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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

Based on the provided trial information, this study involves standard chemotherapy treatments for AML (Acute Myeloid Leukemia) and CLL (Chronic Lymphocytic Leukemia), but specific medications are not explicitly mentioned in the source data. Allogeneic hematopoietic cell transplantation (alloHCT) is a therapy mentioned in the trial for AML patients. This is a procedure where healthy blood-forming stem cells from a donor are used to replace the patient's diseased bone marrow. The trial compares standard intensity versus reduced intensity consolidation treatments, but the specific medications used in these treatments are not detailed in the provided data. The trial also mentions fixed duration treatments for CLL patients, but again, the specific medications are not listed in the source data. Note: Without more specific information about the medications used in the induction chemotherapy and consolidation treatments, I cannot provide details about individual drugs involved in this trial.

What is already known about the treatment

Since no specific medications are mentioned in the provided trial data, I cannot create medication descriptions in the requested format. The data describes a clinical trial comparing different treatment intensities for AML (Acute Myeloid Leukemia) and CLL (Chronic Lymphocytic Leukemia) patients, but doesn't specify particular medications. The trial focuses on MRD (Minimal Residual Disease) monitoring and treatment strategies rather than specific drug evaluations. If you'd like medication descriptions, please provide the names of specific medications involved in the trial, and I will create descriptions according to your requested format.

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 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512503-39-00Protocol codeRESOLVE trialEstimated enrolment365 patientsSponsorMedizinische Hochschule Hannover

sourced from the EU Clinical Trials Register and site verification

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