Ongoing Clinical Trials for Acute Myeloid Leukaemia (in Remission)
There are currently 4 clinical trials recruiting patients with acute myeloid leukaemia in remission across Europe. These studies are testing different treatment approaches, including stem cell transplantation preparation, maintenance therapies to prevent relapse, and therapeutic vaccines. Trials are being conducted in France, Germany, Greece, Spain, Italy, the Czech Republic, and Hungary.
Clinical trial locations
- Czechia
- France
- Study Comparing Clofarabine/Busulfan and Fludarabine/Busulfan for Adults with Acute Myeloid Leukemia Eligible for Stem Cell Transplantation
- Study of Venetoclax and Azacitidine for Maintenance Therapy in Patients with Acute Myeloid Leukemia in First Remission After Chemotherapy
- Study of Galinpepimut-S compared to standard therapy for patients with acute myeloid leukemia who achieved complete remission after second-line treatment
- Germany
- Greece
- Hungary
- Italy
- Study of Venetoclax and Azacitidine for Maintenance Therapy in Patients with Acute Myeloid Leukemia in First Remission After Chemotherapy
- Study of Galinpepimut-S compared to standard therapy for patients with acute myeloid leukemia who achieved complete remission after second-line treatment
- Study on the Effectiveness of Decitabine and Venetoclax for Patients with Acute Myeloid Leukemia Unfit for Intensive Chemotherapy
- Spain
Study Comparing Clofarabine/Busulfan and Fludarabine/Busulfan for Adults with Acute Myeloid Leukemia Eligible for Stem Cell Transplantation
This trial compares two different medication combinations used to prepare patients for stem cell transplantation. Both combinations include busulfan, paired with either clofarabine or fludarabine. These medications are given before the transplant to reduce the number of cancer cells and make room for new, healthy stem cells to grow.
Main inclusion criteria: Participants must be at least 18 years old and have acute myeloid leukaemia in complete remission, meaning less than 5% of certain abnormal cells remain in the bone marrow. Patients must be eligible for a reduced intensity conditioning regimen, which is typically suitable for those aged 60 or older, or younger patients with other health concerns. A matched donor for stem cell transplantation is required, and the transplant must use peripheral blood stem cells. Participants must have a performance status of 0 to 2 on the ECOG scale, which measures their ability to carry out daily activities.
Main exclusion criteria: Patients who are not in complete remission or who do not have acute myeloid leukaemia cannot participate. Those outside the specified age range or who are considered part of a vulnerable population are also excluded.
Focus of the trial: The study aims to determine which of the two medication combinations results in better survival rates over a two-year period. Researchers will monitor how well the new stem cells are accepted by the body, how quickly blood cell counts recover, and whether any side effects occur. The trial will also assess quality of life and immune system recovery following transplantation.
Investigational drugs: Clofarabine and fludarabine are both chemotherapy drugs that work by interfering with DNA synthesis, preventing cancer cells from multiplying. Busulfan is used to slow or stop cancer cell growth, helping to prepare the body for transplant.
Study of Venetoclax and Azacitidine for Maintenance Therapy in Patients with Acute Myeloid Leukemia in First Remission After Chemotherapy
This study tests a combination of venetoclax and azacitidine as maintenance therapy for patients who have achieved their first remission after standard chemotherapy. Maintenance therapy aims to keep the cancer from returning after initial treatment has successfully controlled it.
Main inclusion criteria: Patients must be at least 18 years old with newly diagnosed acute myeloid leukaemia and intermediate or poor risk genetic characteristics. They must have achieved complete remission or complete remission with incomplete blood count recovery after intensive chemotherapy. Patients should have started study treatment within 120 days of achieving remission, or within 75 days of their last chemotherapy dose. An ECOG performance status of 0, 1, or 2 is required. Blood tests must show adequate kidney and liver function, with creatinine clearance of at least 30 mL/minute, appropriate bilirubin levels, neutrophil count of at least 1,500 per microliter, and platelets of at least 100,000 per microliter.
Main exclusion criteria: Patients who have not achieved complete remission or who fall outside the specified age range are excluded. Those not meeting the clinical trial group criteria or who are part of vulnerable populations cannot participate.
Focus of the trial: The study will determine the best dose of venetoclax when combined with azacitidine. It will monitor the safety and effectiveness of this combination in maintaining remission and preventing the cancer from returning. Regular assessments will track patients’ health and any dose-limiting side effects.
Investigational drugs: Venetoclax is a targeted therapy that works by blocking the BCL-2 protein, which helps cancer cells survive. By inhibiting this protein, venetoclax promotes cancer cell death. Azacitidine interferes with cancer cell DNA, disrupting their growth and leading to cell death. It is classified as a hypomethylating agent.
Study of Galinpepimut-S compared to standard therapy for patients with acute myeloid leukemia who achieved complete remission after second-line treatment
This trial compares galinpepimut-S, a therapeutic vaccine, with standard treatment options for patients who have achieved a second or later remission after their cancer returned and was treated again. The goal is to determine whether this vaccine helps patients live longer compared to currently available treatments.
Main inclusion criteria: Participants must be at least 18 years old with acute myeloid leukaemia in second or later complete remission. Blood tests must show platelet count above 20,000/µL, neutrophil count above 1,000/µL, and lymphocyte count above 300/µL. Patients must not be eligible for stem cell transplant at the time of entry and should have completed previous treatment at least 4 weeks before starting the study. Remission must have been achieved within the last 6 months. An ECOG performance status of 0-3 and life expectancy greater than 6 months are required. Women of childbearing age must have a negative pregnancy test, and effective contraception must be used during the study and for 4-6 months after the last dose. Patients must have adequate liver function and be willing to attend follow-up visits.
Main exclusion criteria: Patients with a history of bone marrow or stem cell transplant, active uncontrolled infections, severe heart conditions, severe liver or kidney problems, or other active cancers are excluded. Those who have participated in other clinical trials within the past 30 days, pregnant or breastfeeding women, and patients with known allergies to similar treatments cannot participate. Uncontrolled high blood pressure, major surgery within 4 weeks, HIV or hepatitis infections, and life expectancy less than 3 months are also exclusion criteria.
Focus of the trial: The study will evaluate whether galinpepimut-S helps patients maintain remission longer than standard treatments. Researchers will monitor how long patients survive without their disease returning and measure the presence of any remaining cancer cells in the body. Treatment may continue for up to 36 months.
Investigational drugs: Galinpepimut-S is a therapeutic vaccine given through injections under the skin. It stimulates the immune system to recognize and fight against specific proteins found on leukaemia cells, particularly the Wilms Tumor 1 (WT1) protein. The comparison group receives best available therapy chosen by the physician, which may include various approved medications.
Study on the Effectiveness of Decitabine and Venetoclax for Patients with Acute Myeloid Leukemia Unfit for Intensive Chemotherapy
This study tests the combination of decitabine and venetoclax in patients with acute myeloid leukaemia that developed from myeloproliferative neoplasms, a group of blood disorders. The trial is specifically for patients who are not suitable candidates for intensive chemotherapy.
Main inclusion criteria: Patients must have newly diagnosed, untreated acute myeloid leukaemia that developed from myeloproliferative neoplasms. They should be 60 years or older, or adults of any age who are not suitable for intensive treatment. An ECOG performance status of 0 to 2 is required, though a score of 3 is acceptable if it is due to the disease and reversible with proper care. Written consent must be provided. Male patients with partners who can become pregnant must use reliable birth control during the study and for 3 months after the last dose of decitabine, with female partners continuing contraception for 1 month after venetoclax or 6 months after decitabine, whichever is longer.
Main exclusion criteria: Patients with cancers unrelated to acute myeloid leukaemia secondary to myeloproliferative neoplasms are excluded. Those who are fit for intensive chemotherapy cannot participate. Patients outside the specified age range or not part of the selected clinical trial group are also excluded.
Focus of the trial: The study evaluates how effective the combination of decitabine and venetoclax is in improving patients’ conditions. It will monitor how long patients live without the disease worsening, overall survival, and any side effects. Researchers will collect information on how patients respond to treatment, including changes in blood counts and overall health.
Investigational drugs: Decitabine is given as an intravenous infusion and works by incorporating into DNA and inhibiting DNA methyltransferase, leading to the reactivation of genes that control cell growth. Venetoclax is taken orally as tablets and works by inhibiting the BCL-2 protein, which helps cancer cells survive, thereby promoting their death.
Summary
Four clinical trials are currently recruiting patients with acute myeloid leukaemia in remission across Europe. These studies represent different treatment approaches depending on the stage and characteristics of the disease. The trials are concentrated primarily in France, Germany, Italy, Greece, and Spain, with additional sites in the Czech Republic and Hungary.
Two trials focus on maintenance therapy using venetoclax combined with azacitidine or decitabine to prevent disease relapse after achieving remission. Another study tests galinpepimut-S, a therapeutic vaccine that stimulates the immune system, for patients in second remission. The fourth trial compares two different medication combinations to prepare patients for stem cell transplantation.
Venetoclax appears in multiple trials, highlighting ongoing research interest in this BCL-2 inhibitor for maintaining remission. The studies accommodate different patient populations, from those fit for intensive treatments to those requiring gentler approaches, offering options for patients at various stages of their treatment journey.
