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Corticosteroid

Combination Immunotherapy for Myelodysplastic Syndrome

Phase 1
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- Patients who are refractory to, intolerant of, or ineligible/unable to receive SOC therapeutic options including lenalidomide
- Symptomatic anemia with hemoglobin <10 g/dL that has relapsed after or is refractory to ESAs (or the patient is intolerant to ESAs)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 months
Awards & highlights

Study Summary

This trial is testing the safety and tolerability of different cancer drugs in patients with low-risk blood disorders.

Who is the study for?
Adults diagnosed with lower risk Myelodysplastic Syndrome (MDS) who have specific symptoms like anemia, low platelets, or neutropenia and are not responding to standard treatments. Participants must be able to undergo bone marrow tests and have a performance status indicating they can still perform daily activities.Check my eligibility
What is being tested?
The trial is testing the safety and optimal doses of NIS793, MBG453, and canakinumab alone or in combination for treating MDS. It aims to find out how well patients tolerate these drugs and their combinations.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to the study drugs, increased risk of infections due to immune system suppression by canakinumab, as well as other drug-specific side effects that will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I cannot use standard treatments like lenalidomide due to side effects or other reasons.
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I have anemia with low hemoglobin and treatments haven't worked or I can't tolerate them.
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My platelet count is below 30,000/uL, or I have significant bleeding with a count below 50,000/uL.
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I am willing and able to undergo multiple bone marrow tests as required.
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My white blood cell count is very low, making me prone to infections.
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I can take care of myself but might not be able to do heavy physical work.
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My platelet count is below 30,000/uL, or I have significant bleeding with a count below 50,000/uL.
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I am 18 years old or older.
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I am 18 years old or older.
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I have anemia with low hemoglobin and treatments haven't worked or I can't tolerate them.
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My MDS is classified as very low, low, or intermediate risk with ≤10% bone marrow blasts.
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I can take care of myself but might not be able to do heavy physical work.
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I have anemia with low hemoglobin and haven't used ESA treatments.
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I cannot use standard treatments like lenalidomide due to side effects or other reasons.
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My MDS is classified as very low, low, or intermediate risk with ≤10% bone marrow blasts.
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I have anemia with low hemoglobin and haven't used ESA treatments.
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My white blood cell count is very low, making me prone to infections.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AE and SAE indicence
Dose intensity
Dose interruption reduction
+1 more
Secondary outcome measures
Characterize pharmacokinetics for single agents and combinations: Cmax
Characterize pharmacokinetics for single agents and combinations: Ctrough
Characterize pharmacokinetics for single agents and combinations: Tmax
+11 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Arm 5: MBG453 + canakinumab combinationExperimental Treatment2 Interventions
Treatment with MBG453 + canakinumab combination Q4W to confirm safety and tolerability of combination RD.
Group II: Arm 4: MBG453 + NIS793 combinationExperimental Treatment2 Interventions
Treatment with combination of MBG453 and NIS793 Q3W to confirm safety and tolerability of combination RD.
Group III: Arm 3: canakinumab single agentExperimental Treatment1 Intervention
Treatment with single agent canakinumab Q4W to confirm safety and tolerability of RD.
Group IV: Arm 2: NIS793 single agentExperimental Treatment1 Intervention
Treatment with NIS793 single agent Q3W to establish RD in this indication and confirm safety and tolerability.
Group V: Arm 1: MBG453 single agentExperimental Treatment1 Intervention
Treatment with MBG453 single agent Q4W to confirm safety and tolerability of RD.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NIS793
2017
Completed Phase 1
~120
MBG453
2017
Completed Phase 1
~250
canakinumab
2014
Completed Phase 3
~280

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,851 Previous Clinical Trials
4,197,556 Total Patients Enrolled

Media Library

Canakinumab (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT04810611 — Phase 1
Myelodysplastic Syndrome Research Study Groups: Arm 1: MBG453 single agent, Arm 4: MBG453 + NIS793 combination, Arm 3: canakinumab single agent, Arm 2: NIS793 single agent, Arm 5: MBG453 + canakinumab combination
Myelodysplastic Syndrome Clinical Trial 2023: Canakinumab Highlights & Side Effects. Trial Name: NCT04810611 — Phase 1
Canakinumab (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04810611 — Phase 1

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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)."

Answered by AI
~1 spots leftby May 2024