Clinical trials on Acute Myeloid Leukemia (AML)

Understanding Acute Myeloid Leukemia (AML)

Acute Myeloid Leukemia (AML) is a formidable and rapidly progressing form of cancer that originates in the bone marrow but quickly moves into the blood. It is characterized by the uncontrolled growth of immature white blood cells, known as myeloblasts, which impede the production of normal blood cells. This disruption leads to a myriad of health issues, including anemia, infections, and excessive bleeding. AML is known for its heterogeneity, presenting a wide array of genetic mutations, which complicates its treatment and prognosis.

The diagnosis of AML typically involves a combination of blood tests, bone marrow aspiration, and biopsy, alongside sophisticated genetic testing to identify specific mutations. Treatment strategies are highly personalized, taking into account the patient’s age, general health, and the specific subtype of AML. Options may include chemotherapy, targeted therapy, and in some cases, stem cell transplantation. Despite the aggressive nature of AML, advancements in medical research have led to the development of new treatments that are improving survival rates and quality of life for many patients.

It is crucial for individuals diagnosed with AML to receive care from a multidisciplinary team of specialists. This team approach ensures that patients benefit from the latest treatments and comprehensive support, addressing not only the physical challenges of the disease but also the emotional and psychological aspects. With ongoing research and clinical trials, there is hope for even more effective therapies in the future, offering a beacon of hope for those affected by this challenging condition.

Understanding Acute Myeloid Leukemia (AML)

Acute Myeloid Leukemia (AML) is a fast-progressing cancer of the blood and bone marrow. The prognosis for AML varies significantly depending on several factors, including age, the subtype of AML, and the presence of specific genetic mutations. Generally, younger individuals tend to have a more favorable prognosis compared to older ones, as they are often better candidates for aggressive treatments like chemotherapy and bone marrow transplants. The long-term prospects for individuals with AML have improved over the years due to advances in medical research and the development of targeted therapies. However, the overall five-year survival rate for AML remains relatively low, with outcomes differing widely based on the cytogenetic profile of the disease. Early detection and prompt medical intervention can influence the course of AML, but the aggressive nature of the disease often makes the prognosis uncertain, necessitating ongoing research and treatment optimization.

Complications of Acute Myeloid Leukemia

Acute Myeloid Leukemia (AML) can lead to several serious complications that impact health and daily life. One common issue is an increased risk of infections due to a weakened immune system, resulting in more frequent and severe illnesses. Anemia, a condition characterized by a lack of enough healthy red blood cells, is another complication that can cause fatigue and shortness of breath, making everyday activities challenging. Bleeding problems may also arise because AML affects the blood’s ability to clot, leading to excessive bruising or bleeding from minor cuts. Additionally, there may be weight loss and a decreased appetite, which can weaken the body further. These complications can significantly affect quality of life, making it difficult to maintain normal routines and enjoy activities once loved.

Managing Acute Myeloid Leukemia

For the management of Acute Myeloid Leukemia, several non-clinical trial options are recommended. These include:

  • Dietary adjustments, focusing on a balanced intake of fruits, vegetables, whole grains, and lean proteins, can support overall health.
  • Regular physical activity, tailored to individual ability, may enhance well-being and energy levels.
  • Pharmacotherapy, including the use of specific non-chemotherapy drugs, may be advised to help manage symptoms or side effects of the primary treatment. These medications should be taken under medical supervision.
  • Modern technology offers tools for monitoring health parameters and medication schedules, which can be beneficial for patients. Mobile apps and wearable devices can track physical activity and provide reminders for medication adherence.

Consultation with healthcare professionals is important before making any changes to treatment plans. These alternative methods should complement, not replace, the primary treatment strategy provided by medical experts.

  • CT-EU-00114995

    Evaluating Idasanutlin in Combination Therapy for Young Patients with Leukemia or Solid Tumors

    This clinical trial is an important study that aims to find out how safe and effective a new treatment called Idasanutlin is when used alone or in combination with either chemotherapy or a medication named Venetoclax. This study is specifically for children and young adults who have certain types of cancer that have not responded to previous treatments. These cancers include Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Neuroblastoma, and other solid tumors.

    The study is organized into three parts. The first part will focus on finding the highest dose of Idasanutlin that can be given safely to patients with solid tumors. After that, the study will look at how well Idasanutlin works in combination with chemotherapy or Venetoclax in patients with neuroblastoma, AML, and ALL. The goal is to determine the best dose of Idasanutlin to use in these combinations. In the second part of the study, new patients will be treated with these combinations to further evaluate their safety and how effective they are. There might be a third part to the study, which would allow even more patients to receive these treatments, providing more information on their safety and effectiveness.

    Idasanutlin will be taken orally once a day for the first 5 days of a 28-day cycle. Venetoclax’s dose will depend on the type of cancer being treated and will also be taken orally. The chemotherapy drugs used in the study include Cyclophosphamide, Topotecan, Fludarabine, and Cytarabine, which are given through an IV. Additionally, patients with leukemia will receive intrathecal chemotherapy to treat cancer cells in the spinal fluid.

    The main things the study will look at are how many patients experience side effects and how severe those side effects are, how many patients have serious side effects from the treatment, and how well the treatment works against the cancer. This includes looking at how many patients with neuroblastoma respond to the treatment, how many patients with leukemia achieve complete remission, and how many patients with ALL have no detectable cancer cells after treatment.

    This study is a chance for patients who have not had success with other treatments to try a new approach that could potentially be more effective. It’s also an opportunity to contribute to medical research that could help future patients with similar conditions.

    • cytarabine
    • Intrathecal Chemotherapy
    • Idasanutlin
    • Fludarabine
    • topotecan
    • Cyclophosphamide
    • Venetoclax
  • CT-EU-00091714

    Testing new potential drug with chemotherapy for young leukemia patients

    This is a study of a medicine called JNJ-75276617 when it is combined with usual chemotherapy treatment to help children and young adults battling difficult cases of acute leukemia. The researchers are testing varying doses of the new medicine in the first phase of the study to find the one that is most beneficial and safe when used with regular chemotherapy. The researchers will then use the preferred dose achieved from the first phase to continue testing in the second phase. Scientists are focused on safety and understanding any side-effects that might happen during the trial. These might range from mild discomfort to severe reactions. This trial will also check how the new medicine affects the number and development of dangerous leukemia cells. Researchers are also interested understanding how the new drug affects certain genes that contribute to leukemia.

    • pegaspargase
    • JNJ-75276617- new potential treatment for Acute myeloid leukemia
    • Cytarabine
    • Fludarabine
    • Vincristine
    • Dexamethasone
  • CT-EU-00091258

    Study of Idasanutlin in combination with chemotherapy or other drugs in acute leukemia patients

    This study involves testing a new medication, Idasanutlin, for patients with recurrent or challenging-to-treat leukemias or solid tumors. In certain cases, the new medication will be administered in combination with other anti-cancer drugs, either traditional chemotherapy medications or Venetoclax. The primary objective is to assess the medication for potential side effects and its effectiveness in treating the disease. Initially, efforts will focus on determining a safe and well-tolerated dose for the new medication. Subsequently, the study will further investigate the safety and initial effectiveness of combining this drug with others in three groups: neuroblastoma, acute myeloid leukemia (AML), and acute lymphoblastic leukemia (ALL).

    • Idasanutlin
    • Cytarabine
    • Fludarabine
    • topotecan
    • Cyclophosphamide
    • Venetoclax
  • CT-EU-00091440

    Investigating new drug, JNJ-75276617 for the treatment of patients with acute leukemia

    This study is about a new medicine called JNJ-75276617, designed to help patients with a type of blood cancer called Acute Leukemia. Acute leukemia is an illness where the bone marrow makes too many white blood cells that are abnormal. This study is divided into two parts: first, to figure out the best dose of the new medicine, and second, to check if it’s safe at that dose. For up to 2 years and 10 months, researchers will follow participants closely and check for any changes in their health. They will look at the number of participants who experience bad side effects, how much of the drug is in their bodies, and how the disease is responding to the new medicine. The main goal is to find a dose of the drug that’s both safe and can possibly help patients with acute leukemia.

    • JNJ-75276617- new potential treatment for Acute myeloid leukemia
  • Venetoclax in recurrence of blood cancer after previous stem cell transplantation

    This study aims to investigate the effectiveness and safety of a novel treatment approach, combining the drugs venetoclax and azacitidine, along with donor lymphocyte infusion (DLI) in patients experiencing a relapse of one of two of blood-related disorders: myelodysplastic syndrome (condition where blood cells do not develop properly) or acute myeloid leukemia (bone marrow cells become abnormal and begin to accumulate in excess), following stem cell transplantation. The study involves a group of patients for whom standard treatments have not yielded satisfactory results. The objective is to understand whether the combination of new drugs and donor lymphocyte infusion can effectively control these blood disorders, especially after stem cell transplantation. Researchers are monitoring side effects, assessing disease progression, and determining the safety of the procedure. The results may provide valuable insights into effective therapeutic strategies for these challenging blood-related disorders.
    • azacitidine
    • venetoclax
  • Study on effective dose of new potential drug for Leukemia or myelodysplastic syndrome treatment

    In this study, patients with a type of blood cancer, either Acute Myeloid Leukemia or Myelodysplastic Syndrome that has recurred or not responded to previous treatment, will be administered a new drug named CYAD-02. The initial phase of the study aims to determine the safe dosage of CYAD-02 for patients. Before receiving CYAD-02, patients will undergo a milder form of chemotherapy termed non-myeloablative preconditioning.

    The testing process is divided into three stages, each involving different doses of CYAD-02. The first CYAD-02 treatment will be administered after three consecutive days of chemotherapy. For patients showing stability, additional CYAD-02 treatments may be provided without preceding light chemotherapy. All patients who have received at least one CYAD-02 treatment will be monitored for approximately 15 years.

    • CYAD-02
    • ENDOXAN
    • Fludara
  • Studying effects of ruxolitinib and panobinostat on myelofibrosis and polycythemia vera

    This is a study to check the long-term safety of two drugs – Ruxolitinib alone or Ruxolitinib combined with Panobinostat. In that trial, patients can take part if they’ve previously been involved in a study by Novartis or Incyte, and the treatment was beneficial. All participants will receive either ruxolitinib monotherapy or ruxolitinib in combination with panobinostat, at the same dose/schedule that they were taking in the parent study. Researchers will look at participant’s general health and well-being. They’ll also note down any side effects or health problems that appear during taking the drugs.

    • panobinostat
    • Ruxolitinib
  • Testing new therapy for acute myeloid leukemia treatment

    This clinical trial is all about a potential new medicine called AB8939. This study is important for people with a difficult to treat type of blood cancer known as acute myeloid leukemia (AML). AML patients who didn’t get better with their first medicines, or whose cancer came back, are the ones the study is focusing on. To begin with, doctors want to see how safe AB8939 is and how much medicine a person can tolerate. The researchers will give increasing amounts of this medicine to different groups of patients, so they can find out the best amount to give. The second part of the study will use the dose found in the first part, and see its effects on more people. The ultimate goal is to see if the medicine can reduce or eliminate the cancer in these patients.

    • AB8939- new potential medication for acute myeloid leukemia
    • azacitidine
  • Testing new medicine to treat acute Myeloid Leukemia that returns

    This study introduces AFM28, a potential treatment for Acute Myeloid Leukemia (AML) with certain characteristics (CD123-positive). It’s the first trial of its kind, focusing on finding the safest and most effective dosage. Participants will receive the medicine through an IV once a week. The study will closely watch how they respond to the treatment, including any side effects, to ensure the drug is safe and working as intended. This research is crucial for developing new treatments for AML.

    • AFM28-new medication for acute myeloid leukemia
  • Study on the effects and safety of a new drug in leukemia patients

    In this trial, a medicine named oNKord is under evaluation for its effectiveness in treating Acute Myeloid Leukemia (AML), a type of blood cancer. The trial is for people who, although are getting better, but still have some remaining signs of AML and are not going for stem cell therapy. The study consists of two parts. In the initial phase, the focus is on determining the safe dosage of the medicine. Nine participants will receive the medicine three times, with four-day intervals between administrations. Following the safe dose determination, the second part involves administering the medicine to 24 individuals to evaluate its efficacy in managing AML. After the medicine is administered, regular check-ups will be conducted over the course of a year.

    • Cyclophosphamide-Fludarabine (Cy/Flu)
    • oNKord®
  • Ponatinib treatment for children with various advanced cancers

    This trial focuses on a drug called ponatinib, that is being studied for the treatment of children (aged 1-18) with different harsh illnesses such as leukemias, lymphomas, and solid tumors. The researchers want to understand how safe the drug is, how well it works, and what happens to the drug in the body. Researchers will monitor any side effects that occur within the first 28 days of taking ponatinib. The researchers will also check if the drug is helping to reduce the illness by checking if there are fewer cancer cells in the body. The effects of the drug on the tumor will be monitored through scans like CT or MRI.

    • Ponatinib
  • Examining midostaurin and chemotherapy for new child leukemia patients

    This research study is checking out a medication named Midostaurin. It is aimed at kids who have a certain type of blood cancer (FLT3-mutated Acute Myeloid Leukemia). The drug will be combined with the standard chemotherapy treatment. The researchers will look at how safe this combination is and how well it works. At the same time, they’ll examine how the body absorbs and gets rid of the medication. The study will have two parts. The first one is to figure out the best dosage, and the second one is to confirm how safe and effective it is. Both phases include 2 stages of chemotherapy to defeat the disease, 3 steps of follow-up chemo to make sure the disease doesn’t return, and a year-long treatment with Midostaurin on its own. If at any phase of the treatment, the disease comes back, the therapy will be stopped.

    • idarubicin
    • Midostaurin
    • Cytarabine
    • Daunorubicin
    • Mitoxantrone
    • Fludarabine
    • Etoposide
  • Testing venetoclax for kids with relapsed leukemia

    This health study is focused on children with a certain type of leukemia, which is a type of blood cancer, that has unfortunately returned after initial treatment. The trial is examining a new cancer medicine called venetoclax in combination with other standard cancer treatment drugs to see if it can help these children. Some children will receive the standard treatment and some will also get the additional new drug. The study will see if kids who get the new treatment have better outcomes. Venetoclax has been designed to block a protein called BCL-2 that some cancer cells produce to avoid being killed by the body’s natural defenses. By blocking this protein, the hope is that the cancer cells can be destroyed.

    • Gemtuzumab Ozogamicin
    • Cytarabine
    • Fludarabine
    • Azacitidine
    • Venetoclax
  • Comparing new drug-Cytarabine Danuorubicin with standard chemotheraphy in adults with Acute Myeloid Leukemia

    This study is comparing two types of strong medicine, or ‘chemotherapy’, used to treat a disease called Acute Myeloid Leukemia (AML). This disease can sometimes be harder to treat in some patients due to their genetics. In this study, some people will get the usual strong medicine, and some people will get a new type of strong medicine called CPX-351 (Cytarabine and Danuorubicin). The researchers will also look at who might get fully or almost fully better from the disease.This trial is investigating how a new kind of very strong drug, CPX-351, might work compared to the usual strong drug treatment for a blood cancer called Acute Myeloid Leukemia (AML). These drugs are used when someone has recently found out they have AML, and their body has certain genetic markers making it harder for usual treatments to work. This trial is also looking at different degrees of recovery. The treatments may work differently based on people’s genes.

    • Cytarabine and Danuorubicin/CPX-351
    • Cytarabine
    • Daunorubicin
  • Treatment of patients with acute myeloid leukemia using ivosidenib in combination with azacitidine

    This is a phase 3b medical study that will examine the effects of combining Ivosidenib and Azacitidine in adults who’ve been newly diagnosed with a type of blood cancer known as Acute Myeloid Leukemia (AML) with a gene mutation called IDH1. The study is designed specifically for patients who are not eligible for intensive induction chemotherapy. The research is open-label, meaning everyone knows which drug is being used — there’s no placebo or hidden drug. In this important study, key clinical data will be made available to qualified scientific and medical researchers.

    • Ivosidenib
    • Azacitidine