A study to evaluate the safety and effectiveness of subcutaneous blinatumomab in adults and adolescents with relapsed, refractory, or minimal residual disease positive B-cell precursor acute lymphoblastic leukemia.

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What is this study about?

This study focuses on B cell Precursor Acute Lymphoblastic Leukemia, a type of cancer that affects the blood and bone marrow. The research specifically involves individuals with Relapsed or Refractory B-ALL, which means the cancer has returned after previous treatment or has not responded to existing therapies. It also includes those with Minimal Residual Disease Positive (MRD+) B-ALL, a condition where very small amounts of cancer cells remain in the body even after treatment. The purpose of the study is to evaluate the safety and effectiveness of a new way to give the drug blinatumomab through a subcutaneous injection, which means the medicine is injected just under the skin rather than into a vein.

The study compares two different versions of the medication, referred to as SC1 and SC2. Other medications used as background treatments may include cytarabine, cyclophosphamide, dexamethasone, methotrexate, vincristine sulfate, and levetiracetam. Researchers will monitor how the body processes the medication, a process known as pharmacokinetics, and check for any side effects. The study is conducted in stages, starting with finding the right dose and then observing how well the treatment works in different groups of patients.

Who Can Join the Study?

The patient or their legal representative must provide informed consent, which is a signed document showing they understand and agree to participate in the study.
Participants must have a history of B cell precursor acute lymphoblastic leukemia, which is a type of cancer affecting certain white blood cells.
For some parts of the study, the patient must have had a relapse (the cancer returned after treatment) or have refractory disease (the cancer did not respond to treatment).
For some parts of the study, the patient must have experienced a relapse after receiving an allogeneic hematopoietic stem cell transplant (a procedure where healthy blood-forming cells are taken from a donor and put into the patient).
The patient must have at least 5% blasts, which are immature, abnormal cancer cells, in their bone marrow (the soft tissue inside bones where blood cells are made).
For the Minimal Residual Disease (MRD) group, the amount of remaining cancer cells in the bone marrow must be between 0.1% and 5%.
The patient must have an ECOG Performance Status of 2 or less, which is a scale used by doctors to measure how well a person can perform daily activities and their level of disability.
Depending on the specific group, patients must meet certain age requirements: 18 years or older, between 12 and 17 years old, or between 16 and 18 years old.
Teenagers may be required to have a Karnofsky Performance Score or a Lansky Performance Score of 50% or higher, which are tools used to measure a patient’s ability to function and care for themselves.
Patients in the MRD group must have available archival bone marrow specimens, which are stored samples of bone marrow from previous diagnoses.
For the MRD group, bone marrow function must meet specific levels for absolute neutrophil count (a measure of certain white blood cells that fight infection), platelet count (cells that help blood clot), and hemoglobin (a protein in red blood cells that carries oxygen).
In the Ph-IIRb extended cohort, the patient must weigh less than 45 kg.
Patients with extra medullary disease, which means cancer cells found outside of the bone marrow but not in the central nervous system, are eligible if the amount is less than 5%.
Participants in the Ph-IIC group must agree to additional pharmacokinetic (PK) sampling, which involves collecting samples to see how the body processes the medicine.

Who Cannot Join the Study?

You cannot participate if you have active leukemia in the Central Nervous System (CNS), which is the part of the body that includes the brain and spinal cord. This includes having too many white blood cells (a type of immune cell) in your cerebrospinal fluid (the clear liquid that surrounds the brain and spine).
You cannot join if you have extramedullary (EM) disease, which means the leukemia is growing in parts of the body outside of the bone marrow, or if there are leukemia cells circulating in your blood.
You cannot participate if you have testicular leukemia.
You cannot join if you have received chemotherapy (medicine used to kill cancer cells) within 2 weeks of starting this study, unless it was a specific low dose or a specific type of treatment for the brain.
You cannot participate if you have received immunotherapy (a type of treatment that helps the immune system fight cancer) within 4 weeks of starting this study.
You cannot join if you are currently in another medical study testing a new drug or device, or if you finished one less than 30 days ago.
You cannot participate if your total bilirubin (a yellowish substance produced by the liver) is too high, which may indicate liver issues, unless you have a specific inherited condition like Gilbert’s disease.
You cannot join if your creatinine clearance (a measure of how well your kidneys filter waste) is too low, which indicates poor kidney function.
Women who are pregnant, breastfeeding, or planning to become pregnant or donate eggs cannot participate.
Women of childbearing age who are unwilling to use a highly effective form of contraception (birth control) cannot participate.
You cannot join if you are unlikely to be able to finish all the required study visits or follow the study rules.
You cannot participate if you have a history of serious brain or nervous system issues, such as epilepsy (seizures), stroke, dementia, or Parkinson’s disease.
You cannot join if you have an autoimmune disease (a condition where the body’s immune system attacks its own healthy cells) that could affect the brain or nervous system.
You cannot participate if you have graft versus host disease (a condition where transplanted immune cells attack the recipient’s body) that requires strong medicine to suppress the immune system.
You cannot join if you have a known hypersensitivity (an allergy) to the study drug or any of its ingredients.
You cannot participate if you have an infection with HIV, hepatitis B, or hepatitis C.
You cannot join if you have any active or uncontrolled infections or other medical conditions that could be made worse by this treatment.
You cannot participate if you have had a different type of cancer within the last 3 years, except for certain skin or early-stage cancers that were fully treated.
You cannot join if you have had an allogeneic HSCT (a type of bone marrow or stem cell transplant from a donor) within 12 weeks of starting the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
University Hospital Jena KöR	Jena	Germany
Hospital Universitario De Salamanca	Salamanca	Spain
Centre Hospitalier Universitaire De Lille	Lille	France
Universitaet Leipzig	Leipzig	Germany
Oncopole Claudius Regaud	Toulouse	France
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Centre Hospitalier De Versailles	Le Chesnay-Rocquencourt	France
Hopital Saint Antoine	Paris	France
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Robert Debre University Hospital	Paris	France
Spitalul Universitar De Urgenta Bucuresti	Bucharest	Romania
Prinses Maxima Centrum voor Kinderoncologie B.V.	Utrecht	The Netherlands
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj Napoca	Romania
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Azienda Ospedaliera Santobono Pausilipon	Naples	Italy
Institutul Regional De Oncologie Iasi	Iasi	Romania
Universita Degli Studi Di Brescia	Brescia	Italy
Centre Hospitalier Universitaire De Nice	Nice	France
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Centre Hospitalier Lyon Sud	Pierre Benite	France
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur	Namur	Belgium
Ospedale Pediatrico Bambino Gesu’	Rome	Italy
Anlyowu Onhpyqxukjj Pylq Gjrzbjlq Xwuqy	Bergamo	Italy
Hrxgvyen Uhxbmwuxybgsn Mhjdhtn De Vfsswpqhyg	Santander	Spain
Uhxdzvfiucmpovupqlqod Apvtorzz	Augsburg	Germany
Irnmzfkz Ckacxs Dtsasmeomfvkpypsk	L'hospitalet De Llobregat	Spain
Avxuajbsrg Ptkgnbau Hdduyvhd Db Pimmy	Paris	France
Aizlbyk Uukfa Sdryzippx Ltpozp Do Byqmqzv	Bologna	Italy
Upujopytug Dyyiz Swomu Dd Rcbp Lt Sxhvoudc	Rome	Italy
Umydgnjfeh Hmrvnolo Cycsydg	Cologne	Germany
Eczxupj Uzzaxyqgvnsi Mgldnzu Czpzcot Rbduompkw (gwcibcr Mum	Rotterdam	The Netherlands
Hjydsyqo Vvui dgmeveca	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not yet recruiting	31.10.2025
France	Not yet recruiting	31.10.2025
Germany	Not yet recruiting	31.10.2025
Italy	Not yet recruiting	31.10.2025
Romania	Not yet recruiting	31.10.2025
Spain	Not yet recruiting	31.10.2025
The Netherlands	Not yet recruiting	31.10.2025

Trial locations

Investigated drugs:

Blinatumomab is the primary medication being tested in this study. It is an immunotherapy treatment given as an injection under the skin to help the body’s immune system find and attack certain types of leukemia cells.

Cytarabine is a chemotherapy medication used as part of the background treatment to help kill cancer cells.

Cyclophosphamide is a chemotherapy medication used as part of the background treatment to help kill cancer cells.

Dexamethasone is a steroid medication used as part of the background treatment, which can help reduce inflammation or swelling.

Methotrexate is a chemotherapy medication used as part of the background treatment to help prevent cancer cells from growing.

Vincristine sulfate is a chemotherapy medication used as part of the background treatment to help kill cancer cells.

Levetiracetam is a medication used as part of the background treatment, typically used to prevent or control seizures.

B cell Precursor Acute Lymphoblastic Leukemia – This is a type of cancer that affects the white blood cells, specifically the precursor cells that eventually become B cells. The disease is characterized by the rapid production of abnormal cells in the bone marrow. These cancerous cells crowd out healthy blood cells, which can lead to various issues with blood function. The condition can progress through different stages, sometimes returning after an initial period of improvement. In some cases, tiny amounts of cancer cells remain in the body even after treatment, a state known as minimal residual disease.

Trial ID:

2023-506136-32-00

Protocol code:

20180257

NCT ID:

NCT04521231

Trial Phase:

Human Pharmacology (Phase I) – Other

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A study to evaluate the safety and effectiveness of subcutaneous blinatumomab in adults and adolescents with relapsed, refractory, or minimal residual disease positive B-cell precursor acute lymphoblastic leukemia.

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?