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Trial Title: Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma

NCT ID: NCT06337318

Condition: Classic Follicular Lymphoma
Follicular Lymphoma With Unusual Cytological Features

Conditions: Official terms:
Lymphoma
Lymphoma, Follicular
Rituximab
Antineoplastic Agents, Immunological
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Antibodies, Bispecific

Study type: Interventional

Study phase: Phase 3

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Biospecimen Collection
Description: Undergo blood sample collection
Arm group label: Arm I (Rituximab, rituximab and hyaluronidase)
Arm group label: Arm II (Mosunetuzumab)

Other name: Biological Sample Collection

Other name: Biospecimen Collected

Other name: Specimen Collection

Intervention type: Procedure
Intervention name: Computed Tomography
Description: Undergo CT and/or PET/CT scan
Arm group label: Arm I (Rituximab, rituximab and hyaluronidase)
Arm group label: Arm II (Mosunetuzumab)

Other name: CAT

Other name: CAT Scan

Other name: Computed Axial Tomography

Other name: Computerized Axial Tomography

Other name: Computerized axial tomography (procedure)

Other name: Computerized Tomography

Other name: Computerized Tomography (CT) scan

Other name: CT

Other name: CT Scan

Other name: tomography

Intervention type: Biological
Intervention name: Mosunetuzumab
Description: Given SC
Arm group label: Arm II (Mosunetuzumab)

Other name: Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody BTCT4465A

Other name: BTCT 4465A

Other name: BTCT-4465A

Other name: BTCT4465A

Other name: CD20/CD3 BiMAb BTCT4465A

Other name: Lunsumio

Other name: Mosunetuzumab-axgb

Other name: RG 7828

Other name: RG-7828

Other name: RG7828

Other name: RO7030816

Intervention type: Procedure
Intervention name: Positron Emission Tomography
Description: Undergo PET/CT scan
Arm group label: Arm I (Rituximab, rituximab and hyaluronidase)
Arm group label: Arm II (Mosunetuzumab)

Other name: Medical Imaging, Positron Emission Tomography

Other name: PET

Other name: PET Scan

Other name: Positron emission tomography (procedure)

Other name: Positron Emission Tomography Scan

Other name: Positron-Emission Tomography

Other name: proton magnetic resonance spectroscopic imaging

Other name: PT

Intervention type: Biological
Intervention name: Rituximab
Description: Given IV
Arm group label: Arm I (Rituximab, rituximab and hyaluronidase)

Other name: ABP 798

Other name: BI 695500

Other name: BI-695500

Other name: BI695500

Other name: Blitzima

Other name: C2B8 Monoclonal Antibody

Other name: Chimeric Anti-CD20 Antibody

Other name: CT-P10

Other name: IDEC 102

Other name: IDEC-102

Other name: IDEC-C2B8

Other name: IDEC-C2B8 Monoclonal Antibody

Other name: IDEC102

Other name: Ikgdar

Other name: Mabtas

Other name: MabThera

Other name: Monoclonal Antibody IDEC-C2B8

Other name: PF 05280586

Other name: PF-05280586

Other name: PF05280586

Other name: Riabni

Other name: Ritemvia

Other name: Rituxan

Other name: Rituximab ABBS

Other name: Rituximab ARRX

Other name: Rituximab Biosimilar ABP 798

Other name: Rituximab Biosimilar BI 695500

Other name: Rituximab Biosimilar CT-P10

Other name: Rituximab Biosimilar GB241

Other name: Rituximab Biosimilar IBI301

Other name: Rituximab Biosimilar JHL1101

Other name: Rituximab Biosimilar PF-05280586

Other name: Rituximab Biosimilar RTXM83

Other name: Rituximab Biosimilar SAIT101

Other name: Rituximab Biosimilar SIBP-02

Other name: rituximab biosimilar TQB2303

Other name: Rituximab PVVR

Other name: Rituximab-abbs

Other name: Rituximab-arrx

Other name: Rituximab-blit

Other name: Rituximab-pvvr

Other name: Rituximab-rite

Other name: Rituximab-rixa

Other name: Rituximab-rixi

Other name: Rixathon

Other name: Riximyo

Other name: RTXM 83

Other name: RTXM-83

Other name: RTXM83

Other name: Ruxience

Other name: Truxima

Intervention type: Biological
Intervention name: Rituximab and Hyaluronidase Human
Description: Given SC
Arm group label: Arm I (Rituximab, rituximab and hyaluronidase)

Other name: Rituxan Hycela

Other name: Rituximab Plus Hyaluronidase

Other name: Rituximab/Hyaluronidase

Other name: Rituximab/Hyaluronidase Human

Summary: This phase III trial compares the effectiveness of rituximab to mosunetuzumab in treating patients with follicular lymphoma with a low tumor burden. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. It is not yet known if giving rituximab or mosunetuzumab works better in treating patients with follicular lymphoma with a low tumor burden.

Detailed description: PRIMARY OBJECTIVES: I. To compare the 3-year milestone progression free survival (PFS) probabilities in participants with previously untreated, low tumor burden follicular lymphoma randomized to the rituximab arm versus the mosunetuzumab arm. II. To compare progression free survival (PFS) in participants with previously untreated, low tumor burden follicular lymphoma randomized to the rituximab arm versus the mosunetuzumab arm. SECONDARY OBJECTIVES: I. To compare overall survival (OS) between participants randomized to rituximab versus mosunetuzumab. II. To compare overall response rates at the Week 40 assessment between participants randomized to rituximab versus mosunetuzumab. III. To compare event free survival (EFS) between participants randomized to rituximab versus mosunetuzumab. IV. To compare the frequency and severity of toxicities between participants randomized to rituximab versus mosunetuzumab. V. To compare the restricted chance of longer PFS (2-6 years) between participants randomized to rituximab versus mosunetuzumab. BANKING OBJECTIVE: I. To bank specimens for future correlative studies. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive rituximab intravenously (IV) on day 1 of cycle 1 and receive rituximab and hyaluronidase subcutaneously (SC) on days 8, 15 and 22 of cycle 1 and SC on day 1 of subsequent cycles. Cycles repeat every 56 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) scan and/or positron emission tomography (PET)/CT and blood sample collection on study and during follow up. ARM II: Patients receive mosunetuzumab SC on days 1, 8 and 15 of cycle 1 and on day 1 of subsequent cycles. Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and/or PET/CT and blood sample collection on study and during follow up. After completion of study treatment, patients are followed up every 6 months for 5 years and then yearly for a total of 10 years.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Participants must have a histologically confirmed diagnosis of classic follicular lymphoma (cFL) defined as: Follicular growth pattern, composed of centrocytes and centroblasts and harbor the IGH:BCL2 fusion. cFL was previously categorized as grade 1-3A per World Health Organization (WHO)-HAEM4R, but grading of classic follicular lymphoma (FL) is no longer mandatory. - NOTE: Participants with follicular lymphoma with uncommon features (uFL) are eligible, including FL with diffuse growth pattern with large tumor in the inguinal region: Absence of IGH:BCL2 fusion, frequent STAT6 mutations along with 1p36 deletion or TNFRSF14 mutation - Participants must not have follicular lymphoma with "blastoid" or "large centrocyte" cytological features, or follicular large B-cell lymphoma (FLBL) (previously categorized as follicular lymphoma grade 3B) - Participants must have low-tumor burden follicular lymphoma defined as: - Nodal or extra-nodal tumor mass with diameter less than 7 cm in its greater diameter - Involvement of no more than 3 nodal or extra nodal sites with diameter greater than 3 cm. - Absence of B symptoms - No symptomatic splenomegaly - No compression syndrome (ureteral, orbital, gastrointestinal) - No pleural or peritoneal serous effusion related to follicular lymphoma - Participants must have Ann Arbor stage II, III, or IV follicular lymphoma. Participants with stage I disease may be included if they do not wish to undergo radiation or are not candidates for radiation - Participants must have staging imaging performed within 49 days prior to registration, as follows. PET-CT baseline scans are preferred. If a baseline PET-CT scan cannot be obtained, CT scans of the chest, abdomen, and pelvis, along with a bone marrow biopsy, are acceptable. If CT scans are used for staging at baseline, a CT scan of the neck is recommended. All measurable dominant lesions must be assessed within 49 days prior to registration. Tests to assess non-measurable disease must be performed within 49 days prior to registration. All disease must be assessed and documented on the Baseline Tumor Assessment Form. - NOTE: if the initial evaluation is insufficient to detect measurable disease, treating investigators may obtain a CT scan with contrast - Participants must have bi-dimensionally measurable disease (at least one lesion with longest diameter > 1.5 cm) - Participants must not have had prior systemic therapy for follicular lymphoma. Radiation therapy for a previous diagnosis of early-stage follicular lymphoma is allowed - Participant must be ≥ 18 years of age at the time of registration - Participant must have Zubrod performance status of 0-2 - Participant must have a complete medical history and physical exam within 28 days prior to registration - Leukocytes ≥ 3 x 10^3/uL (within 28 days prior to registration) - Hemoglobin > 9.0 g/dL (within 28 days prior to registration) - Absolute neutrophil count ≥ 1.5 x 10^3/uL (within 28 days prior to registration) - Platelets ≥ 100 x 10^3/uL (within 28 days prior to registration) - Total bilirubin ≤ 2 x institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN (within 28 days prior to registration) - Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 × institutional ULN (within 28 days prior to registration) - Lactate dehydrogenase (LDH) < institutional ULN (within 28 days prior to registration) - Participants must have a creatinine ≤ the institutional upper limit of normal (IULN) OR calculated creatinine clearance ≥ 30 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration - Participants must not have an active or uncontrolled infection before initiation of study treatment in the opinion of the treating investigators - Participants must not have uncontrolled diabetes within 14 days prior to registration in the opinion of the treating investigators - Participants must not have uncontrolled blood pressure and hypertension within 14 days prior to registration in the opinion of the treating investigators - Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration - Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration, if indicated. Participants with a positive total hepatitis (Hep) B core antibody and negative hepatitis B virus surface antigen (HBsAg) at screening are at high risk for reactivation and should receive prophylactic antivirals (e.g., entecavir) before and throughout the treatment - Participants must not have active autoimmune disease requiring systemic therapy - Participants must not have had undergone organ transplants requiring ongoing systemic immunosuppressive therapy - Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to registration, if indicated - Participants must not have known chronic active Epstein Barr Virus infection (CAEBV); testing in asymptomatic participants is not required - Participants must not have a positive test result for COVID-19 within seven (7) days prior to registration - Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen - Participants must not have a history of confirmed progressive multifocal leukoencephalopathy (PML) - Participants must not have received allogeneic stem cell transplantation - Participants must not have a history of macrophage activation syndrome (MAS) or hemophagocytic lymphohistiocytosis (HLH) - Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. Participant must not have significant cardiovascular disease such as class III or IV cardiac disease, myocardial infarction within 6 months prior to registration. Participants with unstable arrhythmias, or unstable angina, should be excluded - Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen - Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System - NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system. - Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines - For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

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: Akil A. Merchant
Email: Principal Investigator

Facility:
Name: Helen F Graham Cancer Center

Address:
City: Newark
Zip: 19713
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 302-623-4450
Email: lbarone@christianacare.org

Investigator:
Last name: Gregory A. Masters
Email: Principal Investigator

Facility:
Name: Medical Oncology Hematology Consultants PA

Address:
City: Newark
Zip: 19713
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 302-623-4450
Email: lbarone@christianacare.org

Investigator:
Last name: Gregory A. Masters
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: 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: 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: Peter Riedell
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: 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: Memorial Hospital East

Address:
City: Shiloh
Zip: 62269
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 314-747-9912
Email: dschwab@wustl.edu

Investigator:
Last name: Brad S. Kahl
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: Mary Greeley Medical Center

Address:
City: Ames
Zip: 50010
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 515-956-4132

Investigator:
Last name: Joseph J. Merchant
Email: Principal Investigator

Facility:
Name: McFarland Clinic - Ames

Address:
City: Ames
Zip: 50010
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 515-239-4734
Email: ksoder@mcfarlandclinic.com

Investigator:
Last name: Joseph J. Merchant
Email: Principal Investigator

Facility:
Name: McFarland Clinic - Boone

Address:
City: Boone
Zip: 50036
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 515-956-4132

Investigator:
Last name: Joseph J. Merchant
Email: Principal Investigator

Facility:
Name: Mercy Hospital

Address:
City: Cedar Rapids
Zip: 52403
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 319-365-4673

Investigator:
Last name: Deborah W. Wilbur
Email: Principal Investigator

Facility:
Name: Oncology Associates at Mercy Medical Center

Address:
City: Cedar Rapids
Zip: 52403
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 319-363-2690

Investigator:
Last name: Deborah W. Wilbur
Email: Principal Investigator

Facility:
Name: McFarland Clinic - Trinity Cancer Center

Address:
City: Fort Dodge
Zip: 50501
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 515-956-4132

Investigator:
Last name: Joseph J. Merchant
Email: Principal Investigator

Facility:
Name: McFarland Clinic - Jefferson

Address:
City: Jefferson
Zip: 50129
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 515-956-4132

Investigator:
Last name: Joseph J. Merchant
Email: Principal Investigator

Facility:
Name: McFarland Clinic - Marshalltown

Address:
City: Marshalltown
Zip: 50158
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 515-956-4132

Investigator:
Last name: Joseph J. Merchant
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: Marc S. Hoffmann
Email: Principal Investigator

Facility:
Name: University of Kansas Cancer Center-Overland Park

Address:
City: Overland Park
Zip: 66210
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

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

Investigator:
Last name: Marc S. Hoffmann
Email: Principal Investigator

Facility:
Name: Salina Regional Health Center

Address:
City: Salina
Zip: 67401
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 785-452-7038
Email: mleepers@srhc.com

Investigator:
Last name: Marc S. Hoffmann
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: Marc S. Hoffmann
Email: Principal Investigator

Facility:
Name: Essentia Health Saint Joseph's Medical Center

Address:
City: Brainerd
Zip: 56401
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 218-786-3308
Email: CancerTrials@EssentiaHealth.org

Investigator:
Last name: Bret E. Friday
Email: Principal Investigator

Facility:
Name: Minnesota Oncology - Burnsville

Address:
City: Burnsville
Zip: 55337
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 952-993-1517
Email: mmcorc@healthpartners.com

Investigator:
Last name: David M. King
Email: Principal Investigator

Facility:
Name: Mercy Hospital

Address:
City: Coon Rapids
Zip: 55433
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 952-993-1517
Email: mmcorc@healthpartners.com

Investigator:
Last name: David M. King
Email: Principal Investigator

Facility:
Name: Essentia Health - Deer River Clinic

Address:
City: Deer River
Zip: 56636
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 218-786-3308
Email: CancerTrials@EssentiaHealth.org

Investigator:
Last name: Bret E. Friday
Email: Principal Investigator

Facility:
Name: Essentia Health Cancer Center

Address:
City: Duluth
Zip: 55805
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 218-786-3308
Email: CancerTrials@EssentiaHealth.org

Investigator:
Last name: Bret E. Friday
Email: Principal Investigator

Facility:
Name: Fairview Southdale Hospital

Address:
City: Edina
Zip: 55435
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 952-993-1517
Email: mmcorc@healthpartners.com

Investigator:
Last name: David M. King
Email: Principal Investigator

Facility:
Name: Essentia Health Hibbing Clinic

Address:
City: Hibbing
Zip: 55746
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 218-786-3308

Investigator:
Last name: Bret E. Friday
Email: Principal Investigator

Facility:
Name: Abbott-Northwestern Hospital

Address:
City: Minneapolis
Zip: 55407
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 952-993-1517
Email: mmcorc@healthpartners.com

Investigator:
Last name: David M. King
Email: Principal Investigator

Facility:
Name: Mayo Clinic in Rochester

Address:
City: Rochester
Zip: 55905
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 855-776-0015

Investigator:
Last name: Jose C. Villasboas
Email: Principal Investigator

Facility:
Name: Park Nicollet Clinic - Saint Louis Park

Address:
City: Saint Louis Park
Zip: 55416
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 952-993-1517
Email: mmcorc@healthpartners.com

Investigator:
Last name: David M. King
Email: Principal Investigator

Facility:
Name: Regions Hospital

Address:
City: Saint Paul
Zip: 55101
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 952-993-1517
Email: mmcorc@healthpartners.com

Investigator:
Last name: David M. King
Email: Principal Investigator

Facility:
Name: United Hospital

Address:
City: Saint Paul
Zip: 55102
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 952-993-1517
Email: mmcorc@healthpartners.com

Investigator:
Last name: David M. King
Email: Principal Investigator

Facility:
Name: Essentia Health Sandstone

Address:
City: Sandstone
Zip: 55072
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 218-786-3308
Email: CancerTrials@EssentiaHealth.org

Investigator:
Last name: Bret E. Friday
Email: Principal Investigator

Facility:
Name: Essentia Health Virginia Clinic

Address:
City: Virginia
Zip: 55792
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 218-786-3308
Email: CancerTrials@EssentiaHealth.org

Investigator:
Last name: Bret E. Friday
Email: Principal Investigator

Facility:
Name: Saint Francis Medical Center

Address:
City: Cape Girardeau
Zip: 63703
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 573-334-2230
Email: sfmc@sfmc.net

Investigator:
Last name: Bryan A. Faller
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: Brad S. Kahl
Email: Principal Investigator

Facility:
Name: University of Kansas Cancer Center - North

Address:
City: Kansas City
Zip: 64154
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

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

Investigator:
Last name: Marc S. Hoffmann
Email: Principal Investigator

Facility:
Name: University of Kansas Cancer Center - Lee's Summit

Address:
City: Lee's Summit
Zip: 64064
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

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

Investigator:
Last name: Marc S. Hoffmann
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: Brad S. Kahl
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: Brad S. Kahl
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: Brad S. Kahl
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: Brad S. Kahl
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: 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: 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: Carolinas Medical Center/Levine Cancer Institute

Address:
City: Charlotte
Zip: 28203
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 800-804-9376

Investigator:
Last name: Nilanjan Ghosh
Email: Principal Investigator

Facility:
Name: Atrium Health Pineville/LCI-Pineville

Address:
City: Charlotte
Zip: 28210
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 980-442-2000

Investigator:
Last name: Nilanjan Ghosh
Email: Principal Investigator

Facility:
Name: Levine Cancer Institute-SouthPark

Address:
City: Charlotte
Zip: 28211
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 980-442-2000

Investigator:
Last name: Nilanjan Ghosh
Email: Principal Investigator

Facility:
Name: Atrium Health University City/LCI-University

Address:
City: Charlotte
Zip: 28262
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 800-804-9376

Investigator:
Last name: Nilanjan Ghosh
Email: Principal Investigator

Facility:
Name: Atrium Health Cabarrus/LCI-Concord

Address:
City: Concord
Zip: 28025
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 800-804-9376

Investigator:
Last name: Nilanjan Ghosh
Email: Principal Investigator

Facility:
Name: Essentia Health Cancer Center-South University Clinic

Address:
City: Fargo
Zip: 58103
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 218-786-3308
Email: CancerTrials@EssentiaHealth.org

Investigator:
Last name: Bret E. Friday
Email: Principal Investigator

Facility:
Name: M D Anderson Cancer Center

Address:
City: Houston
Zip: 77030
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 877-632-6789
Email: askmdanderson@mdanderson.org

Investigator:
Last name: Paolo Strati
Email: Principal Investigator

Facility:
Name: Duluth Clinic Ashland

Address:
City: Ashland
Zip: 54806
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 218-786-3308
Email: CancerTrials@EssentiaHealth.org

Investigator:
Last name: Bret E. Friday
Email: Principal Investigator

Start date: October 23, 2024

Completion date: March 31, 2032

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/NCT06337318

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