cancer cells, helping the immune system to destroy these cells. The goal of using obinutuzumab in this trial is to see how effective it is in achieving complete remission in patients.

Rituximab is another medication being tested in this trial for the treatment of adult patients with newly diagnosed CD20-positive acute lymphoblastic leukemia (ALL). Like obinutuzumab, rituximab is a targeted therapy that binds to a specific protein on cancer cells, aiding the immune system in attacking and eliminating these cells. The trial aims to compare the effectiveness of rituximab with obinutuzumab in achieving complete remission in patients.

Acute Lymphoblastic Leukemia – Acute lymphoblastic leukemia (ALL) is a type of cancer that affects the blood and bone marrow. It is characterized by the overproduction of immature white blood cells, known as lymphoblasts. These abnormal cells crowd out normal cells, leading to symptoms such as fatigue, fever, and increased risk of infections. The disease progresses rapidly, requiring prompt medical attention. It is most commonly diagnosed in children but can also occur in adults. The progression involves the accumulation of these immature cells in the bone marrow and blood, which can spread to other organs if not managed.

Trial ID:
2024-517389-40-00
Protocol code:
PALG ALL7 “OVERALL”
Trial Phase:
Therapeutic exploratory (Phase II)

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