Recruiting
Phase 2

Inotuzumab Ozogamicin & Blinatumomab

Sponsor:

National Cancer Institute (NCI)

Code:

NCT03739814

Conditions

B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative

Recurrent B Acute Lymphoblastic Leukemia

Refractory B Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Blinatumomab

Bone Marrow Aspiration

Bone Marrow Biopsy

Inotuzumab Ozogamicin

Study Details

Brief summary:

This phase II trial studies how well inotuzumab ozogamicin and blinatumomab with or without ponatinib work in treating patients with CD22-positive B-lineage acute lymphoblastic leukemia that is newly diagnosed, has come back after a period of improvement (recurrent), or does not respond to treatment (refractory). Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a chemotherapy drug, called ozogamicin. Inotuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD22 receptors, and delivers ozogamicin to kill them. Blinatumomab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Ponatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving inotuzumab ozogamicin and blinatumomab with or without ponatinib may be effective in treating patients with newly diagnosed, recurrent or refractory CD22 positive B-lineage acute lymphoblastic leukemia.

Conditions

B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative

Recurrent B Acute Lymphoblastic Leukemia

Refractory B Acute Lymphoblastic Leukemia

Study ID

NCT03739814

Start date

May 8, 2019

Status verified date

Aug, 2026

Completion date

Feb 1, 2027

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • STEP 0: Submission of bone marrow aspirate and peripheral blood for MRD analysis is mandatory prior to registration; the bone marrow sample should be from the first aspiration (i.e. first pull). Aspirate needle should be redirected if needed to get first pull bone marrow aspirate. It should be initiated as soon as possible after pre-registration. The specimens should be sent to the HEME Biobank.

  • Lumbar Puncture (Spinal Tap) and Intrathecal Methotrexate:

  • Patients may receive the day 1 of course IA dose of intrathecal (IT) methotrexate during the prior-to-registration lumbar puncture (or the venous line placement) to avoid a second lumbar puncture. If the dose is administered prior to registration, then systemic chemotherapy must begin within 7 days of this IT chemotherapy.
  • STEP 1: Morphologic diagnosis of precursor B-cell acute lymphoblastic leukemia (ALL) based on World Health Organization (WHO) criteria. Patients with Burkitt lymphoma/leukemia are not eligible.
  • STEP 1: CD22-positive disease defined as CD22 expression by >= 20% of lymphoblasts by local hematopathology evaluation.
  • STEP 1: Philadelphia chromosome/BCR-ABL1-negative or Philadelphia chromosome/BCR-ABL1-positive B-cell ALL by cytogenetics, fluorescence in situ hybridization (FISH), and/or polymerase chain reaction (PCR).
  • STEP 1: No active central nervous system (CNS) leukemia (i.e. only CNS-1 disease allowed). Active CNS leukemia is defined as morphologic evidence of lymphoblasts in the cerebrospinal fluid (CSF), use of CNS-directed local treatment for active disease within 28 days prior to registration, symptomatic CNS leukemia (i.e. cranial nerve palsies or other significant neurological dysfunction) within the 28 days prior to registration, and/or known asymptomatic parenchymal CNS mass lesions; see below for additional guidance. Prophylactic intrathecal medication alone is not an exclusion.

  • Categories of CNS Involvement for CNS Evaluation Prior to Registration:

  • CNS 1: CSF has < 5 WBC/uL with cytospin negative for blasts; or >= 10 red blood cell (RBC)/uL with cytospin negative for blasts.
  • CNS 2: CSF has < 5 WBC/uL with cytospin positive for blasts; or >= 10 RBC/uL with cytospin positive for blasts; or >= 10 RBC/uL, WBC/uL >= 5 but less than Steinherz/Bleyer algorithm with cytospin positive for blasts (see below).
  • CNS 3: CSF has >= 5 WBC/uL with cytospin positive for blasts; or >= 10 RBC/uL, >= 5 WBC/uL and positive by Steinherz/Bleyer algorithm (see below); or clinical signs of CNS leukemia (such as facial nerve palsy, brain/eye involvement or hypothalamic syndrome). Steinherz/Bleyer Method of Evaluating Initial Traumatic Lumbar Punctures:

  • If the patient has leukemia cells in the peripheral blood and the lumbar puncture is traumatic and contains >= 5 WBC/uL with blasts, the following algorithm should be used to define CNS disease: CSF WBC/CSF RBC > 2 x (Blood WBC/Blood RBC count)
  • STEP 1: Patients with known or suspected testicular involvement by leukemia are allowed provided that the patient receives concomitant scrotal/testicular radiotherapy.

  • Unilateral or bilateral testicular enlargement should be assessed by ultrasound or other imaging technique. Biopsy is recommended if clinical findings are equivocal or suggestive of hydrocele or a non-leukemic mass, but further assessments are per treating physician discretion.
  • STEP 1: Not pregnant and not nursing.

  • This study involves agents that have known genotoxic, mutagenic, and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required.
  • STEP 1: Eastern Cooperative Oncology Group (ECOG) performance status: 0-2
  • STEP 1: No unstable cardiac disease such as myocardial infarction, angina pectoris, uncontrolled heart failure, or uncontrolled cardiac arrhythmia within 6 months of registration.
  • STEP 1: No impaired cardiac function, defined as left ventricular ejection fraction (LVEF) < 45% or New York Heart Association (NYHA) stage III or IV congestive heart failure (CHF).
  • STEP 1: Patients with known human immunodeficiency virus (HIV) infection are eligible if they have been on effective antiretroviral therapy with an undetectable viral load tested within 6 months of registration.
  • STEP 1: Patients with hepatitis B virus (HBV) are eligible only if they meet all the following:

  • On HBV-suppressive therapy.
  • No evidence of active virus.
  • No evidence of HBV-related liver damage.
  • STEP 1: Patients with hepatitis C virus (HCV) are eligible only if they meet all the following:

  • Successfully completed complete-eradication therapy with undetectable viral load.
  • No evidence of HCV-related liver damage.
  • STEP 1: No history of clinically relevant neurologic disorder such as epilepsy, seizure, aphasia, stroke, severe brain injury, structural brain abnormality, benign brain tumor, dementia, Parkinson's disease, movement disorder, cerebellar disease, or other significant CNS abnormalities.
  • STEP 1: No prior additional malignancy (i.e. in addition to ALL) except adequately treated basal- or squamous-cell skin cancer, in situ cervical cancer, stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for >= 2 years.
  • STEP 1: No history of clinically significant ventricular arrhythmia, unexplained non-vasovagal syncope, or chronic bradycardic states such as sinoatrial block or higher degree of atrioventricular block unless a permanent pacemaker has been implanted.
  • STEP 1: No history of chronic liver disease, including cirrhosis.
  • STEP 1: No history of sinusoidal occlusion syndrome/veno-occlusive disease of the liver.
  • STEP 1: No uncontrolled infection or recent history (within 4 months prior to registration) of deep tissue infections such as fasciitis or osteomyelitis.
  • STEP 1: Total bilirubin, serum =< 1.5 x upper limit of normal (ULN)\*

  • Except in the event of: 1) Gilbert disease, in which case total bilirubin must be =< 2 x ULN, or 2) elevated bilirubin believed by investigator to be due to leukemic infiltration, in which case total bilirubin must be =< 2 x ULN.
  • STEP 1: Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x ULN
  • STEP 1: Creatinine, serum =< 1.5 ULN OR creatinine clearance >= 40 mL/min
  • STEP 1: QT interval by Fridericia's correction formula (QTcF) =< 470 msec
  • COHORT 1: Age >= 60 years.
  • COHORT 1: Diagnosis of Philadelphia chromosome/BCR-ABL1-negative B-cell ALL.
  • COHORT 1: No prior treatment for ALL except a single dose of intrathecal chemotherapy, corticosteroids, hydroxyurea, and/or leukapheresis to reduce peripheral blast count and prevent ALL complications. Allowed therapy may be administered for no more than 14 days and must be completed >= 24 hours prior to the initiation of protocol therapy.
  • COHORT 1: No plan for allogeneic or autologous hematopoietic cell transplantation (HCT).
  • COHORT 2: Age >= 18 years.
  • COHORT 2: Diagnosis of Philadelphia chromosome/BCR-ABL1-negative B-cell ALL.
  • COHORT 2: Relapsed or refractory disease in salvage 1 or 2.
  • COHORT 2: No isolated extramedullary relapse.
  • COHORT 2: Prior allogeneic HCT permitted.
  • COHORT 2: Patients with prior allogeneic HCT must have completed transplantation >= 4 months prior to registration.
  • COHORT 2: Patients with prior allogeneic HCT must have no evidence of graft-versus-host disease and must have completed immunosuppressive therapy >= 30 days prior to registration.
  • COHORT 2: Prior treatment with inotuzumab ozogamicin, blinatumomab, other CD22-directed therapy, or other CD19-directed therapy is not allowed.
  • COHORT 2: Prior treatment with rituximab must be completed >= 7 days prior to registration.
  • COHORT 2: Prior treatment with other monoclonal antibodies must be completed >= 6 weeks prior to registration.
  • COHORT 2: Prior treatment for ALL must be completed >= 14 days prior to registration with the following exceptions: intrathecal chemotherapy, hydroxyurea, corticosteroids, 6-mercaptopurine, methotrexate, vincristine, and/or leukapheresis to reduce circulating absolute lymphoblast count to =< 10,000/uL or prevent complications related to ALL are allowed but must be completed >= 24 hours prior to the initiation of protocol therapy.
  • COHORT 2: Patients should have resolution of any acute non-hematologic toxicities of prior therapy to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 grade =< 1.
  • COHORT 2: Peripheral blood absolute lymphoblast count =< 10,000/uL (treatment allowed as above to reduce blast count to =< 10,000/uL)
  • COHORT 3: Age ≥ 75 years OR age ≥ 18 years AND ineligible for hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone (HyperCVAD) regimens
  • COHORT 3: Diagnosis of Philadelphia chromosome/BCR-ABL1-positive B-cell ALL
  • COHORT 3: No prior treatment for ALL except a single dose of intrathecal chemotherapy, corticosteroids, hydroxyurea, BCR-ABL1-targeted tyrosine kinase inhibitor, and/or leukapheresis to reduce peripheral blast count and prevent ALL complications. Allowed non-protocol therapy may be administered for no more than 14 days and must be completed ≥ 24 hours prior to the initiation of protocol therapy.
  • COHORT 3: No chronic, strong CYP3A4 inducers

Study Design

Enrollment

84 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1 (inotuzumab ozogamicin, blinatumomab)

See Detailed Description..

experimental: Cohort 2 (inotuzumab ozogamicin, blinatumomab)

See Detailed Description.

experimental: Cohort 3 (inotuzumab ozogamicin, blinatumomab, ponatinib))

See detailed description

Interventions

Biospecimen Collection

Undergo blood sample and cerebrospinal fluid collection

Blinatumomab

Given IV

Bone Marrow Aspiration

Undergo bone marrow aspiration

Bone Marrow Biopsy

Undergo bone marrow biopsy

Inotuzumab Ozogamicin

Given IV

Lumbar Puncture

Undergo lumbar puncture

Ponatinib

Given PO

Primary outcome measure

  • Event-free survival [ Time Frame: At 1 year ]
  • Completion of protocol treatment (cohort 3) [ Time Frame: Up to 10 years ]

Central Contacts and Locations

Locations

City of Hope Comprehensive Cancer Center

Recruiting

Duarte, California, United States, 91010

Contacts

Site Public Contact

800-826-4673becomingapatient@coh.org

Principal Investigator:

Ibrahim Aldoss

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Recruiting

Irvine, California, United States, 92612

Contacts

Site Public Contact

877-827-8839ucstudy@uci.edu

Principal Investigator:

Deepa Jeyakumar

UC San Diego Moores Cancer Center

Recruiting

La Jolla, California, United States, 92093

Contacts

Site Public Contact

858-822-5354cancercto@ucsd.edu

Principal Investigator:

James K. Mangan

UC Irvine Health/Chao Family Comprehensive Cancer Center

Recruiting

Orange, California, United States, 92868

Contacts

Site Public Contact

877-827-8839ucstudy@uci.edu

Principal Investigator:

Deepa Jeyakumar

Helen F Graham Cancer Center

Recruiting

Newark, Delaware, United States, 19713

Contacts

Site Public Contact

302-623-4450lbarone@christianacare.org

Principal Investigator:

Gregory A. Masters

Medical Oncology Hematology Consultants PA

Recruiting

Newark, Delaware, United States, 19713

Contacts

Site Public Contact

302-623-4450lbarone@christianacare.org

Principal Investigator:

Gregory A. Masters

MedStar Georgetown University Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20007

Contacts

Site Public Contact

202-444-2223

Principal Investigator:

Kimberley Doucette

Jupiter Medical Center

Recruiting

Jupiter, Florida, United States, 33458

Contacts

Site Public Contact

561-263-5791clinicaltrials@jupitermed.com

Principal Investigator:

Ryan H. Devine

Emory University Hospital/Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Site Public Contact

404-778-1868

Principal Investigator:

William G. Blum

Emory Saint Joseph's Hospital

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Site Public Contact

404-851-7115

Principal Investigator:

William G. Blum

Saint Alphonsus Cancer Care Center-Nampa

Recruiting

Nampa, Idaho, United States, 83687

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

Christopher M. Reynolds

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Site Public Contact

312-695-1301cancer@northwestern.edu

Principal Investigator:

Shira N. Dinner

University of Illinois

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Site Public Contact

312-355-3046

Principal Investigator:

John G. Quigley

University of Chicago Comprehensive Cancer Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Site Public Contact

773-702-8222cancerclinicaltrials@bsd.uchicago.edu

Principal Investigator:

Wendy Stock

Cancer Care Specialists of Illinois - Decatur

Recruiting

Decatur, Illinois, United States, 62526

Contacts

Site Public Contact

217-876-4762morganthaler.jodi@mhsil.com

Principal Investigator:

Bryan A. Faller

Crossroads Cancer Center

Recruiting

Effingham, Illinois, United States, 62401

Contacts

Site Public Contact

217-876-4762morganthaler.jodi@mhsil.com

Principal Investigator:

Bryan A. Faller

Loyola University Medical Center

Recruiting

Maywood, Illinois, United States, 60153

Contacts

Site Public Contact

708-226-4357

Principal Investigator:

Stephanie B. Tsai

UC Comprehensive Cancer Center at Silver Cross

Recruiting

New Lenox, Illinois, United States, 60451

Contacts

Site Public Contact

773-702-8222cancerclinicaltrials@bsd.uchicago.edu

Principal Investigator:

Wendy Stock

University of Chicago Medicine-Orland Park

Recruiting

Orland Park, Illinois, United States, 60462

Contacts

Site Public Contact

773-702-8222cancerclinicaltrials@bsd.uchicago.edu

Principal Investigator:

Wendy Stock

Illinois CancerCare-Peoria

Recruiting

Peoria, Illinois, United States, 61615

Contacts

Site Public Contact

309-243-3605andersonj@illinoiscancercare.com

Principal Investigator:

Bryan A. Faller

University of Kansas Cancer Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Site Public Contact

913-588-3671KUCC_Navigation@kumc.edu

Principal Investigator:

Kenneth Byrd

University of Kansas Hospital-Westwood Cancer Center

Recruiting

Westwood, Kansas, United States, 66205

Contacts

Site Public Contact

913-588-3671KUCC_Navigation@kumc.edu

Principal Investigator:

Kenneth Byrd

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Recruiting

Ann Arbor, Michigan, United States, 48106

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Christopher M. Reynolds

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Recruiting

Brighton, Michigan, United States, 48114

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Christopher M. Reynolds

Trinity Health Medical Center - Brighton

Recruiting

Brighton, Michigan, United States, 48114

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Christopher M. Reynolds

Trinity Health IHA Medical Group Hematology Oncology - Canton

Recruiting

Canton, Michigan, United States, 48188

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Christopher M. Reynolds

Trinity Health Medical Center - Canton

Recruiting

Canton, Michigan, United States, 48188

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Christopher M. Reynolds

Chelsea Hospital

Recruiting

Chelsea, Michigan, United States, 48118

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Christopher M. Reynolds

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Recruiting

Chelsea, Michigan, United States, 48118

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Christopher M. Reynolds

Henry Ford Health Saint John Hospital

Recruiting

Detroit, Michigan, United States, 48236

Contacts

Site Public Contact

313-343-3166Kkeenan1@hfhs.org

Principal Investigator:

Christopher M. Reynolds

Henry Ford River District Hospital

Recruiting

East China Township, Michigan, United States, 48054

Contacts

Site Public Contact

313-343-3166kforman1@hfhs.org

Principal Investigator:

Christopher M. Reynolds

Cancer Hematology Centers - Flint

Recruiting

Flint, Michigan, United States, 48503

Contacts

Site Public Contact

810-762-8038wstrong@ghci.org

Principal Investigator:

Christopher M. Reynolds

Genesys Hurley Cancer Institute

Recruiting

Flint, Michigan, United States, 48503

Contacts

Site Public Contact

810-762-8038wstrong@ghci.org

Principal Investigator:

Christopher M. Reynolds

Hurley Medical Center

Recruiting

Flint, Michigan, United States, 48503

Contacts

Site Public Contact

810-762-8038wstrong@ghci.org

Principal Investigator:

Christopher M. Reynolds

Henry Ford Saint John Hospital - Academic

Recruiting

Grosse Pointe Woods, Michigan, United States, 48236

Contacts

Site Public Contact

313-343-3166kforman1@hfhs.org

Principal Investigator:

Christopher M. Reynolds

Henry Ford Saint John Hospital - Van Elslander

Recruiting

Grosse Pointe Woods, Michigan, United States, 48236

Contacts

Site Public Contact

313-343-3166kforman1@hfhs.org

Principal Investigator:

Christopher M. Reynolds

Trinity Health Saint Mary Mercy Livonia Hospital

Recruiting

Livonia, Michigan, United States, 48154

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Christopher M. Reynolds

Henry Ford Saint John Hospital - Macomb Medical

Recruiting

Macomb, Michigan, United States, 48044

Contacts

Site Public Contact

313-343-3166kforman1@hfhs.org

Principal Investigator:

Christopher M. Reynolds

Trinity Health Saint Joseph Mercy Oakland Hospital

Recruiting

Pontiac, Michigan, United States, 48341

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Christopher M. Reynolds

MyMichigan Medical Center Saginaw

Recruiting

Saginaw, Michigan, United States, 48601

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Christopher M. Reynolds

MyMichigan Medical Center Tawas

Recruiting

Tawas City, Michigan, United States, 48764

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Christopher M. Reynolds

Henry Ford Health Warren Hospital

Recruiting

Warren, Michigan, United States, 48093

Contacts

Site Public Contact

313-343-3166kforman1@hfhs.org

Principal Investigator:

Christopher M. Reynolds

Henry Ford Warren Hospital - GLCMS

Recruiting

Warren, Michigan, United States, 48093

Contacts

Site Public Contact

313-343-3166kforman1@hfhs.org

Principal Investigator:

Christopher M. Reynolds

Huron Gastroenterology PC

Recruiting

Ypsilanti, Michigan, United States, 48106

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Christopher M. Reynolds

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Recruiting

Ypsilanti, Michigan, United States, 48197

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Christopher M. Reynolds

Siteman Cancer Center at Saint Peters Hospital

Recruiting

City of Saint Peters, Missouri, United States, 63376

Contacts

Site Public Contact

800-600-3606info@siteman.wustl.edu

Principal Investigator:

Geoffrey L. Uy

Siteman Cancer Center at West County Hospital

Recruiting

Creve Coeur, Missouri, United States, 63141

Contacts

Site Public Contact

800-600-3606info@siteman.wustl.edu

Principal Investigator:

Geoffrey L. Uy

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Site Public Contact

800-600-3606info@siteman.wustl.edu

Principal Investigator:

Geoffrey L. Uy

Mercy Hospital South

Recruiting

St Louis, Missouri, United States, 63128

Contacts

Site Public Contact

314-525-6042Danielle.Werle@mercy.net

Principal Investigator:

Jay W. Carlson

Siteman Cancer Center-South County

Recruiting

St Louis, Missouri, United States, 63129

Contacts

Site Public Contact

800-600-3606info@siteman.wustl.edu

Principal Investigator:

Geoffrey L. Uy

Siteman Cancer Center at Christian Hospital

Recruiting

St Louis, Missouri, United States, 63136

Contacts

Site Public Contact

800-600-3606info@siteman.wustl.edu

Principal Investigator:

Geoffrey L. Uy

Mercy Hospital Saint Louis

Recruiting

St Louis, Missouri, United States, 63141

Contacts

Site Public Contact

314-251-7066

Principal Investigator:

Jay W. Carlson

OptumCare Cancer Care at Charleston

Recruiting

Las Vegas, Nevada, United States, 89102

Contacts

Site Public Contact

702-384-0013research@sncrf.org

Principal Investigator:

John A. Ellerton

OptumCare Cancer Care at Fort Apache

Recruiting

Las Vegas, Nevada, United States, 89183

Contacts

Site Public Contact

702-384-0013research@sncrf.org

Principal Investigator:

John A. Ellerton

Northwell Health/Center for Advanced Medicine

Recruiting

Lake Success, New York, United States, 11042

Contacts

Site Public Contact

516-734-8896

Principal Investigator:

Bradley H. Goldberg

North Shore University Hospital

Recruiting

Manhasset, New York, United States, 11030

Contacts

Site Public Contact

516-734-8896

Principal Investigator:

Bradley H. Goldberg

Long Island Jewish Medical Center

Recruiting

New Hyde Park, New York, United States, 11040

Contacts

Site Public Contact

516-734-8896

Principal Investigator:

Bradley H. Goldberg

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Contacts

Site Public Contact

585-275-5830

Principal Investigator:

Kristen M. O'Dwyer

Stony Brook University Medical Center

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Site Public Contact

800-862-2215

Principal Investigator:

Suhu Liu

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Site Public Contact

336-713-6771

Principal Investigator:

Bayard L. Powell

University of Cincinnati Cancer Center-UC Medical Center

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Site Public Contact

513-584-7698cancer@uchealth.com

Principal Investigator:

Emily K. Curran

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Site Public Contact

800-293-5066Jamesline@osumc.edu

Principal Investigator:

Gregory K. Behbehani

University of Cincinnati Cancer Center-West Chester

Recruiting

West Chester, Ohio, United States, 45069

Contacts

Site Public Contact

513-584-7698cancer@uchealth.com

Principal Investigator:

Emily K. Curran

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Site Public Contact

405-271-8777ou-clinical-trials@ouhsc.edu

Principal Investigator:

Zimu Gong

Clackamas Radiation Oncology Center

Recruiting

Clackamas, Oregon, United States, 97015

Contacts

Site Public Contact

503-215-2614CanRsrchStudies@providence.org

Principal Investigator:

Alison K. Conlin

Providence Newberg Medical Center

Recruiting

Newberg, Oregon, United States, 97132

Contacts

Site Public Contact

503-215-2614CanRsrchStudies@providence.org

Principal Investigator:

Alison K. Conlin

Providence Willamette Falls Medical Center

Recruiting

Oregon City, Oregon, United States, 97045

Contacts

Site Public Contact

503-215-2614CanRsrchStudies@providence.org

Principal Investigator:

Alison K. Conlin

Providence Portland Medical Center

Recruiting

Portland, Oregon, United States, 97213

Contacts

Site Public Contact

503-215-2614CanRsrchStudies@providence.org

Principal Investigator:

Alison K. Conlin

Providence Saint Vincent Medical Center

Recruiting

Portland, Oregon, United States, 97225

Contacts

Site Public Contact

503-215-2614CanRsrchStudies@providence.org

Principal Investigator:

Alison K. Conlin

VCU Massey Comprehensive Cancer Center

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Site Public Contact

804-628-6430CTOclinops@vcu.edu

Principal Investigator:

Keri R. Maher

West Virginia University Healthcare

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Site Public Contact

304-293-7374cancertrialsinfo@hsc.wvu.edu

Principal Investigator:

Ashkan Emadi

Marshfield Medical Center-EC Cancer Center

Recruiting

Eau Claire, Wisconsin, United States, 54701

Contacts

Site Public Contact

800-782-8581oncology.clinical.trials@marshfieldresearch.org

Principal Investigator:

Kareem H. Abdelhadi

Marshfield Medical Center-Marshfield

Recruiting

Marshfield, Wisconsin, United States, 54449

Contacts

Site Public Contact

800-782-8581oncology.clinical.trials@marshfieldresearch.org

Principal Investigator:

Kareem H. Abdelhadi

Froedtert Menomonee Falls Hospital

Recruiting

Menomonee Falls, Wisconsin, United States, 53051

Contacts

Site Public Contact

262-257-5100

Principal Investigator:

Ehab L. Atallah

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Site Public Contact

414-805-3666

Principal Investigator:

Ehab L. Atallah

Marshfield Medical Center - Minocqua

Recruiting

Minocqua, Wisconsin, United States, 54548

Contacts

Site Public Contact

800-782-8581oncology.clinical.trials@marshfieldresearch.org

Principal Investigator:

Kareem H. Abdelhadi

Froedtert and MCW Moorland Reserve Health Center

Recruiting

New Berlin, Wisconsin, United States, 53151

Contacts

Site Public Contact

414-805-0505

Principal Investigator:

Ehab L. Atallah

Drexel Town Square Health Center

Recruiting

Oak Creek, Wisconsin, United States, 53154

Contacts

Site Public Contact

414-805-0505

Principal Investigator:

Ehab L. Atallah

Marshfield Medical Center-Rice Lake

Recruiting

Rice Lake, Wisconsin, United States, 54868

Contacts

Site Public Contact

800-782-8581oncology.clinical.trials@marshfieldresearch.org

Principal Investigator:

Kareem H. Abdelhadi

Marshfield Medical Center-River Region at Stevens Point

Recruiting

Stevens Point, Wisconsin, United States, 54482

Contacts

Site Public Contact

800-782-8581oncology.clinical.trials@marshfieldresearch.org

Principal Investigator:

Kareem H. Abdelhadi

Froedtert West Bend Hospital/Kraemer Cancer Center

Recruiting

West Bend, Wisconsin, United States, 53095

Contacts

Site Public Contact

414-805-0505

Principal Investigator:

Ehab L. Atallah

Marshfield Medical Center - Weston

Recruiting

Weston, Wisconsin, United States, 54476

Contacts

Site Public Contact

800-782-8581oncology.clinical.trials@marshfieldresearch.org

Principal Investigator:

Kareem H. Abdelhadi

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-09-02.