Tumor response assessment via imaging, physical examination, constitutional symptoms, hematologic evaluation, and bone marrow biopsy, as required, will be performed every 12 weeks up to and including cycle 25, and every 24 weeks thereafter or more frequently if clinically indicated. Adverse events ...
Constitutional 26 (22.2) Fatigue 7 (6.0) Fever 20 (17.1) Dermatology and skin: rash 2 (1.7) Gastrointestinal 56 (47.9) Anorexia 12 (10.3) Diarrhoea 10 (8.5) Mucositis 37 (31.6) Nausea 14 (12.0) Perforated small bowel 2 (1.7) Vomiting 7 (6.0) Haemorrhage 9 (7.7) 2 ...
with inhibitory ability along three key signalling pathways: Janus kinase (JAK) 1, and JAK2 and activin A receptor, type I (ACVR1).1,2,3,4Inhibition of JAK1 and JAK2 may improve constitutional symptoms and splenomegaly.1,2,4Additionally, direct inhibition of ACVR1 leads to a de...
As MF evolves, bone marrow failure progresses, leading to impaired erythropoiesis/worsening anemia, and splenomegaly; and constitutional symptoms often become worse [37]. In this setting, increasing the dose of ruxolitinib to treat splenomegaly and symptoms may not be a viable option because it ...
Female Time between first diagnosis and registration (months) Binet stage B vs. A C vs. A Severe constitutional symptoms Yes vs. No ECOG performance status = 1 vs. = 0 = 2 vs. = 0 = 3 vs. = 0 > 0 vs. = 0 CIRS total score > 0 vs. = 0 > 6 vs. ≤ 6 LDH (U/L) ...
However, injections with these drugs are commonly associated with injection-site reactions (ISRs), injection-site pain, and flu-like symptoms (FLS), which can lead to poor adherence to treatment in some patients [7, 8]. A formulation of IFNβ-1a has been developed without fetal bovine serum...
Myelofibrosis is a myeloid malignancy associated with anemia, splenomegaly, and constitutional symptoms. Patients with myelofibrosis frequently harbor JAK-STAT activating mutations that are sensitive to TG101348. Phase I trial results focused on safety and efficacy of Fedratinib in patients with high- ...
“Addressing key manifestations of myelofibrosis, including anemia, constitutional symptoms and splenomegaly, makes a significant difference in the treatment regimen for these patients who have limited options to address these aspects of the disease.” MOMENTUM The double-blind, active-controlled phase 3 ...
Hypersensitivity reactions have been reported with dolutegravir and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury Clinically, it is not possible to determine whether a hypersensitivity reaction with TRIUMEQ or TRIUMEQ PD would be caused by abacav...
Fedratinib (SAR302503 or TG101348) is a selective JAK2 inhibitor. In a phase I trial in intermediate- and high-risk patients with PMF or PPV MF/PET MF, fedratinib substantially relieved constitutional symptoms. After 6 to 12 cycles, a significant proportion of patients achieved spleen size ...