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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.
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    Itacitinib or Placebo in Combo w/ Corticosteroids for the Tx of First-Line Acute GVHD

    Protocol: OSU-17209

    Principal Investigator: Yvonne A Efebera, MD

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    Multicenter Study Of Natalizumab Plus Standard Steroid Treatment For High Risk Acute Graft-Versus-Host Disease

    Protocol: OSU-15270

    Eligibility:

    Inclusion Criteria: - New onset high risk acute GVHD (Ann Arbor score 3 as defined in Appendix C of the protocol) following allogeneic bone marrow transplantation. Any clinical severity (Glucksberg grade I-IV) is eligible. - Any donor type (e.g., related, unrelated) or stem cell source (bone marrow, peripheral blood, cord blood). Recipients of non-myeloablative and myeloablative transplants are eligible. - No prior systemic treatment for acute GVHD except for a maximum of 72 hours of prednisone ≤2 mg/kg/day (or IV methylprednisolone equivalent). Topical skin steroid treatment is permissible. Non-absorbable oral steroid treatment for GI GVHD is prohibited. - Age 12 years or older. - If the patient is a woman of child-bearing potential, the patient and their sexual partner must agree to practice effective contraception. - Written informed consent from patient, parent, or guardian. - Written assent from patients age 12 to 17 years. - Biopsy of acute GVHD target organ is strongly recommended, but not required. Enrollment should not be delayed for biopsy or pathology results. Patients who do not enroll within 72 hours of new onset acute GVHD are not permitted to participate. Exclusion Criteria: - Progressive or relapsed malignancy - Uncontrolled active infection - Patients with chronic GVHD - Known seropositivity for JC virus - History of Progressive Multifocal Leukoencephalopathy (PML) - Known hypersensitivity to natalizumab - Pregnant or nursing (lactating) women - Use of other drugs for the treatment of acute GVHD - Patients on dialysis - Patients requiring ventilator support - Investigational agent within 30 days of enrollment without approval from the Sponsor-Investigator

    Principal Investigator: Yvonne A Efebera, MD

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    Ph2 Bruton's Tyrosine Kinase Inhibitor PCI-32765 for Treatment of Relapsed Hairy Cell Leukemia

    Protocol: OSU-12200

    Principal Investigator: Kerry Rogers, MD

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    Combination Chemotherapy with or without Blinatumomab in Treating Patients with Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia

    Protocol: ECOG-E1910

    Eligibility:

    Inclusion Criteria:

    PRE-REGISTRATION

    Diagnostic bone marrow and peripheral blood specimens must be submitted for immunophenotyping and selected molecular testing, and the establishment of BCR/ABL status; testing will be performed by the Eastern Cooperative Oncology Group (ECOG)-American College of Radiation Imaging Network (ACRIN) Leukemia Translational Research Laboratory (LTRL) and reported to the institution

    NOTE: IT IS ESSENTIAL THAT A SAMPLE CONTAINING SUFFICIENT BLAST CELLS BE SUBMITTED TO THE ECOG-ACRIN LTRL AT BASELINE SO THAT SUBSEQUENT BONE MARROW ASSESSMENTS OF MRD CAN BE DONE; IN ADDITION TO ALLOWING THE LTRL TO CONFIRM ELIGIBILITY BASED ON BLAST CELL IMMUNOPHENOTYPE AND BCR/ABL STATUS, IT IS ALSO IMPERATIVE THAT AN ADEQUATE NUMBER OF BLASTS BE BANKED FOR ANALYSIS BY DRS MULLIGHAN/WILLMAN. WITHOUT ADEQUATE BASELINE SAMPLES, PATIENTS WILL NOT BE ABLE TO BE TREATED AND RANDOMIZED ON THIS PROTOCOL; IF A BONE MARROW ASPIRATE IS NOT AVAILABLE FOR LTRL SUBMISSION AT BASELINE, IT IS IMPERATIVE THAT DR PAIETTA FROM THE LTRL IS CALLED TO DISCUSS THE PERIPHERAL BLOOD WBC AND BLAST COUNT BEFORE BLOOD ONLY IS SUBMITTED

    INDUCTION ELIGIBILITY CRITERIA-STEP 1

    New diagnosis of B lineage ALL must be made upon bone marrow or peripheral blood immunophenotyping; cases with myeloid antigen expression, but unequivocal lymphoid immunophenotype, are eligible

    Mature B ALL (Burkitt’s-like leukemia) is excluded from enrollment in this trial

    Negativity for the Philadelphia chromosome must be established by conventional cytogenetics, fluorescence in situ hybridization (FISH) and/or polymerase chain reaction (PCR); patients who are negative for the Philadelphia chromosome by conventional cytogenetics must have FISH or PCR performed for BCR/ABL to exclude occult translocations

    Cytogenetic analysis must be performed from diagnostic bone marrow (preferred) or if adequate number of circulating blasts from peripheral blood; FISH testing for common B-lineage ALL abnormalities including t(9;22) (BCR/ABL1), t(12;21) (ETS-variant gene 6 [ETV6]/runt-related transcription factor 1 [RUNX1]), t(1;19) (pre-B-cell leukemia homeobox 1 [PBX1]/transcription factor 3 [TCF3]), +4,+10,+17, (centromeric [Cen]4/Cen10/Cen17), t(11q23;var), (myeloid/lymphoid or mixed lineage leukemia [MLL]), deletion (del)(9p) (cyclin-dependent kinase inhibitor 2A [CDKN2A]/Cen9), and t(14;var) (immunoglobulin heavy chain [IGH] is encouraged); if there are few or no circulating blasts and an adequate marrow sample cannot be obtained for cytogenetic analysis, the patient may still enroll on the trial

    Patient must not have a concurrent active malignancy for which they are receiving treatment

    Serum direct bilirubin < 2 mg/dl or serum total bilirubin =< 3; NOTE: the above stipulation for normal hepatic function does not apply if liver dysfunction is due to leukemia infiltration

    Serum creatinine < 2 mg/dl; NOTE: the above stipulation for normal hepatic function does not apply if liver dysfunction is due to leukemia infiltration

    Patient should be human leukocyte antigen (HLA) typed (A, B, C, DR and DQ) during induction therapy phase or a written explanation for not undergoing HLA typing on the flow sheet

    Patient must not have intercurrent organ damage or medical problems that will jeopardize the outcome of therapy (i.e., psychiatric disorder, drug abuse, pregnancy)

    Patients with known human immunodeficiency virus (HIV) infections are not eligible

    Patient must not have an antecedent hematologic disorder

    Patient must have no history of recent myocardial infarction (within three months), uncontrolled congestive heart failure, or uncontrolled cardiac arrhythmia

    Patient must not have a history or presence of clinically relevant central nervous system (CNS) pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia; Parkinson’s disease, cerebellar disease, organic brain syndrome, psychosis, or other significant CNS abnormalities

    Patient must have a normal cardiac ejection fraction by pretreatment multigated acquisition scan (MUGA) or echocardiogram within 4 weeks prior to registration (resting ejection fraction >= 40% or >= 5% increase with exercise), shortening fraction by echocardiogram >= 24%, or to within the normal range of values for the institution

    Patient must not have an active uncontrolled infection

    Women must not be pregnant or breast-feeding and must not become pregnant or breastfeed during protocol therapy and for at least 3 months after protocol therapy; woman of childbearing potential must abstain from sexual activity or be willing to use 2 highly effective forms of contraception throughout protocol therapy and for at least an additional 3 months after the last dose of protocol-specified therapy; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)

    Men who have a female partner of childbearing potential must be willing to use 2 highly effective forms of contraception throughout protocol therapy and for at least an additional 3 months after the last dose of protocol-specified therapy; men who have a pregnant partner must be willing to use a condom during sexual activity throughout protocol therapy and for 3 months after the last dose of protocol-specified therapy

    ECOG performance score 0-3

    Patient must have given written informed consent

    POST-INDUCTION THERAPY ELIGIBILITY CRITERIA (PRIOR TO INTENSIFICATION-STEP 2)

    ECOG performance status 0-2

    Patients must have achieved a CR or CRi

    Patients who have achieved a CR or CRi must have maintained peripheral blood evidence of a CR or CRi

    Patient must be CNS (cerebrospinal fluid [CSF]) negative for leukemia

    Patients must have resolved any serious infectious complications related to induction

    Any significant medical complications related to induction must have resolved

    Serum creatinine =< 2.0 mg/dl

    Serum direct bilirubin < 2 mg/dL or serum total bilirubin =< 3

    Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x upper limit of normal (ULN)

    RANDOMIZATION TO BLINATUMOMAB OR NO BLINATUMOMAB-STEP 3

    Patients must have an ECOG performance status of 0-2

    Patients must have maintained peripheral blood evidence of a remission and must have a CR or CRi, confirmed on restaging bone marrow (BM) aspirate and biopsy and cytogenetic analysis

    Patients must have resolved any serious infectious complications related to therapy

    Any significant medical complications related to therapy must have resolved

    Direct or total bilirubin < 1.5 x ULN (unless related to Gilbert’s or Meulengracht’s syndrome); the values must be obtained within 48 hours prior to randomization

    Serum creatinine < 1.5 x ULN; the values must be obtained within 48 hours prior to randomization

    Bone marrow aspirates must be submitted for centralized minimal residual disease (MRD) assessment performed by the ECOG-ACRIN Leukemia Translational Research Laboratory

    MRD results will be reported to the submitting institution

    NOTE: FOR MRD ASSESSMENTS, AN ASPIRATE FROM A SEPARATE BONE MARROW ASPIRATION SITE MUST BE SUBMITTED (THE NEEDLE CAN BE RE-DIRECTED THROUGH THE SAME SKIN PUNCTURE SITE); ONLY SUBMIT ASPIRATES FROM THE FIRST PULL OF AN ASPIRATION SITE FOR MRD TESTING; DO NOT SUBMIT SAMPLES FROM THE SECOND OR THIRD PULL OF THE SAME ASPIRATION SITE

    In B-lineage ALL, MRD levels in peripheral blood or from a dilute marrow aspiration can be 300% lower, on average, than those in bone marrow at a given time point; submitting a first pull from a separate aspiration site will ensure that MRD determinations used in randomization and trial interpretation are accurate

    • NOTE: failure to submit bone marrow aspirates will result in a major violation at the time of an audit

    CRITERIA FOR ALLOGENEIC TRANSPLANTATION

    A suitable donor must be identified; there are no restrictions on donor type and can include a matched sibling, a matched or mismatched unrelated donor, a family haplotype matched donor or a cord blood donor (single or double)

    Patients should meet the eligibility criteria for RANDOMIZATION TO BLINATUMOMAB OR NO BLINATUMOMAB-STEP 3

    Patients must be considered reliable enough to comply with the medication regimen and follow-up, and have social support necessary to allow this compliance

    CRITERIA FOR MAINTENANCE THERAPY-STEP 4: Patients must have an ECOG performance status of 0-3

    CRITERIA FOR MAINTENANCE THERAPY-STEP 4: Patients must have maintained peripheral blood evidence of a remission and must have a CR or CRi, confirmed on restaging BM aspirate and biopsy and cytogenetic analysis

    CRITERIA FOR MAINTENANCE THERAPY-STEP 4: Patients must have resolved any serious infectious complications related to therapy

    CRITERIA FOR MAINTENANCE THERAPY-STEP 4: Any significant medical complications related to therapy must have resolved

    Principal Investigator: Bhavana Bhatnagar, DO

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    MAP to Prov Acc to CTL019, forALL or DLBCL pt w Out of Spec Leuk Prod and/or Manuf Tisagenlecleucel

    Protocol: OSU-18224

    Principal Investigator: Samantha M Jaglowski, MD

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