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Trial Title: Testing the Effects of Novel Therapeutics for Newly Diagnosed, Untreated Patients With High-Risk Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)

NCT ID: NCT05554406

Condition: Acute Myeloid Leukemia
Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Acute Myeloid Leukemia Post Cytotoxic Therapy
Acute Myeloid Leukemia, Myelodysplasia-Related

Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Cytarabine
Azacitidine
Venetoclax
Daunorubicin

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Azacitidine
Description: Given SC or IV
Arm group label: Arm III (azacitidine, venetoclax)

Other name: 5 AZC

Other name: 5-AC

Other name: 5-Azacitidine

Other name: 5-Azacytidine

Other name: 5-AZC

Other name: Azacytidine

Other name: Azacytidine, 5-

Other name: Ladakamycin

Other name: Mylosar

Other name: U-18496

Other name: Vidaza

Intervention type: Procedure
Intervention name: Biospecimen Collection
Description: Undergo collection of blood
Arm group label: Arm I (cytarabine, daunorubicin)
Arm group label: Arm II (cytarabine, daunorubicin, venetoclax)
Arm group label: Arm III (azacitidine, venetoclax)
Arm group label: Arm IV (daunorubicin and cytarabine liposome)
Arm group label: Arm V (daunorubicin and cytarabine liposome, venetoclax)

Other name: Biological Sample Collection

Other name: Biospecimen Collected

Other name: Specimen Collection

Intervention type: Procedure
Intervention name: Bone Marrow Aspiration
Description: Undergo bone marrow aspiration
Arm group label: Arm I (cytarabine, daunorubicin)
Arm group label: Arm II (cytarabine, daunorubicin, venetoclax)
Arm group label: Arm IV (daunorubicin and cytarabine liposome)
Arm group label: Arm V (daunorubicin and cytarabine liposome, venetoclax)

Intervention type: Drug
Intervention name: Cytarabine
Description: Given IV
Arm group label: Arm I (cytarabine, daunorubicin)
Arm group label: Arm II (cytarabine, daunorubicin, venetoclax)

Other name: .beta.-Cytosine arabinoside

Other name: 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone

Other name: 1-.beta.-D-Arabinofuranosylcytosine

Other name: 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone

Other name: 1-Beta-D-arabinofuranosylcytosine

Other name: 1.beta.-D-Arabinofuranosylcytosine

Other name: 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-

Other name: 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-

Other name: Alexan

Other name: Ara-C

Other name: ARA-cell

Other name: Arabine

Other name: Arabinofuranosylcytosine

Other name: Arabinosylcytosine

Other name: Aracytidine

Other name: Aracytin

Other name: Aracytine

Other name: Beta-Cytosine Arabinoside

Other name: CHX-3311

Other name: Cytarabinum

Other name: Cytarbel

Other name: Cytosar

Other name: Cytosine Arabinoside

Other name: Cytosine-.beta.-arabinoside

Other name: Cytosine-beta-arabinoside

Other name: Erpalfa

Other name: Starasid

Other name: Tarabine PFS

Other name: U 19920

Other name: U-19920

Other name: Udicil

Other name: WR-28453

Intervention type: Drug
Intervention name: Daunorubicin Hydrochloride
Description: Given IV
Arm group label: Arm I (cytarabine, daunorubicin)
Arm group label: Arm II (cytarabine, daunorubicin, venetoclax)

Other name: Cerubidin

Other name: Cerubidine

Other name: Cloridrato de Daunorubicina

Other name: Daunoblastin

Other name: Daunoblastina

Other name: Daunoblastine

Other name: Daunomycin Hydrochloride

Other name: Daunomycin, hydrochloride

Other name: Daunorubicin.HCl

Other name: Daunorubicini Hydrochloridum

Other name: FI-6339

Other name: Ondena

Other name: RP-13057

Other name: Rubidomycin Hydrochloride

Other name: Rubilem

Intervention type: Procedure
Intervention name: Echocardiography
Description: Undergo ECHO
Arm group label: Arm I (cytarabine, daunorubicin)
Arm group label: Arm II (cytarabine, daunorubicin, venetoclax)
Arm group label: Arm III (azacitidine, venetoclax)
Arm group label: Arm IV (daunorubicin and cytarabine liposome)
Arm group label: Arm V (daunorubicin and cytarabine liposome, venetoclax)

Other name: EC

Intervention type: Drug
Intervention name: Liposome-encapsulated Daunorubicin-Cytarabine
Description: Given IV
Arm group label: Arm IV (daunorubicin and cytarabine liposome)
Arm group label: Arm V (daunorubicin and cytarabine liposome, venetoclax)

Other name: CPX 351

Other name: CPX-351

Other name: CPX351

Other name: Cytarabine and Daunorubicin Liposomal

Other name: Cytarabine-Daunorubicin Liposome for Injection

Other name: Daunorubicin and Cytarabine (Liposomal)

Other name: Liposomal AraC-Daunorubicin CPX-351

Other name: Liposomal Cytarabine-Daunorubicin

Other name: Liposome-encapsulated Combination of Daunorubicin and Cytarabine

Other name: Vyxeos

Intervention type: Procedure
Intervention name: Multigated Acquisition Scan
Description: Undergo MUGA
Arm group label: Arm I (cytarabine, daunorubicin)
Arm group label: Arm II (cytarabine, daunorubicin, venetoclax)
Arm group label: Arm III (azacitidine, venetoclax)
Arm group label: Arm IV (daunorubicin and cytarabine liposome)
Arm group label: Arm V (daunorubicin and cytarabine liposome, venetoclax)

Other name: Blood Pool Scan

Other name: Equilibrium Radionuclide Angiography

Other name: Gated Blood Pool Imaging

Other name: Gated Heart Pool Scan

Other name: MUGA

Other name: MUGA Scan

Other name: Multi-Gated Acquisition Scan

Other name: Radionuclide Ventriculogram Scan

Other name: Radionuclide Ventriculography

Other name: RNV Scan

Other name: RNVG

Other name: SYMA Scanning

Other name: Synchronized Multigated Acquisition Scanning

Intervention type: Drug
Intervention name: Venetoclax
Description: Given PO
Arm group label: Arm II (cytarabine, daunorubicin, venetoclax)
Arm group label: Arm III (azacitidine, venetoclax)
Arm group label: Arm V (daunorubicin and cytarabine liposome, venetoclax)

Other name: ABT 199

Other name: ABT-0199

Other name: ABT-199

Other name: ABT199

Other name: GDC 0199

Other name: GDC-0199

Other name: GDC0199

Other name: RG7601

Other name: Venclexta

Other name: Venclyxto

Summary: This phase II MyeloMATCH treatment trial tests whether the standard approach of cytarabine and daunorubicin in comparison to the following experimental regimens works to shrink cancer in patients with high risk acute myeloid leukemia (AML): 1) daunorubicin and cytarabine liposome alone; 2) cytarabine and daunorubicin with venetoclax; 3) azacitidine and venetoclax; 4) daunorubicin and cytarabine liposome and venetoclax. "High-risk" refers to traits that have been known to make the AML harder to treat. Cytarabine is in a class of medications called antimetabolites. It works by slowing or stopping the growth of cancer cells in the body. Daunorubicin is in a class of medications called anthracyclines. It also works by slowing or stopping the growth of cancer cells in the body. Azacitidine is in a class of medications called demethylation agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. There is evidence that these newer experimental treatment regimens may work better in getting rid of more AML compared to the standard approach of cytarabine and daunorubicin.

Detailed description: PRIMARY OBJECTIVE: I. To compare measurable residual disease (MRD) negative complete remission (CR) rates between each of the experimental regimens and cytarabine + daunorubicin (7+3). SECONDARY OBJECTIVES: I. To estimate the frequency and severity of toxicities with each of the regimens. II. To estimate complete remission (CR) rates, complete remission with incomplete count recovery (CRi, with and without MRD) rates, event-free survival (EFS), time to relapse, relapse-free survival (RFS), and overall survival (OS) with each of the regimens. III. To describe and compare MRD negative CR rates by genomic subgroups within and across randomized arms. BAKING OBJECTIVE: I. To bank specimens for future correlative studies. OUTLINE: Patients are randomized to 1 of 5 arms. ARM I: Patients receive cytarabine intravenously (IV) continuously on days 1-7 and daunorubicin IV on days 1-3 per standard approach of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of cytarabine IV continuously on days 1-5 and daunorubicin IV on days 1-2. Patients undergo echocardiography (ECHO) or multigated acquisition (MUGA) scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial. ARM II: Patients receive cytarabine IV continuously on days 2-8 and daunorubicin IV on days 2-4 with venetoclax orally (PO) on days 1-11 of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of cytarabine IV continuously on days 2-6 and daunorubicin IV on days 2-3 with venetoclax PO on days 1-8. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial. ARM III: Patients receive azacitidine subcutaneously (SC) or IV on days 1-7 and venetoclax PO on days 1-28 of each cycle. Cycles repeat every 28 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial. ARM IV: Patients receive daunorubicin and cytarabine liposome IV over 90 minutes on days 1, 3, and 5 of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of daunorubicin and cytarabine liposome IV over 90 minutes on days 1 and 3. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial. ARM V: Patients receive daunorubicin and cytarabine liposome IV over 90 minutes on days 1, 3, and 5 and venetoclax PO on days 1-14 of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of daunorubicin and cytarabine liposome IV over 90 minutes on days 1 and 3 and venetoclax PO on days 1-7. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial. After completion of study treatment, patients follow up every month for first year, every 2 months for the second year, every 3 months for the third year and every 6 months to year 5.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - STEP 1 REGISTRATION: - Participants must have been registered to Master Screening and Re-Assessment Protocol, MYELOMATCH, prior to consenting to this study. Participants must have been assigned to this clinical trial, via MATCHBox, prior to registration to this study. - Note: Pre-enrollment/diagnosis labs must have already been performed under the MYELOMATCH - Participants must have newly diagnosed, untreated acute myeloid leukemia (AML) per World Health Organization (WHO) criteria - Participants must have high-risk (adverse) AML per European LeukemiaNet (ELN) 2017 criteria - Participants with therapy-related AML (t-AML), or with AML evolving from an antecedent hematologic disorder (such as myeloproliferative neoplasm), or AML with myelodysplasia-related changes (AML-MRC) are eligible - Acute promyelocytic leukemia is excluded - Participants with favorable or intermediate risk disease are excluded - Participants with FLT3 mutations (ITD or TKD) are excluded - Participants with t(9;22) translocation are excluded - A single dose of intrathecal chemotherapy is allowed prior to study entry - Prior anthracycline therapy is allowed but must not exceed a cumulative lifetime dose of 200 mg/m^2 daunorubicin or equivalent. Prior hypomethylating agent (HMA) exposure is allowed, as long as not for AML diagnosis - Participants must not have received or be currently receiving any prior therapy for acute myeloid leukemia. Hydroxyurea to control the white blood cells (WBC) is allowed prior to registration and initiation of protocol-defined therapy. All trans retinoic acid (ATRA) given until a diagnosis of acute promyelocytic leukemia is ruled out is also allowed. - Participants must not be receiving or planning to receive any other investigational agents before completing protocol therapy - Participants must be between 18 and 59 years of age - Participants must have Zubrod performance status =< 3 as determined by a history and physical (H&P) completed within 14 days prior to registration - Participants must have a complete medical history and physical exam within 7 days prior to registration - 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 known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at time of registration and have undetectable HIV viral load within 6 months prior to registration - Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load within 28 days prior to registration and be on suppressive therapy, if indicated - Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with active HCV infection who are currently on treatment must have an undetectable HCV viral load within 28 days prior to registration - The following tests must be performed within 14 days prior to registration to establish baseline values: - Complete blood count (CBC)/differential/platelets - Total bilirubin - Lactate dehydrogenase (LDH) - Albumin - Glucose - Fibrinogen - Participants must have adequate kidney function as evidenced by creatinine clearance >= 30mL/min (by Cockcroft Gault) within 28 days prior to registration - Participants must have adequate liver function as evidenced by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3.0 x upper limit of normal (ULN), and total bilirubin =< 2.0 x ULN (or 5.0 x ULN if the participant has a history of Gilbert's disease) within 28 days prior to registration - Total bilirubin =< 2.0 x ULN (or 5.0 x ULN if the participant has a history of Gilbert's disease) within 28 days prior to registration - Participants must have adequate cardiac function as determined by echocardiography or MUGA scan with an ejection fraction >= 50% within 28 days prior to registration - Participants with a prior or concurrent malignancy whose natural history (in the opinion of the treating physician) does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. No concurrent therapies for such malignancy are allowed with the exception of hormonal therapy - Participants with known history of Wilson's disease or other known copper-metabolism disorder are excluded - Participants must not be pregnant or nursing. Women/men of reproductive potential must have agreed to use 2 contraception methods. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods (e.g., hormonal contraceptives [examples include birth control pills, vaginal rings, or patches] associated with inhibition of ovulation for at least 1 month prior to taking study drug), "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures. A barrier method should be used during this study along with hormonal contraceptives from initial study drug administration to 30 days after the last dose of study drug as drug-drug interaction with venetoclax is unknown - Participants must have agreed to have specimens submitted for translational medicine (MRD) under the myeloMATCH MSRP and specimens must be submitted - 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 - 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

Gender: All

Minimum age: 18 Years

Maximum age: 59 Years

Healthy volunteers: No

Locations:

Facility:
Name: Banner University Medical Center - Tucson

Address:
City: Tucson
Zip: 85719
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact
Email: UACC-IIT@uacc.arizona.edu

Investigator:
Last name: Sharad Khurana
Email: Principal Investigator

Facility:
Name: University of Arizona Cancer Center-North Campus

Address:
City: Tucson
Zip: 85719
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact
Email: UACC-IIT@uacc.arizona.edu

Investigator:
Last name: Sharad Khurana
Email: Principal Investigator

Facility:
Name: Cedars Sinai Medical Center

Address:
City: Los Angeles
Zip: 90048
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 310-423-8965

Investigator:
Last name: Noah M. Merin
Email: Principal Investigator

Facility:
Name: Augusta University Medical Center

Address:
City: Augusta
Zip: 30912
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 706-721-2388
Email: ga_cares@augusta.edu

Investigator:
Last name: Vamsi Kota
Email: Principal Investigator

Facility:
Name: Kootenai Health - Coeur d'Alene

Address:
City: Coeur d'Alene
Zip: 83814
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Investigator:
Last name: John M. Schallenkamp
Email: Principal Investigator

Facility:
Name: Kootenai Clinic Cancer Services - Post Falls

Address:
City: Post Falls
Zip: 83854
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Investigator:
Last name: John M. Schallenkamp
Email: Principal Investigator

Facility:
Name: Kootenai Clinic Cancer Services - Sandpoint

Address:
City: Sandpoint
Zip: 83864
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Investigator:
Last name: John M. Schallenkamp
Email: Principal Investigator

Facility:
Name: OSF Saint Joseph Medical Center

Address:
City: Bloomington
Zip: 61701
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com

Investigator:
Last name: Bryan A. Faller
Email: Principal Investigator

Facility:
Name: Illinois CancerCare-Bloomington

Address:
City: Bloomington
Zip: 61704
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com

Investigator:
Last name: Bryan A. Faller
Email: Principal Investigator

Facility:
Name: Illinois CancerCare-Canton

Address:
City: Canton
Zip: 61520
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com

Investigator:
Last name: Bryan A. Faller
Email: Principal Investigator

Facility:
Name: Illinois CancerCare-Carthage

Address:
City: Carthage
Zip: 62321
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com

Investigator:
Last name: Bryan A. Faller
Email: Principal Investigator

Facility:
Name: Northwestern University

Address:
City: Chicago
Zip: 60611
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 312-695-1301
Email: cancer@northwestern.edu

Investigator:
Last name: Yasmin Abaza
Email: Principal Investigator

Facility:
Name: University of Chicago Comprehensive Cancer Center

Address:
City: Chicago
Zip: 60637
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 773-702-8222
Email: cancerclinicaltrials@bsd.uchicago.edu

Investigator:
Last name: Olatoyosi M. Odenike
Email: Principal Investigator

Facility:
Name: Cancer Care Specialists of Illinois - Decatur

Address:
City: Decatur
Zip: 62526
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 217-876-4762
Email: morganthaler.jodi@mhsil.com

Investigator:
Last name: Bryan A. Faller
Email: Principal Investigator

Facility:
Name: Decatur Memorial Hospital

Address:
City: Decatur
Zip: 62526
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 217-876-4762
Email: morganthaler.jodi@mhsil.com

Investigator:
Last name: Bryan A. Faller
Email: Principal Investigator

Facility:
Name: Illinois CancerCare-Dixon

Address:
City: Dixon
Zip: 61021
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 815-285-7800

Investigator:
Last name: Bryan A. Faller
Email: Principal Investigator

Facility:
Name: Crossroads Cancer Center

Address:
City: Effingham
Zip: 62401
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 217-876-4762
Email: morganthaler.jodi@mhsil.com

Investigator:
Last name: Bryan A. Faller
Email: Principal Investigator

Facility:
Name: Illinois CancerCare-Eureka

Address:
City: Eureka
Zip: 61530
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com

Investigator:
Last name: Bryan A. Faller
Email: Principal Investigator

Facility:
Name: Illinois CancerCare-Galesburg

Address:
City: Galesburg
Zip: 61401
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com

Investigator:
Last name: Bryan A. Faller
Email: Principal Investigator

Facility:
Name: Illinois CancerCare-Kewanee Clinic

Address:
City: Kewanee
Zip: 61443
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com

Investigator:
Last name: Bryan A. Faller
Email: Principal Investigator

Facility:
Name: Illinois CancerCare-Macomb

Address:
City: Macomb
Zip: 61455
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com

Investigator:
Last name: Bryan A. Faller
Email: Principal Investigator

Facility:
Name: Illinois CancerCare-Ottawa Clinic

Address:
City: Ottawa
Zip: 61350
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com

Investigator:
Last name: Bryan A. Faller
Email: Principal Investigator

Facility:
Name: Illinois CancerCare-Pekin

Address:
City: Pekin
Zip: 61554
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com

Investigator:
Last name: Bryan A. Faller
Email: Principal Investigator

Facility:
Name: Illinois CancerCare-Peoria

Address:
City: Peoria
Zip: 61615
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com

Investigator:
Last name: Bryan A. Faller
Email: Principal Investigator

Facility:
Name: Methodist Medical Center of Illinois

Address:
City: Peoria
Zip: 61636
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com

Investigator:
Last name: Bryan A. Faller
Email: Principal Investigator

Facility:
Name: OSF Saint Francis Medical Center

Address:
City: Peoria
Zip: 61637
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com

Investigator:
Last name: Bryan A. Faller
Email: Principal Investigator

Facility:
Name: Illinois CancerCare-Peru

Address:
City: Peru
Zip: 61354
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com

Investigator:
Last name: Bryan A. Faller
Email: Principal Investigator

Facility:
Name: Illinois CancerCare-Princeton

Address:
City: Princeton
Zip: 61356
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com

Investigator:
Last name: Bryan A. Faller
Email: Principal Investigator

Facility:
Name: Southern Illinois University School of Medicine

Address:
City: Springfield
Zip: 62702
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 217-545-7929

Investigator:
Last name: Bryan A. Faller
Email: Principal Investigator

Facility:
Name: Springfield Clinic

Address:
City: Springfield
Zip: 62702
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 800-444-7541

Investigator:
Last name: Bryan A. Faller
Email: Principal Investigator

Facility:
Name: Springfield Memorial Hospital

Address:
City: Springfield
Zip: 62781
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 217-528-7541
Email: pallante.beth@mhsil.com

Investigator:
Last name: Bryan A. Faller
Email: Principal Investigator

Facility:
Name: Illinois CancerCare - Washington

Address:
City: Washington
Zip: 61571
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com

Investigator:
Last name: Bryan A. Faller
Email: Principal Investigator

Facility:
Name: University of Kansas Clinical Research Center

Address:
City: Fairway
Zip: 66205
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 913-588-3671
Email: KUCC_Navigation@kumc.edu

Investigator:
Last name: Tara L. Lin
Email: Principal Investigator

Facility:
Name: University of Kansas Cancer Center

Address:
City: Kansas City
Zip: 66160
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 913-588-3671
Email: KUCC_Navigation@kumc.edu

Investigator:
Last name: Tara L. Lin
Email: Principal Investigator

Facility:
Name: University of Kansas Hospital-Indian Creek Campus

Address:
City: Overland Park
Zip: 66211
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 913-588-3671
Email: KUCC_Navigation@kumc.edu

Investigator:
Last name: Tara L. Lin
Email: Principal Investigator

Facility:
Name: University of Kansas Hospital-Westwood Cancer Center

Address:
City: Westwood
Zip: 66205
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 913-588-3671
Email: KUCC_Navigation@kumc.edu

Investigator:
Last name: Tara L. Lin
Email: Principal Investigator

Facility:
Name: The James Graham Brown Cancer Center at University of Louisville

Address:
City: Louisville
Zip: 40202
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 502-562-3429

Investigator:
Last name: Mohamed M. Hegazi
Email: Principal Investigator

Facility:
Name: UofL Health Medical Center Northeast

Address:
City: Louisville
Zip: 40245
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 502-852-2755
Email: ctoinfo@louisville.edu

Investigator:
Last name: Mohamed M. Hegazi
Email: Principal Investigator

Facility:
Name: Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Address:
City: Ann Arbor
Zip: 48106
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 734-712-7251
Email: MCRCwebsitecontactform@stjoeshealth.org

Investigator:
Last name: Tareq Al baghdadi
Email: Principal Investigator

Facility:
Name: Trinity Health IHA Medical Group Hematology Oncology - Brighton

Address:
City: Brighton
Zip: 48114
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 734-712-7251
Email: MCRCwebsitecontactform@stjoeshealth.org

Investigator:
Last name: Tareq Al baghdadi
Email: Principal Investigator

Facility:
Name: Trinity Health IHA Medical Group Hematology Oncology - Canton

Address:
City: Canton
Zip: 48188
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 734-712-7251
Email: MCRCwebsitecontactform@stjoeshealth.org

Investigator:
Last name: Tareq Al baghdadi
Email: Principal Investigator

Facility:
Name: Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Address:
City: Chelsea
Zip: 48118
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 734-712-7251
Email: MCRCwebsitecontactform@stjoeshealth.org

Investigator:
Last name: Tareq Al baghdadi
Email: Principal Investigator

Facility:
Name: Wayne State University/Karmanos Cancer Institute

Address:
City: Detroit
Zip: 48201
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 313-576-9790
Email: ctoadmin@karmanos.org

Investigator:
Last name: Vijendra Singh
Email: Principal Investigator

Facility:
Name: Weisberg Cancer Treatment Center

Address:
City: Farmington Hills
Zip: 48334
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 313-576-9790
Email: ctoadmin@karmanos.org

Investigator:
Last name: Vijendra Singh
Email: Principal Investigator

Facility:
Name: Genesee Cancer and Blood Disease Treatment Center

Address:
City: Flint
Zip: 48503
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 810-762-8038
Email: wstrong@ghci.org

Investigator:
Last name: Tareq Al baghdadi
Email: Principal Investigator

Facility:
Name: Genesee Hematology Oncology PC

Address:
City: Flint
Zip: 48503
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 810-762-8038
Email: wstrong@ghci.org

Investigator:
Last name: Tareq Al baghdadi
Email: Principal Investigator

Facility:
Name: Genesys Hurley Cancer Institute

Address:
City: Flint
Zip: 48503
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 810-762-8038
Email: wstrong@ghci.org

Investigator:
Last name: Tareq Al baghdadi
Email: Principal Investigator

Facility:
Name: Hurley Medical Center

Address:
City: Flint
Zip: 48503
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 810-762-8038
Email: wstrong@ghci.org

Investigator:
Last name: Tareq Al baghdadi
Email: Principal Investigator

Facility:
Name: Trinity Health Saint Mary Mercy Livonia Hospital

Address:
City: Livonia
Zip: 48154
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 734-712-7251
Email: MCRCwebsitecontactform@stjoeshealth.org

Investigator:
Last name: Tareq Al baghdadi
Email: Principal Investigator

Facility:
Name: Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Address:
City: Ypsilanti
Zip: 48197
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 734-712-7251
Email: MCRCwebsitecontactform@stjoeshealth.org

Investigator:
Last name: Tareq Al baghdadi
Email: Principal Investigator

Facility:
Name: Baptist Memorial Hospital and Cancer Center-Golden Triangle

Address:
City: Columbus
Zip: 39705
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 901-226-1366
Email: BCCclintrials@bmhcc.org

Investigator:
Last name: Salil Goorha
Email: Principal Investigator

Facility:
Name: Baptist Cancer Center-Grenada

Address:
City: Grenada
Zip: 38901
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 901-226-1366
Email: BCCclintrials@bmhcc.org

Investigator:
Last name: Salil Goorha
Email: Principal Investigator

Facility:
Name: Baptist Memorial Hospital and Cancer Center-Union County

Address:
City: New Albany
Zip: 38652
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 901-226-1366
Email: BCCclintrials@bmhcc.org

Investigator:
Last name: Salil Goorha
Email: Principal Investigator

Facility:
Name: Baptist Memorial Hospital and Cancer Center-Oxford

Address:
City: Oxford
Zip: 38655
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 901-226-1366
Email: BCCclintrials@bmhcc.org

Investigator:
Last name: Salil Goorha
Email: Principal Investigator

Facility:
Name: Baptist Memorial Hospital and Cancer Center-Desoto

Address:
City: Southhaven
Zip: 38671
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 901-226-1366
Email: BCCclintrials@bmhcc.org

Investigator:
Last name: Salil Goorha
Email: Principal Investigator

Facility:
Name: Siteman Cancer Center at West County Hospital

Address:
City: Creve Coeur
Zip: 63141
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 800-600-3606
Email: info@siteman.wustl.edu

Investigator:
Last name: Ramzi Abboud
Email: Principal Investigator

Facility:
Name: Washington University School of Medicine

Address:
City: Saint Louis
Zip: 63110
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 800-600-3606
Email: info@siteman.wustl.edu

Investigator:
Last name: Ramzi Abboud
Email: Principal Investigator

Facility:
Name: Siteman Cancer Center-South County

Address:
City: Saint Louis
Zip: 63129
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 800-600-3606
Email: info@siteman.wustl.edu

Investigator:
Last name: Ramzi Abboud
Email: Principal Investigator

Facility:
Name: Siteman Cancer Center at Christian Hospital

Address:
City: Saint Louis
Zip: 63136
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 800-600-3606
Email: info@siteman.wustl.edu

Investigator:
Last name: Ramzi Abboud
Email: Principal Investigator

Facility:
Name: Siteman Cancer Center at Saint Peters Hospital

Address:
City: Saint Peters
Zip: 63376
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 800-600-3606
Email: info@siteman.wustl.edu

Investigator:
Last name: Ramzi Abboud
Email: Principal Investigator

Facility:
Name: Billings Clinic Cancer Center

Address:
City: Billings
Zip: 59101
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 800-996-2663
Email: research@billingsclinic.org

Investigator:
Last name: John M. Schallenkamp
Email: Principal Investigator

Facility:
Name: Bozeman Health Deaconess Hospital

Address:
City: Bozeman
Zip: 59715
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Investigator:
Last name: John M. Schallenkamp
Email: Principal Investigator

Facility:
Name: Benefis Sletten Cancer Institute

Address:
City: Great Falls
Zip: 59405
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Investigator:
Last name: John M. Schallenkamp
Email: Principal Investigator

Facility:
Name: Logan Health Medical Center

Address:
City: Kalispell
Zip: 59901
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Investigator:
Last name: John M. Schallenkamp
Email: Principal Investigator

Facility:
Name: Community Medical Center

Address:
City: Missoula
Zip: 59804
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Investigator:
Last name: John M. Schallenkamp
Email: Principal Investigator

Facility:
Name: Nebraska Medicine-Bellevue

Address:
City: Bellevue
Zip: 68123
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 402-559-6941
Email: unmcrsa@unmc.edu

Investigator:
Last name: Michael Haddadin
Email: Principal Investigator

Facility:
Name: Nebraska Medicine-Village Pointe

Address:
City: Omaha
Zip: 68118
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 402-559-5600

Investigator:
Last name: Michael Haddadin
Email: Principal Investigator

Facility:
Name: University of Nebraska Medical Center

Address:
City: Omaha
Zip: 68198
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 402-559-6941
Email: unmcrsa@unmc.edu

Investigator:
Last name: Michael Haddadin
Email: Principal Investigator

Facility:
Name: OptumCare Cancer Care at Seven Hills

Address:
City: Henderson
Zip: 89052
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 702-384-0013
Email: research@sncrf.org

Investigator:
Last name: John A. Ellerton
Email: Principal Investigator

Facility:
Name: OptumCare Cancer Care at Charleston

Address:
City: Las Vegas
Zip: 89102
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 702-384-0013
Email: research@sncrf.org

Investigator:
Last name: John A. Ellerton
Email: Principal Investigator

Facility:
Name: OptumCare Cancer Care at Fort Apache

Address:
City: Las Vegas
Zip: 89148
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 702-384-0013
Email: research@sncrf.org

Investigator:
Last name: John A. Ellerton
Email: Principal Investigator

Facility:
Name: University of New Mexico Cancer Center

Address:
City: Albuquerque
Zip: 87106
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 505-925-0348
Email: HSC-ClinicalTrialInfo@salud.unm.edu

Investigator:
Last name: Charles Foucar
Email: Principal Investigator

Facility:
Name: Montefiore Medical Center - Moses Campus

Address:
City: Bronx
Zip: 10467
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 718-379-6866
Email: eskwak@montefiore.org

Investigator:
Last name: Ioannis Mantzaris
Email: Principal Investigator

Facility:
Name: University of Rochester

Address:
City: Rochester
Zip: 14642
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 585-275-5830

Investigator:
Last name: Paul M. Barr
Email: Principal Investigator

Facility:
Name: State University of New York Upstate Medical University

Address:
City: Syracuse
Zip: 13210
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 315-464-5476

Investigator:
Last name: Teresa C. Gentile
Email: Principal Investigator

Facility:
Name: Duke University Medical Center

Address:
City: Durham
Zip: 27710
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 888-275-3853

Investigator:
Last name: Harry P. Erba
Email: Principal Investigator

Facility:
Name: University of Oklahoma Health Sciences Center

Address:
City: Oklahoma City
Zip: 73104
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 405-271-8777
Email: ou-clinical-trials@ouhsc.edu

Investigator:
Last name: Manu Pandey
Email: Principal Investigator

Facility:
Name: Oregon Health and Science University

Address:
City: Portland
Zip: 97239
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 503-494-1080
Email: trials@ohsu.edu

Investigator:
Last name: Curtis A. Lachowiez
Email: Principal Investigator

Facility:
Name: Reading Hospital

Address:
City: West Reading
Zip: 19611
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 610-988-9323

Investigator:
Last name: Terrence P. Cescon
Email: Principal Investigator

Facility:
Name: Prisma Health Cancer Institute - Spartanburg

Address:
City: Boiling Springs
Zip: 29316
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 864-241-6251

Investigator:
Last name: Suzanne R. Fanning
Email: Principal Investigator

Facility:
Name: Prisma Health Cancer Institute - Easley

Address:
City: Easley
Zip: 29640
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 864-522-2066
Email: Kim.Williams3@prismahealth.org

Investigator:
Last name: Suzanne R. Fanning
Email: Principal Investigator

Facility:
Name: Prisma Health Cancer Institute - Butternut

Address:
City: Greenville
Zip: 29605
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 864-241-6251

Investigator:
Last name: Suzanne R. Fanning
Email: Principal Investigator

Facility:
Name: Prisma Health Cancer Institute - Faris

Address:
City: Greenville
Zip: 29605
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 864-241-6251

Investigator:
Last name: Suzanne R. Fanning
Email: Principal Investigator

Facility:
Name: Prisma Health Cancer Institute - Eastside

Address:
City: Greenville
Zip: 29615
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 864-241-6251

Investigator:
Last name: Suzanne R. Fanning
Email: Principal Investigator

Facility:
Name: Prisma Health Cancer Institute - Greer

Address:
City: Greer
Zip: 29650
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 864-241-6251

Investigator:
Last name: Suzanne R. Fanning
Email: Principal Investigator

Facility:
Name: Prisma Health Cancer Institute - Seneca

Address:
City: Seneca
Zip: 29672
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 864-241-6251

Investigator:
Last name: Suzanne R. Fanning
Email: Principal Investigator

Facility:
Name: Baptist Memorial Hospital and Cancer Center-Collierville

Address:
City: Collierville
Zip: 38017
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 901-226-1366
Email: BCCclintrials@bmhcc.org

Investigator:
Last name: Salil Goorha
Email: Principal Investigator

Facility:
Name: Baptist Memorial Hospital and Cancer Center-Memphis

Address:
City: Memphis
Zip: 38120
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 901-226-1366
Email: BCCclintrials@bmhcc.org

Investigator:
Last name: Salil Goorha
Email: Principal Investigator

Facility:
Name: University of Virginia Cancer Center

Address:
City: Charlottesville
Zip: 22908
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 434-243-6303
Email: uvacancertrials@hscmail.mcc.virginia.edu

Investigator:
Last name: Daniel R. Reed
Email: Principal Investigator

Facility:
Name: Gundersen Lutheran Medical Center

Address:
City: La Crosse
Zip: 54601
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 608-775-2385
Email: cancerctr@gundersenhealth.org

Investigator:
Last name: David E. Marinier
Email: Principal Investigator

Facility:
Name: Centro Comprensivo de Cancer de UPR

Address:
City: San Juan
Zip: 00927
Country: Puerto Rico

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 888-823-5923
Email: ctsucontact@westat.com

Investigator:
Last name: Luis J. Santos Reyes
Email: Principal Investigator

Facility:
Name: San Juan City Hospital

Address:
City: San Juan
Zip: 00936
Country: Puerto Rico

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 787-763-1296

Investigator:
Last name: Luis J. Santos Reyes
Email: Principal Investigator

Start date: September 25, 2024

Completion date: March 31, 2027

Lead sponsor:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: National Cancer Institute (NCI)

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05554406

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