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Study of Galinpepimut-S compared to standard therapy for patients with acute myeloid leukemia who achieved complete remission after second-line treatment

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 studies the effectiveness and safety of Galinpepimut-S compared to standard treatment options in patients with Acute Myeloid Leukemia who have achieved a second or later complete remission after salvage therapy. The study uses several medications including Azacitidine, Sargramostim, Cytarabine, Venetoclax, and Decitabine.

The main purpose is to determine if Galinpepimut-S helps patients live longer compared to currently available treatments. The medication is given through injections under the skin, and patients will be monitored regularly to track their response to treatment and any side effects.

The study will evaluate how long patients survive without their disease returning and will also measure the presence of remaining cancer cells in the body. Treatment may continue for up to 36 months, depending on how well patients respond and tolerate the medication.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment and treatment group assignment

    After joining the study, you will be randomly assigned to one of two treatment groups: either Galinpepimut-S (GPS) or Best Available Treatment (BAT) chosen by your doctor

    Your blood tests will be reviewed to confirm you meet the requirements: platelet count above 20,000/µL, neutrophil count above 1,000/µL, and lymphocyte count above 300/µL

  2. Step 2

    Treatment administration

    If assigned to the GPS group, you will receive the medication through an injection under the skin (subcutaneous injection)

    If assigned to the BAT group, you may receive one of these treatments:

    - Azacitidine as an injection under the skin

    - Venetoclax as tablets taken by mouth

    - Decitabine through an intravenous infusion

    - Cytarabine either through intravenous infusion or as an injection under the skin

  3. Step 3

    Monitoring period

    Regular check-ups will monitor your response to treatment

    Blood tests will be performed to check your blood cell counts

    Bone marrow tests will be conducted to check for any signs of leukemia returning

    Your overall health and any side effects will be monitored

  4. Step 4

    Study completion

    The study will continue until June 2026

    Your participation may end earlier if your condition changes or you choose to stop

    Follow-up visits will continue to monitor your health status

Who can join the trial?

16 criteria

  • Must be able to understand and provide signed informed consent for the study
  • Must be at least 18 years of age
  • Must have been diagnosed with Acute Myeloid Leukemia (AML) according to WHO criteria
  • Must be in second or later complete remission with blood platelet count above 20,000/µL
  • Must have more than 300 lymphocytes (white blood cells) per microliter of blood
  • Must not be eligible for stem cell transplant at the time of study entry
  • Must have completed previous leukemia treatment at least 4 weeks before starting the study
  • Must have achieved remission within the last 6 months
  • Must have a performance status rating of 0-3 on the ECOG scale (measure of daily living abilities)
  • Must have a life expectancy greater than 6 months
  • For women of childbearing age: must have a negative pregnancy test
  • Must use effective contraception during the study and for 4-6 months after the last dose
  • Must have recovered from side effects of previous treatments (except for platelet count)
  • Must not have end-stage kidney disease
  • Must have adequate liver function as measured by blood tests
  • Must be willing to attend follow-up visits and comply with study requirements

Who cannot join the trial?

15 criteria

  • History of bone marrow transplant or other stem cell therapy
  • Active or uncontrolled infections requiring intravenous antibiotics
  • Uncontrolled or severe heart conditions, including heart failure or recent heart attack (within 6 months)
  • Severe liver problems (liver function tests more than 3 times above normal limits)
  • Severe kidney problems requiring dialysis
  • Presence of active or untreated cancer in other parts of the body
  • Participation in other clinical trials within the past 30 days
  • Pregnant or breastfeeding women
  • Known allergic reactions to similar treatments
  • Mental conditions that could affect ability to provide informed consent
  • Uncontrolled high blood pressure (hypertension)
  • Major surgery within the past 4 weeks
  • HIV, hepatitis B, or hepatitis C infection
  • Life expectancy less than 3 months
  • Use of medications that could interfere with the study treatment
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Investigated drugs

  • Galinpepimut-S (GPS)

    is a therapeutic vaccine designed to help maintain remission in patients with acute myeloid leukemia. It works by stimulating the immune system to recognize and fight against specific proteins found on leukemia cells, potentially preventing the cancer from returning after treatment.

  • Best Available Therapy (BAT)

    refers to the standard treatment options chosen by the physician based on individual patient needs. This could include various approved medications or therapies that are considered the most appropriate treatment for maintaining remission in acute myeloid leukemia patients after their second complete remission.

What is already known about the treatment

Galinpepimut-S (GPS) - A therapeutic peptide vaccine administered via injection that is currently being investigated in clinical trials for acute myeloid leukemia (AML) maintenance therapy. The medication is designed to work as an immunotherapy by targeting the Wilms Tumor 1 (WT1) protein, which is overexpressed in leukemia cells, helping the immune system recognize and attack cancer cells. It is specifically being studied in patients who have achieved complete remission after second-line salvage therapy, representing a novel approach to maintaining remission in AML patients. The drug belongs to the class of cancer vaccines and immunotherapeutic agents, showing promise in preventing disease relapse in patients who have responded to previous treatments.

Investigated diseases

Acute Myeloid Leukemia (AML) - A type of blood and bone marrow cancer that develops when young blood cells called myeloid cells begin growing abnormally. In AML, immature blood cells (blasts) build up in the bone marrow and fail to develop into healthy blood cells. The disease progresses rapidly, affecting the production of normal white blood cells, red blood cells, and platelets. Complete remission occurs when blood cell counts return to normal and no leukemia cells are detected in bone marrow samples. Second or later remission (CR2/CRp2) refers to achieving this state after the disease has returned following initial treatment.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516405-23-00Protocol codeSLSG18-301Estimated enrolment171 patientsSponsorSellas Life Sciences Group Inc.

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