New combo therapy aims to boost remission in IDH2-Mutated AML
NCT ID NCT06672146
First seen Jun 25, 2026 · Last updated Sep 18, 2026 · Updated 19 times
Summary
This phase II trial tests whether adding enasidenib to standard ASTX727 and venetoclax improves remission rates in older adults (or younger unfit patients) with newly diagnosed IDH2-mutated acute myeloid leukemia (AML). About 93 participants will be randomly assigned to receive either the two-drug or three-drug combination. The main goal is to see if the triple therapy leads to deeper remissions with no detectable cancer cells.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ASTX727 (decitabine and cedazuridine), venetoclax, and enasidenib
- What this could lead to
- If successful, this could lead to a more effective treatment option for older adults with IDH2-mutated AML, potentially increasing the chance of achieving deep remission.
- What could go wrong
- This is a phase II trial with only 93 participants, so results are preliminary. Adding enasidenib may increase side effects without improving outcomes, and the study uses a lenient statistical threshold.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 93 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participants must have been registered to the MYELOMATCH Master Screening and Reassessment Protocol prior to consenting to this study. Participants must have disease with a detectable IDH2 mutation based on central testing through the MYELOMATCH and be assigned to this clinical trial via MATCHBox prior to registration to this study * Note: Pre-enrollment/diagnosis labs must have already been performed under MYELOMATCH * Participants must have newly diagnosed, untreated acute myeloid leukemia (AML) defined by having ≥ 20% blasts in the bone marrow and/or peripheral blood, or with an AML defining genetic abnormality as described by the World Health Organization (WHO) classification of AML, excluding acute promyelocytic leukemia (APL) with PML-RARA * Participants must not be receiving or planning to receive any other investigational agents while on protocol therapy * Participants must not have received prior therapy for AML, myelodysplastic syndrome (MDS) or myeloproliferative neoplasm (MPN) with the exception of hydroxyurea, all-trans retinoic acid (ATRA), BCR-ABL directed tyrosine kinase inhibitor, colony-stimulating factors, erythropoiesis-stimulating agents, thrombopoietin receptor agonist, lenalidomide, luspatercept, immunosuppressive therapy, intrathecal chemotherapy, cytarabine (up to 1 g/m\^2 for the purpose of cytoreduction for hyperleukocytosis/trial eligibility), and/or leukapheresis, with a maximum limit of 1 month of exposure. * Note: White blood cell (WBC) must be \< 25 x 10\^9/L prior to start of treatment. Hydroxyurea, leukapheresis, and cytarabine ≤ 1g/m\^2 are permitted to control the WBC prior to enrollment and initiation of protocol-defined therapy but must be stopped prior to initiation of protocol therapy. * Participants must be ≥ 60 years old; OR must be ≥ 18 years old and considered not eligible for cytarabine-based induction therapy * Participants must have Zubrod Performance Status of 0-3 as determined by a history and physical (H\&P) exam completed within 14 days prior to registration * Participants must have a complete medical history and physical exam within 14 days prior to registration * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) unless history of Gilbert's syndrome. Participants with history of Gilbert's syndrome must have total bilirubin ≤ 3 x institutional ULN (within 14 days prior to registration) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 × institutional ULN, unless considered to be elevated due to disease involvement (within 14 days prior to registration) * Participants must have adequate kidney function as evidenced by creatinine clearance ≥ 30mL/min (by Cockcroft Gault) within 14 days prior to registration * Participants must not have a baseline corrected QT interval ≥ 480 msec using Fridericia correction (QTcF). * NOTE: Since older participants are at risk for prolonged QTc and may require supportive care with agents that affect QTc, an electrocardiogram (ECG) is recommended if clinically indicated. If the QTc is prolonged, they should be treated on MYELOMATCH TAP instead of MM1OA-S03 * Participants must have adequate cardiac function in the assessment of their treating physician. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2 or better * Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration * Participants with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration, if indicated * Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to registration, if indicated * Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen * Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen * Participants must be able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of oral medications * Participants with central nervous system (CNS) involvement are eligible if follow-up CNS evaluation shows no evidence of progression, or if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy * Participants must have agreed to have specimens submitted for translational medicine for MRD under MYELOMATCH and specimens must be submitted * Enrollment to this treatment study requires prior enrollment into the myeloMATCH Master Protocol (MYELOMATCH). Participants enrolled in MYELOMATCH will submit bone marrow samples, peripheral blood samples, and buccal swabs to the Molecular Diagnostics Network (MDNet), the Clinical Laboratory Improvement Act (CLIA) laboratory network for myeloMATCH * In addition to the MYELOMATCH specimens, there will be specimens obtained on treatment for this substudy. These specimens will be derived from procedures performed as part of standard assessments in the clinical care and management of AML with material being sent to the MDNet laboratories as specified. Therefore, participants must be asked for their consent for the biobanking of specimens for future unspecified research. Participants may refuse this, but it is mandatory for sites to ask participants * Participants must be offered the opportunity to participate in specimen banking * NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations
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Get notified about this study
Sign up to get updates when this study changes or when new studies for Acute myeloid leukemia are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
134 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Locations
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Abbott-Northwestern Hospital
RECRUITINGMinneapolis, Minnesota, 55407, United States
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Allegiance Health
RECRUITINGJackson, Michigan, 49201, United States
Contact Email: •••••@•••••
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Alta Bates Summit Medical Center-Herrick Campus
ACTIVE_NOT_RECRUITINGBerkeley, California, 94704, United States
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Augusta University Medical Center
RECRUITINGAugusta, Georgia, 30912, United States
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Banner University Medical Center - Tucson
RECRUITINGTucson, Arizona, 85719, United States
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Benefis Sletten Cancer Institute
RECRUITINGGreat Falls, Montana, 59405, United States
Contact Email: •••••@•••••
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Billings Clinic Cancer Center
RECRUITINGBillings, Montana, 59101, United States
Contact Email: •••••@•••••
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Bozeman Health Deaconess Hospital
RECRUITINGBozeman, Montana, 59715, United States
Contact Email: •••••@•••••
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Cancer Hematology Centers - Flint
RECRUITINGFlint, Michigan, 48503, United States
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Carolinas Medical Center/Levine Cancer Institute
RECRUITINGCharlotte, North Carolina, 28203, United States
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Centro Comprensivo de Cancer de UPR
RECRUITINGSan Juan, 00927, Puerto Rico
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Community Hospital of Anaconda
RECRUITINGAnaconda, Montana, 59711, United States
Contact Email: •••••@•••••
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Community Medical Center
RECRUITINGMissoula, Montana, 59804, United States
Contact Email: •••••@•••••
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Community Medical Center
RECRUITINGToms River, New Jersey, 08755, United States
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Cooperman Barnabas Medical Center
RECRUITINGLivingston, New Jersey, 07039, United States
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Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
RECRUITINGLebanon, New Hampshire, 03756, United States
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Duke University Medical Center
RECRUITINGDurham, North Carolina, 27710, United States
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Duluth Clinic Ashland
RECRUITINGAshland, Wisconsin, 54806, United States
Contact Email: •••••@•••••
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East Carolina University
RECRUITINGGreenville, North Carolina, 27834, United States
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Edward Hines Jr VA Hospital
RECRUITINGHines, Illinois, 60141, United States
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Essentia Health - Deer River Clinic
RECRUITINGDeer River, Minnesota, 56636, United States
Contact Email: •••••@•••••
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Essentia Health Cancer Center
RECRUITINGDuluth, Minnesota, 55805, United States
Contact Email: •••••@•••••
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Essentia Health Hibbing Clinic
RECRUITINGHibbing, Minnesota, 55746, United States
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Essentia Health Sandstone
RECRUITINGSandstone, Minnesota, 55072, United States
Contact Email: •••••@•••••
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Essentia Health Virginia Clinic
RECRUITINGVirginia, Minnesota, 55792, United States
Contact Email: •••••@•••••
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Fairview Southdale Hospital
RECRUITINGEdina, Minnesota, 55435, United States
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Geisinger Medical Center
RECRUITINGDanville, Pennsylvania, 17822, United States
Contact Email: •••••@•••••
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Geisinger Wyoming Valley/Henry Cancer Center
RECRUITINGWilkes-Barre, Pennsylvania, 18711, United States
Contact Email: •••••@•••••
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Genesee Hematology Oncology PC
SUSPENDEDFlint, Michigan, 48503, United States
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Genesys Hurley Cancer Institute
RECRUITINGFlint, Michigan, 48503, United States
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Gundersen Lutheran Medical Center
RECRUITINGLa Crosse, Wisconsin, 54601, United States
Contact Email: •••••@•••••
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Henry Ford Hospital
RECRUITINGDetroit, Michigan, 48202, United States
Contact Email: •••••@•••••
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Henry Ford Macomb Hospital-Clinton Township
RECRUITINGClinton Township, Michigan, 48038, United States
Contact Email: •••••@•••••
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Henry Ford Medical Center-Columbus
RECRUITINGNovi, Michigan, 48377, United States
Contact Email: •••••@•••••
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Henry Ford West Bloomfield Hospital
RECRUITINGWest Bloomfield, Michigan, 48322, United States
Contact Email: •••••@•••••
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Huntsman Cancer Institute/University of Utah
RECRUITINGSalt Lake City, Utah, 84112, United States
Contact Email: •••••@•••••
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Kootenai Clinic Cancer Services - Post Falls
RECRUITINGPost Falls, Idaho, 83854, United States
Contact Email: •••••@•••••
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Kootenai Clinic Cancer Services - Sandpoint
RECRUITINGSandpoint, Idaho, 83864, United States
Contact Email: •••••@•••••
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Kootenai Health - Coeur d'Alene
RECRUITINGCoeur d'Alene, Idaho, 83814, United States
Contact Email: •••••@•••••
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LSU Health Baton Rouge-North Clinic
RECRUITINGBaton Rouge, Louisiana, 70805, United States
Contact Email: •••••@•••••
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Logan Health Medical Center
RECRUITINGKalispell, Montana, 59901, United States
Contact Email: •••••@•••••
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Loyola University Medical Center
RECRUITINGMaywood, Illinois, 60153, United States
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MaineHealth Cancer Care and IV Therapy - Brunswick
RECRUITINGBrunswick, Maine, 04011, United States
Contact Email: •••••@•••••
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MaineHealth Cancer Care and IV Therapy - South Portland
RECRUITINGSouth Portland, Maine, 04106, United States
Contact Email: •••••@•••••
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MaineHealth Maine Medical Center - Portland
RECRUITINGPortland, Maine, 04102, United States
Contact Email: •••••@•••••
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MaineHealth Maine Medical Center- Scarborough
RECRUITINGScarborough, Maine, 04074, United States
Contact Email: •••••@•••••
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Marshfield Medical Center - Weston
RECRUITINGWeston, Wisconsin, 54476, United States
Contact Email: •••••@•••••
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Marshfield Medical Center-River Region at Stevens Point
RECRUITINGStevens Point, Wisconsin, 54482, United States
Contact Email: •••••@•••••
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Medical College of Wisconsin
RECRUITINGMilwaukee, Wisconsin, 53226, United States
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Memorial Hospital West
RECRUITINGPembroke Pines, Florida, 33028, United States
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Memorial Regional Hospital/Joe DiMaggio Children's Hospital
RECRUITINGHollywood, Florida, 33021, United States
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Memorial Sloan Kettering Basking Ridge
RECRUITINGBasking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Bergen
RECRUITINGMontvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center
RECRUITINGNew York, New York, 10065, United States
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Memorial Sloan Kettering Commack
RECRUITINGCommack, New York, 11725, United States
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Memorial Sloan Kettering Monmouth
RECRUITINGMiddletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau
RECRUITINGUniondale, New York, 11553, United States
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Memorial Sloan Kettering Westchester
RECRUITINGHarrison, New York, 10604, United States
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Mercy Hospital
RECRUITINGCoon Rapids, Minnesota, 55433, United States
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Miami Cancer Institute
RECRUITINGMiami, Florida, 33176, United States
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Mid Coast Hospital
RECRUITINGBrunswick, Maine, 04011, United States
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Mills Health Center
ACTIVE_NOT_RECRUITINGSan Mateo, California, 94401, United States
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Monmouth Medical Center
RECRUITINGLong Branch, New Jersey, 07740, United States
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NorthShore University HealthSystem-Evanston Hospital
RECRUITINGEvanston, Illinois, 60201, United States
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NorthShore University HealthSystem-Glenbrook Hospital
RECRUITINGGlenview, Illinois, 60026, United States
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NorthShore University HealthSystem-Highland Park Hospital
RECRUITINGHighland Park, Illinois, 60035, United States
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Northwestern Medicine Cancer Center Delnor
RECRUITINGGeneva, Illinois, 60134, United States
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Northwestern Medicine Cancer Center Kishwaukee
RECRUITINGDeKalb, Illinois, 60115, United States
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Northwestern Medicine Cancer Center Warrenville
RECRUITINGWarrenville, Illinois, 60555, United States
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Northwestern Medicine Glenview Outpatient Center
RECRUITINGGlenview, Illinois, 60026, United States
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Northwestern Medicine Grayslake Outpatient Center
RECRUITINGGrayslake, Illinois, 60030, United States
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Northwestern Medicine Lake Forest Hospital
RECRUITINGLake Forest, Illinois, 60045, United States
Contact Email: •••••@•••••
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Northwestern Medicine Orland Park
RECRUITINGOrland Park, Illinois, 60462, United States
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Northwestern University
RECRUITINGChicago, Illinois, 60611, United States
Contact Email: •••••@•••••
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OSF Saint Francis Hospital and Medical Group
RECRUITINGEscanaba, Michigan, 49829, United States
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Oregon Health and Science University
SUSPENDEDPortland, Oregon, 97239, United States
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Our Lady of The Lake
RECRUITINGBaton Rouge, Louisiana, 70808, United States
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Our Lady of the Lake Physician Group
RECRUITINGBaton Rouge, Louisiana, 70808, United States
Contact Email: •••••@•••••
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Park Nicollet Clinic - Saint Louis Park
RECRUITINGSaint Louis Park, Minnesota, 55416, United States
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Prisma Health Cancer Institute - Butternut
RECRUITINGGreenville, South Carolina, 29605, United States
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Prisma Health Cancer Institute - Easley
RECRUITINGEasley, South Carolina, 29640, United States
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Prisma Health Cancer Institute - Eastside
RECRUITINGGreenville, South Carolina, 29615, United States
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Prisma Health Cancer Institute - Faris
RECRUITINGGreenville, South Carolina, 29605, United States
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Prisma Health Cancer Institute - Greer
RECRUITINGGreer, South Carolina, 29650, United States
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Prisma Health Cancer Institute - Seneca
RECRUITINGSeneca, South Carolina, 29672, United States
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Prisma Health Cancer Institute - Spartanburg
RECRUITINGBoiling Springs, South Carolina, 29316, United States
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Regions Hospital
RECRUITINGSaint Paul, Minnesota, 55101, United States
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Rhode Island Hospital
RECRUITINGProvidence, Rhode Island, 02903, United States
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Roswell Park Cancer Institute
RECRUITINGBuffalo, New York, 14263, United States
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Rutgers Cancer Institute of New Jersey
RECRUITINGNew Brunswick, New Jersey, 08903, United States
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Saint Alphonsus Cancer Care Center-Nampa
RECRUITINGNampa, Idaho, 83687, United States
Contact Email: •••••@•••••
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Saint Luke's Cancer Institute - Boise
RECRUITINGBoise, Idaho, 83712, United States
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Saint Luke's Cancer Institute - Fruitland
RECRUITINGFruitland, Idaho, 83619, United States
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Saint Luke's Cancer Institute - Meridian
RECRUITINGMeridian, Idaho, 83642, United States
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Saint Luke's Cancer Institute - Nampa
RECRUITINGNampa, Idaho, 83687, United States
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Saint Vincent Hospital Cancer Center Green Bay
RECRUITINGGreen Bay, Wisconsin, 54301, United States
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Saint Vincent Hospital Cancer Center at Oconto Falls
RECRUITINGOconto Falls, Wisconsin, 54154, United States
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Saint Vincent Hospital Cancer Center at Saint Mary's
RECRUITINGGreen Bay, Wisconsin, 54303, United States
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Saint Vincent Hospital Cancer Center at Sheboygan
RECRUITINGSheboygan, Wisconsin, 53081, United States
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Saint Vincent Hospital Cancer Center at Sturgeon Bay
RECRUITINGSturgeon Bay, Wisconsin, 54235-1495, United States
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San Juan City Hospital
RECRUITINGSan Juan, 00936, Puerto Rico
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Sheboygan Physicians Group
RECRUITINGSheboygan, Wisconsin, 53081, United States
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Stony Brook University Medical Center
RECRUITINGStony Brook, New York, 11794, United States
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Swedish Cancer Institute-Edmonds
RECRUITINGEdmonds, Washington, 98026, United States
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Swedish Cancer Institute-Issaquah
RECRUITINGIssaquah, Washington, 98029, United States
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Swedish Medical Center-First Hill
RECRUITINGSeattle, Washington, 98122, United States
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The James Graham Brown Cancer Center at University of Louisville
SUSPENDEDLouisville, Kentucky, 40202, United States
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Thomas Jefferson University Hospital
RECRUITINGPhiladelphia, Pennsylvania, 19107, United States
Contact Email: •••••@•••••
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Trinity Health IHA Medical Group Hematology Oncology - Brighton
RECRUITINGBrighton, Michigan, 48114, United States
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Trinity Health IHA Medical Group Hematology Oncology - Canton
RECRUITINGCanton, Michigan, 48188, United States
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Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
RECRUITINGChelsea, Michigan, 48118, United States
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Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
RECRUITINGYpsilanti, Michigan, 48197, United States
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Trinity Health Saint Joseph Mercy Oakland Hospital
RECRUITINGPontiac, Michigan, 48341, United States
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Trinity Health Saint Mary Mercy Livonia Hospital
RECRUITINGLivonia, Michigan, 48154, United States
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Tufts Medical Center
RECRUITINGBoston, Massachusetts, 02111, United States
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UC Comprehensive Cancer Center at Silver Cross
RECRUITINGNew Lenox, Illinois, 60451, United States
Contact Email: •••••@•••••
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UCSF Medical Center-Parnassus
RECRUITINGSan Francisco, California, 94143, United States
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UChicago Medicine Northwest Indiana
RECRUITINGCrown Point, Indiana, 46307, United States
Contact Email: •••••@•••••
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UPMC Hillman Cancer Center
RECRUITINGPittsburgh, Pennsylvania, 15232, United States
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United Hospital
RECRUITINGSaint Paul, Minnesota, 55102, United States
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University of Arizona Cancer Center-North Campus
RECRUITINGTucson, Arizona, 85719, United States
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University of Arkansas for Medical Sciences
RECRUITINGLittle Rock, Arkansas, 72205, United States
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University of Chicago Comprehensive Cancer Center
RECRUITINGChicago, Illinois, 60637, United States
Contact Email: •••••@•••••
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University of Chicago Medicine-Orland Park
RECRUITINGOrland Park, Illinois, 60462, United States
Contact Email: •••••@•••••
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University of Illinois
RECRUITINGChicago, Illinois, 60612, United States
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University of Kansas Cancer Center
RECRUITINGKansas City, Kansas, 66160, United States
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University of Kansas Clinical Research Center
RECRUITINGFairway, Kansas, 66205, United States
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University of Kansas Hospital-Westwood Cancer Center
RECRUITINGWestwood, Kansas, 66205, United States
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University of New Mexico Cancer Center
RECRUITINGAlbuquerque, New Mexico, 87106, United States
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University of Oklahoma Health Sciences Center
RECRUITINGOklahoma City, Oklahoma, 73104, United States
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University of Rochester
RECRUITINGRochester, New York, 14642, United States
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University of Tennessee - Knoxville
RECRUITINGKnoxville, Tennessee, 37920, United States
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UofL Health Medical Center Northeast
RECRUITINGLouisville, Kentucky, 40245, United States
Contact Email: •••••@•••••
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VCU Massey Comprehensive Cancer Center
RECRUITINGRichmond, Virginia, 23298, United States
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Wake Forest University Health Sciences
RECRUITINGWinston-Salem, North Carolina, 27157, United States
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William S Middleton VA Medical Center
RECRUITINGMadison, Wisconsin, 53705, United States
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