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NCT06577441RecruitingPhase 2

Testing the Addition of an IDH2 Inhibitor, Enasidenib, to Usual Treatment (Cedazuridine-Decitabine) for Higher-Risk Myelodysplastic Syndrome (MDS) With IDH2 Mutation (A MyeloMATCH Treatment Trial)

A Randomized Phase II Trial of Enasidenib-Based Therapies Versus Cedazuridine-Decitabine in Higher-Risk IDH2-Mutated Myelodysplastic Syndrome: A MyeloMATCH Sub-Study

Source: ClinicalTrials.gov · Last updated 4 Nov 2026

Brief summary (registry, in English)

This phase II MyeloMATCH treatment trial compares the usual treatment of cedazuridine-decitabine (ASTX727) to the combination treatment of ASTX727 and enasidenib in treating patients with higher-risk, IDH2-mutated myelodysplastic syndrome (MDS). ASTX727 is a combination of two drugs, decitabine and cedazuridine. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Enasidenib is an enzyme inhibitor that may stop the growth of cells by blocking some of the enzymes needed for cell growth. Giving ASTX727 in combination with enasidenib may be effective in treating patients with higher-risk IDH2-mutated MDS.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
54 (estimated)
First submitted
28 Aug 2024
Start date
12 Jun 2025
Primary completion date
1 Mar 2027
Lead sponsor
National Cancer Institute (NCI)
NCT number
NCT06577441

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 54
  • From 12 Jun 2025 to the primary completion date, 1 Mar 2027
  • 151 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • GENERAL MYLEOMATCH REGISTRATION CRITERIA:
    • Patients must be registered to the Master Screening and Reassessment Protocol (MYELOMATCH) and assigned to this protocol by the MATCHBox Treatment Verification Team.
    • Participants must not have received prior anti-cancer therapy for AML or MDS.
    • Note: Hydroxyurea to control the white blood cell count (WBC) is allowed.
    • Note: Prior erythroid stimulating agent (ESA) is not considered prior therapy for the purposes of eligibility.
    • Participants must not be currently receiving any cytarabine-containing therapy other than up to 1 g/m\^2 of cytarabine, which is allowed for urgent cytoreduction. The use of prior hydroxyurea, all-trans retinoic acid (ATRA), BCR-ABL directed tyrosine kinase inhibitor, erythropoiesis-stimulating agent, thrombopoietin receptor agonist and lenalidomide is allowed
  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients must have a morphologically-confirmed diagnosis of MDS with a Revised International Prognostic Scoring System (IPSS-R) score ≥ 4.
  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients must have a detectable pathogenic IDH2 mutation based on the National Cancer Institute (NCI) Myeloid Panel.
  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): No prior treatment with deoxyribonucleic acid (DNA) methyltransferase inhibitors (ASTX727, azacitidine, or decitabine).
  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Prior treatment with growth factors (ESA, granulocyte colony-stimulating factor \[g-CSF\], thrombopoietin \[TPO\] agonist) or luspatercept is allowed.
  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Prior treatment with lenalidomide with a maximum limit of 1 month of exposure is allowed.
  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients with therapy-related MDS are allowed.
  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Age ≥ 18 years.
  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
    • Unless elevated due to Gilbert's syndrome. In patients with Gilbert's syndrome, if the total bilirubin is ≤ 3.0 x ULN, then they are eligible for enrollment.
  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase \[SGPT\]) ≤ 3.0 x upper limit of normal (ULN).
  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Creatinine clearance ≥ 30 mL/min
    • To be calculated using Cockroft Gault formula.
  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Not pregnant and not nursing, because this study involves: an agent that has known genotoxic, mutagenic and teratogenic effects.
    • Therefore, for women of childbearing potential only, a negative pregnancy test done as part of screening lab work prior to registration is required.
  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial.
  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
  • RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Patients on the ASTX727 monotherapy arm (Regimen 1) that do not achieve a CR (complete response), CRL (CR with limited count recovery), or CRh (CR with partial count recovery) after completing 6 cycles of study treatment.
  • RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): ECOG performance status ≤ 2.
  • RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Total bilirubin ≤ 1.5 x upper limit of normal (ULN).
    • Unless elevated due to Gilbert's syndrome. In patients with Gilbert's syndrome if the total bilirubin is ≤ 3.0 x ULN, then they are eligible for enrollment.
  • RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): AST (SGOT)/ALT (SGPT) ≤ 3.0 x upper limit of normal (ULN)
  • RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Creatinine clearance ≥ 30 mL/min
    • To be calculated using Cockroft Gault formula.
  • RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Not pregnant and not nursing, because this study involves: an agent that has known genotoxic, mutagenic and teratogenic effects.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (151)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Centro Comprensivo de Cancer de UPR
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San JuanPuerto RicoRecruiting
San Juan City Hospital
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San JuanPuerto RicoRecruiting
Phoebe Putney Memorial Hospital
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AlbanyUnited StatesRecruiting
University of New Mexico Cancer Center
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AlbuquerqueUnited StatesRecruiting
Community Hospital of Anaconda
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AnacondaUnited StatesRecruiting
UI Health Care Mission Cancer and Blood - Ankeny Clinic
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AnkenyUnited StatesRecruiting
Duluth Clinic Ashland
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AshlandUnited StatesRecruiting
LSU Health Baton Rouge-North Clinic
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Baton RougeUnited StatesRecruiting
Our Lady of The Lake
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Baton RougeUnited StatesRecruiting
Our Lady of the Lake Physician Group
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Baton RougeUnited StatesRecruiting
Alta Bates Summit Medical Center-Herrick Campus
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BerkeleyUnited StatesActive, not recruiting
Walter Reed National Military Medical Center
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BethesdaUnited StatesRecruiting
Billings Clinic Cancer Center
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BillingsUnited StatesRecruiting
Illinois CancerCare-Bloomington
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BloomingtonUnited StatesRecruiting
Prisma Health Cancer Institute - Spartanburg
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Boiling SpringsUnited StatesRecruiting
Saint Luke's Cancer Institute - Boise
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BoiseUnited StatesRecruiting
Tufts Medical Center
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BostonUnited StatesRecruiting
Bozeman Health Deaconess Hospital
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BozemanUnited StatesRecruiting
Essentia Health Saint Joseph's Medical Center
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BrainerdUnited StatesRecruiting
Trinity Health IHA Medical Group Hematology Oncology - Brighton
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BrightonUnited StatesRecruiting
Roswell Park Cancer Institute
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BuffaloUnited StatesRecruiting
Trinity Health IHA Medical Group Hematology Oncology - Canton
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CantonUnited StatesRecruiting
Illinois CancerCare-Canton
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CantonUnited StatesRecruiting
Illinois CancerCare-Carthage
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CarthageUnited StatesRecruiting
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
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ChelseaUnited StatesRecruiting
Swedish Covenant Hospital
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ChicagoUnited StatesRecruiting
Northwestern University
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ChicagoUnited StatesRecruiting
University of Chicago Comprehensive Cancer Center
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ChicagoUnited StatesRecruiting
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
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CliveUnited StatesRecruiting
Kootenai Health - Coeur d'Alene
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Coeur d'AleneUnited StatesRecruiting
Ohio State University Comprehensive Cancer Center
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ColumbusUnited StatesRecruiting
UChicago Medicine Northwest Indiana
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Crown PointUnited StatesRecruiting
Geisinger Medical Center
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DanvilleUnited StatesRecruiting
Carle at The Riverfront
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DanvilleUnited StatesRecruiting
Cancer Care Specialists of Illinois - Decatur
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DecaturUnited StatesRecruiting
Decatur Memorial Hospital
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DecaturUnited StatesRecruiting
Essentia Health - Deer River Clinic
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Deer RiverUnited StatesRecruiting
Northwestern Medicine Cancer Center Kishwaukee
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DeKalbUnited StatesRecruiting
UI Health Care Mission Cancer and Blood - Des Moines Clinic
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Des MoinesUnited StatesRecruiting
UI Health Care Mission Cancer and Blood - Laurel Clinic
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Des MoinesUnited StatesRecruiting
Mercy Medical Center - Des Moines
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Des MoinesUnited StatesRecruiting
Iowa Methodist Medical Center
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Des MoinesUnited StatesRecruiting
Illinois CancerCare-Dixon
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DixonUnited StatesRecruiting
Essentia Health Cancer Center
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DuluthUnited StatesRecruiting
Duke University Medical Center
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DurhamUnited StatesRecruiting
Prisma Health Cancer Institute - Easley
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EasleyUnited StatesRecruiting
Minnesota Oncology - Edina
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EdinaUnited StatesRecruiting
Fairview Southdale Hospital
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EdinaUnited StatesRecruiting
Swedish Cancer Institute-Edmonds
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EdmondsUnited StatesRecruiting
Carle Physician Group-Effingham
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EffinghamUnited StatesRecruiting
Crossroads Cancer Center
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EffinghamUnited StatesRecruiting
Illinois CancerCare-Eureka
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EurekaUnited StatesRecruiting
NorthShore University HealthSystem-Evanston Hospital
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EvanstonUnited StatesRecruiting
University of Kansas Clinical Research Center
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FairwayUnited StatesRecruiting
Essentia Health Cancer Center-South University Clinic
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FargoUnited StatesRecruiting
Parkland Health Center - Farmington
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FarmingtonUnited StatesRecruiting
Genesys Hurley Cancer Institute
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FlintUnited StatesRecruiting
Genesee Hematology Oncology PC
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FlintUnited StatesSuspended
Cancer Hematology Centers - Flint
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FlintUnited StatesRecruiting
Saint Luke's Cancer Institute - Fruitland
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FruitlandUnited StatesRecruiting
UF Health Cancer Institute - Gainesville
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GainesvilleUnited StatesRecruiting
Illinois CancerCare-Galesburg
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GalesburgUnited StatesRecruiting
Northwestern Medicine Cancer Center Delnor
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GenevaUnited StatesRecruiting
NorthShore University HealthSystem-Glenbrook Hospital
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GlenviewUnited StatesRecruiting
Northwestern Medicine Glenview Outpatient Center
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GlenviewUnited StatesRecruiting
Northwestern Medicine Grayslake Outpatient Center
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GrayslakeUnited StatesRecruiting
Benefis Sletten Cancer Institute
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Great FallsUnited StatesRecruiting
Saint Vincent Hospital Cancer Center Green Bay
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Green BayUnited StatesRecruiting
Saint Vincent Hospital Cancer Center at Saint Mary's
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Green BayUnited StatesRecruiting
East Carolina University
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GreenvilleUnited StatesRecruiting
Prisma Health Cancer Institute - Eastside
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GreenvilleUnited StatesRecruiting
Prisma Health Cancer Institute - Faris
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GreenvilleUnited StatesRecruiting
Prisma Health Cancer Institute - Butternut
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GreenvilleUnited StatesRecruiting
Prisma Health Cancer Institute - Greer
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GreerUnited StatesRecruiting
Essentia Health Hibbing Clinic
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HibbingUnited StatesRecruiting
NorthShore University HealthSystem-Highland Park Hospital
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Highland ParkUnited StatesRecruiting
Edward Hines Jr VA Hospital
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HinesUnited StatesRecruiting
University of Iowa/Holden Comprehensive Cancer Center
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Iowa CityUnited StatesRecruiting
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
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IrvineUnited StatesRecruiting
Swedish Cancer Institute-Issaquah
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IssaquahUnited StatesRecruiting
Logan Health Medical Center
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KalispellUnited StatesRecruiting
University of Kansas Cancer Center
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Kansas CityUnited StatesRecruiting
Illinois CancerCare-Kewanee Clinic
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KewaneeUnited StatesRecruiting
University of Tennessee - Knoxville
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KnoxvilleUnited StatesSuspended
Gundersen Lutheran Medical Center
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La CrosseUnited StatesRecruiting
Northwestern Medicine Lake Forest Hospital
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Lake ForestUnited StatesRecruiting
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
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LebanonUnited StatesRecruiting
Cooperman Barnabas Medical Center
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LivingstonUnited StatesRecruiting
Trinity Health Saint Mary Mercy Livonia Hospital
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LivoniaUnited StatesRecruiting
Monmouth Medical Center
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Long BranchUnited StatesRecruiting
UofL Health Medical Center Northeast
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LouisvilleUnited StatesRecruiting
The James Graham Brown Cancer Center at University of Louisville
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LouisvilleUnited StatesRecruiting
Illinois CancerCare-Macomb
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MacombUnited StatesRecruiting
William S Middleton VA Medical Center
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MadisonUnited StatesRecruiting
Carle Physician Group-Mattoon/Charleston
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MattoonUnited StatesRecruiting
Loyola University Medical Center
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MaywoodUnited StatesRecruiting
Saint Luke's Cancer Institute - Meridian
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MeridianUnited StatesRecruiting
Miami Cancer Institute
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MiamiUnited StatesRecruiting
Medical College of Wisconsin
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MilwaukeeUnited StatesRecruiting
Hennepin County Medical Center
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MinneapolisUnited StatesRecruiting
Abbott-Northwestern Hospital
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MinneapolisUnited StatesRecruiting
Community Medical Center
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MissoulaUnited StatesRecruiting
Saint Luke's Cancer Institute - Nampa
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NampaUnited StatesRecruiting
Saint Alphonsus Cancer Care Center-Nampa
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NampaUnited StatesRecruiting
Rutgers Cancer Institute of New Jersey
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New BrunswickUnited StatesRecruiting
UC Comprehensive Cancer Center at Silver Cross
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New LenoxUnited StatesRecruiting
Cancer Care Center of O'Fallon
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O'FallonUnited StatesRecruiting
HSHS Saint Elizabeth's Hospital
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O'FallonUnited StatesRecruiting
University of Oklahoma Health Sciences Center
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Oklahoma CityUnited StatesRecruiting
UC Irvine Health- Chao Family Comprehensive Cancer Center
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OrangeUnited StatesRecruiting
Northwestern Medicine Orland Park
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Orland ParkUnited StatesRecruiting
University of Chicago Medicine-Orland Park
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Orland ParkUnited StatesRecruiting
Illinois CancerCare-Ottawa Clinic
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OttawaUnited StatesRecruiting
Illinois CancerCare-Pekin
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PekinUnited StatesRecruiting
UI Healthcare Mission Cancer and Blood - Pella
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PellaUnited StatesRecruiting
Memorial Hospital West
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Pembroke PinesUnited StatesRecruiting
Illinois CancerCare-Peoria
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PeoriaUnited StatesRecruiting
Illinois CancerCare-Peru
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PeruUnited StatesRecruiting
UPMC Hillman Cancer Center
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PittsburghUnited StatesRecruiting
Trinity Health Saint Joseph Mercy Oakland Hospital
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PontiacUnited StatesRecruiting
Kootenai Clinic Cancer Services - Post Falls
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Post FallsUnited StatesRecruiting
Illinois CancerCare-Princeton
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PrincetonUnited StatesRecruiting
VCU Massey Comprehensive Cancer Center
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RichmondUnited StatesRecruiting
Sainte Genevieve County Memorial Hospital
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Sainte GenevieveUnited StatesRecruiting
Park Nicollet Clinic - Saint Louis Park
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Saint Louis ParkUnited StatesRecruiting
United Hospital
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Saint PaulUnited StatesRecruiting
Regions Hospital
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Saint PaulUnited StatesRecruiting
Huntsman Cancer Institute/University of Utah
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Salt Lake CityUnited StatesRecruiting
Kootenai Clinic Cancer Services - Sandpoint
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SandpointUnited StatesRecruiting
Essentia Health Sandstone
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SandstoneUnited StatesRecruiting
Mills Health Center
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San MateoUnited StatesActive, not recruiting
Swedish Medical Center-First Hill
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SeattleUnited StatesRecruiting
Prisma Health Cancer Institute - Seneca
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SenecaUnited StatesRecruiting
Springfield Memorial Hospital
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SpringfieldUnited StatesRecruiting
Springfield Clinic
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SpringfieldUnited StatesRecruiting
Southern Illinois University School of Medicine
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SpringfieldUnited StatesRecruiting
Marshfield Medical Center-River Region at Stevens Point
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Stevens PointUnited StatesRecruiting
Missouri Baptist Medical Center
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St LouisUnited StatesRecruiting
Stony Brook University Medical Center
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Stony BrookUnited StatesRecruiting
Saint Vincent Hospital Cancer Center at Sturgeon Bay
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Sturgeon BayUnited StatesRecruiting
Missouri Baptist Sullivan Hospital
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SullivanUnited StatesRecruiting
Community Medical Center
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Toms RiverUnited StatesRecruiting
Carle Cancer Center
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UrbanaUnited StatesRecruiting
Essentia Health Virginia Clinic
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VirginiaUnited StatesRecruiting
Northwestern Medicine Cancer Center Warrenville
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WarrenvilleUnited StatesRecruiting
Illinois CancerCare - Washington
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WashingtonUnited StatesRecruiting
UI Health Care Mission Cancer and Blood - Waukee Clinic
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WaukeeUnited StatesRecruiting
Marshfield Medical Center - Weston
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WestonUnited StatesRecruiting
University of Kansas Hospital-Westwood Cancer Center
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WestwoodUnited StatesRecruiting
Geisinger Wyoming Valley/Henry Cancer Center
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Wilkes-BarreUnited StatesRecruiting
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
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YpsilantiUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.