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Evaluating venetoclax with drug combination in relapsed/refractory T‑cell acute lymphoblastic leukemia patients

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What is this trial about?

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

The trial focuses on patients with relapsed/refractory T-cell Acute Lymphoblastic Leukemia, a rare blood cancer that has returned after treatment or does not respond to standard therapy. The study tests several oral and intravenous medicines, including the pill venetoclax, the injection recombinant l-asparaginase, the oral tablet tofacitinib, the injectable suspension azacitidine, and the tablet everolimus. These drugs are chosen based on laboratory tests that try to match the cancer’s specific characteristics.

The purpose of the study is to see whether a precision‑medicine strategy that combines these targeted drugs can improve the rate of blood‑cell recovery, known as hematologic remission, compared with standard approaches. Hematologic remission means that the abnormal blood cells are reduced to very low levels, indicating that the leukemia is under control.

Participants are randomly assigned to receive either the personalized drug combination or the standard treatment. After starting therapy, they will have regular clinic visits and simple blood tests over several months to monitor response and any side effects. The study continues for a period that allows researchers to observe how long the response lasts and whether the disease returns.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial venetoclax administration

    venetoclax is provided as a 400 mg film‑coated tablet taken by mouth.

    The tablet is taken according to the schedule defined in the trial protocol, typically once each day.

    Treatment with venetoclax continues for the period specified by the protocol.

  2. Step 2

    Recombinant l‑asparaginase infusion

    recombinant l‑asparaginase is supplied as a 25 mg/m2 solution for intravenous administration.

    The solution is given by a health professional through an infusion as directed by the trial protocol.

    Infusions are performed for the duration required by the protocol.

  3. Step 3

    Tofacitinib administration

    tofacitinib is provided as a 20 mg film‑coated tablet taken by mouth.

    The tablet is taken according to the schedule defined in the trial protocol, usually once daily.

    Treatment with tofacitinib continues for the period specified by the protocol.

  4. Step 4

    Azacitidine injection

    azacitidine is supplied as a 75 mg/m2 powder for suspension for subcutaneous injection.

    The suspension is injected under the skin as instructed by the trial protocol.

    Injections are given for the duration required by the protocol.

  5. Step 5

    Everolimus administration

    everolimus is provided as a 5 mg tablet taken by mouth.

    The tablet is taken according to the schedule defined in the trial protocol, typically once daily.

    Treatment with everolimus continues for the period specified by the protocol.

Who can join the trial?

13 criteria

  • You must be at least 15 years old. If you are younger than 18, you can only take part if you live in France.
  • You must give informed consent – a written agreement after the doctors explain the study. If you are 18 years or older, you sign it yourself; if you are between 15 and 17 years old (in France) both parents must sign.
  • You must have T‑cell acute lymphoblastic leukemia that has come back (relapse) or has not responded to treatment (refractory). This includes:
    • First relapse that happened within 24 months after the disease was in full remission and when another drug called nelarabine is not suitable.
    • Second or later relapses.
    • Refractory disease, meaning the cancer did not improve after at least two rounds of chemotherapy (initial treatment plus a salvage regimen).
    • Relapse after a stem‑cell transplant or after CAR‑T cell therapy.
    • There must be enough blast cells (immature leukemia cells) in your blood or bone‑marrow that can be sent to one of the three reference laboratories in France, Spain, or the Netherlands, or you must have had a recent (within 10 days) lab test showing at least one approved targeted treatment option such as:
      • venetoclax + tofacitinib
      • venetoclax + everolimus + enrylaze
      • venetoclax + 5‑azacytidine
      • Your overall health must be rated as an ECOG score of 0 to 3. This score measures how well you can perform daily activities, where 0 means fully active and 3 means you are still able to care for yourself but are limited.
      • You must be covered by your country’s national health system (public health insurance).
      • You must not have any medical reason (a contra‑indication) that prevents you from taking the study drugs: venetoclax, tofacitinib, everolimus, enrylaze, or 5‑azacytidine.
      • If you are a woman who could become pregnant, or a man whose partner could become pregnant, you must agree to use an effective form of contraception during the study and for at least three months after it ends.

Who cannot join the trial?

13 criteria

  • Being in palliative care, which means care focused on comfort rather than trying to cure the disease.
  • Having received any live or weakened (live‑attenuated vaccines) within 4 weeks before the first dose of the study medicine.
  • Having a psychiatric disorder (a mental health condition) or any other problem that makes it difficult to follow the study procedures.
  • Having a late relapse, meaning the leukemia came back more than 24 months after the first complete remission.
  • Having only an extramedullary relapse (the disease returning outside the bone marrow) or having symptoms from the central nervous system (CNS) (brain or spinal fluid) involvement.
  • Being pregnant or lactating (breast‑feeding).
  • Participating in another clinical trial with an experimental drug at the time of enrollment.
  • Having another active cancer that is not under control (active uncontrolled malignancy).
  • Having an active infection with HBV (hepatitis B), HCV (hepatitis C), or HIV (human immunodeficiency virus).
  • Being under legal guardianship (curatorship) or being in prison (deprived of liberty), except for children.
  • Having a contra‑indication to chemotherapy (a reason not to use chemotherapy), such as:
    • Liver enzymes ASAT (SGOT) or ALAT (SGPT) more than 5 times the normal limit (ULN).
    • Total bilirubin 2.5 times the normal limit.
    • Glomerular filtration rate (GFR) below 50 mL/min, measured using the MDRD equation.
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Investigated drugs

  • Venetoclax

    is an oral tablet that helps kill cancer cells by blocking a protein that lets them survive. In this trial, it is given to patients with relapsed or refractory T‑cell acute lymphoblastic leukemia to see if it improves the blood‑cancer response when used in a precision‑medicine combination.

  • Enrylaze

    (recombinant L‑asparaginase) is a liquid given through a vein. It works by removing a nutrient called asparagine that leukemia cells need to grow. In the study, it is added to the treatment plan to test whether cutting off this nutrient helps control the disease.

  • XELJANZ

    (tofacitinib) is an oral tablet that blocks certain signals inside cells that can promote cancer growth. The trial uses it to explore if interrupting these signals can boost the effectiveness of other targeted drugs for T‑cell leukemia.

  • Azacitidine

    is a powder that is mixed for injection under the skin. It works by changing the way genes are read in cancer cells, which can slow their growth. In this trial, it is tested as part of a precision‑medicine regimen to see if it helps patients achieve a better blood‑cancer response.

  • Afinitor

    (everolimus) is an oral tablet that blocks a pathway that cancer cells use to grow and survive. The study includes it to determine whether stopping this pathway can improve outcomes when combined with other targeted treatments for T‑cell acute lymphoblastic leukemia.

What is already known about the treatment

  • Venetoclax

    Venetoclax is taken by mouth as a film‑coated tablet. It is an approved medicine for several blood cancers and is widely reported in medical studies. It works by binding to the BCL‑2 protein, which helps cancer cells die, and it is classified as a BCL‑2 inhibitor, a type of targeted therapy.

  • Enrylaze

    Enrylaze is given by intravenous injection as a clear solution. It is an approved enzyme drug for treating acute lymphoblastic leukemia and is described in many clinical papers. The drug removes the amino acid asparagine that leukemia cells need to grow, and it belongs to the asparaginase class of antineoplastic enzymes.

  • XELJANZ

    XELJANZ is taken orally as a film‑coated tablet. It is an approved treatment for rheumatoid arthritis and ulcerative colitis and is frequently referenced in research on immune diseases. It blocks Janus kinase (JAK) enzymes that send signals for inflammation, and it is classified as a JAK inhibitor, a targeted oral medication.

  • Azacitidine Mylan

    Azacitidine Mylan is given by subcutaneous injection as a powder that forms a suspension. It is an approved drug for myelodysplastic syndromes and acute myeloid leukemia and is well documented in the literature. The medicine adds small chemical groups to DNA, slowing the growth of cancer cells, and it is classified as a hypomethylating agent.

  • Afinitor

    Afinitor is taken by mouth as a regular tablet. It is an approved therapy for several cancers such as kidney and breast cancer and appears in many clinical studies. It works by blocking the mTOR pathway, which cancers use to grow, and it is classified as an mTOR inhibitor, a type of targeted cancer drug.

Investigated diseases

T-cell acute lymphoblastic leukemia - It is a blood cancer where immature T‑cell precursors grow uncontrollably in the bone marrow, crowding out normal blood cells. This can lead to low blood counts, causing fatigue, easy bruising, and frequent infections. When the disease is relapsed or refractory, it returns after initial treatment or fails to respond, and the abnormal cells keep increasing. The leukemia may spread to other organs such as the spleen or central nervous system. Over time, the growing number of cancerous T‑cells can worsen these symptoms.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516570-30-00Estimated enrolment86 patientsSponsorCentre Hospitalier De Versailles

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