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NCT06649812RecruitingPhase 2

Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma

A Phase II Study of Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed or Refractory CD10-Negative Diffuse Large B-Cell Lymphoma (DLBCL) and High-Grade B-Cell Lymphoma With MYC and BCL2 Rearrangements (HGBCL-DH-BCL2)

Source: ClinicalTrials.gov · Last updated 21 Oct 2026

Brief summary (registry, in English)

This phase II trial tests how well venetoclax, ibrutinib, prednisone, obinutuzumab, and Revlimid® (ViPOR) works in treating patients with CD10 negative diffuse large B-cell lymphoma (DLBCL) and high-grade lymphoma with MYC and BCL2 rearrangements that has come back after a period of improvement (relapsed) and/or that has not responded to previous treatment (refractory). Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Ibrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers at abnormal levels. This may help keep cancer cells from growing and spreading. Anti-inflammatory drugs, such as prednisone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Obinutuzumab, a monoclonal antibody, binds to a protein called CD20, which is found on B cells and some types of leukemia and lymphoma cells. Obinutuzumab may block CD20 and help the immune system kill cancer cells. Revlimid, a type of anti-angiogenesis agent and a type of immunomodulating agent, may help the immune system kill abnormal blood cells or cancer cells. It may also prevent the growth of new blood vessels that cancers need to grow. ViPOR may be an effective treatment option for patients with relapsed and/or refractory CD10 negative DLBCL and high-grade B-cell lymphoma with MYC and BCL2 rearrangements.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
120 (estimated)
First submitted
18 Oct 2024
Start date
7 Oct 2025
Primary completion date
1 Sept 2028
Lead sponsor
National Cancer Institute (NCI)
NCT number
NCT06649812

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 120
  • From 7 Oct 2025 to the primary completion date, 1 Sept 2028
  • 114 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • Patient must be ≥ 18 years of age
  • Patient must have histologically or cytologically confirmed aggressive B-cell lymphoma as follows:
    • Cohort 1: CD10-negative DLBCL, which includes:
    • CD10-negative non-GCB DLBCL, not otherwise specified (NOS) (i.e., CD10-/BCL6- or CD10-/BCL6+/MUM1+ DLBCL)
    • CD10-negative GCB DLBCL, NOS (i.e., CD10-/BCL6+/MUM1- DLBCL)
    • CD10-negative HGBCL with MYC and BCL6 (without BCL2) translocations (HGBCL-DH-BCL6)
    • CD10-negative HGBCL, NOS (without MYC and BCL2 translocations)
    • CD10-negative T-cell/histiocyte-rich large B-cell lymphoma (THRLBCL) OR
    • Cohort 2: CD10-positive or negative HGBCL with MYC and BCL2 rearrangements (with or without BCL6 rearrangement) (HGBCL-DH-BCL2)
    • NOTE: The site principal investigator must review and verify the pathology report findings to ensure the patient is eligible and is assigned to the respective cohort at the time of registration
  • Patient must have relapsed and/or refractory disease after at least 1 prior anthracycline and anti-CD20 antibody-containing regimen
  • Patient must not have confirmed or suspected primary mediastinal large B-cell lymphoma (PMBL)
  • Patient must not be pregnant due to the potential harm to an unborn fetus with the treatment regimens being used.
    • All patients of childbearing potential must have a serum or urine study with a sensitivity of at least 25 mIU/mL within 14 days prior to registration to rule out pregnancy and again within 24 hours prior to starting cycle 1 day 1 of treatment.
    • A patient of childbearing potential is defined as anyone, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
  • Patients of childbearing potential must not expect to conceive children by abstaining from sexual intercourse or by using accepted and effective methods of contraception throughout the entire duration of protocol treatment, including during dose interruptions, and for 6 months after the last dose of protocol treatment. Male patients must not father children by abstaining from sexual intercourse or by using a condom during sexual contact with pregnant partners or partners of childbearing potential throughout the entire duration of protocol treatment, including dose interruptions, and for 6 months after the last dose of protocol treatment even if they have had a successful vasectomy
  • Male patients must agree to not donate semen or sperm during the entire duration of protocol treatment or for at least 28 days after the last dose of lenalidomide
  • Patient must agree to abstain from breastfeeding during the entire duration of protocol treatment and for at least 6 months after the last dose of protocol treatment
  • Patient must agree to abstain from donating blood during the entire duration of protocol treatment and for at least 28 days after the last dose of lenalidomide
  • Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
  • Absolute neutrophil count (ANC) ≥ 1,000/mcL without requirement for granulocyte colony stimulating factor (G-CSF) support (obtained ≤ 7 days prior to registration)
  • Hemoglobin ≥ 8 g/dL (obtained ≤ 7 days prior to registration)
  • Platelets ≥ 75,000/mcL without requirement for platelet transfusion support (obtained ≤ 7 days prior to registration)
  • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (or ≤ 3.0 x institutional ULN for patients with documented Gilberts syndrome) (obtained ≤ 7 days prior to registration)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3.0 x institutional ULN (obtained ≤ 7 days prior to registration)
  • Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 30 mL/min/1.73 m\^2 (estimated by Cockcroft-Gault method or measured) (obtained ≤ 7 days prior to registration)
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
  • Patient must not have confirmed or suspected primary DLBCL of the central nervous system (CNS) (PCNSL)
  • Patients with history of secondary CNS lymphoma (SCNSL) are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  • Patient must not have taken or require warfarin or other strong CYP3A inhibitors or inducers within 7 days prior to registration.
    • NOTE: Antiplatelet agents, other anticoagulants aside from warfarin, as well as mild or moderate CYP3A inhibitors or inducers are permitted on study but should be used with caution
  • Patient must not have an uncontrolled intercurrent illness that would interfere with the safety or efficacy assessment of this protocol
  • Patient must not have evidence of an active infection at the time of registration
  • Patient must not have the following current or prior anti-cancer treatment:
    • Any chemotherapy, targeted therapy, anti-cancer antibodies, antibody-drug conjugates, or bi-specific antibodies received within 2 weeks prior to registration
    • NOTE: Short courses of corticosteroids or palliative external beam radiation therapy (XRT) prior to registration are permitted
    • More than 3 prior lines of cytotoxic chemotherapy, excluding targeted therapy, anti-cancer antibodies, antibody-drug conjugates, bi-specific antibodies, and radio- or toxin-immunoconjugates
    • NOTE: Cytoreductive chemotherapy followed by autologous stem cell transplant (ASCT) counts as 1 line of cytotoxic therapy. Similarly, cytoreductive chemotherapy (either pre-T-cell collection or as bridging therapy) followed by pre-conditioning therapy/chimeric antigen receptor T-cell (CAR-T) counts as 1 line of therapy, as long as no disease progression occurs between interventions. For both therapies, if progressive disease is documented between 2 distinct regimens, then they should be counted as 2 lines of cytotoxic chemotherapy
    • Radio- or toxin-immunoconjugates within 10 weeks prior to registration
    • Previous treatment with more than one of the following study agents: venetoclax (or another BCL2 inhibitor), ibrutinib (or another BTK inhibitor), or lenalidomide (or another immunomodulatory imide drug \[IMiD\])
    • Prior autologous stem cell transplant (ASCT), chimeric antigen receptor T-cell (CAR-T) therapy, or allogeneic stem cell (or other organ) transplant within 3 months prior to registration
    • Any evidence of active graft-versus-host disease or requirement for immunosuppressants within 28 days prior to registration
    • NOTE: In addition, patient must have recovered (i.e., ≤ grade 1 or baseline) from all adverse events due to previously administered anti-cancer treatment, surgery, or procedure
    • NOTE: Exceptions to this include events not considered to place the patient at unacceptable risk of participation in the opinion of the treating investigator (i.e., alopecia)
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
  • Patient must have adequate formalin fixed paraffin embedded (FFPE) tumor tissue specimen from the initial diagnostic biopsy or on-study repeat tumor tissue biopsy for molecular analysis
    • NOTE: Excisional tumor biopsy is preferred. Core needle biopsies will be considered adequate if there is enough tissue for the mandatory molecular analysis. Submission of an entire FFPE tumor block is preferred, but if unavailable 10 x 10um FFPE scrolls may be submitted as an alternative. If adequate archived FFPE tumor tissue is unavailable, the patient must be willing to undergo research biopsy for molecular analysis
  • Patient must have measurable disease
  • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (114)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
McFarland Clinic - Ames
Coordinator of this site? Confirm its status
AmesUnited StatesRecruiting
Mary Greeley Medical Center
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AmesUnited StatesRecruiting
Community Hospital of Anaconda
Coordinator of this site? Confirm its status
AnacondaUnited StatesSuspended
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Coordinator of this site? Confirm its status
AnkenyUnited StatesRecruiting
Duluth Clinic Ashland
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AshlandUnited StatesRecruiting
Nebraska Medicine-Bellevue
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BellevueUnited StatesRecruiting
Walter Reed National Military Medical Center
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BethesdaUnited StatesRecruiting
National Institutes of Health Clinical Center
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BethesdaUnited StatesRecruiting
Billings Clinic Cancer Center
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BillingsUnited StatesRecruiting
McFarland Clinic - Boone
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BooneUnited StatesSuspended
Bozeman Health Deaconess Hospital
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BozemanUnited StatesSuspended
Essentia Health Saint Joseph's Medical Center
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BrainerdUnited StatesRecruiting
Roswell Park Cancer Institute
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BuffaloUnited StatesRecruiting
University of Vermont and State Agricultural College
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BurlingtonUnited StatesRecruiting
University of Vermont Medical Center
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BurlingtonUnited StatesRecruiting
Aultman Health Foundation
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CantonUnited StatesRecruiting
Saint Anthony Regional Hospital
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CarrollUnited StatesRecruiting
Mercy Hospital
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Cedar RapidsUnited StatesRecruiting
Oncology Associates at Mercy Medical Center
Coordinator of this site? Confirm its status
Cedar RapidsUnited StatesRecruiting
University of Virginia Cancer Center
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CharlottesvilleUnited StatesRecruiting
Northwestern University
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting
University of Cincinnati Cancer Center-UC Medical Center
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CincinnatiUnited StatesRecruiting
Siteman Cancer Center at Saint Peters Hospital
Coordinator of this site? Confirm its status
City of Saint PetersUnited StatesRecruiting
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Coordinator of this site? Confirm its status
CliveUnited StatesRecruiting
Kootenai Health - Coeur d'Alene
Coordinator of this site? Confirm its status
Coeur d'AleneUnited StatesRecruiting
Ohio State University Comprehensive Cancer Center
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ColumbusUnited StatesRecruiting
Siteman Cancer Center at West County Hospital
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Creve CoeurUnited StatesRecruiting
Northwest Cancer Center - Crown Point
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Crown PointUnited StatesRecruiting
Carle at The Riverfront
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DanvilleUnited StatesSuspended
Essentia Health - Deer River Clinic
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Deer RiverUnited StatesRecruiting
Northwestern Medicine Cancer Center Kishwaukee
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DeKalbUnited StatesRecruiting
Smilow Cancer Hospital-Derby Care Center
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DerbyUnited StatesRecruiting
Iowa Methodist Medical Center
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Des MoinesUnited StatesRecruiting
Broadlawns Medical Center
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Des MoinesUnited StatesRecruiting
UI Health Care Mission Cancer and Blood - Laurel Clinic
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Des MoinesUnited StatesRecruiting
UI Health Care Mission Cancer and Blood - Des Moines Clinic
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Des MoinesUnited StatesRecruiting
Essentia Health Cancer Center
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DuluthUnited StatesRecruiting
Duke University Medical Center
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DurhamUnited StatesSuspended
Northwest Oncology LLC
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DyerUnited StatesRecruiting
Carle Physician Group-Effingham
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EffinghamUnited StatesSuspended
OSF Saint Francis Hospital and Medical Group
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EscanabaUnited StatesRecruiting
Essentia Health Cancer Center-South University Clinic
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FargoUnited StatesRecruiting
McFarland Clinic - Trinity Cancer Center
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Fort DodgeUnited StatesRecruiting
UI Healthcare Mission Cancer and Blood - Fort Dodge
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Fort DodgeUnited StatesRecruiting
Northwestern Medicine Cancer Center Delnor
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GenevaUnited StatesRecruiting
Northwestern Medicine Glenview Outpatient Center
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GlenviewUnited StatesRecruiting
Northwestern Medicine Grayslake Outpatient Center
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GrayslakeUnited StatesRecruiting
Benefis Sletten Cancer Institute
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Great FallsUnited StatesRecruiting
Saint Vincent Hospital Cancer Center Green Bay
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Green BayUnited StatesRecruiting
Saint Vincent Hospital Cancer Center at Saint Mary's
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Green BayUnited StatesRecruiting
Smilow Cancer Hospital Care Center - Guilford
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GuilfordUnited StatesRecruiting
Essentia Health Hibbing Clinic
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HibbingUnited StatesRecruiting
Saint Mary Medical Center
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HobartUnited StatesRecruiting
Providence Hood River Memorial Hospital
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Hood RiverUnited StatesRecruiting
Saint Catherine Hospital
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IndianapolisUnited StatesRecruiting
Mercyhealth Hospital and Cancer Center - Janesville
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JanesvilleUnited StatesRecruiting
McFarland Clinic - Jefferson
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JeffersonUnited StatesSuspended
Logan Health Medical Center
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KalispellUnited StatesSuspended
Gundersen Lutheran Medical Center
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La CrosseUnited StatesRecruiting
Northwestern Medicine Lake Forest Hospital
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Lake ForestUnited StatesRecruiting
Cedars-Sinai Medical Center
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Los AngelesUnited StatesRecruiting
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
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MadisonUnited StatesRecruiting
University of Wisconsin Carbone Cancer Center - University Hospital
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MadisonUnited StatesRecruiting
Schoolcraft Memorial Hospital
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ManistiqueUnited StatesRecruiting
McFarland Clinic - Marshalltown
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MarshalltownUnited StatesRecruiting
Carle Physician Group-Mattoon/Charleston
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MattoonUnited StatesSuspended
Froedtert Menomonee Falls Hospital
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Menomonee FallsUnited StatesRecruiting
Medical College of Wisconsin
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MilwaukeeUnited StatesRecruiting
Community Medical Center
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MissoulaUnited StatesRecruiting
ProHealth D N Greenwald Center
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MukwonagoUnited StatesRecruiting
Women's Diagnostic Center - Munster
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MunsterUnited StatesRecruiting
The Community Hospital
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MunsterUnited StatesRecruiting
Providence Newberg Medical Center
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NewbergUnited StatesRecruiting
Froedtert and MCW Moorland Reserve Health Center
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New BerlinUnited StatesRecruiting
Yale University
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New HavenUnited StatesRecruiting
Ochsner Medical Center Jefferson
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New OrleansUnited StatesSuspended
Carle BroMenn Medical Center
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NormalUnited StatesSuspended
Carle Cancer Institute Normal
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NormalUnited StatesSuspended
Northwestern Medicine Oak Brook
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Oak BrookUnited StatesRecruiting
Drexel Town Square Health Center
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Oak CreekUnited StatesRecruiting
ProHealth Oconomowoc Memorial Hospital
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OconomowocUnited StatesRecruiting
Saint Vincent Hospital Cancer Center at Oconto Falls
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Oconto FallsUnited StatesRecruiting
University of Oklahoma Health Sciences Center
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Oklahoma CityUnited StatesSuspended
Nebraska Medicine-Village Pointe
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OmahaUnited StatesRecruiting
University of Nebraska Medical Center
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OmahaUnited StatesRecruiting
Providence Willamette Falls Medical Center
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Oregon CityUnited StatesRecruiting
Northwestern Medicine Orland Park
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Orland ParkUnited StatesRecruiting
Thomas Jefferson University Hospital
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PhiladelphiaUnited StatesRecruiting
Providence Portland Medical Center
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PortlandUnited StatesRecruiting
Providence Saint Vincent Medical Center
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PortlandUnited StatesRecruiting
Kootenai Clinic Cancer Services - Post Falls
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Post FallsUnited StatesRecruiting
VCU Massey Comprehensive Cancer Center
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RichmondUnited StatesRecruiting
Kootenai Clinic Cancer Services - Sandpoint
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SandpointUnited StatesRecruiting
Essentia Health Sandstone
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SandstoneUnited StatesRecruiting
Swedish Medical Center-First Hill
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SeattleUnited StatesRecruiting
Sheboygan Physicians Group
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SheboyganUnited StatesRecruiting
Saint Vincent Hospital Cancer Center at Sheboygan
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SheboyganUnited StatesRecruiting
Memorial Hospital East
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ShilohUnited StatesRecruiting
Essentia Health-Spooner Clinic
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SpoonerUnited StatesRecruiting
Siteman Cancer Center-South County
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St LouisUnited StatesRecruiting
Siteman Cancer Center at Christian Hospital
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St LouisUnited StatesRecruiting
Washington University School of Medicine
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St LouisUnited StatesRecruiting
Saint Vincent Hospital Cancer Center at Sturgeon Bay
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Sturgeon BayUnited StatesRecruiting
Essentia Health Saint Mary's Hospital - Superior
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SuperiorUnited StatesRecruiting
Banner University Medical Center - Tucson
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TucsonUnited StatesActive, not recruiting
University of Arizona Cancer Center-North Campus
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TucsonUnited StatesActive, not recruiting
Carle Cancer Center
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UrbanaUnited StatesSuspended
Northwest Cancer Center - Valparaiso
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ValparaisoUnited StatesRecruiting
Essentia Health Virginia Clinic
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VirginiaUnited StatesRecruiting
Northwestern Medicine Cancer Center Warrenville
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WarrenvilleUnited StatesRecruiting
UI Health Care Mission Cancer and Blood - Waukee Clinic
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WaukeeUnited StatesRecruiting
UW Cancer Center at ProHealth Care
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WaukeshaUnited StatesRecruiting
Froedtert West Bend Hospital/Kraemer Cancer Center
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West BendUnited StatesRecruiting
University of Cincinnati Cancer Center-West Chester
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West ChesterUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.