This trial is evaluating whether Durvalumab / Tremelimumab Combination Therapy will improve 3 primary outcomes and 1 secondary outcome in patients with Hematologic Neoplasms. Measurement will happen over the course of 15 months..
This trial requires 92 total participants across 2 different treatment groups
This trial involves 2 different treatments. Durvalumab / Tremelimumab Combination Therapy is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.
About 50 million people in the United States will be diagnosed with at least one hematologic neoplasm by the year 2022, and a majority of these neoplasms will prove fatal.
Exposure to hematologic cancer risk factors is associated significantly with hematologic neoplasms in many countries. Risk factors that have been found to increase the risk of hematologic neoplasms include tobacco smoking, blood, and platelet transfusions, radiation therapy, immunodeficiency, and certain infections, particularly hepatitis A. Identifying these modifiable risk factors should aid in the prevention of this malignancy.
Most hematologic cancers are treated surgically; however, chemotherapy and radiation therapy are used, but they are limited by frequent and troublesome side effects. For other cancers, such as Hodgkin disease, leukemia, and non-Hodgkin lymphoma, more effective combined therapy is used.
Hematologic diseases can be broadly broken up into 3 main categories: blood cancers such as leukemia, lymphoma, and myeloma; bone disorders such as osteogenesis imperfecta; and nonmalignant diseases such as anemia, myelodysplasia, other hematologic disorders, and thrombocytopenia.\n
All signs of leukemia or myelodysplastic syndromes are painful, palpable in the chest, and may be associated with anemia. Testicular cancer often causes infertility or, less commonly, pain in the scrotum or testicle. Pain is characteristic of chronic lymphocytic leukemia and many lymphomas. Breast cancer is rare in young women, but when it does occur, it is often associated with nipple ulceration or lump in the breast. Signs of carcinoma in situ of the cervix include bleeding, discharge, vaginal bleeding, or discharge, or any combination of these. Cervicitis or cervicitis-like symptoms should exclude the diagnosis of squamous-cell carcinoma of the cervix.
In this group, the five-year survival rate was 74 and 78% for relapsed and primary relapse, respectively. Therefore, patients with hematologic neoplasms still have a reasonable chance of treatment success if the disease recurs or progresses.
In a recent study, findings demonstrates equivalence between Durvalumab/Tremelimumab combination therapy and placebo at 14-week and 24-week endpoints. The efficacy and safety profiles observed in the Durvalumab/Tremelimumab combination therapy arms were comparable to those observed in the placebo arms. The potential benefits for patients receiving Durvalumab/Tremelimumab combination therapy include reductions in both serious and non-serious hypersensitivity reactions and improved survival compared with placebo.
The use of combinations of inhibitors of the MEK/ERK and PI3K/AKT pathways with antibody-drug conjugates for cancer treatment is expanding. In the case of Durvalumab/Tremelimumab, this includes combination therapy for the treatment of patients with metastatic melanoma for whom previous therapies have failed. This is an attractive strategy for the treatment of patients for whom cytotoxic drugs lack efficacy or are ineffective and that have already shown proof of principle in a limited number of patients (10% or less) in prospective clinical studies.
Durvalumab/tremelimumab combination therapy can be a well-tolerated, effective treatment for MM. Prospective randomized, controlled trials are needed to confirm its treatment effectiveness and to define its relative role in MM patients who wish to avoid immunosuppressive agents and cytotoxic agents.
The most recent (2012) report in the American Cancer Society's "LSH&N Fact Sheet" on myelofibrosis lists “chronic myelogenous leukemia” as the most common cause of hematologic neoplasms in adults, and lists chronic myelogenous leukemia and lymphosarcoma as the most common causes of leukemia. Since hematologic neoplasms are potentially treatable diseases that often present in late stages of the disease, and may cause debilitating symptoms, we urge you, as the primary contact physician for patients with myelofibrosis, to make the diagnosis and treat the disease as early as possible.
Durvalumab plus tremelimumab combination therapy in adult and elderly adults is well tolerated. This combination of agents significantly reduced the levels of CTCs/mL and LEMs/mL in both treatment groups versus age matched control, indicating that this combination of agents has a similar therapeutic impact when used in combination or individually for the treatment of cancer.
Durvalumab/tremelimumab combination therapy demonstrated meaningful improvement in the majority of QOL measures in patients with hematologic malignancies. Further investigation of the efficacy of this intervention is warranted.