CLINICAL TRIAL

IFN-γ (interferon gamma-1b) injection for Myelodysplastic Syndromes

1 Prior Treatment
Grade IV
Relapsed
Recruiting · 18+ · All Sexes · Seattle, WA

This study is evaluating whether a type of white blood cell may help treat leukemia.

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About the trial for Myelodysplastic Syndromes

Eligible Conditions
Myelodysplastic Syndromes · Syndrome · Leukemia · Leukemia, Myeloid, Acute · Allogeneic Stem Cell Transplantation · Preleukemia · Leukemia, Myeloid · Myeloid Leukemias

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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
IFN-γ (interferon gamma-1b) injection
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
People who have had a stem cell transplant from a matched donor for Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) and have had a relapse with 5-20% blasts in their bone marrow by flow cytometry, with an immunophenotype that is typical of leukemia, are eligible to enroll in this study show original
of immunosuppression The patient has not had any increase in their systemic immunosuppression in the past four weeks, with the exception of maintaining therapeutic levels. show original
is recommended in pediatric patients with nephrotic syndrome There is no need for a systemic corticosteroid with a high dose in pediatric patients with nephrotic syndrome show original
There is no documented history of grade IV acute GVHD. show original
No new medications that suppress the immune system were started in the previous two weeks because of GVHD. show original
The study participants are willing to donate their bone marrow and peripheral blood if needed. show original
Must be able to give informed consent
Age 18 or older
The subject has a good performance status and a KPS score of more than 60%. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 6 months
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 6 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 6 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

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.

Upregulation of HLA ll (HLA-DR/DQ)
UP TO 6 MONTHS
Upregulation of HLA ll (HLA-DR/DQ) in bone marrow malignant blasts post-IFN-γ treatment, measured by the change in mean florescent intensity by flow cytometry.
UP TO 6 MONTHS
Incidence of de novo GVHD
UP TO 6 MONTHS
Incidence of graft-versus-host disease (GVHD) progression after IFN-γ therapy and subsequent DLI.
UP TO 6 MONTHS
Upregulation of ICAM-1
UP TO 6 MONTHS
Upregulation of ICAM-1 in bone marrow malignant blasts post-IFN-γ treatment, measured by the change in mean florescent intensity by flow cytometry as a percentage of positive cells.
UP TO 6 MONTHS
Generation of phosphorylated-STAT1
UP TO 6 MONTHS
Generation of phosphorylated-STAT1 in bone marrow malignant blasts post-IFN-γ treatment, measured by the change in mean florescent intensity by flow cytometry as a percentage of positive cells.
UP TO 6 MONTHS
Incidence of GVHD
UP TO 6 MONTHS
Incidence of Graft Versus Host Disease (GVHD) progression or de novo GVHD after INF-g therapy and subsequent donor lymphocyte infusion.
UP TO 6 MONTHS
Upregulation HLA l (HLA-ABC)
UP TO 6 MONTHS
Upregulation of HLA l (HLA-ABC) in bone marrow malignant blasts post-IFN-γ treatment, measured by the change in mean florescent intensity by flow cytometry.
UP TO 6 MONTHS
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer
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