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Study on Tioguanine and Drug Combination for Patients Aged 0-45 with Newly Diagnosed Acute Lymphoblastic Leukemia

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying treatments for Acute Lymphoblastic Leukemia (ALL), a type of cancer that affects the blood and bone marrow. The study aims to improve the survival and quality of life for children and young adults diagnosed with this disease. Participants in the trial will receive various treatments, including medications like tioguanine, Hydrocortisone Sodium Succinate, Mercaptopurine, Blinatumomab, Vincristine Sulfate, Doxorubicin, Dexamethasone, Methotrexate, Imatinib, Inotuzumab Ozogamicin, Methylprednisolone Sodium Succinate, Prednisolone Sodium Succinate, and cytarabine. Some participants may receive a placebo as part of the study.

The purpose of the study is to test these treatments in a structured way to see how well they work and to gather information about their effects. The study will involve different phases where participants will receive these treatments over a period of time. The treatments will be given in various forms, such as oral suspensions, tablets, or injections, depending on the specific medication. The study will also explore the potential benefits of new types of treatments, such as immunotherapy, for certain groups of patients.

Throughout the study, participants will be monitored to assess the effectiveness of the treatments and to identify any side effects. The study will collect data on survival rates, the occurrence of any relapses, and the overall quality of life of the participants. This information will help researchers understand how these treatments can be used to improve outcomes for people with Acute Lymphoblastic Leukemia.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm the diagnosis of acute lymphoblastic leukaemia (ALL). This involves a series of tests and evaluations to ensure eligibility for the trial.

  2. Step 2

    Treatment initiation

    The treatment phase begins with the administration of various medications. These include tioguanine and mercaptopurine taken orally, and vincristine sulfate and doxorubicin given intravenously. The specific dosage and frequency are determined by the medical team based on individual needs.

  3. Step 3

    Intrathecal therapy

    Intrathecal therapy involves administering medications directly into the spinal fluid. This includes methotrexate and cytarabine. This step is crucial for targeting leukaemia cells in the central nervous system.

  4. Step 4

    Oral medication phase

    During this phase, oral medications such as dexamethasone and imatinib are taken regularly. The medical team provides specific instructions on dosage and timing.

  5. Step 5

    Monitoring and adjustments

    Regular monitoring is conducted to assess the response to treatment. Adjustments to the medication regimen may be made based on these assessments to optimize outcomes.

  6. Step 6

    Maintenance therapy

    Maintenance therapy involves continued use of certain medications to prevent relapse. This phase includes oral medications like mercaptopurine and methotrexate, taken over an extended period.

  7. Step 7

    Follow-up and evaluation

    After completing the treatment phases, regular follow-up appointments are scheduled to monitor long-term health and detect any potential recurrence of leukaemia.

Who can join the trial?

9 criteria

  • Patients must be newly diagnosed with either T-lymphoblastic (T-cell) leukaemia or B-lymphoblastic precursor (BCP) leukaemia. These are specific types of blood cancer.
  • The diagnosis must be confirmed by a recognized laboratory at a participating children's cancer center or adult blood disease center.
  • Patients must be between the ages of 0 days and less than 46 years old at the time of diagnosis.
  • Patients with a specific genetic feature called surface IG negative BCP-ALL and an IG::MYC rearrangement can participate, unless they have another genetic feature called BCL2/6 rearrangement. T-ALL patients with MYC translocations are also eligible.
  • Informed consent must be signed by the patient and/or their parents/legal guardians, following the guidelines specific to their country.
  • The patient must be diagnosed and treated at a participating children's cancer center or adult blood disease center in the participating countries.
  • The patient should live permanently in one of the participating countries or plan to settle there, such as applying for asylum. Tourists are not eligible, but returning expatriates with a primary diagnosis from abroad may be included if no treatment has been given and diagnostic tests are repeated at a participating center.
  • All women who can have children must have a negative pregnancy test within 2 weeks before starting treatment.
  • Additional criteria may apply for each specific treatment or randomization within the study.

Who cannot join the trial?

4 criteria

  • Patients who do not have Acute Lymphoblastic Leukaemia cannot participate.
  • Patients who are not infants, children, or young adults are excluded.
  • Patients who are not part of the specified clinical trial groups are excluded.
  • Patients who are not considered part of a vulnerable population are excluded.
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Investigated drugs

Immunotherapy is a type of treatment that helps your immune system fight cancer. In this trial, a subgroup of patients with acute lymphoblastic leukemia (ALL) may receive a novel form of immunotherapy. This therapy works by boosting the body's natural defenses to recognize and attack cancer cells more effectively.

What is already known about the treatment

  • Methotrexate

    Methotrexate is one of the oldest and most widely used chemotherapy medicines, given in this trial both as tablets by mouth and as an injection directly into the fluid around the spinal cord to protect the brain from leukaemia cells. It is a standard component of treatment for acute lymphoblastic leukaemia and is also used at lower doses for diseases such as rheumatoid arthritis. It blocks an enzyme called dihydrofolate reductase, which cells need to make folate-based building blocks of DNA, so rapidly dividing leukaemia cells cannot copy their genetic material and die. It is classified as an antimetabolite of the folate type.

  • Mercaptopurine

    Mercaptopurine is a chemotherapy tablet taken by mouth, usually every day during the long maintenance phase of leukaemia treatment. It has been a cornerstone of childhood leukaemia therapy for decades and is credited with a large part of the improvement in cure rates. Inside cells it is converted into false building blocks that become incorporated into DNA, disrupting its copying and leading to the death of dividing leukaemia cells. It belongs to the group of antimetabolites known as purine analogues.

  • Tioguanine

    Tioguanine is a chemotherapy medicine taken by mouth, in this trial as an oral suspension, and is closely related to mercaptopurine. It is an established treatment for acute leukaemias and has been studied extensively in children. Like mercaptopurine, it is transformed in the body into abnormal purine building blocks that are inserted into the DNA of leukaemia cells, blocking their ability to multiply. It is classified as a purine-analogue antimetabolite.

  • Cytarabine

    Cytarabine is a chemotherapy medicine that in this trial is injected into the fluid surrounding the brain and spinal cord to destroy leukaemia cells that may hide there. It has been a standard drug in leukaemia treatment since the 1960s and remains essential in modern protocols. It mimics cytidine, one of the natural building blocks of DNA, and once incorporated it stops the DNA chain from growing, so dividing cells die. It belongs to the antimetabolite group known as pyrimidine analogues.

  • Vincristine

    Vincristine is a chemotherapy medicine given as a quick injection into a vein and derived from the periwinkle plant. It is part of nearly every treatment schedule for acute lymphoblastic leukaemia in children and adults. It attaches to a cell protein called tubulin and prevents the cell from building the internal scaffolding it needs to divide, so leukaemia cells are frozen in mid-division and die. It is classified as a vinca alkaloid.

  • Doxorubicin

    Doxorubicin is a chemotherapy medicine given as an infusion into a vein and used against a very wide range of cancers, including leukaemias and lymphomas. It has been in clinical use for decades and is one of the best-studied anticancer drugs. It works by sliding between the strands of DNA and blocking the enzyme topoisomerase II, which causes breaks in the DNA of dividing cells and leads to their death. It belongs to the anthracycline class of anticancer agents.

Investigated diseases

Acute Lymphoblastic Leukaemia – Acute Lymphoblastic Leukaemia 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 blood cells, leading to symptoms such as fatigue, frequent infections, and easy bruising or bleeding. The disease progresses rapidly, requiring prompt medical attention. As the condition advances, it can spread to other parts of the body, including the lymph nodes, liver, and spleen. The progression of the disease can vary, with some cases advancing more quickly than others.
Trial detailsLast updated 22 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2022-501050-11-01Protocol codeALLTogether1Estimated enrolment8 503 patientsSponsorKarolinska University Hospital

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