Study Comparing Inotuzumab Ozogamicin to Drug Combination for Children with High-Risk Relapsed B-cell Acute Lymphoblastic Leukemia

1 1 1

What is this study about?

This clinical trial is focused on studying a type of blood cancer called Acute Lymphoblastic Leukemia (ALL), specifically in children who have experienced a high-risk first relapse. The study is comparing a new treatment using a medication called Inotuzumab Ozogamicin with a standard treatment known as ALLR3. The purpose of the study is to determine if Inotuzumab Ozogamicin is more effective than the standard treatment in helping children with this type of leukemia.

Participants in the study will receive either Inotuzumab Ozogamicin or the standard treatment. Inotuzumab Ozogamicin is given as an infusion, which means it is administered directly into the bloodstream through a vein. The study will last for a period of up to 28 days, during which the effects of the treatment will be closely monitored. Other medications that may be used in the study include Dexamethasone, Pegaspargase, Vincristine Sulfate, and Mitoxantrone Hydrochloride, which are commonly used in treating leukemia.

The study aims to see if the new treatment can help achieve a state where no cancer cells are detectable in the blood, known as minimal residual disease-negative status. This is an important goal in treating leukemia, as it indicates a better response to treatment. The study will also look at other outcomes, such as the time it takes for the disease to progress, the duration of response to treatment, and overall survival rates. Participants will be monitored for any side effects or adverse events during the study period.

1 joining the study

Upon joining the study, the participant is confirmed to have a diagnosis of first relapse high-risk B-cell precursor acute lymphoblastic leukemia (ALL).

The participant is between 1 and less than 18 years old and meets specific health criteria, including adequate kidney and liver function.

2 induction treatment

The participant receives Inotuzumab Ozogamicin as a monotherapy. This medication is administered through an intravenous infusion.

The goal of this phase is to achieve minimal residual disease (MRD)-negative status, which means reducing the number of leukemia cells to a very low level.

3 monitoring and assessment

Throughout the treatment, the participant’s response is closely monitored. This includes regular assessments to check for MRD negativity and overall health status.

The participant’s progress is evaluated to determine if the treatment is effective in achieving complete remission or partial remission.

4 secondary outcomes

Secondary outcomes include measuring event-free survival (EFS), which tracks the time until disease progression, relapse, or other significant events.

Other outcomes include duration of response (DOR), overall survival (OS), and the incidence and severity of any side effects experienced during the trial.

5 completion of trial

The trial is expected to continue until July 2031, with ongoing assessments and data collection to evaluate the long-term effectiveness and safety of the treatment.

Participants may continue to receive follow-up care and monitoring as part of the study protocol.

Who Can Join the Study?

  • Participants must be boys or girls between 1 and less than 18 years old.
  • Participants must have a confirmed diagnosis of first relapse of high-risk B-cell precursor acute lymphoblastic leukemia (BCP ALL). This means the leukemia has returned within 18 to 30 months after the first diagnosis or within 6 months after finishing the initial treatment, and does not have certain very high-risk genetic changes.
  • The leukemia must be CD22-positive, which is a specific marker found on the cancer cells.
  • There must be at least 5% cancer cells in the bone marrow.
  • Participants must have acceptable blood test results, including:
    • Adequate kidney function, measured by a test called glomerular filtration rate (eGFR) or creatinine clearance (eCrCl), which should be at least 30 mL/min.
    • Liver enzymes, aspartate aminotransferase (AST) and alanine aminotransferase (ALT), should be no more than 5 times the normal limit.
    • Total bilirubin should be no more than 1.5 times the normal limit, unless the participant has a condition called Gilbert’s syndrome.
  • Participants who have had blood clots while using certain medications in the past can join if they receive preventive treatment for blood clots according to guidelines.
  • The heart’s ability to pump blood, measured by a test called echocardiogram or MUGA, should be at least 30% or more than 50%, respectively.

Who Cannot Join the Study?

  • Patients who have a different type of leukemia other than Acute Lymphoblastic Leukemia (ALL) cannot participate. Leukemia is a type of cancer that affects the blood and bone marrow.
  • Patients who are not between the ages of 1 and less than 18 years old are excluded. This means the study is only for children and teenagers.
  • Patients who do not have a specific type of leukemia called CD22-positive B-cell precursor acute lymphoblastic leukemia (BCP ALL) cannot join. This is a specific kind of leukemia that affects certain cells in the blood.
  • Patients who have not experienced a first bone marrow relapse are not eligible. A relapse means the leukemia has returned after treatment.
  • Patients who are not considered high risk (HR) for a first bone marrow relapse are excluded. High risk means there is a greater chance of the leukemia coming back.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Hospital Infantil Universitario Nino Jesus Madrid Spain
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Hopital Des Enfants Toulouse France
Hospital Sant Joan De Deu Barcelona Esplugues De Llobregat Spain
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
St. Anna Kinderspital GmbH Vienna Austria
ARNAS Civico Di Cristina Benfratelli Palermo Italy
Azienda Ospedaliera Santobono Pausilipon Naples Italy
Narodny Ustav Detskych Chorob Bratislava Slovakia
Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo Trieste Italy
Azienda Ospedaliera di Padova Padua Italy
Szpital Uniwersytecki Nr 1 Im. Dr. A. Jurasza W Bydgoszczy Bydgoszcz Poland
Virgen del Rocío University Hospital Sevilla Spain
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Region Skane Skanes Universitetssjukhus Lund Sweden
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Fakultni Nemocnice Brno Brno Czechia
Karolinska University Hospital Solna Sweden
Semmelweis University Budapest Hungary
Robert Debre University Hospital Paris France
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Centre Hospitalier Universitaire De Montpellier Montpellier France
Universidade De Santiago De Compostela Santiago De Compostela Spain
Prinses Maxima Centrum voor Kinderoncologie B.V. Utrecht The Netherlands
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz Miskolc Hungary
Assistance Publique Hopitaux De Paris Paris France
Justus-Liebig-Universitaet Giessen Giessen Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Rennes Rennes France
Rigshospitalet Copenhagen Denmark
IRCCS Istituto Giannina Gaslini Genoa Italy
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Universitair Ziekenhuis Gent Gent Belgium
Pellegrin Hospital Bordeaux France
Ospedale Pediatrico Bambino Gesu’ Rome Italy
Ospedale Infantile Regina Margherita Turin Italy
Citkvtxhi Uszvuzaovlcysc Sfxugtiro Woluwe-Saint-Lambert Belgium
Ulektiqigt Mygayaf Chwodi Hnxplqypkelkshsug Hamburg Germany
Umkupkxzpwghlnepjxjrp Eonfc Ajt Essen Germany
Azfwk Sxxlkp Cjuduycybihjddtf Havuqwly Athens Greece
Icwfmlnk dlddjjaxmtgaxflcvfm ep drdxirpbkymzopnbo Pynrxrrwrci (phtyd Lyon France
Pygfb Tznmltxdqgohaeb Ksvddydi Kiexrbd Hungary
Fyfskxujnc Mrdk &dsvuij Eqxcclqzgk Puuhmanplu Monza Italy
Sdzznspkqvh Ugqhhnsbxjxxrztydptvb Öhuhz Gothenburg Sweden
Fcczmqxk nxnovsjjh Mqoxu a Havmwgy Prague Czechia
Uuvkcbqklmumdfwhobapb Djnvgizwcqk Agc Duesseldorf Germany
Hnwkfzlc Uttloonvzp Cijyekz Huwgvxxe Helsinki Finland
Uaqapwvcozeclkblomgde Mdkiifil Aht Munster Germany
Cafh Dv Nybbu Vandoeuvre Les Nancy France
Getigs Ultnbvyuak Fmetgqaro Frankfurt Germany
Uwbawlppgggxgjwnhkrsr Wkuwovghp Aue Wuerzburg Germany
Aihkcxp Uoyzq Smdwqmqeb Lpjxuu Dk Blotpdt Bologna Italy
Fkbzbjcmd Pqae Lc Issdknkexlivj Beswtgavm Duv Hrhttoxo Uvzldamgwqdie Lq Pxq Madrid Spain
Hyhxojcm Vagz dbhrjmro Barcelona Spain
Hhrthrra Udqrekptmpfxwd Siliwrlkhv &vcorth Hjzmham dy Hlsfcjtotti STRASBOURG, Alsace France

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

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
31.07.2023
Belgium Belgium
Recruiting
31.07.2023
Czechia Czechia
Recruiting
31.07.2023
Denmark Denmark
Recruiting
31.07.2023
Finland Finland
Recruiting
31.07.2023
France France
Recruiting
31.07.2023
Germany Germany
Recruiting
31.07.2023
Greece Greece
Not recruiting
31.07.2023
Hungary Hungary
Not recruiting
31.07.2023
Italy Italy
Recruiting
31.07.2023
Norway Norway
Recruiting
31.07.2023
Poland Poland
Not recruiting
31.07.2023
Slovakia Slovakia
Recruiting
31.07.2023
Spain Spain
Recruiting
31.07.2023
Sweden Sweden
Recruiting
31.07.2023
The Netherlands The Netherlands
Recruiting
31.07.2023

Trial locations

Inotuzumab Ozogamicin is a medication used in this clinical trial as a monotherapy. It is being tested to see if it is more effective than the current standard treatment for children who have a high-risk first relapse of a type of blood cancer called B-cell precursor acute lymphoblastic leukemia. This medication works by targeting specific cancer cells and delivering a substance that can help kill these cells.

Acute Lymphoblastic Leukemia (ALL) – This is a type of cancer that affects the blood and bone marrow, characterized by the overproduction of immature white blood cells, known as lymphoblasts. It progresses rapidly, leading to an accumulation of these cells in the bone marrow, which interferes with the production of normal blood cells. As the disease advances, it can spread to other parts of the body, including the lymph nodes, liver, spleen, and central nervous system. Symptoms may include fatigue, fever, frequent infections, and easy bruising or bleeding. The disease is most common in children, but it can also occur in adults. Early detection and intervention are crucial for managing the progression of the disease.

Trial ID:
2023-509810-13-00
Protocol code:
B1931036
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • Study of Ruxolitinib and Venetoclax for Children with Relapsed or Refractory Leukemia or Lymphoma with IL-7R/JAK-STAT Pathway Mutations

    Recruiting

    1 1 1
    Investigated drugs:
    Austria Belgium Denmark Finland France Germany +5
  • Study of Blinatumomab and a drug combination for older adults with newly diagnosed Philadelphia-negative B-cell precursor Acute Lymphoblastic Leukemia

    Recruiting

    1 1 1 1
    Austria Belgium Bulgaria Czechia Denmark Estonia +11