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Study comparing standard and reduced intensity treatment in patients with acute myeloid leukemia or chronic lymphocytic leukemia who have no detectable disease after initial therapy

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What is this trial about?

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

This clinical trial studies patients with Acute Myeloid Leukemia (AML) and Chronic Lymphocytic Leukemia (CLL). The study evaluates different treatment approaches based on the presence of minimal residual disease (MRD), which refers to cancer cells that may remain after initial treatment. For AML patients, the study compares standard intensity treatment involving stem cell transplantation with reduced intensity treatment. For CLL patients, the study examines whether treatment can be stopped early in patients who show no detectable disease.

The treatments used in this study include several anti-cancer medications: cytarabine, daunorubicin, etoposide, cladribine, mitoxantrone, obinutuzumab, ibrutinib, venetoclax, and fludarabine. Some patients may also receive cyclophosphamide, busulfan, or treosulfan as part of their treatment. The medications are given either through intravenous infusion or as oral tablets, depending on the specific drug.

The main purpose of this study is to determine if less intensive treatment can be as effective as standard treatment in patients who show no signs of remaining disease after initial therapy. The study will monitor patients' survival, side effects, and whether the disease returns after treatment. Participants will be followed for several years to evaluate the long-term effectiveness of these treatment approaches.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial diagnosis and classification

    Your condition will be classified as either Acute Myeloid Leukemia (AML) or Chronic Lymphocytic Leukemia (CLL).

    A bone marrow test will be performed to determine your specific disease characteristics.

  2. Step 2

    Treatment pathway - AML patients

    You will receive 1-2 cycles of standard chemotherapy treatment using combinations of medications given through an IV (intravenous) line.

    The medications may include: cytarabine, daunorubicin, etoposide, or mitoxantrone.

    After treatment, your bone marrow will be tested to check for remaining cancer cells (called MRD - Minimal Residual Disease).

  3. Step 3

    Treatment pathway - CLL patients

    You will receive either 7 or 9 cycles of treatment, depending on your specific treatment plan.

    Treatment may include combinations of: venetoclax (taken by mouth) with either obinutuzumab (given by IV) or ibrutinib (taken by mouth).

    Blood tests will be performed to check for remaining cancer cells.

  4. Step 4

    Treatment assignment - AML patients

    If your tests show no detectable cancer cells, you will be randomly assigned to one of two groups:

    Group 1: Stem cell transplant (alloHCT)

    Group 2: Standard consolidation treatment without stem cell transplant

  5. Step 5

    Treatment assignment - CLL patients

    If your tests show no detectable cancer cells, you will be randomly assigned to one of two groups:

    Group 3: Complete the full planned treatment duration

    Group 4: Stop treatment early

  6. Step 4

    Follow-up period

    Regular check-ups will continue to monitor your response to treatment.

    The study will continue until May 2030.

Who can join the trial?

10 criteria

  • Age requirements: patients must be between 18-70 years old for AML arm, or 65 years or older for CLL arm

  • Must be newly diagnosed with either:

    • Acute myeloid leukemia (AML) or
    • Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
  • Must provide written informed consent to participate in the study
  • Must not participate in other clinical trials while in this study
  • Must be able to use effective birth control methods during treatment and for 6 months after treatment ends

  • Female patients must:

    • Not breastfeed during treatment and for up to 18 months after treatment
    • Have a negative pregnancy test before starting treatment
    • Agree to regular pregnancy testing during treatment
  • Male patients must not donate sperm during treatment and for 6 months after treatment ends

  • For AML patients:

    • Must be fit enough for stem cell transplant
    • Must have achieved remission after initial chemotherapy
    • Must have a suitable stem cell donor available

  • For CLL patients:

    • Must have active disease requiring treatment
    • Must be either untreated or in first-line treatment
    • Must have suitable blood markers for monitoring disease levels
  • Must be registered in the special disease monitoring registry

Who cannot join the trial?

12 criteria

  • Patients under 18 years old
  • Patients with acute myeloid leukemia (AML) who have received more than 2 cycles of chemotherapy
  • Patients with chronic lymphocytic leukemia (CLL) who have received previous treatment
  • Pregnant or breastfeeding women
  • Patients unable to provide informed consent
  • Patients with active uncontrolled infections
  • Patients with severe heart, liver, or kidney problems that would make treatment unsafe
  • Patients participating in other clinical trials
  • Patients with known allergies to the study medications
  • Patients who cannot follow the study protocol or attend required visits
  • Patients with mental conditions that could interfere with study compliance
  • Patients with myelodysplastic syndrome (MDS) who do not meet the WHO 2022 classification criteria
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Investigated drugs

  • ETOPOSIDE

    is a chemotherapy medicine given through a vein. In this trial it is used as part of the standard‑intensity treatment for patients with acute myeloid leukemia (AML) to help kill cancer cells after the initial induction phase.

  • DAUNORUBICIN

    is a chemotherapy drug that is also given by vein infusion. It is included in the standard‑intensity AML regimen and works by interfering with the DNA of leukemia cells, helping to stop their growth.

  • BUSULFAN

    is a chemotherapy agent given by vein infusion. In the study it serves as a comparison treatment (reduced‑intensity) for AML patients during the consolidation phase, aiming to maintain remission with less intense therapy.

  • CYTARABINE AND DAUNORUBICIN

    is a combination of two chemotherapy drugs given together through an intravenous drip. This mixture is used in the standard‑intensity AML arm to provide a stronger attack on leukemia cells after induction therapy.

  • FLUDARABINE

    is a chemotherapy medication administered intravenously. It is part of the standard‑intensity AML consolidation regimen, helping to prevent the return of leukemia by targeting dividing cancer cells.

  • OBINUTUZUMAB

    is a targeted antibody therapy given as an infusion. In the trial it is used as a comparison (reduced‑intensity) treatment for patients with chronic lymphocytic leukemia (CLL) to see if a less aggressive approach can still keep the disease under control.

What is already known about the treatment

  • ETOPOSIDE

    This drug is given by slow intravenous injection. It is an approved chemotherapy used worldwide for several blood cancers, including acute myeloid leukemia. It works by interfering with an enzyme called topoisomerase II, which prevents cancer cells from repairing their DNA. It belongs to the class of topoisomerase II inhibitors.

  • DAUNORUBICIN

    Daunorubicin is administered as an intravenous infusion. It is a standard, approved treatment for acute myeloid leukemia and other leukemias. It binds to DNA and blocks an enzyme called topoisomerase II, causing DNA breaks that kill cancer cells. It is classified as an anthracycline antibiotic chemotherapy.

  • BUSULFAN

    Busulfan is given by intravenous infusion. It is an established alkylating chemotherapy used in bone‑marrow transplant conditioning and some leukemias. It adds chemical groups to DNA, which prevents the cells from dividing. It belongs to the class of alkylating agents.

  • CYTARABINE AND DAUNORUBICIN

    This combination is delivered as an intravenous drip. Both drugs are approved for treating acute myeloid leukemia and are often used together to increase effectiveness. Cytarabine blocks DNA building blocks, while daunorubicin interferes with topoisomerase II, together causing DNA damage that kills cancer cells. The regimen combines an antimetabolite (cytarabine) with an anthracycline (daunorubicin).

  • FLUDARABINE

    Fludarabine is given by intravenous injection. It is an approved therapy for chronic lymphocytic leukemia and certain other blood cancers. It mimics a building block of DNA, causing faulty DNA synthesis that stops cancer cell growth. It is classified as a purine analog antimetabolite.

  • OBINUTUZUMAB

    Obinutuzumab is provided as an infusion solution for intravenous use. It is an approved monoclonal antibody for chronic lymphocytic leukemia and other B‑cell cancers, and has orphan‑drug status for some rare conditions. It attaches to the CD20 protein on B‑cells, marking them for destruction by the immune system. It belongs to the class of anti‑CD20 monoclonal antibodies.

Investigated diseases

  • Acute Myeloid Leukemia (AML)

    A type of blood cancer that begins in the bone marrow and affects the production of normal blood cells. In AML, immature blood cells called myeloblasts accumulate in the bone marrow and fail to develop into healthy blood cells. The condition develops rapidly, with abnormal cells multiplying quickly and interfering with normal blood cell production. AML can arise as a new condition or develop from a pre-existing blood disorder called myelodysplastic syndrome (MDS).

  • Myelodysplastic Syndrome (MDS)

    A group of blood disorders where bone marrow fails to produce enough healthy blood cells. The blood cells that are produced are abnormal in shape and function. MDS develops gradually and can progress over time, affecting the production of red blood cells, white blood cells, and platelets.

  • Chronic Lymphocytic Leukemia (CLL)

    A slow-growing blood cancer that affects white blood cells called lymphocytes. In CLL, abnormal lymphocytes accumulate primarily in the blood and bone marrow. The condition typically develops slowly, and many people don't experience symptoms in early stages. The abnormal cells gradually crowd out healthy blood cells and can spread to lymph nodes and other organs.

  • Small Lymphocytic Lymphoma (SLL)

    A type of blood cancer that is essentially the same disease as CLL but primarily affects the lymph nodes rather than the blood and bone marrow. SLL develops when abnormal lymphocytes accumulate in the lymph nodes. The condition progresses slowly, causing enlarged lymph nodes and potentially affecting other lymphoid tissues.

Trial detailsLast updated 21 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512503-39-00Protocol codeRESOLVE trialEstimated enrolment365 patientsSponsorMedizinische Hochschule Hannover

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