New treatment for B-Cell leukemia

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    What is this study about?

    This trial is about a new medication called AZD0486. It’s being tested on patients who have a type of cancer called B-cell acute lymphoblastic leukaemia or B-ALL for short. In specific, it’s for patients who have had at least two other treatments but the cancer has come back or has not responded. The first part of the study is to find out the highest safe dose for the drug. The second part is to find the ideal dose for effective treatment. And lastly, the third part will increase the number of patients on the best-performing dose from the second part. The researchers will watch for any side effects or health changes during the study as a way to measure the drug’s safety. The main goal is to see how many patients have their cancer respond to the treatment. Also, there will be a check on what percentage of patients have complete disappearance of the cancer cells at any time during the study.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Marseille , France

      Nantes , France

      Paris , France

      Pierre Bu00e9nite , France

      Frankfurt A. Main , Germany

      Freiburg , Germany

      Halle , Germany

      Hamburg , Germany

      Ku00f6ln , Germany

      Muenchen , Germany

      Mu00fcnster , Germany

      Wu00fcrzburg , Germany

      Bologna , Italy

      Monza , Italy

      Roma , Italy

      Barcelona , Spain

      Madrid , Spain

      Madrid , Spain

      Valencia , Spain

      London , United Kingdom

      Manchester , United Kingdom

      You can join this study in:

      Spain: Barcelona, Madrid.

      Italy: Bologna, Monza.

      Germany: Halle, Hamburg.

      United Kingdom: Manchester.

      France: Marseille, Nantes, Paris.


      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      Based on the information provided about this clinical trial (D7405C00001), here are the key steps a patient would likely go through:

      1. Screening and Enrollment

      • Patient is confirmed to have CD19+ B-cell Acute Lymphoblastic Leukemia (B-ALL) that has relapsed or is refractory after at least 2 prior therapies
      • Patient meets other eligibility criteria and provides informed consent to participate

      2. Treatment with AZD0486

      • Patients will receive the investigational drug AZD0486 via IV infusion
      • There are 3 parts to the study:
        • Part A: Dose Escalation – Different ascending dose levels tested in patients 16-80 years old
        • Part B: Dose Optimization – The recommended phase 2 dose (RP2D) will be determined in patients 12-80 years old
        • Part C: Dose Expansion – A larger group of patients 12-80 years old will receive the RP2D determined in Part B
      • Treatment continues until end of study, disease progression, unacceptable toxicity, or other reason for discontinuation

      3. Monitoring and Follow-up

      • Safety evaluations performed throughout the study to assess potential side effects
      • Efficacy assessments like overall response rate are key endpoints
      • Patients are followed for up to 36 months from first dose for outcomes like overall survival

      The total duration a patient is on study will vary but is estimated to average around 8 months. The study started in December 2023 and is expected to be completed in February 2027.


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      Based on the eligibility criteria in the provided clinical trial information, to join this study you need to have:

      • CD19+ B-cell Acute Lymphoblastic Leukemia (B-ALL) confirmed by a local lab, with:
        • Bone marrow infiltration with at least 5% blasts
        • Either relapsed or refractory disease after a minimum of 2 prior therapies, or after 1 prior line of therapy if no standard of care treatment options are available

      In Part A of the study, participants with Philadelphia chromosome positive (Ph+) B-ALL are allowed if they are intolerant or refractory to tyrosine kinase inhibitors (TKIs).

      The study excludes patients with:

      • Active central nervous system (CNS) involvement by B-ALL
      • Isolated extramedullary disease relapse
      • Testicular leukemia

      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      To join the study, you need to meet the following Inclusion Criteria:

      1. Age: You must be at least 16 years old for Part A of the study or at least 12 years old for Parts B and C of the study.
      2. Diagnosis: You must have CD19+ B-cell Acute Lymphoblastic Leukemia as confirmed by a local laboratory. This means you have a type of leukemia in which a particular marker known as CD19 is found on the surface of the cancerous B cells in your blood.
      3. Bone Marrow Infiltration: There must be a bone marrow infiltration with 5% or more blasts. Blasts are immature blood cells, and their presence in high numbers in the bone marrow indicates leukemia.
      4. Disease Status:
        1. You have either relapsed or are refractory after a minimum of 2 prior therapies; ‘relapsed’ means the cancer has returned after treatment, while ‘refractory’ means the cancer is not responding to treatment.
        2. Alternatively, you have relapsed or are refractory after 1 prior line of therapy if there is no standard of care (SOC) treatment option available.
      5. Philadelphia Chromosome Status: If you have Philadelphia positive disease, you can participate in Part A of the study if you are intolerant or refractory to tyrosine kinase inhibitors (TKIs), which are medications typically used to treat this condition.
      6. Performance Status: Your performance status, as measured by the Eastern Cooperative Oncology Group (ECOG) Performance Status, should be less than or equal to 2, or your Lansky score should be more or equal to 50%. The ECOG Performance Status is a scale used to assess how a patient’s disease is progressing and how the disease affects the daily living abilities of the patient, with scores ranging from 0 (fully active) to 5 (death). The Lansky score is similar but adapted for children, with scores ranging from 100 (fully active) to 0 (death).

      Please note that these criteria are a summary, and other inclusion criteria details may apply.

      What Reasons Could Exclude Me from the Study?

      Based on the eligibility criteria, you may not be able to take part in the study if you have any of the following:

      Leukemia Involvement:
      – Active central nervous system (CNS) involvement by B-cell acute lymphoblastic leukemia (B-ALL), meaning leukemia cells are present in the fluid surrounding the brain and spinal cord
      – Isolated extramedullary disease relapse (leukemia relapse outside of bone marrow)
      – Testicular leukemia

      Neurological Conditions:
      – History or presence of clinically relevant CNS conditions such as:
      – Epilepsy (a brain disorder that causes seizures)
      – Seizures
      – Paresis (partial or complete paralysis)
      – Aphasia (difficulty with speaking or understanding speech)
      – Stroke
      – Severe brain injuries
      – Dementia (decline in memory and thinking skills)
      – Parkinson’s disease (a brain disorder affecting movement)
      – Cerebellar disease (conditions affecting balance and coordination)
      – Organic brain syndrome (decreased mental function due to a medical condition)
      – Psychosis (a disconnection from reality)
      – Previous severe (Grade 4) neurotoxicity with CAR-T cell therapy or T-cell engaging antibody therapy

      Other Cancers:
      – History of other malignancies (some exceptions apply)

      Unresolved Side Effects:
      – Unresolved side effects, Grade 2 or higher, from previous therapies

      Recent Previous Therapies:
      – T-cell engaging antibody therapy within 4 weeks prior to study treatment
      – CAR T-cell therapy or autologous hematopoietic stem cell transplant (HSCT) within 8 weeks prior to study treatment
      – Allogeneic stem cell transplant (alloSCT) within 12 weeks of starting study treatment
      – Graft-versus-host disease (GVHD) requiring immunosuppressive therapy within 3 weeks prior to study treatment

      This is a summary of the main exclusion criteria. Other detailed exclusion criteria may apply.


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The main drug involved in this clinical trial is:

      • AZD0486 (active substance): An investigational product administered via intravenous infusion. AZD0486 is being evaluated as a monotherapy treatment for patients with relapsed or refractory B-cell Acute Lymphoblastic Leukemia (B-ALL) who have received at least 2 prior lines of therapy. The study aims to assess the safety, tolerability, and efficacy of AZD0486 at different dose levels and schedules to determine the recommended phase 2 dose (RP2D).

      The study is divided into three parts:

      • Part A: Dose Escalation – Evaluates ascending dose levels of AZD0486 in B-ALL patients aged 16-80 years.
      • Part B: Dose Optimization – Assesses prior declared safe doses and schedules to determine the RP2D in patients aged 12-80 years with Ph(-) B-ALL.
      • Part C: Dose Expansion – Expands the cohort at the RP2D to assess efficacy in a larger number of patients aged 12-80 years.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      Based on the information provided in the clinical trial record, there is one investigational product being studied:

      • AZD0486: This appears to be a novel investigational drug. The trial record states it is being evaluated for safety and efficacy, indicating it is not an already approved treatment. No additional details are provided about the type of drug or mechanism of action, so it is likely a new substance that is not well established in the medical literature yet.

      Study ID

      CT-EU-00033202

      Recruitment status

      Recruting new patients

      Start of the trial

      6 months ago