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    Participants who either do not have cancer but are at high risk for developing the disease or have had cancer and are at high risk for developing a new cancer.
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    These trials look at ways to improve the quality of life of cancer patients, especially those who have side effects from cancer and its treatment. They find new ways to help people cope with pain, nutrition problems, infection, nausea and vomiting, sleep disorders, depression and other health problems.
  • open for enrollment

    Trametinib with or without Whole Brain Radiation Therapy in Treating Patients with Brain Metastases

    Protocol: OSU-13197

    Eligibility:

    Inclusion Criteria:

    Histologically confirmed cancer with measurable or evaluable brain metastases by computed tomography (CT) or magnetic resonance imaging (MRI); MRI is preferred, but a CT scan is acceptable for patients that are unable to have an MRI

    Eastern Cooperative Oncology Group (ECOG) performance status 0 -1

    All prior treatment- related toxicities must be Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0) =< grade 1 (except alopecia) at the time of enrollment

    Absolute neutrophil count >= 1.5 x 10^9/L

    Hemoglobin >= 9 g/dL

    Platelets >= 100 x10^9/L

    Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN) unless using warfarin for therapeutic anti-coagulation

    Albumin >= 2.5 g/dL

    Total bilirubin =< 1.5 x ULN

    Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN

    Creatinine =< 1.5 ULN or calculated creatinine clearance >= 50 mL/min or 24-hour urine creatinine clearance >= 50 mL/min; calculated by the Cockcroft-Gault formula

    Left ventricular ejection fraction (LVEF) >= 50% by echocardiogram (ECHO) or multigated acquisition scan (MUGA); same method as used at baseline must be use throughout the study, ECHO is the preferred method

    Life expectancy of at least 3 months in the opinion of investigator

    Able to swallow and retain orally administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels

    Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed

    Women of child-bearing potential (WOCBP) must have a negative pregnancy test within 14 days prior to start of study treatment, and counselled on contraception/abstinence while receiving the study treatment; urine or serum human chorionic gonadotropin (HCG) is an acceptable pregnancy assessment; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; women of child-bearing potential must have a negative serum or urine pregnancy test within 14 days prior to randomization; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of trametinib administration

    Exclusion Criteria:

    Prior radiation therapy to the whole brain (prior stereotactic radiosurgery or fractionated stereotactic radiation therapy to focal areas is allowed)

    Evidence of leptomeningeal metastases

    Urgent need of treatment to prevent acute neurologic deterioration

    Radiosensitive primary tumor such as small cell lung cancer, germ cell tumors, lymphoma, leukemia, or multiple myeloma

    History of another malignancy that makes determination of the source of the brain metastases uncertain

    History of interstitial lung disease or pneumonitis

    Any major surgery, extensive radiotherapy, chemotherapy with delayed toxicity, biologic therapy, or immunotherapy within 14 days prior to enrollment and/or daily or weekly chemotherapy with the potential for delayed toxicity within 14 days prior to enrollment

    Use of other anti-cancer therapies within five half-lives from the previous dose of the prior anti-cancer therapy preceding enrollment and during the study

    Symptomatic or untreated spinal cord compression

    Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trametinib, or excipients or to dimethyl sulfoxide (DMSO)

    Current use of a prohibited medication; the following medications or non-drug therapies are prohibited:

    Other anti-cancer therapy while on study treatment; (note: megestrol [Megace] if used as an appetite stimulant is allowed)

    Concurrent treatment with bisphosphonates is permitted; however, treatment must be initiated prior to enrollment; prophylactic use of bisphosphonates in patients without bone disease is not permitted, except for the treatment of osteoporosis

    Concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, St. John’s wort, kava, ephedra [ma huang], gingko biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng)

    Drugs that potently inhibit or induce CYP3A4 should be administered with caution; below are a few examples of the agents:

    Drugs that may increase exposure of trametinib (CYP3A4 inhibitors):

    • Antivirals: amprenavir, atazanavir, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir
    • Antibiotics: clarithromycin, erythromycin, telithromycin, troleandomycin
    • Antifungals: fluconazole, itraconazole, ketoconazole, voriconazole
    • Antidepressants: nefazodone
    • Calcium channel blockers: mibefradil, diltiazem, verapamil
    • Miscellaneous: aprepitant

    Drugs that may decrease exposure of trametinib (CYP3A4 inducers)

    • Antivirals: efavirenz, nevirapine
    • Antibiotic: rifampin
    • Anticonvulsants: carbamazepine, phenobarbital, phenytoin

    Caution should be exercised when dosing trametinib concurrently with medications with narrow therapeutic windows that are substrates of CYP2C8; below are a few examples of the agents

    • Drug metabolism potentially affected by trametinib resulting in increased exposure of these substrates

    *** 3-hydroxy-3-methyl-glutaryl-CoA (HMG CoA)-reductase inhibitors: cerivastatin

    *** Thiazolidinediones: rosiglitazone, pioglitazone

    *** Miscellaneous: chloroquine, zopiclone, repaglinide

    As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product

    History or current evidence/risk of retinal vein occlusion (RVO) or retinal pigment epithelial detachment (RPED):

    History of RVO or RPED, or predisposing factors to RVO or RPED (e.g., uncontrolled glaucoma or ocular hypertension, uncontrolled systemic disease such as hypertension, diabetes mellitus, or history of hyperviscosity or hypercoagulability syndromes)

    Visible retinal pathology as assessed by ophthalmic exam that is considered a risk factor for RVO or RPED such as evidence of new optic disc cupping, evidence of new visual field defects, and intraocular pressure > 21 mm Hg

    History or evidence of cardiovascular risk including any of the following:

    LVEF < lower limit of normal (LLN)

    A QT interval corrected for heart rate using the Bazett’s formula QTcB >= 480 msec

    History or evidence of current clinically significant uncontrolled arrhythmias (exception: patients with controlled atrial fibrillation for > 30 days prior to registration are eligible)

    History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to registration

    History or evidence of current >= class II congestive heart failure as defined by the New York Heart Association (NYHA) functional classification system

    Treatment-refractory hypertension defined as a blood pressure of systolic > 140 mmHg and/or diastolic > 90 mmHg which cannot be controlled by anti-hypertensive therapy

    Patients with intra-cardiac defibrillators

    Known cardiac metastases

    Known hepatitis B virus (HBV), or hepatitis C virus (HCV) infection (with the exception of chronic or cleared HBV and HCV infection, which will be allowed); patients with human immunodeficiency virus (HIV) are not eligible if on anti-retroviral medications

    Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

    Pregnancy or breastfeeding (women of childbearing potential should be advised to avoid pregnancy and use effective methods of contraception; men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception; if a female patient or a female partner of a patient becomes pregnant while the patient receives trametinib, the potential hazard to the fetus should be explained to the patient and partner (as applicable); radiation therapy is also contraindicated in pregnancy

    Unable to reliably be immobilized for safe administration of whole brain radiation therapy

    Principal Investigator: Evan J Wuthrick, MD

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  • open for enrollment

    Trametinib, Combination Chemotherapy, and Radiation Therapy in Treating Patients with Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery

    Protocol: OSU-14034

    Eligibility:

    Inclusion Criteria:

    Patients must have histologically confirmed, newly diagnosed or recurrent from a previously treated early stage lung cancers that are locally confined, non-small cell lung cancers that are considered unresectable and for which chemoradiation will be considered definitive therapy; patients with recurrent cancer that is amendable for chemoradiation can be eligible only if patients with prior lobectomy for stage I cancer had not had adjuvant chemotherapy, and more than 8 weeks have elapsed from surgery to allow for wound healing; patients who recur from prior X-ray therapy (XRT) or stereotactic body radiation therapy (SBRT) will not be eligible

    Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan, magnetic resonance imaging (MRI), or calipers by clinical exam

    Prior thoracic radiation allowed only if there is minimal to no overlap with the treatment area estimated at the time of consultation, and there is no cumulative esophageal dose that exceeds more than 50% of the maximal acceptable dose tolerance

    Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)

    Life expectancy of greater than 6 months

    Able to swallow and retain orally-administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels

    Absolute neutrophil count (ANC) >= 1.5 x 10^9/L

    Hemoglobin >= 9 g/dL

    Platelets >= 100 x 10^9/L

    Albumin >= 2.5 g/dL

    Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)

    Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x institutional ULN

    Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min

    Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x institutional ULN

    Left ventricular ejection fraction >= institutional lower limit of normal (LLN) by echocardiogram (ECHO) or multi gated acquisition scan (MUGA)

    Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, during the study participation, and for four months after the last dose of the drug; women of child-bearing potential must have a negative serum pregnancy test within 14 days prior to registration and agree to use effective contraception throughout the treatment period and for 4 months after the last dose of study treatment; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately

    Ability to understand and the willingness to sign a written informed consent document

    Activating Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation (any G12, G13, Q61) confirmed by Clinical Laboratory Improvement Amendments (CLIA)-certified testing

    The availability of formalin-fixed paraffin embedded archival tissue from core biopsy of tumors is recommended for exploratory analysis

    Exclusion Criteria:

    History of another malignancy

    Exception: patients who have been disease-free for 3 years, or patients with a history of completely resected non-melanoma skin cancer and/or patients with indolent secondary malignancies, are eligible; consult the Cancer Therapy Evaluation Program (CTEP) Medical Monitor if unsure whether second malignancies meet the requirements specified above

    History of interstitial lung disease or pneumonitis

    Any major surgery, extensive radiotherapy, chemotherapy with delayed toxicity, biologic therapy, or immunotherapy within 21 days prior to enrollment

    Use of other investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of trametinib and during the study

    Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trametinib, or excipients or to dimethyl sulfoxide (DMSO) or to either carboplatin or paclitaxel

    Current use of a prohibited medication; the following medications or non-drug therapies are prohibited:

    Other anti-cancer therapy while on study treatment; (note: megestrol [Megace] if used as an appetite stimulant is allowed)

    Concurrent treatment with bisphosphonates is permitted; however, treatment must be initiated prior to the first dose of study therapy; prophylactic use of bisphosphonates in patients without bone disease is not permitted, except for the treatment of osteoporosis

    Concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, St. John’s wort, kava, ephedra [ma huang], gingko biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng)

    History or current evidence/risk of retinal vein occlusion (RVO)

    History or evidence of cardiovascular risk including any of the following:

    Left ventricular ejection fraction (LVEF) < LLN

    A QT interval corrected for heart rate using the Bazett’s formula corrected QT (QTcB) >= 480 msec

    History or evidence of current clinically significant uncontrolled arrhythmias (exception: patients with controlled atrial fibrillation for > 30 days prior to registration are eligible)

    History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to registration

    History or evidence of current >= class II congestive heart failure as defined by the New York Heart Association (NYHA) functional classification system

    Treatment-refractory hypertension defined as a blood pressure of systolic > 140 mmHg and/or diastolic > 90 mmHg which cannot be controlled by anti-hypertensive therapy

    Known cardiac metastases

    Known hepatitis B virus (HBV), or hepatitis C virus (HCV) infection (patients with chronic or cleared HBV and HCV infection are eligible); patients with human immunodeficiency virus (HIV) are not eligible if on anti-retroviral medications

    Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

    Pregnant women or nursing mothers; women of childbearing potential should be advised to avoid pregnancy and use effective methods of contraception; men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception; if a female patient or a female partner of a patient becomes pregnant while the patient receives trametinib, the potential hazard to the fetus should be explained to the patient and partner (as applicable)

    HIV-positive patients on combination antiretroviral therapy are ineligible

    Patients who do not consent for PK studies to be performed (alternatively: patients who initially consent to be on study but withdraws consent for PK study will be taken off study and replaced)

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  • open for enrollment

    Ph 1/2 brentuximab vedotin in comb w/ nivolumab w/ relap/refractory Hodgkin lymphoma

    Protocol: OSU-15164

    Principal Investigator: Beth A Christian, MD

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  • open for enrollment

    Ph II CD24Fc for Prevention of Acute GVHD Following Myeloablative Allogeneic HSCT

    Protocol: OSU-15286

    Principal Investigator: Samantha M Jaglowski, MD

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  • open for enrollment

    Ph II GempoxFollowed By A Single Cycle Of AuHPCR For Pts W/ Recurrent Or Progressive CNS Germ Cell T

    Protocol: OSU-16184

    Principal Investigator: Pierre Giglio, MD

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  • open for enrollment

    Maintenance Pembrolizumab vs Placebo after First-line Chemo in Pts w/ Metastatic Urothelial Cancer

    Protocol: OSU-16133

    Principal Investigator: Amir Mortazavi, MD

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  • open for enrollment

    Carfilzomib for Treatment of Chronic Graft vs. Host Disease

    Protocol: OSU-15279

    Principal Investigator: Samantha M Jaglowski, MD

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  • open for enrollment

    Chemotherapy and Pelvic Radiation Therapy with or without Additional Chemotherapy in Treating Patients with High-Risk Early-Stage Cervical Cancer after Radical Hysterectomy

    Protocol: RTOG-0724

    Eligibility:

    Inclusion Criteria:

    Patients must have undergone radical hysterectomy (open, laparoscopically or robotic) and staging including pelvic node sampling or dissection for cervical carcinoma within 70 days prior to study entry (NOTE: if the patient did not have a para-aortic lymph node sampling/dissection, but had common iliac node dissection that was negative, a positron emission tomography [PET]-computed tomography [CT] is recommended, but not required; a negative pre or post-operative PET scan or PET-CT scan of the para–aortic nodes is required if the patient did not undergo para-aortic or common iliac nodal sampling/dissection)

    Patients with clinical stage IA2, IB or IIA squamous, adenosquamous, or adenocarcinoma of the cervix who have any/all of the following high-risk features after surgery:

    Positive pelvic nodes

    Positive parametrium

    Positive para-aortic nodes- completely resected, PET/CT negative (PET only required if positive para-aortic nodes during surgery)

    No distant metastases, based upon the following minimum diagnostic workup (NOTE: patients with positive para-aortic nodes- completely resected, PET/CT negative are eligible):

    History/physical examination within 56 days prior to study entry

    Contrast-enhanced imaging of the abdomen and pelvis by either CT, magnetic resonance imaging (MRI), or whole body PET-CT (with or without contrast) within 90 days prior to registration (NOTE: whole body PET-CT is preferred)

    Chest x-ray (posterioranterior [PA] and lateral) or chest CT within 70 days prior to study entry (except for those who have had whole body PET-CT)

    Zubrod performance status 0-1

    Absolute neutrophil count (ANC) >= 1,800 cells/mm^3

    Platelets >= 100,000 cells/mm^3

    Hemoglobin >= 10.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 10.0 g/dl is acceptable)

    White blood cell count >= 4000 cells/mm^3

    Serum creatinine =< 1.5 mg/dL within 14 days prior to study entry

    Bilirubin =< 1.5 times normal 14 days prior to study entry

    Alkaline phosphatase within upper limits of institutional normal within 14 days prior to study entry

    Alanine aminotransferase (ALT)/serum glutamate pyruvate transaminase (SGPT) and/or aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) within upper limits of institutional normal within 14 days prior to study entry

    Patients with known human immunodeficiency virus (HIV) positive must have a cluster of differentiation (CD)4 cell count be >= 350 cells/mm^3 within 14 days prior to study entry (note, however, that HIV testing is not required for entry into this protocol)

    Patient must provide study-specific informed consent prior to study entry

    Exclusion Criteria:

    Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)

    Patients can not have any neuroendocrine histology in pathology

    Prior systemic chemotherapy for the current cervical cancer; note that prior chemotherapy for a different cancer is allowable

    Prior radiation therapy to the pelvis that would result in overlap of radiation therapy fields

    Severe, active co-morbidity, defined as follows:

    Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months

    Transmural myocardial infarction within the last 6 months

    Acute bacterial or fungal infection requiring intravenous antibiotics at the time of study entry

    Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of study entry

    Coagulation defects; note, however, that coagulation parameters are not required for entry into this protocol

    Prior allergic reaction to carboplatin, paclitaxel, and/or cisplatin

    Patients who have gross residual disease or distant metastatic disease

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  • open for enrollment

    Intensity Modulated Accelerated Partial Breast Irradiation in Treating Older Patients with Hormone Responsive Stage 0-I Breast Cancer before Surgery

    Protocol: OSU-13282

    Eligibility:

    Inclusion Criteria:

    COHORT I:

    The patient must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelines

    Patient must be > 18 years

    The patient must have clinical node negative, stage I breast cancer

    The surgical treatment must be intended to be a lumpectomy

    The biopsy site must have been demarcated by a clip(s)

    Gross disease must be unifocal on mammogram (mammo)/magnetic resonance imaging (MRI) imaging

    Patient must be able to tolerate lying in the prone position with arms extended forward

    Must be able to tolerate MRI scan with contrast

    COHORT II: The patient must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelines

    COHORT II: Patient must be >= 60 years

    COHORT II: Core biopsy demonstrating breast cancer and receptors that are estrogen receptor (ER) or progesterone receptor (PR) positive

    COHORT II: Core tissue must have human epidermal growth factor receptor 2 (HER 2) testing

    COHORT II: The patient must have clinical node negative, stage I breast cancer

    COHORT II: The surgical treatment must be intended to be a lumpectomy

    COHORT II: The biopsy site must have been demarcated by a clip(s)

    COHORT II: Gross disease must be unifocal on Mammo/ MRI imaging

    COHORT II: Patients must have estrogen receptor (ER) and progesterone receptor (PR) analysis performed on core biopsy

    COHORT II: Patient must be able to tolerate lying in the prone position with arms extended forward

    COHORT II: Must be able to tolerate MRI scan with contrast

    COHORT II: At the time of enrollment, patients must have had bilateral mammograms within 6 months

    COHORT II: Patients must be willing to undergo breast cancer surgery minimally 4, maximally 6 weeks post APBI

    COHORT II: Patients with a history of non-breast malignancies are eligible if they have been disease free for 5 or more years prior to enrollment and are deemed by their physicians to be at low risk for recurrence; patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin

    Exclusion Criteria:

    COHORT II:

    Age < 60 years

    Hormone unresponsive breast cancer

    T-2 (> 3.0 cm), T-3, stage III, or stage IV breast cancer

    N-1, N-2, or N-3 pathologic axillary nodes

    Mastectomy intended

    Unwilling to undergo anti-endocrine therapy

    Suspicious microcalcification, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign

    Non-epithelial breast malignancies such as sarcoma or lymphoma

    Paget’s disease of the nipple

    Proven multicentric carcinoma (invasive or ductal carcinoma in situ [DCIS]) in more than one quadrant or separated by > 4 centimeters

    Any prior treatment with radiation therapy, chemotherapy, biotherapy, or hormone therapy for the currently diagnosed breast cancer prior to study enrollment

    Prior breast or thoracic radiation therapy (RT) for any condition

    Psychiatric of addictive disorders or other condition that in the opinion of the investigator would preclude the patient from meeting the study requirements

    Principal Investigator: Julia White, MD

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  • open for enrollment

    A Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL

    Protocol: OSU-15070

    Eligibility:

    Inclusion Criteria:

    Major Inclusion Criteria:

    1. Age >18 years

    2. Histologically confirmed diagnosis of DLBCL

    3. Tumour tissue for central pathology review and correlative studies must be provided.

    4. Patients must have:

    relapsed and/or refractory disease

    at least one bidimensionally measurable, PET positive disease site (transverse

    diameter of ≥1.5 cm and perpendicular diameter of ≥1.0 cm at baseline)

    received at least one, but no more than three previous systemic regimens for the

    treatment of DLBCL and one therapy line must have included a CD20-targeted

    therapy

    Eastern Cooperative Oncology Group 0 to 2

    5. Patients not considered in the opinion of the investigator eligible, or patients

    unwilling to undergo intensive salvage therapy including ASCT

    6. Patients must meet the following laboratory criteria at screening:

    absolute neutrophil count ≥1.5 × 109/L

    platelet count ≥90 × 109/L

    total serum bilirubin ≤2.5 × ULN or ≤5 × ULN in cases of Glibert's Syndrome or

    liver involvement by lymphoma

    alanine transaminase, aspartate aminotransferase and alkaline phosphatase ≤3 ×

    ULN or <5 × ULN in cases of liver involvement

    serum creatinine clearance ≥60 mL/minute

    7. Females of childbearing potential (FCBP) must:

    not be pregnant

    refrain from breastfeeding and donating blood or oocytes

    agree to ongoing pregnancy testing

    commit to continued abstinence from heterosexual intercourse, or agree to use

    and be able to comply with the use of double-barrier contraception

    8. Males (if sexually active with a FCBP) must

    use an effective barrier method of contraception

    refrain from donating blood or sperm

    9. In the opinion of the investigator the patients must:

    be able and willing to receive adequate prophylaxis and/or therapy for

    thromboembolic events

    be able to understand the reason for complying with the special conditions of

    the pregnancy prevention risk management plan and give written acknowledgement

    of this.

    Major Exclusion Criteria:

    1. Patients who have:

    other histological type of lymphoma

    primary refractory DLBCL

    a history of "double/triple hit" genetics

    2. Patients who have, within 14 days prior to Day 1 dosing:

    not discontinued CD20-targeted therapy, chemotherapy, radiotherapy,

    investigational anticancer therapy or other lymphoma specific therapy

    undergone major surgery or suffered from significant traumatic injury

    received live vaccines.

    required parenteral antimicrobial therapy for active, intercurrent infections

    3. Patients who:

    were previously treated with CD19-targeted therapy or IMiDs® (e.g. thalidomide,

    LEN)

    have undergone ASCT within the period ≤ 3 months prior to signing the informed

    consent form.

    have undergone previous allogenic stem cell transplantation

    have a history of deep venous thrombosis/embolism and who are not willing/able

    to take venous thromboembolic event prophylaxis during the entire treatment

    period

    concurrently use other anticancer or experimental treatments

    4. Prior history of malignancies other than DLBCL, unless the patient has been free of

    the disease for ≥5 years prior to screening.

    5. Patients with:

    positive hepatitis B and/or C serology.

    known seropositivity for or history of active viral infection with human

    immunodeficiency virus (HIV)

    CNS lymphoma involvement

    history or evidence of clinically significant cardiovascular, CNS and/or other

    systemic disease that would in the investigator's opinion preclude participation

    in the study or compromise the patient's ability to give informed consent.

    Exclusion Criteria:

    Major Inclusion Criteria:

    1. Age >18 years

    2. Histologically confirmed diagnosis of DLBCL

    3. Tumour tissue for central pathology review and correlative studies must be provided.

    4. Patients must have:

    relapsed and/or refractory disease

    at least one bidimensionally measurable, PET positive disease site (transverse

    diameter of ≥1.5 cm and perpendicular diameter of ≥1.0 cm at baseline)

    received at least one, but no more than three previous systemic regimens for the

    treatment of DLBCL and one therapy line must have included a CD20-targeted

    therapy

    Eastern Cooperative Oncology Group 0 to 2

    5. Patients not considered in the opinion of the investigator eligible, or patients

    unwilling to undergo intensive salvage therapy including ASCT

    6. Patients must meet the following laboratory criteria at screening:

    absolute neutrophil count ≥1.5 × 109/L

    platelet count ≥90 × 109/L

    total serum bilirubin ≤2.5 × ULN or ≤5 × ULN in cases of Glibert's Syndrome or

    liver involvement by lymphoma

    alanine transaminase, aspartate aminotransferase and alkaline phosphatase ≤3 ×

    ULN or <5 × ULN in cases of liver involvement

    serum creatinine clearance ≥60 mL/minute

    7. Females of childbearing potential (FCBP) must:

    not be pregnant

    refrain from breastfeeding and donating blood or oocytes

    agree to ongoing pregnancy testing

    commit to continued abstinence from heterosexual intercourse, or agree to use

    and be able to comply with the use of double-barrier contraception

    8. Males (if sexually active with a FCBP) must

    use an effective barrier method of contraception

    refrain from donating blood or sperm

    9. In the opinion of the investigator the patients must:

    be able and willing to receive adequate prophylaxis and/or therapy for

    thromboembolic events

    be able to understand the reason for complying with the special conditions of

    the pregnancy prevention risk management plan and give written acknowledgement

    of this.

    Major Exclusion Criteria:

    1. Patients who have:

    other histological type of lymphoma

    primary refractory DLBCL

    a history of "double/triple hit" genetics

    2. Patients who have, within 14 days prior to Day 1 dosing:

    not discontinued CD20-targeted therapy, chemotherapy, radiotherapy,

    investigational anticancer therapy or other lymphoma specific therapy

    undergone major surgery or suffered from significant traumatic injury

    received live vaccines.

    required parenteral antimicrobial therapy for active, intercurrent infections

    3. Patients who:

    were previously treated with CD19-targeted therapy or IMiDs® (e.g. thalidomide,

    LEN)

    have undergone ASCT within the period ≤ 3 months prior to signing the informed

    consent form.

    have undergone previous allogenic stem cell transplantation

    have a history of deep venous thrombosis/embolism and who are not willing/able

    to take venous thromboembolic event prophylaxis during the entire treatment

    period

    concurrently use other anticancer or experimental treatments

    4. Prior history of malignancies other than DLBCL, unless the patient has been free of

    the disease for ≥5 years prior to screening.

    5. Patients with:

    positive hepatitis B and/or C serology.

    known seropositivity for or history of active viral infection with human

    immunodeficiency virus (HIV)

    CNS lymphoma involvement

    history or evidence of clinically significant cardiovascular, CNS and/or other

    systemic disease that would in the investigator's opinion preclude participation

    in the study or compromise the patient's ability to give informed consent.

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