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

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What is this study about?

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.

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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Universitaet Leipzig	Leipzig	Germany

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Geniko Nosokomeio Thessalonikis George Papanikolaou	Thessaloniki	Greece
Hippokration Hospital	Athens	Greece
Evangelismos S.A.	Athens	Greece
University General Hospital Of Thessaloniki Ahepa	Thessaloniki	Greece
University General Hospital Of Ioannina	Ioannina	Greece
Klinikum Chemnitz gGmbH	Chemnitz	Germany
General University Hospital Of Patras	Patras	Greece
University General Hospital Of Alexandroupoli	Alexandroupoli	Greece
Lghmg Ggygxbh Htmyinfw Oo Atuqol	Athens	Greece
Aebuubr Oqwaaonmbbv Naywastfo Sd Avsxdgr E Bsvtwv E C Aorqjz Aztwcfnrlof	Alexandria	Italy
Cjthvo Hpjoqkdwlyx Rstinzvt Drssprpisatkpl	Angers	France
Uvfifwidfv Gddgknw Hbqhlbmh Aeuxdev	Athens	Greece

Trial status

Country	Status	Recruitment Start
France	Not recruiting	03.09.2021
Germany	Not recruiting	03.09.2021
Greece	Not recruiting	03.09.2021
Italy	Not recruiting	03.09.2021
Spain	Not recruiting	03.09.2021

Trial locations

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.

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 ID:

2024-516405-23-00

Protocol code:

SLSG18-301

NCT ID:

NCT04229979

Trial Phase:

Therapeutic confirmatory (Phase III)

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?