Filter Your Search

  • ?
    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.
  • ?
    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

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

    Protocol: OSU-17209

    Principal Investigator: Yvonne A Efebera, MD

    Learn More
  • open for enrollment

    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

    Learn More
  • open for enrollment

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

    Protocol: OSU-12200

    Principal Investigator: Kerry Rogers, MD

    Learn More
  • open for enrollment

    Venetoclax in Combination with Obinutuzumab and Ibrutinib in Treating Patients with Relapsed, Refractory, or Previously Untreated Chronic Lymphocytic Leukemia

    Protocol: OSU-14266

    Eligibility:

    Inclusion Criteria:

    Diagnosis of CLL meeting criteria established in the World Health Organization (WHO) classification of hematologic disorders

    Eastern Cooperative Oncology Group (ECOG) performance status =< 1

    Relapsed or refractory CLL patients must meet the following requirements:

    Received at least 1 prior therapy

    Require treatment in the opinion of the investigator

    Relapsed patients must have developed progressive disease following a response to a prior therapy

    Refractory patients must have failed to respond or relapsed within 6 months to the last prior therapy

    Treatment-naïve CLL patients must meet the following requirements (Phase II only):

    Symptomatic disease as defined by International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria

    Received no prior chemotherapy, immunotherapy, or targeted therapy for the treatment of CLL with the exceptions of palliative loco-regional radiotherapy and corticosteroids for symptom control

    Hemoglobin >= 8 g/dL

    Absolute neutrophil count (ANC) >= 1000/mm^3

    Platelets >= 40,000/mm^3

    Prothrombin time (PT)/partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN)

    Total bilirubin =< 1.5 x ULN (excepting Gilbert's syndrome)

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

    Serum creatinine < 2.0 mg/dL or creatinine clearance (Cockcroft) >= 50 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal

    Female patients must be surgically sterile, post-menopausal (for at least 1 year), or have negative results from a pregnancy test performed as follows:

    At screening, on a serum sample obtained within 14 days prior to the first study drug administration, and

    Prior to dosing, on a urine sample obtained on day 1 of treatment if it has been > 7 days since obtaining the serum pregnancy test result

    All female patients not surgically sterile or post-menopausal (for at least 1 year) and non-vasectomized male patients must practice at least one of the following methods of birth control:

    Total abstinence from sexual intercourse (minimum one complete menstrual cycle)

    A vasectomized partner

    Hormonal contraceptives for at least 2 months prior to day 1 of treatment

    Double-barrier method

    Non-vasectomized male patients must practice at least one of the following methods of birth control throughout the duration of study participation and for at least 3 months after study treatment:

    A partner who is surgically sterile or postmenopausal (for at least 1 year) or who is taking hormonal contraceptives (oral, parenteral, vaginal ring, or transdermal) for at least 3 months prior to study drug administration

    Total abstinence from sexual intercourse

    Double-barrier method (condom, diaphragm or cervical cup with spermicidal, contraceptive sponge, jellies, or cream)

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

    Exclusion Criteria:

    Patients who have had chemotherapy, immunotherapy, radiotherapy, or investigational therapy within 28 days prior to entering the study or those who have not recovered from adverse events due to agents administered more than 28 days earlier; steroids for control of disease related symptoms are permitted

    Patients who are receiving any other investigational agents

    Uncontrolled autoimmune hemolytic anemia or thrombocytopenia

    Active Richter’s transformation

    Known active involvement of the central nervous system by lymphoma or leukemia

    Patients who require warfarin anticoagulation or who have received warfarin or equivalent vitamin K antagonists =< 7 days prior to treatment day 1; patients may be eligible if able to be taken off warfarin and started on an alternative anticoagulant

    Received potent cytochrome P450 3A4 (CYP3A4) inhibitors (such as fluconazole, ketoconazole, and clarithromycin) within 7 days prior to the first dose of study treatment

    Received potent CYP3A4 inducers (such as rifampin, carbamazepine, phenytoin, St. John’s wort) within 7 days prior to the first dose of study treatment

    Consumed grapefruit or grapefruit products, Seville oranges (including marmalade containing Seville oranges), or star fruit within 3 days prior to the first dose of study treatment

    History of a prior significant toxicity, other than thrombocytopenia, from another Bcl-2 family protein inhibitor

    Known cysteine-481 Bruton's tyrosine kinase (BTK) mutation or CLL refractory to or progressed during ibrutinib or other cysteine (Cys)-481 binding BTK inhibitor treatment

    Known infection with the human immunodeficiency virus (HIV) virus

    A cardiovascular disability status of New York Heart Association class >= 2, defined as cardiac disease in which patients are comfortable at rest but ordinary physical activity results in fatigue, palpitations, dyspnea, or angina pain

    Positive hepatitis serology:

    Hepatitis B virus (HBV): patients with positive serology for hepatitis B defined as positivity for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (anti-HBc); patients who are positive for anti-HBc may be considered for inclusion in the study on a case-by-case basis if they are hepatitis B viral deoxyribonucleic acid (DNA) negative and are willing to undergo ongoing HBV DNA testing by real-time polymerase chain reaction (PCR); patients with positive serology may be referred to a hepatologist or gastroenterologist for appropriate monitoring and management

    • Patients with positive HBSAg consistent with prior vaccination to HBV (i.e., anti-HBs+, anti-HBc-) may participate
    • Patients suspected to have false positive serologic studies because of IV immunoglobulin administration are potentially eligible after negative PCR studies for viral DNA/ribonucleic acid (RNA) and discussion with the principal investigator

    Hepatitis C (HCV): patients with positive hepatitis C serology unless HCV RNA is confirmed negative and may be considered for inclusion in the study on a case-by-case basis (e.g., patients with negative viral load after HCV-specific treatment)

    History of severe (defined as grade 4 and/or requiring permanent discontinuation of prior antibody therapy) allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies

    A female patient who is pregnant or breast-feeding

    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

    History of other active malignancies other than CLL within the past 3 years prior to study entry, with the exception of:

    Adequately treated in situ carcinoma or the cervix uteri or breast

    Basal cell or localized squamous cell carcinoma of the skin

    Previous malignancy confirmed and surgically resected (or treated with other modalities) with curative intent or without relapse for >= 2 years

    Vaccination with a live vaccine < 28 days prior to the start of treatment

    Inability to swallow capsules or tablets, or disease significantly affecting gastrointestinal function and/or inhibiting small intestine absorption (malabsorption syndrome, resection of the small bowel, poorly controlled inflammatory bowel disease, etc.)

    Principal Investigator: Kerry Rogers, MD

    Learn More
  • open for enrollment

    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

    Learn More
  • open for enrollment

    HLA-Mismatched Unrelated Donor Bone Marrow Transplantation With Post-Transplantation Cyclophosphamide

    Protocol: OSU-16165

    Eligibility:

    Inclusion Criteria:

    Inclusion Criteria:

    1. Age ≥ 15 years and < 71 years at the time of signing the informed consent form

    2. Partially HLA-mismatched unrelated donor: HLA typing will be performed at high

    resolution (allele level) for the HLA-A, -B, -C, and -DRB1 loci; a minimum match of

    4/8 at HLA-A, -B, -C, and -DRB1 is required

    3. Product planned for infusion is bone marrow

    4. Disease and disease status:

    1. Acute Leukemias or T lymphoblastic lymphoma in 1st or subsequent complete

    remission (CR): Acute lymphoblastic leukemia (ALL)/T lymphoblastic lymphoma;

    acute myelogenous leukemia (AML); acute biphenotypic leukemia (ABL); acute

    undifferentiated leukemia (AUL)

    2. Myelodysplastic Syndrome (MDS), fulfilling the following criteria: Subjects with

    de novo MDS who have or have previously had Intermediate-2 or High risk disease

    as determined by the International Prognostic Scoring System (IPSS). Current

    Intermediate-2 or High risk disease is not a requirement; Subjects must have <

    20% bone marrow blasts, assessed within 60 days of informed consent; Subjects

    may have received prior therapy for the treatment of MDS prior to enrollment

    3. Chronic Lymphocytic Leukemia (CLL) in CR if RIC is to be used; in CR or partial

    response (PR) if FIC is to be used

    4. Chemotherapy-sensitive lymphoma in status other than 1st CR

    5. Performance status: Karnofsky or Lansky score ≥ 60% (Appendix A)

    6. Adequate organ function defined as:

    1. Cardiac: left ventricular ejection fraction (LVEF) at rest ≥ 35% (RIC cohort) or

    LVEF at rest ≥ 40% (FIC cohort), or left ventricular shortening fraction (LVFS)

    ≥ 25%

    2. Pulmonary: diffusing capacity of the lungs for carbon monoxide (DLCO), forced

    expiratory volume (FEV1), forced vital capacity (FVC) ≥ 50% predicted by

    pulmonary function tests (PFTs)

    3. Hepatic: total bilirubin ≤ 2.5 mg/dL, and alanine aminotransferase (ALT),

    aspartate aminotransferase (AST), and alkaline phosphatase (ALP) < 5 x upper

    limit of (ULN) (unless disease related)

    4. Renal: serum creatinine (SCr) within normal range for age (see table 2.3). If

    SCr is outside normal range for age, creatinine clearance (CrCl) > 40

    mL/min/1.73m2 must be obtained (measured by 24-hour (hr) urine specimen or

    nuclear glomerular filtration rate (GFR), or calculated GFR (by Cockcroft-Gault

    formula for those aged ≥ 18 years; by Original Schwartz estimate for those < 18

    years))

    7. Subjects ≥ 18 years of age must have the ability to give informed consent according

    to applicable regulatory and local institutional requirements. Legal guardian

    permission must be obtained for subjects < 18 years of age. Pediatric subjects will

    be included in age appropriate discussion in order to obtain assent.

    8. Subjects with documentation of confirmed HIV-1 infection (i.e. HIV-positive), and a

    hematologic malignancy who meets all other eligibility requirements must:

    1. Receive only RIC regimen (i.e. Regimen A)

    2. Be willing to comply with effective antiretroviral therapy (ARV)

    3. Have achieved a sustained virologic response for 12 weeks after cessation of

    hepatitis C antiviral treatment (in HIV-positive subjects with hepatitis C)

    Exclusion Criteria:

    1. HLA-matched related or 8/8 allele matched (HLA-A, -B, -C, -DRB1) unrelated donor

    available. This exclusion does not apply to HIV-positive subjects who have a

    CCR5delta32 homozygous donor.

    2. Autologous HCT < 3 months prior to the time of signing the informed consent form

    3. Females who are breast-feeding or pregnant

    4. HIV-positive subjects:

    1. Acquired immunodeficiency syndrome (AIDS) related syndromes or symptoms that may

    pose an excessive risk for transplantation-related morbidity as determined by

    the Treatment Review Committee (see Appendix D).

    2. Untreatable HIV infection due to multidrug ARV resistance. Subjects with a

    detectable or standard viral load > 750 copies/mL should be evaluated with an

    HIV drug resistance test (HIV-1 genotype). The results should be included as

    part of the ARV review (described in Appendix D).

    3. May not be currently prescribed ritonavir, cobacistat and/or zidovudine

    5

    Exclusion Criteria:

    Inclusion Criteria:

    1. Age ≥ 15 years and < 71 years at the time of signing the informed consent form

    2. Partially HLA-mismatched unrelated donor: HLA typing will be performed at high

    resolution (allele level) for the HLA-A, -B, -C, and -DRB1 loci; a minimum match of

    4/8 at HLA-A, -B, -C, and -DRB1 is required

    3. Product planned for infusion is bone marrow

    4. Disease and disease status:

    1. Acute Leukemias or T lymphoblastic lymphoma in 1st or subsequent complete

    remission (CR): Acute lymphoblastic leukemia (ALL)/T lymphoblastic lymphoma;

    acute myelogenous leukemia (AML); acute biphenotypic leukemia (ABL); acute

    undifferentiated leukemia (AUL)

    2. Myelodysplastic Syndrome (MDS), fulfilling the following criteria: Subjects with

    de novo MDS who have or have previously had Intermediate-2 or High risk disease

    as determined by the International Prognostic Scoring System (IPSS). Current

    Intermediate-2 or High risk disease is not a requirement; Subjects must have <

    20% bone marrow blasts, assessed within 60 days of informed consent; Subjects

    may have received prior therapy for the treatment of MDS prior to enrollment

    3. Chronic Lymphocytic Leukemia (CLL) in CR if RIC is to be used; in CR or partial

    response (PR) if FIC is to be used

    4. Chemotherapy-sensitive lymphoma in status other than 1st CR

    5. Performance status: Karnofsky or Lansky score ≥ 60% (Appendix A)

    6. Adequate organ function defined as:

    1. Cardiac: left ventricular ejection fraction (LVEF) at rest ≥ 35% (RIC cohort) or

    LVEF at rest ≥ 40% (FIC cohort), or left ventricular shortening fraction (LVFS)

    ≥ 25%

    2. Pulmonary: diffusing capacity of the lungs for carbon monoxide (DLCO), forced

    expiratory volume (FEV1), forced vital capacity (FVC) ≥ 50% predicted by

    pulmonary function tests (PFTs)

    3. Hepatic: total bilirubin ≤ 2.5 mg/dL, and alanine aminotransferase (ALT),

    aspartate aminotransferase (AST), and alkaline phosphatase (ALP) < 5 x upper

    limit of (ULN) (unless disease related)

    4. Renal: serum creatinine (SCr) within normal range for age (see table 2.3). If

    SCr is outside normal range for age, creatinine clearance (CrCl) > 40

    mL/min/1.73m2 must be obtained (measured by 24-hour (hr) urine specimen or

    nuclear glomerular filtration rate (GFR), or calculated GFR (by Cockcroft-Gault

    formula for those aged ≥ 18 years; by Original Schwartz estimate for those < 18

    years))

    7. Subjects ≥ 18 years of age must have the ability to give informed consent according

    to applicable regulatory and local institutional requirements. Legal guardian

    permission must be obtained for subjects < 18 years of age. Pediatric subjects will

    be included in age appropriate discussion in order to obtain assent.

    8. Subjects with documentation of confirmed HIV-1 infection (i.e. HIV-positive), and a

    hematologic malignancy who meets all other eligibility requirements must:

    1. Receive only RIC regimen (i.e. Regimen A)

    2. Be willing to comply with effective antiretroviral therapy (ARV)

    3. Have achieved a sustained virologic response for 12 weeks after cessation of

    hepatitis C antiviral treatment (in HIV-positive subjects with hepatitis C)

    Exclusion Criteria:

    1. HLA-matched related or 8/8 allele matched (HLA-A, -B, -C, -DRB1) unrelated donor

    available. This exclusion does not apply to HIV-positive subjects who have a

    CCR5delta32 homozygous donor.

    2. Autologous HCT < 3 months prior to the time of signing the informed consent form

    3. Females who are breast-feeding or pregnant

    4. HIV-positive subjects:

    1. Acquired immunodeficiency syndrome (AIDS) related syndromes or symptoms that may

    pose an excessive risk for transplantation-related morbidity as determined by

    the Treatment Review Committee (see Appendix D).

    2. Untreatable HIV infection due to multidrug ARV resistance. Subjects with a

    detectable or standard viral load > 750 copies/mL should be evaluated with an

    HIV drug resistance test (HIV-1 genotype). The results should be included as

    part of the ARV review (described in Appendix D).

    3. May not be currently prescribed ritonavir, cobacistat and/or zidovudine

    5

    Learn More
  • open for enrollment

    Ph1b/2 study Pinometostat in Combination w/standard induction chemotherapy newly diagnosed AML w/MLL

    Protocol: OSU-18296

    Principal Investigator: James S Blachly, MD

    Learn More