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S095031-178: Ivosidenib (IVO) Monotherapy and Azacitidine (AZA) Monotherapy in Patients With Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS) With an IDH1 Mutation

This clinical trial is studying two different investigational treatments for patients with a blood disorder called myelodysplastic syndromes (MDS) who have a specific genetic mutation (IDH1) and have not been treated with certain drugs before. The study will compare the effects of two study drugs, Ivosidenib (IVO) and Azacitidine (AZA), given separately, to see how well they help patients. Researchers will track how many patients experience improvements, how long the treatment effects last, and overall survival.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

Depending on the visit, you will meet with a study team member to go through a variety of tests such as a physical examination, vital signs testing, pregnancy testing,ECG testing, ECHO Examination, bone marrow aspirate collection, diary and questionnaire review, and medication compliance assessments.

In-person visits:
10+

Total length of participation:
2 years

Looking for Specific Volunteers

Able to participate:

You have Myelodysplastic Syndromes (MDS) with an IDH1 mutation.
You have not received prior treatment with a hypomethylating agent (HMA).
You are 18 years or older and willing to attend regular study visits.

Not eligible if:

You have already received treatment for MDS with certain cancer drugs.
You are pregnant or planning to be pregnant
You have a different form of cancer than MDS with IDH1 mutation.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Research
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Visit Study Website

Primary Visit Location

Lineberger Comprehensive Cancer Center
NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Joshua Zeidner
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Leukemia)

IRB Number

25-0197

ClinicalTrials.gov

NCT06465953

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