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