Recruiting
Phase 3

Inotuzumab Ozogamicin & Chemotherapy

Sponsor:

Alliance for Clinical Trials in Oncology

Code:

NCT03150693

Conditions

B Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex: All

Age: 18 - 39

Healthy Volunteers: Not accepted

Interventions

Allopurinol

Cytarabine

Daunorubicin Hydrochloride

Vincristine Sulfate

Dexamethasone

Study Details

Brief summary:

This phase III trial studies the side effects of inotuzumab ozogamicin and how well it works when given with frontline chemotherapy in treating patients with newly diagnosed B acute lymphoblastic leukemia. 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. Chemotherapy drugs, such as \[intervention\], work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin with chemotherapy may work better in treating young adults with B acute lymphoblastic leukemia.

Conditions

B Acute Lymphoblastic Leukemia

Study ID

NCT03150693

Start date

Sep 20, 2017

Status verified date

Sep, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 39

Healthy Volunteers: Not accepted

Inclusion Criteria:

REGISTRATION ELIGIBILITY CRITERIA (STEP 1)

  • Newly diagnosed patients with CD-22 positive B-cell acute lymphoblastic leukemia (WHO criteria) are eligible. Patients with Burkitt type ALL are NOT eligible
  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Single-dose intrathecal cytarabine is allowed prior to registration or prior to initiation of systematic therapy for patient convenience; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; systemic chemotherapy must begin within 72 hours of this intrathecal therapy
  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Age >= 18 years and < 40 years
  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =< 3 x upper limit of normal (ULN), unless suspected leukemic involvement of the liver
  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Direct bilirubin =< 3 x upper limit of normal (ULN), unless suspected leukemic involvement of the liver
  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Calculated (calc.) creatinine clearance >= 50 mL/min by Cockcroft-Gault
  • RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Completion of remission induction therapy
  • RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) CONFIRMATION OF TOLERABILITY AND PHASE III ONLY):Patients with M2 marrow or better are eligible; patients with M3 or M4 marrow (greater than 25% lymphoblasts) will not be eligible to be randomized

  • Rating: M0, M1; Blast Cells (%): 0-5.0
  • Rating: M2; Blast Cells (%): 5.1-25.0
  • Rating: M3; Blast Cells (%): > 25-50
  • Rating: M4; Blast Cells (%): > 50.0
  • The term "blast cell" includes any cell that cannot be classified as a more mature normal element, and includes "leukemic cells," pathologic lymphocytes, and stem cells
  • RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) (CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Absolute neutrophil count (ANC) >= 750/mm\^3
  • RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) (CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Platelet count >= 75,000/mm\^3
  • RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) (CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Total bilirubin =< 1.5 x upper limit of normal (ULN), except for patients with known Gilbert's syndrome
  • RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) (CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Aspartate aminotransferase (AST) =< 8 x upper limit of normal (ULN)

EXCLUSION CRITERIA

  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients who have BCR-ABL fusion transcript determined by fluorescence in situ hybridization (FISH) or real time-polymerase chain reaction (RT-PCR) or t(9;22)(q34;q11) by cytogenetics are not eligible and should be considered for enrollment on studies that incorporate imatinib during induction; please note: patients must also be assessed for CD20 positivity and other markers; positivity for CD22 and CD20 is defined as baseline expression of the CD22 or CD20 antigen in more than 20% of leukemic cells using local multiparameter flow-cytometric immunophenotyping with the use of CD45 expression as a marker to gate the ALL blast population, according to recommendations from the European LeukemiaNet
  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): No prior therapy for ALL except for limited treatment (=< 7 days) with corticosteroids or hydroxyurea and a single dose of intrathecal cytarabine; however, patients who are being treated with chronic steroids for other reasons (for example, to treat asthma, autoimmune disorders, lupus, etc.) are eligible
  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): No prior therapy for acute leukemia except emergency therapy (corticosteroids or hydroxyurea) for blast cell crisis, superior vena cava syndrome, or renal failure due to leukemic infiltration of the kidneys; when indicated, leukapheresis or exchange transfusion is recommended to reduce the WBC
  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Not pregnant and not nursing, because this study involves agents that have known genotoxic, mutagenic and teratogenic effects; therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done =< 8 days prior to registration is required
  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients with down syndrome are excluded from this study due to the likelihood of excessive toxicity resulting; these patients should be treated in consultation with a pediatric oncologist

Study Design

Enrollment

303 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arm I (frontline chemotherapy)

See detailed description.

experimental: Arm II (frontline chemotherapy, inotuzumab ozogamicin)

Patients receive inotuzumab ozogamicin IV on days 1, 8, and 15 and undergo bone marrow aspirate and biopsy on day 28. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients who are MRD+ and CD19+ after completion of 2 cycles of inotuzumab ozogamicin receive dexamethasone IV or PO on day 1 and blinatumomab IV via continuous infusion on days 1-28, followed by a 14 day break. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive remission consolidated chemotherapy, interim maintenance chemotherapy, delayed intensification, and maintenance therapy as in Arm I. Patients undergo MUGA or echocardiography and x ray imaging during screening, bone marrow aspiration and biopsy and lumbar puncture and blood sample collection throughout the study.

Interventions

Allopurinol

Given PO

Cytarabine

Given IT, IV, SC

Daunorubicin Hydrochloride

Given IV

Vincristine Sulfate

Given IV

Dexamethasone

Given PO or IV

Pegylated L-Asparaginase

Given IV

Methotrexate

Given IT, IV, PO

Bone Marrow Aspiration and Biopsy

Undergo bone marrow aspiration and biopsy

Cyclophosphamide

Given IV

Mercaptopurine

Given PO

Rituximab

Given IV

Doxorubicin

Given IV

Thioguanine

Given PO

Inotuzumab Ozogamicin

Given IV

Laboratory Biomarker Analysis

Correlative studies

Primary outcome measure

  • Event-free survival (EFS) [ Time Frame: Time from induction response to the time of progressive-disease, secondary malignancy, or death, assessed up to 3 years ]

Central Contacts and Locations

Central contacts

Daniel J. DeAngelo, MD, PhD

617-632-2645daniel_deangelo@dfci.harvard.edu

Locations

Kaiser Permanente-Deer Valley Medical Center

Recruiting

Antioch, California, United States, 94531

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jennifer M. Suga

Community Cancer Institute

Recruiting

Clovis, California, United States, 93611

Contacts

Site Public Contact

559-387-1827

Principal Investigator:

Mohammed S. Bukari

UC Irvine Health Cancer Center-Newport

Recruiting

Costa Mesa, California, United States, 92627

Contacts

Site Public Contact

877-827-8839

Principal Investigator:

Deepa Jeyakumar

Kaiser Permanente Dublin

Recruiting

Dublin, California, United States, 94568

Contacts

Site Public Contact

877-642-4691

Principal Investigator:

Jennifer M. Suga

Kaiser Permanente-Fremont

Recruiting

Fremont, California, United States, 94538

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jennifer M. Suga

Kaiser Permanente Fresno Orchard Plaza

Recruiting

Fresno, California, United States, 93720

Contacts

Site Public Contact

833-574-2273

Principal Investigator:

Jennifer M. Suga

Kaiser Permanente-Fresno

Recruiting

Fresno, California, United States, 93720

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jennifer M. Suga

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

Kaiser Permanente- Modesto MOB II

Recruiting

Modesto, California, United States, 95356

Contacts

Site Public Contact

877-642-4691

Principal Investigator:

Jennifer M. Suga

Kaiser Permanente-Modesto

Recruiting

Modesto, California, United States, 95356

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jennifer M. Suga

Kaiser Permanente-Oakland

Recruiting

Oakland, California, United States, 94611

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jennifer M. Suga

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

Stanford Cancer Institute Palo Alto

Recruiting

Palo Alto, California, United States, 94304

Contacts

Site Public Contact

650-498-7061cancertrialsinfo@stanford.edu

Principal Investigator:

Michaela Liedtke

Kaiser Permanente-Richmond

Recruiting

Richmond, California, United States, 94801

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jennifer M. Suga

Kaiser Permanente-Roseville

Recruiting

Roseville, California, United States, 95661

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jennifer M. Suga

Kaiser Permanente Downtown Commons

Recruiting

Sacramento, California, United States, 95814

Contacts

Site Public Contact

877-642-4691kpoct@kp.org

Principal Investigator:

Jennifer M. Suga

University of California Davis Comprehensive Cancer Center

Recruiting

Sacramento, California, United States, 95817

Contacts

Site Public Contact

916-734-3089

Principal Investigator:

Brian A. Jonas

Kaiser Permanente-South Sacramento

Recruiting

Sacramento, California, United States, 95823

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jennifer M. Suga

Kaiser Permanente-San Francisco

Recruiting

San Francisco, California, United States, 94115

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jennifer M. Suga

Kaiser Permanente-Santa Teresa-San Jose

Recruiting

San Jose, California, United States, 95119

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jennifer M. Suga

Kaiser Permanente San Leandro

Recruiting

San Leandro, California, United States, 94577

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jennifer M. Suga

Kaiser San Rafael-Gallinas

Recruiting

San Rafael, California, United States, 94903

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jennifer M. Suga

Kaiser Permanente Medical Center - Santa Clara

Recruiting

Santa Clara, California, United States, 95051

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jennifer M. Suga

Kaiser Permanente-Santa Rosa

Recruiting

Santa Rosa, California, United States, 95403

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jennifer M. Suga

Kaiser Permanente-South San Francisco

Recruiting

South San Francisco, California, United States, 94080

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jennifer M. Suga

Kaiser Permanente-Stockton

Recruiting

Stockton, California, United States, 95210

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jennifer M. Suga

Kaiser Permanente Medical Center-Vacaville

Recruiting

Vacaville, California, United States, 95688

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jennifer M. Suga

Kaiser Permanente-Vallejo

Recruiting

Vallejo, California, United States, 94589

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jennifer M. Suga

Kaiser Permanente-Walnut Creek

Recruiting

Walnut Creek, California, United States, 94596

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jennifer M. Suga

Yale University

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Site Public Contact

203-785-5702canceranswers@yale.edu

Principal Investigator:

Lourdes M. Mendez

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Recruiting

Hollywood, Florida, United States, 33021

Contacts

Site Public Contact

954-265-1847OHR@mhs.net

Principal Investigator:

Fernando M. Vargas Madueno

Orlando Health Cancer Institute

Recruiting

Orlando, Florida, United States, 32806

Contacts

Site Public Contact

321-841-7246CancerClinicalTrials@orlandohealth.com

Principal Investigator:

Jose E. Sarriera

Emory University Hospital/Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Site Public Contact

404-778-1868

Principal Investigator:

William G. Blum

Augusta University Medical Center

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Site Public Contact

706-721-2388ga_cares@augusta.edu

Principal Investigator:

Vamsi Kota

Straub Clinic and Hospital

Recruiting

Honolulu, Hawaii, United States, 96813

Contacts

Site Public Contact

808-522-4333

Principal Investigator:

Craig S. Boddy

Kapiolani Medical Center for Women and Children

Recruiting

Honolulu, Hawaii, United States, 96826

Contacts

Site Public Contact

808-983-6090

Principal Investigator:

Craig S. Boddy

Pali Momi Medical Center

Recruiting

‘Aiea, Hawaii, United States, 96701

Contacts

Site Public Contact

808-486-6000

Principal Investigator:

Craig S. Boddy

Saint Alphonsus Cancer Care Center-Boise

Recruiting

Boise, Idaho, United States, 83706

Contacts

Site Public Contact

734-712-3671stephanie.couch@stjoeshealth.org

Principal Investigator:

Tareq Al baghdadi

Saint Luke's Cancer Institute - Boise

Recruiting

Boise, Idaho, United States, 83712

Contacts

Site Public Contact

208-381-2774eslinget@slhs.org

Principal Investigator:

Alison K. Conlin

Saint Alphonsus Cancer Care Center-Caldwell

Recruiting

Caldwell, Idaho, United States, 83605

Contacts

Site Public Contact

734-712-3671stephanie.couch@stjoeshealth.org

Principal Investigator:

Tareq Al baghdadi

Kootenai Health - Coeur d'Alene

Recruiting

Coeur d'Alene, Idaho, United States, 83814

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Saint Luke's Cancer Institute - Fruitland

Recruiting

Fruitland, Idaho, United States, 83619

Contacts

Site Public Contact

208-381-2774eslinget@slhs.org

Principal Investigator:

Alison K. Conlin

Saint Luke's Cancer Institute - Meridian

Recruiting

Meridian, Idaho, United States, 83642

Contacts

Site Public Contact

208-381-2774eslinget@slhs.org

Principal Investigator:

Alison K. Conlin

Saint Alphonsus Cancer Care Center-Nampa

Recruiting

Nampa, Idaho, United States, 83687

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

Tareq Al baghdadi

Saint Luke's Cancer Institute - Nampa

Recruiting

Nampa, Idaho, United States, 83687

Contacts

Site Public Contact

208-381-2774eslinget@slhs.org

Principal Investigator:

Alison K. Conlin

Kootenai Clinic Cancer Services - Post Falls

Recruiting

Post Falls, Idaho, United States, 83854

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Kootenai Clinic Cancer Services - Sandpoint

Recruiting

Sandpoint, Idaho, United States, 83864

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Saint Luke's Cancer Institute - Twin Falls

Recruiting

Twin Falls, Idaho, United States, 83301

Contacts

Site Public Contact

208-381-2774eslinget@slhs.org

Principal Investigator:

Alison K. Conlin

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Site Public Contact

312-695-1301cancer@northwestern.edu

Principal Investigator:

Shira N. Dinner

Rush MD Anderson Cancer Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Site Public Contact

312-226-2371Cancer_Studies@rush.edu

Principal Investigator:

Melissa L. Larson

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

NorthShore University HealthSystem-Evanston Hospital

Recruiting

Evanston, Illinois, United States, 60201

Contacts

Site Public Contact

847-570-2109

Principal Investigator:

Amy Y. Wang

NorthShore University HealthSystem-Glenbrook Hospital

Recruiting

Glenview, Illinois, United States, 60026

Contacts

Site Public Contact

847-570-2109

Principal Investigator:

Amy Y. Wang

NorthShore University HealthSystem-Highland Park Hospital

Recruiting

Highland Park, Illinois, United States, 60035

Contacts

Site Public Contact

847-570-2109

Principal Investigator:

Amy Y. Wang

Loyola University Medical Center

Recruiting

Maywood, Illinois, United States, 60153

Contacts

Site Public Contact

708-226-4357

Principal Investigator:

Patrick A. Hagen

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

University of Iowa/Holden Comprehensive Cancer Center

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Site Public Contact

800-237-1225

Principal Investigator:

Grerk Sutamtewagul

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

Cancer Center of Kansas - Wichita

Recruiting

Wichita, Kansas, United States, 67214

Contacts

Site Public Contact

316-291-4774research@viachristi.org

Principal Investigator:

Dennis F. Moore

University of Kentucky/Markey Cancer Center

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Site Public Contact

859-257-3379

Principal Investigator:

Ayman Qasrawi

University of Maryland/Greenebaum Cancer Center

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Site Public Contact

800-888-8823

Principal Investigator:

Shella Saint Fleur-Lominy

Massachusetts General Hospital Cancer Center

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Site Public Contact

877-726-5130

Principal Investigator:

Daniel J. DeAngelo

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Site Public Contact

877-442-3324

Principal Investigator:

Daniel J. DeAngelo

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:

Tareq Al baghdadi

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:

Tareq Al baghdadi

Trinity Health Medical Center - Brighton

Recruiting

Brighton, Michigan, United States, 48114

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Tareq Al baghdadi

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:

Tareq Al baghdadi

Trinity Health Medical Center - Canton

Recruiting

Canton, Michigan, United States, 48188

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Tareq Al baghdadi

Chelsea Hospital

Recruiting

Chelsea, Michigan, United States, 48118

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Tareq Al baghdadi

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:

Tareq Al baghdadi

Wayne State University/Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Site Public Contact

800-527-6266ctoadmin@karmanos.org

Principal Investigator:

Jay Yang

Weisberg Cancer Treatment Center

Recruiting

Farmington Hills, Michigan, United States, 48334

Contacts

Site Public Contact

313-576-9790ctoadmin@karmanos.org

Principal Investigator:

Jay Yang

Cancer Hematology Centers - Flint

Recruiting

Flint, Michigan, United States, 48503

Contacts

Site Public Contact

810-762-8038wstrong@ghci.org

Principal Investigator:

Tareq Al baghdadi

Genesys Hurley Cancer Institute

Recruiting

Flint, Michigan, United States, 48503

Contacts

Site Public Contact

810-762-8038wstrong@ghci.org

Principal Investigator:

Tareq Al baghdadi

Hurley Medical Center

Recruiting

Flint, Michigan, United States, 48503

Contacts

Site Public Contact

810-762-8038wstrong@ghci.org

Principal Investigator:

Tareq Al baghdadi

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Site Public Contact

616-391-1230crcwm-regulatory@crcwm.org

Principal Investigator:

Kathleen Y. Butler

Bronson Methodist Hospital

Recruiting

Kalamazoo, Michigan, United States, 49007

Contacts

Site Public Contact

616-391-1230crcwm-regulatory@crcwm.org

Principal Investigator:

Kathleen Y. Butler

West Michigan Cancer Center

Recruiting

Kalamazoo, Michigan, United States, 49007

Contacts

Site Public Contact

616-391-1230crcwm-regulatory@crcwm.org

Principal Investigator:

Kathleen Y. Butler

Beacon Kalamazoo Cancer Center

Recruiting

Kalamazoo, Michigan, United States, 49009

Contacts

Site Public Contact

574-647-7370

Principal Investigator:

Kathleen Y. Butler

Trinity Health Saint Mary Mercy Livonia Hospital

Recruiting

Livonia, Michigan, United States, 48154

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Tareq Al baghdadi

Henry Ford Saint John Hospital - Macomb Medical

Recruiting

Macomb, Michigan, United States, 48044

Contacts

Site Public Contact

313-343-3166kforman1@hfhs.org

Principal Investigator:

Tareq Al baghdadi

Corewell Health Lakeland Hospitals - Niles Hospital

Recruiting

Niles, Michigan, United States, 49120

Contacts

Site Public Contact

616-391-1230

Principal Investigator:

Kathleen Y. Butler

Trinity Health Saint Joseph Mercy Oakland Hospital

Recruiting

Pontiac, Michigan, United States, 48341

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Tareq Al baghdadi

Corewell Health Reed City Hospital

Recruiting

Reed City, Michigan, United States, 49677

Contacts

Site Public Contact

616-391-1230crcwm-regulatory@crcwm.org

Principal Investigator:

Kathleen Y. Butler

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

Recruiting

Saint Joseph, Michigan, United States, 49085

Contacts

Site Public Contact

616-391-1230crcwm-regulatory@crcwm.org

Principal Investigator:

Kathleen Y. Butler

Munson Medical Center

Recruiting

Traverse City, Michigan, United States, 49684

Contacts

Site Public Contact

616-391-1230crcwm-regulatory@crcwm.org

Principal Investigator:

Kathleen Y. Butler

University of Michigan Health - West

Recruiting

Wyoming, Michigan, United States, 49519

Contacts

Site Public Contact

616-391-1230crcwm-regulatory@crcwm.org

Principal Investigator:

Kathleen Y. Butler

Huron Gastroenterology PC

Recruiting

Ypsilanti, Michigan, United States, 48106

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Tareq Al baghdadi

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:

Tareq Al baghdadi

Essentia Health Cancer Center

Recruiting

Duluth, Minnesota, United States, 55805

Contacts

Site Public Contact

218-786-3308CancerTrials@EssentiaHealth.org

Principal Investigator:

Bret E. Friday

Abbott-Northwestern Hospital

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

Yan Ji

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Site Public Contact

855-776-0015

Principal Investigator:

Aasiya Matin

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

Mercy Hospital Saint Louis

Recruiting

St Louis, Missouri, United States, 63141

Contacts

Site Public Contact

314-251-7066

Principal Investigator:

Jay W. Carlson

Community Hospital of Anaconda

Recruiting

Anaconda, Montana, United States, 59711

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Billings Clinic Cancer Center

Recruiting

Billings, Montana, United States, 59101

Contacts

Site Public Contact

800-996-2663research@billingsclinic.org

Principal Investigator:

John M. Schallenkamp

Bozeman Health Deaconess Hospital

Recruiting

Bozeman, Montana, United States, 59715

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Benefis Sletten Cancer Institute

Recruiting

Great Falls, Montana, United States, 59405

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Logan Health Medical Center

Recruiting

Kalispell, Montana, United States, 59901

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Community Medical Center

Recruiting

Missoula, Montana, United States, 59804

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Nebraska Medicine-Bellevue

Recruiting

Bellevue, Nebraska, United States, 68123

Contacts

Site Public Contact

402-559-6941unmcrsa@unmc.edu

Principal Investigator:

Krishna Gundabolu

Nebraska Medicine-Village Pointe

Recruiting

Omaha, Nebraska, United States, 68118

Contacts

Site Public Contact

402-559-5600

Principal Investigator:

Krishna Gundabolu

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Site Public Contact

402-559-6941unmcrsa@unmc.edu

Principal Investigator:

Krishna Gundabolu

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

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

Site Public Contact

800-767-9355askroswell@roswellpark.org

Principal Investigator:

Eunice S. Wang

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

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Contacts

Site Public Contact

212-824-7309CCTO@mssm.edu

Principal Investigator:

Hannah Levavi

NYP/Weill Cornell Medical Center

Recruiting

New York, New York, United States, 10065

Contacts

Site Public Contact

212-746-1848

Principal Investigator:

Gail J. Roboz

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Contacts

Site Public Contact

585-275-5830

Principal Investigator:

Kristen M. O'Dwyer

UNC Lineberger Comprehensive Cancer Center

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Site Public Contact

877-668-0683cancerclinicaltrials@med.unc.edu

Principal Investigator:

Daniel R. Richardson

East Carolina University

Recruiting

Greenville, North Carolina, United States, 27834

Contacts

Site Public Contact

252-744-1015eubankss@ecu.edu

Principal Investigator:

Darla K. Liles

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

Case Western Reserve University

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Site Public Contact

800-641-2422CTUReferral@UHhospitals.org

Principal Investigator:

Brenda W. Cooper

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Site Public Contact

866-223-8100TaussigResearch@ccf.org

Principal Investigator:

Anjali S. Advani

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Site Public Contact

800-293-5066Jamesline@osumc.edu

Principal Investigator:

Meixiao Long

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:

Mohamad Khawandanah

Providence Newberg Medical Center

Recruiting

Newberg, Oregon, United States, 97132

Contacts

Site Public Contact

503-215-2614CanRsrchStudies@providence.org

Principal Investigator:

Alison K. Conlin

Saint Alphonsus Cancer Care Center-Ontario

Recruiting

Ontario, Oregon, United States, 97914

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

Tareq Al baghdadi

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

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Site Public Contact

503-494-1080trials@ohsu.edu

Principal Investigator:

Brandon M. Hayes-Lattin

Lehigh Valley Hospital-Cedar Crest

Recruiting

Allentown, Pennsylvania, United States, 18103

Contacts

Site Public Contact

610-402-9543Morgan_M.Horton@lvhn.org

Principal Investigator:

Tareq Al baghdadi

Lehigh Valley Hospital - Muhlenberg

Recruiting

Bethlehem, Pennsylvania, United States, 18017

Contacts

Site Public Contact

610-402-9543Morgan_M.Horton@lvhn.org

Principal Investigator:

Tareq Al baghdadi

University of Pennsylvania/Abramson Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Site Public Contact

215-349-8245PMCancerResearch@pennmedicine.upenn.edu

Principal Investigator:

Keith W. Pratz

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Site Public Contact

215-600-9151ONCTrialNow@jefferson.edu

Principal Investigator:

Lindsay Wilde

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Site Public Contact

401-444-1488

Principal Investigator:

Rabin Niroula

Prisma Health Cancer Institute - Spartanburg

Recruiting

Boiling Springs, South Carolina, United States, 29316

Contacts

Site Public Contact

864-522-4317Kim.Williams3@prismahealth.org

Principal Investigator:

Ki Y. Chung

Prisma Health Richland Hospital

Recruiting

Columbia, South Carolina, United States, 29203

Contacts

Site Public Contact

864-522-4317Kim.Williams3@prismahealth.org

Principal Investigator:

Ki Y. Chung

Prisma Health Cancer Institute - Easley

Recruiting

Easley, South Carolina, United States, 29640

Contacts

Site Public Contact

864-522-4317Kim.Williams3@prismahealth.org

Principal Investigator:

Ki Y. Chung

Saint Francis Hospital

Recruiting

Greenville, South Carolina, United States, 29601

Contacts

Site Public Contact

864-603-6234Heather_Rich@bshsi.org

Principal Investigator:

Stephen H. Dyar

Prisma Health Cancer Institute - Butternut

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Site Public Contact

864-522-4317Kim.Williams3@prismahealth.org

Principal Investigator:

Ki Y. Chung

Prisma Health Cancer Institute - Faris

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Site Public Contact

864-522-4317Kim.Williams3@prismahealth.org

Principal Investigator:

Ki Y. Chung

Prisma Health Greenville Memorial Hospital

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Site Public Contact

864-522-4317Kim.Williams3@prismahealth.org

Principal Investigator:

Ki Y. Chung

Saint Francis Cancer Center

Recruiting

Greenville, South Carolina, United States, 29607

Contacts

Site Public Contact

864-603-6234Heather_Rich@bshsi.org

Principal Investigator:

Stephen H. Dyar

Prisma Health Cancer Institute - Eastside

Recruiting

Greenville, South Carolina, United States, 29615

Contacts

Site Public Contact

864-522-4317Kim.Williams3@prismahealth.org

Principal Investigator:

Ki Y. Chung

Prisma Health Cancer Institute - Greer

Recruiting

Greer, South Carolina, United States, 29650

Contacts

Site Public Contact

864-522-4317Kim.Williams3@prismahealth.org

Principal Investigator:

Ki Y. Chung

Prisma Health Cancer Institute - Seneca

Recruiting

Seneca, South Carolina, United States, 29672

Contacts

Site Public Contact

864-522-4317Kim.Williams3@prismahealth.org

Principal Investigator:

Ki Y. Chung

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Site Public Contact

713-790-2700

Principal Investigator:

Siddhartha Ganguly

Huntsman Cancer Institute/University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Site Public Contact

888-424-2100cancerinfo@hci.utah.edu

Principal Investigator:

Paul J. Shami

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

Swedish Cancer Institute-Edmonds

Recruiting

Edmonds, Washington, United States, 98026

Contacts

Site Public Contact

206-215-2343PCRC-NCORP@Swedish.org

Principal Investigator:

Alison K. Conlin

Swedish Medical Center-First Hill

Recruiting

Seattle, Washington, United States, 98122

Contacts

Site Public Contact

206-215-2343PCRC-NCORP@Swedish.org

Principal Investigator:

Alison K. Conlin

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Recruiting

Madison, Wisconsin, United States, 53718

Contacts

Site Public Contact

800-622-8922clinicaltrials@cancer.wisc.edu

Principal Investigator:

Ryan J. Mattison

University of Wisconsin Carbone Cancer Center - University Hospital

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Site Public Contact

800-622-8922clinicaltrials@cancer.wisc.edu

Principal Investigator:

Ryan J. Mattison

Marshfield Medical Center-Marshfield

Recruiting

Marshfield, Wisconsin, United States, 54449

Contacts

Site Public Contact

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

Principal Investigator:

Chady A. Leon

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Site Public Contact

414-805-3666

Principal Investigator:

Guru Subramanian Guru Murthy

Ottawa Hospital and Cancer Center-General Campus

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Site Public Contact

613-761-4395

Principal Investigator:

Jill Fulcher

More Information

Sponsor

Alliance for Clinical Trials in Oncology

Last update posted

Sep 2, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Alliance for Clinical Trials in Oncology on 2026-09-02.