Clinical trials on Acute Lymphoblastic Leukemia (ALL)

Understanding Acute Lymphoblastic Leukemia (ALL)

Acute Lymphoblastic Leukemia (ALL) is a type of cancer that primarily affects the blood and bone marrow, the spongy tissue inside bones where blood cells are made. Characterized by the overproduction of immature white blood cells, known as lymphoblasts or leukemic blasts, ALL leads to an inability of the bone marrow to produce healthy blood cells. This condition is most commonly diagnosed in children, making it the most prevalent type of cancer in children, although it can also occur in adults. The onset of ALL is typically rapid and acute, necessitating immediate treatment. Symptoms may include fatigue, fever, bleeding or bruising easily, frequent infections, pain in the bones or joints, and swollen lymph nodes. The exact cause of ALL remains unclear, but it is believed to result from a combination of genetic and environmental factors. Treatment options for ALL are diverse and may include chemotherapy, radiation therapy, stem cell transplantation, and targeted therapy, depending on the specific characteristics of the leukemia and the health status of the patient. Advancements in medical research have significantly improved the prognosis for individuals diagnosed with ALL, especially for children. Early diagnosis and tailored treatment approaches are crucial for enhancing survival rates and achieving remission. Continuous research and clinical trials are underway to explore new treatment modalities and to understand the underlying mechanisms of the disease better, aiming to increase the efficacy of existing treatments and to discover novel therapeutic strategies.

Understanding Acute Lymphoblastic Leukemia (ALL)

Acute Lymphoblastic Leukemia (ALL) is a rapidly progressing cancer that affects white blood cells. The long-term outlook for individuals diagnosed with ALL can significantly vary, influenced by factors such as age, genetic features of the leukemia, initial response to therapy, and the presence of leukemia cells in the central nervous system at diagnosis. While children diagnosed with ALL generally have a more favorable prognosis, adults often face a more challenging outlook. The disease progression and response to treatment can be unpredictable, but continuous research and clinical trials are gradually improving the long-term outlook for individuals with ALL.

Prognosis of ALL

Children diagnosed with ALL have higher overall survival rates, with cure rates reaching 80-90%. However, adults diagnosed with ALL often face a more challenging prognosis, with lower survival rates compared to children. The progression of the disease and response to treatment can be unpredictable, and while some individuals may achieve complete remission, others may experience a more refractory course.

Complications Associated with ALL

  • Infections: Increased risk due to a weakened immune system.
  • Anemia: May cause fatigue and shortness of breath.
  • Bleeding problems: Reduced platelet count can lead to easy bruising or difficult-to-stop bleeding.
  • Bone and joint pain: Can make physical activities challenging.

Managing ALL

Effective management involves a combination of diet, physical activity, pharmacotherapy, and modern technology.

  • Diet: Nutrient-rich foods like fruits, vegetables, whole grains, and lean proteins can support the immune system.
  • Exercise: Regular, tailored physical activity enhances overall health and may improve treatment tolerance.
  • Medications: Healthcare professionals may prescribe treatments for symptoms or to support the body during other treatments.
  • Technology: Mobile apps for diet and medication tracking can aid in managing ALL. Wearable devices may monitor vital signs, providing valuable data for healthcare providers.

Consultation with healthcare providers is vital to customize these strategies to individual needs.

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    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.

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    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.

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    Study to find the best way to administer pegaspargase in children with acute lymphoblastic leukemia

    This is a study to investigate treatment strategies for children and adolescents diagnosed with acute lymphoblastic leukemia (ALL). The study focuses on evaluating the efficacy of a drug called pegaspargase. The drug works by depriving tumor cells of essential nutrients, contributing to its potential efficacy against ALL in pediatric patients. The study aims to determine the optimal way to administer pegaspargase, comparing a single high dose with two lower doses, with additional doses later in treatment. For those at highest risk, a more intensive treatment plan is being investigated. This includes two larger initial doses, followed by additional doses later in treatment. The study is evaluating factors such as potential serious side effects and overall treatment efficacy.

  • 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).

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    Testing the safety and efficacy of Rapcabtagene autoleucel in combination with ibrutinib for the treatment of various leukemia

    This study is looking at a new drug called rapcabtagene autoleucel in people with different types of blood cancer. The treatment is divided into two phases. In phase I, the study is testing the safety and efficacy of the new treatment in three different patient groups. The first group is adults with CLL/SLL, a type of blood cancer that has not shown a good response to the drug ibrutinib. The second group is adults with DLBCL, another type of blood cancer, who have failed at least two other treatments and who are unable or unwilling to undergo a stem cell transplant. The third group is adults with ALL, another type of blood cancer, who have not responded to other treatments. Phase II extends Phase I, focusing on the two main groups. The aim of this part is to obtain additional information on the efficacy of the new treatment. The aim of both phases is to determine the best dose of rapcabtagene autoleucel, to see how safe it is and how well it works against these tumors. After the treatment part of the study is completed, patients will be followed up for at least two years to monitor their health status and the long-term effects of the treatment.

  • 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.

  • Advanced cancer treatment with elraglusib

    This study is about testing a new drug called elraglusib (9-ING-41) on people who have aggressive types of cancers that have not responded to other treatments to fight it. elraglusib is a new type of drug that could help in blocking a specific cancer growth pathway, used alone or with chemotherapy. This research trial aims to see if elraglusib is both safe and effective when used alone or together with common chemotherapy drugs. This research hopes to offer a promising new treatment option for patients facing challenging cancer types.

  • Exploring new drug impact and safety on relapsed B-cell leukemia

    This is a scientific study for people who have a type of blood cancer known as B-cell Acute Lymphoblastic Leukemia (B-ALL) which has come back or is not responding to treatments anymore. The main goal of this important research is to test a new engineered cell treatment named UCART22. This trial is going to try and figure out the safest and most effective dose to give people. The researchers will also pay close attention to how patients react to the treatment and any side effects that occur. This might include anything from minor issues to serious health events that are directly related to the trial.

  • Exploring the effectiveness and safety of Tisagenlecleucel in B-Cell Acute Lymphoblastic Leukemia treatment

    This study aims to investigate the efficacy of a new treatment called tisagenlecleucel in helping children and young adults combat B-cell Acute Lymphoblastic Leukemia (B-ALL), a high-risk form of blood cancer. The research is conducted across multiple hospitals and involves several stages, including eligibility assessments, treatment preparation, treatment administration, regular check-ups to monitor progress, and long-term follow-up. After receiving tisagenlecleucel, patients will have more frequent hospital visits in the initial month, followed by regular visits every few months for the first two years, and then annually until the study concludes, approximately eight years after the first patient undergoes treatment.

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  • Study on carfilzomib effect on children’s leukemia

    This clinical trial focuses on children who face the difficult situation of acute lymphoblastic leukemia (ALL), a type of blood cancer. When cancer returns or does not respond to standard treatments, doctors call it relapsed or refractory, and it can be difficult to treat. The study is evaluating a drug called carfilzomib, which is being tested alongside common chemotherapy drugs. The drugs used in the clinical trial include carfilzomib, dexamethasone, mitoxantrone, PEG-asparaginase, vincristine, Intrathecal Methotrexate, Intrathecal Triple Therapy (Intrathecal Cytarabine, Hydrocortisone, and Methotrexate), 6-mercaptopurine, cyclophosphamide, cytarabine, and daunorubicin. The process has two main goals. First, he wants to find an appropriate dose of carfilzomib that is safe for children. This is significant because finding the right dose means balancing effectiveness with minimizing side effects. Once a safe dose is determined, the second part of the study begins. This part is about seeing how well carfilzomib works when it is part of a treatment regimen. Doctors and researchers will carefully monitor the children’s response to treatment. They will check whether the cancer responds to the new approach and how the children’s bodies cope with it. They will also track any side effects to ensure your treatment is safe.

  • Study on Blinatumomab injection safety for treating acute leukemia

    This research study involves a medicine called Blinatumomab that’s given through a shot under the skin. It is for people who have Acute Lymphoblastic Leukemia (ALL), a type of blood cancer that affects white blood cells. Blinatumomab, has been tested previously, and the current study aims to assess its efficacy and safety when administered as a shot under the skin. The study also seeks to determine the optimal dosage of Blinatumomab for this method of administration. Additionally, two different preparations of the medicine, labeled SC1 and SC2, will be compared to evaluate the speed and effectiveness of the body’s response to each.

  • Assessing long-term safety of asciminib therapy in Chronic Myelogenous Leukemia

    This trial serves as a follow-up study for individuals who participated in a previous Novartis-sponsored investigation involving the medication asciminib. The primary objective is to monitor any potential long-term side effects that may arise in individuals who have continued taking Asciminib beyond the initial study. This global study is conducted across numerous hospitals and clinics and is characterized as ‘open-label,’ signifying that participants are aware that they are receiving asciminib. During each visit, the team will assess and record whether participants continue to experience benefits from asciminib.

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  • Understanding the effect of Inotuzumab Ozogamicin on children with first relapse acute lymphoblastic leukemia

    This research is about testing a medicine known as Inotuzumab Ozogamicin (InO). the study will involve kids aged from 1 to 18 years old with first relapse acute lymphoblastic leukemia (ALL). Approximately 100 participants will receive 1 cycle of either InO monotherapy or ALLR3 (vincristine, mitoxantrone, dexamethasone, and asparaginase) therapy during treatment. By seeing how each childs body responds to the medicine, the scientists can learn more about how InO works against their symptoms and if it has any side effects that were not expected. The study will monitor various outcomes such as heart function, symptom relief and quality of life.

  • New treatment for B-Cell leukemia

    This trial is about a new medication called AZD0486. It’s being tested on patients who have a type of cancer called B-cell acute lymphoblastic leukaemia or B-ALL for short. In specific, it’s for patients who have had at least two other treatments but the cancer has come back or has not responded. The first part of the study is to find out the highest safe dose for the drug. The second part is to find the ideal dose for effective treatment. And lastly, the third part will increase the number of patients on the best-performing dose from the second part. The researchers will watch for any side effects or health changes during the study as a way to measure the drug’s safety. The main goal is to see how many patients have their cancer respond to the treatment. Also, there will be a check on what percentage of patients have complete disappearance of the cancer cells at any time during the study.

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  • Study of new drugs in acute lymphoblastic leukemia

    This clinical trial focuses on improving treatment strategies for acute lymphoblastic leukemia (ALL) in a diverse age group, from infants to young adults up to 45 years old. The study combines standard treatments with new drugs, for example, Inotuzumab Ozogamicin and Blinatumomab. The trial aims to tailor treatment to individual patient needs and reduce toxicity while maintaining treatment quality. By carefully monitoring event- and disease-free survival rates, as well as minimal residual disease responses, the trial aims to improve the standard of care for ALL and improve both survival outcomes and patient quality of life.

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