Study of asciminib, dexamethasone, blinatumomab, and vincristine sulfate in children and young adults with relapsed or refractory Philadelphia chromosome-positive acute lymphoblastic leukemia

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What is this study about?

This study focuses on treating children, adolescents, and young adults with Acute Lymphoblastic Leukemia, which is a type of cancer that affects the blood and bone marrow. The research specifically targets patients with certain genetic markers, known as BCR::ABL1-positive or Ph-like, where the cancer cells have specific changes in their DNA. This study is for patients whose disease has either returned after previous treatment, which is called relapsed, or has not responded to initial treatments, which is called refractory.

The purpose of the study is to evaluate the safety and effectiveness of a combination of treatments. The experimental treatment includes the drug asciminib, which is taken by mouth, alongside chemotherapy, a type of treatment using strong medicines to kill cancer cells. Following this, the drug blinatumomab, which is given through an IV infusion, may be used. Other medications that may be part of the background care include vincristine sulfate, dexamethasone, cytarabine, methotrexate, hydrocortisone, and prednisolone acetate.

The study is divided into different stages to find the most appropriate dose of the medicine. In the first stage, researchers look at how the body reacts to different amounts of the drug to ensure safety. In the second stage, the focus shifts to determining how many patients achieve complete remission, a state where all signs of cancer have disappeared. Throughout the process, doctors will monitor for any side effects or changes in health to ensure the treatment is managed carefully.

Who Can Join the Study?

  • Both males and females can join the study.
  • Participants must be at least 1 year old and no older than 30 years old at the time of the initial screening.
  • Participants must have a documented history of Philadelphia positive (Ph+) acute lymphoblastic leukemia (ALL) or Philadelphia-like (Ph-like) ALL, which are specific types of blood cancer.
  • The cancer must involve specific genetic changes known as ABL1 or ABL2 rearrangements, which means certain parts of the DNA have changed or moved.
  • Participants with a specific genetic mutation called T315I are allowed to join.
  • The study is for patients with active B-Cell ALL, a type of cancer affecting white blood cells, where the cancer cells (called blasts) are measurable through specific blood or bone marrow tests.
  • The cancer must be either primary refractory, meaning it did not respond to the initial treatment, or relapsed, meaning the cancer has returned after previous treatment.
  • Participants can have cancer that has spread to the central nervous system (CNS), which includes the brain and spinal cord, at different levels of severity labeled as CNS1, CNS2, CNS3a, or CNS3b.
  • The cancer must show the presence of a marker called CD19 on the surface of the cancer cells, which can be checked in the blood or bone marrow (the soft tissue inside bones where blood cells are made).
  • If a patient previously received treatments that target the CD19 marker, such as CAR T cell therapy or blinatumomab, they must still have CD19 expressing cells present after finishing those treatments.

Who Cannot Join the Study?

  • You cannot participate if you have had more than three relapses of acute lymphoblastic leukemia (ALL), which is a type of cancer that affects the white blood cells.
  • You are not eligible if you have extramedullary disease, which means the cancer has spread outside of the bone marrow to other parts of the body, such as the central nervous system (CNS), which is the brain and spinal cord.
  • You cannot join if you show signs of CNS3c, which means the cancer is actively affecting the central nervous system (CNS) through physical signs like facial nerve weakness, issues with the brain or eyes, or hypothalamic syndrome, a condition affecting the part of the brain that controls hormones and body functions.
  • You are excluded if you have had a hematopoietic stem cell transplant, a procedure where healthy blood-forming cells are put into the body, within the last 12 weeks.
  • You cannot participate if you have active graft-versus-host disease (GVHD), which is a condition where transplanted immune cells attack the recipient’s body, whether it is acute (happening suddenly) or chronic (happening over a long period).
  • You are not eligible if you have received any medication to treat or prevent graft-versus-host disease (GVHD) within the last 4 weeks.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Bordeaux Bordeaux France

Other Sites

Site Name City Country Status
IRCCS Istituto Giannina Gaslini Genoa Italy
Hospital Sant Joan De Deu Barcelona Esplugues De Llobregat Spain
Institute Of Hematology And Blood Transfusion Prague Czechia
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Universitaetsklinikum Erlangen AöR Erlangen Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Robert Debre University Hospital Paris France
Prinses Maxima Centrum voor Kinderoncologie B.V. Utrecht The Netherlands
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Rennes Rennes France
Rigshospitalet Copenhagen Denmark
Centre Hospitalier Lyon Sud Pierre Benite France
Ospedale Pediatrico Bambino Gesu’ Rome Italy
Upblekxvow Mesuync Cyoang Hvsosmwzvlxccsnxo Hamburg Germany
Ubxebfyceypfpumnnkghm Eqhpd Axx Essen Germany
Updpnnesyr Hqihslpm Ctdsycu Cologne Germany
Frsekanz nmwsrmhcm Mjzmw a Hxekces Prague Czechia
Aqxvjkxcul Pqiajfre Hlamrjsx Dl Ptafp Paris France
Atmuvpxsuj Pukozzlt Hqpkjsrz Dr Miyqiqwsn Marseille France
Gabsdk Uxuofsalna Fvkoqlxwz Frankfurt Germany
Fifmienmj Phya Lk Ikzghcboideej Bmwleajrp Dof Hweutqvi Uqbydxhuhfkgx Lb Pim Madrid Spain
Hfqynmya Vxyv doexkajq Barcelona Spain

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

Trial status

Country Status Recruitment Start
Czechia Czechia
Not yet recruiting
26.03.2026
Denmark Denmark
Not yet recruiting
26.03.2026
France France
Not yet recruiting
26.03.2026
Germany Germany
Not yet recruiting
26.03.2026
Italy Italy
Not yet recruiting
26.03.2026
Spain Spain
Not yet recruiting
26.03.2026
The Netherlands The Netherlands
Not yet recruiting
26.03.2026

Trial locations

Asciminib is a medication taken by mouth that is being tested to see how well it works in treating specific types of leukemia.

Dexamethasone is a steroid medication that can be taken by mouth or given through an IV infusion to help treat the condition.

Blinatumomab is a therapy given through an IV infusion that helps the body’s immune system target and fight leukemia cells.

Vincristine is a chemotherapy medication given through an IV infusion to help kill cancer cells.

Investigated diseases:

Relapsed or refractory BCR::ABL1-positive or BCR::ABL1-like acute lymphoblastic leukemia – This is a type of cancer that affects the white blood cells in the bone marrow and blood. It occurs when the disease returns after initial treatment or when it does not respond to standard therapies. The condition is characterized by specific genetic changes, such as the presence of a particular protein or a similar genetic pattern. As the disease progresses, abnormal white blood cells multiply rapidly and crowd out healthy blood cells. This accumulation interferes with the normal production of essential blood components.

Trial ID:
2025-522019-40-00
Protocol code:
CABL001L12101
Trial Phase:
Human Pharmacology (Phase I) – Other

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