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Combination Immunotherapy for Myelodysplastic Syndrome
Study Summary
This trial is testing the safety and tolerability of different cancer drugs in patients with low-risk blood disorders.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- I haven't used any blood cell growth boosters in the last 2 weeks or more.I cannot use standard treatments like lenalidomide due to side effects or other reasons.I have anemia with low hemoglobin and treatments haven't worked or I can't tolerate them.My platelet count is below 30,000/uL, or I have significant bleeding with a count below 50,000/uL.I am willing and able to undergo multiple bone marrow tests as required.My white blood cell count is very low, making me prone to infections.I can take care of myself but might not be able to do heavy physical work.My platelet count is below 30,000/uL, or I have significant bleeding with a count below 50,000/uL.I am 18 years old or older.I have been diagnosed with CMML or MDS/MPN.I haven't taken high-dose steroids or immunosuppressants in the last week.My white blood cell count is below 500.I am 18 years old or older.I have anemia with low hemoglobin and treatments haven't worked or I can't tolerate them.My MDS is classified as very low, low, or intermediate risk with ≤10% bone marrow blasts.I can take care of myself but might not be able to do heavy physical work.I have anemia with low hemoglobin and haven't used ESA treatments.I cannot use standard treatments like lenalidomide due to side effects or other reasons.I am willing and able to undergo multiple bone marrow tests as required.I haven't had cancer treatment or experimental therapy in the last 14 days or 5 half-lives, whichever is longer.My MDS is classified as very low, low, or intermediate risk with ≤10% bone marrow blasts.I have anemia with low hemoglobin and haven't used ESA treatments.My white blood cell count is very low, making me prone to infections.
- Group 1: Arm 1: MBG453 single agent
- Group 2: Arm 4: MBG453 + NIS793 combination
- Group 3: Arm 3: canakinumab single agent
- Group 4: Arm 2: NIS793 single agent
- Group 5: Arm 5: MBG453 + canakinumab combination
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has NIS793 been investigated in any prior research initiatives?
"NIS793 was first investigated in 2017 at Novartis Investigative Site, and since then 56 trials have been concluded. Currently 27 studies are ongoing, with a majority of them situated in Tampa, FL."
What is the ultimate aim of this trial?
"This 30-month experiment will assess the effectiveness of varying doses, with secondary evaluation criteria including single agent efficacy and combination performance for transfusion independent patients (TTP), progression free survival in transfusion dependent individuals (PFS), as well as pharmacokinetic properties such as Tmax."
What adverse effects might be associated with NIS793?
"As NIS793 is a Phase 1 trial, our Power team gave it a score of 1 due to the limited evidence supporting its safety and efficacy."
How many subjects is this clinical investigation examining?
"Novartis Pharmaceuticals seeks to recruit 90 participants that meet the study's inclusion criteria, and will be conducting this trial at two esteemed medical centres - H Lee Moffitt Cancer Center & Research Institute in Tampa and MD Anderson Cancer Center/University of Texas MD Anderson in Houston."
Does this research mark a precedent in the field?
"Research into the effects of NIS793 has been conducted since 2017. Initially, Novartis Pharmaceuticals led the trial which included 243 participants and resulted in Phase 1 drug approval. Currently, there are 27 active studies regarding it's efficacy across 333 cities spanning 56 nations."
Are there any current vacancies to join this experiment?
"Affirmative. According to clinicaltrials.gov, the investigation is recruiting and has been since June 18th 2021; its last update was on November 11th 2022. Four sites are attempting to enroll 90 volunteers in total."
Where have researchers implemented this research protocol?
"Currently, 4 different medical centres are hosting this clinical trial. These locations include Tampa, Houston and Columbus as well as an additional quartet of sites. To reduce any possible traveling demands related to enrollment, it is advisable to select the closest clinic available."
In what circumstances is NIS793 typically prescribed?
"NIS793 has been proven to be a successful form of treatment for muckle-wells syndrome (mws), active systemic juvenile idiopathic arthritis, and neonatal-onset multisystem inflammatory disease (nomid)."
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