IFN-γ (interferon gamma-1b) injection for Myelodysplastic Syndromes
This study is evaluating whether a type of white blood cell may help treat leukemia.
See full descriptionAbout the trial for Myelodysplastic Syndromes
Treatment Groups
This trial involves 2 different treatments. IFN-γ (interferon Gamma-1b) Injection 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 and are in the first stage of evaluation with people.
Eligibility
This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Myelodysplastic Syndromes or one of the other 7 conditions listed above. There are 9 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether IFN-γ (interferon gamma-1b) injection will improve 5 primary outcomes and 3 secondary outcomes in patients with Myelodysplastic Syndromes. Measurement will happen over the course of Up to 6 months.
Patient Q & A Section
What is myelodysplastic syndromes?
AMDS refers to any patient found in the MDS Diagnosis and Treatment Guidelines. The International Working Group Working Party classification, based on cytogenetic and WHO classification systems, has been chosen by the authors to designate this category. The patients in this category have a disease that is defined by an abnormal karyotype (i.e., chromosomal abnormality) that is generally not a chromosomal abnormality but rather related to a disease of cell division (i.e., cancer). However, there are numerous subcategories within MDS. A patient's MDS subcategory in this working group (AMDS) system is based on chromosome abnormalities, WHO classification, and marrow disease.
How many people get myelodysplastic syndromes a year in the United States?
Myelodysplastic syndromes are more common in individuals older than 62 years and are twice as common in women relative to men. myelodysplastic syndromes have been associated and have been known to be a part of the syndrome known as chronic lymphocytic leukemia. The high prevalence of myelodysplastic syndrome in patients with chronic lymphocytic leukemia might be explained because of the tendency of patients with chronic lymphocytic leukemia to develop an autoimmune disease rather than a cancer.
What are common treatments for myelodysplastic syndromes?
Treatment for patients with myelodysplastic syndromes should be individualized based on the individual patient's clinical and disease characteristics. Drugs used for treatment of myelodysplastic syndromes are primarily used to treat disease-related features and symptoms.
Can myelodysplastic syndromes be cured?
There is limited evidence that myelodysplastic syndromes may be cured with azacitidine. More recent studies have shown that some myelodysplastic syndromes respond to high dose myeloablative chemotherapy but with minimal long-term benefits. The evidence needs more rigorous study and is at present limited to retrospective investigations. This may be due to the difficulties associated with evaluating small group patients with myelodysplastic syndrome. It is clear that more precise definition of disease type and prognosis are important to understand.
What are the signs of myelodysplastic syndromes?
Many of the symptoms and findings discussed may be attributed to other diseases, particularly, solid tumors. Physicians must be aware of other conditions that may cause similar signs and symptoms. An underlying diagnosis will allow for more effective management and treatment during the initial evaluation.
What causes myelodysplastic syndromes?
The occurrence of MDS cannot be explained by a single stimulus or genetic factor. It is likely due to a multiplicity of factors or combinations of factors.
How does ifn-γ (interferon gamma-1b) injection work?
IFN-γ plays an important pathophysiological role and regulates the production of immunoregulatory mediators (e.g., IL-10, IL-12, IL-17, TGF-β1), Th1 cell differentiation, and T cell function and apoptosis. Thus it is not surprising that IFN-γ administration leads to an increased number of CD123+ MDS cells, and that IFN-γ reduces the CD123 levels and results in a reversal of CD123+ cell dysfunction.
Who should consider clinical trials for myelodysplastic syndromes?
Patients with refractory or refractory/relapsing disease did not have a statistically significant advantage to clinical trial enrollment. The main reason for exclusion from clinical trials was the presence of other active disease by the time of trial inclusion but the reasons for exclusion of patients from clinical trials were as follows: older patients (<65 years) excluded due to a higher mortality rate; and patients with very poor nutritional status excluded for lack of appropriate study treatment.
Is ifn-γ (interferon gamma-1b) injection typically used in combination with any other treatments?
IFN-γ was the most frequently used treatment, regardless of the combination with other treatments. It was used most frequently in patients with MDS and in those receiving cladribine plus IFN-γ alone. It is recommended that clinicians consider using IFN-γ injections as a first choice treatments for MDS. If IFN-γ injections were used in combination with other treatments, it was mainly used in combination with cladribine.
Does ifn-γ (interferon gamma-1b) injection improve quality of life for those with myelodysplastic syndromes?
IFN-γ injection results in improvements in QOL for MDS patients. The IFN-γ therapy also provides a safe and effective therapy for selected MDS patients who are ineligible for ASCT.
How serious can myelodysplastic syndromes be?
A patient with a BMF of 13 to 20% has an OS of 2.8 months, and one with a BMF of 22% has an OS of 2.9 months. Most patients with a BMF < 20%, and those with < 20% on DSIP score, should have further evaluation for MDS. Patients with a BMF of 22% or 30% have an OS of 2.5 months. Patients with a BMF of > 50% have an OS of 2.1 months. Patients with a BMF of 50% on DSIP score should have further evaluation for MDS.
What is the latest research for myelodysplastic syndromes?
A growing evidence support the benefit of the addition of azacitidine to thalidomide for the treatment of refractory myelodysplastic syndrome. The role of demethylating agents at the initial treatment is unclear.