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+Patients with a history of hepatic sinusoid obstructive syndrome (veno-occlusive disease) within the prior 3 months
+History of malabsorption syndrome or other condition that would interfere with enteral absorption
+Known history of Gilbert's syndrome
+Presence of GVHD overlap syndrome.
+Myelodysplastic syndrome with isolated del(5q) (5q-syndrome)
+Myelodysplastic syndrome (MDS), unclassifiable
+Abnormal glucuronidation of bilirubin, known Gilbert's syndrome
+History of reversible posterior leukoencephalopathy syndrome (RPLS)
+Trisomy 21 (Down syndrome)
+Malabsorption syndrome or other condition that would interfere with enteral absorption
+Patients known to have one of the following concomitant genetic syndromes: Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome
+Patients with Down syndrome
+Patients with Down syndrome are not eligible
+Down syndrome
+Patients with down syndrome are excluded from this study
+Patients with known symptomatic Fanconi anemia (FA), ataxia-telangiectasia (A-T) syndrome, Bloom syndrome (BS) and Nijmegen breakage syndrome (NBS) are not eligible (asymptomatic carriers are acceptable)
+Subject has malabsorption syndrome or other condition which may affect an enteral route of administration
+Malabsorption syndrome or other condition that would interfere with enteral absorption
+Please note: patients who do not meet the above criteria because of Gilbert’s syndrome are still eligible
+History of sarcoidosis syndrome
+Difficulty with swallowing or an active malabsorption syndrome.
+Patients must not have evidence or history of veno-occlusive disease or sinusoidal obstruction syndrome
+History of known radiation sensitivity syndrome
+Subjects with solitary plasmacytoma; active or history of plasma cell leukemia (PCL); Waldenstrom's macroglobulinemia; Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, Skin changes (POEMS) syndrome; or symptomatic amyloidosis
+Malabsorption syndrome or other conditions that preclude enteral route of administration
+Has active hemolytic anemia, plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, amyloidosis, significant autoimmune, CNS or other malignant disease
+Bilirubin ? 1.5 x ULN (unless considered due to Gilbert's syndrome or hemolysis)
+POEMS syndrome
+Diagnosis of autoimmune disorder, including RA, SLE, or Sjogren's syndrome
+Malabsorption syndrome or other condition that precludes enteral route of administration
+Subjects with Gilbert's syndrome;
+Myelodysplastic or myeloproliferative syndrome other than MDS.
+Acute coronary syndrome within 6 months prior to starting treatment
+POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
+Participants with Gilbert's syndrome will be eligible for the study
+Mycosis fungoide/Sezary syndrome
+History of Steven's Johnson's syndrome or toxic epidermal necrolysis syndrome.
+History of nephrotic syndrome
+Diagnosis of any of the following cancers:\r\n* POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein [M-protein] and skin changes)\r\n* Non-secretory myeloma (no measurable protein on serum free lite assay)\r\n* Plasma cell leukemia\r\n* Human T-cell lymphotrophic virus (HTLV)1/HTLV2 positive
+Patients with nevoid BCC syndrome (Gorlin syndrome) should not enroll in this study
+Acute coronary syndrome
+POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
+POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
+Myelodysplastic Syndrome (MDS)
+Have a history of Gilbert's syndrome.
+Pre-existing renal disease including glomerulonephritis, nephritic syndrome, Fanconi Syndrome or renal tubular acidosis.
+Any history of serotonin syndrome (SS) after receiving 1 or more serotonergic drugs
+Known history of Gilbert's syndrome.
+Has polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes (POEMS) syndrome, monoclonal gammopathy of unknown significance, smoldering myeloma, solitary plasmacytoma, amyloidosis, Waldenstrom macroglobinemia or immunoglobulin M (IgM) myeloma, or lymphoplasmacytic lymphoma (LPL).
+Myelodysplastic syndrome
+Patients with Down’s syndrome
+ENROLLMENT TO THE DOSE ESCALATION, EXPANSION AND PART II: History of Gilbert’s syndrome
+AML that progressed out of myelodysplastic syndrome (MDS) is eligible if the patient did not receive treatment directed at the MDS
+Patients with 5q- syndrome should have failed to respond to or progressed on treatment with lenalidomide, where available and indicated
+Patients with Down syndrome
+History of hemolytic-uremic syndrome.
+History of malabsorption syndrome or other condition that would interfere with enteral absorption
+TBL < 2.5 mg/dL, except for participants with Gilbert's syndrome.
+Malabsorption syndrome or other condition precluding enteral route of administration
+Erythema multiforme, toxic epidermal necrolysis, or Stevens-Johnson syndrome
+Known history of Gilbert's Syndrome.
+Subjects with known POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or light-chain (AL) amyloidosis.
+Clonal cytogenetic abnormalities consistent with pre-myelodysplastic syndrome (pre-MDS) or MDS on marrow examination (e.g. Monosomy 7).
+Myeloproliferative/myelodysplastic syndrome other than CMML. CMML with t(5;12) that have not yet received imatinib.
+POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein [protein] and skin changes)
+Malabsorption syndrome or other conditions that would interfere with intestinal absorption
+Any evidence of myelodysplastic syndrome or marrow chromosomal changes suggesting myelodysplasia (-7, -5 etc)
+Diagnosis of Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome, plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome.
+History of sarcoidosis syndrome
+Plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein), and skin changes (POEMS) syndrome
+History of known malabsorption syndrome or prior surgery(ies) that may lead to malabsorption
+Malabsorption syndrome or other condition that precludes oral route of administration of lenalidomide.
+History of multiple sclerosis or other demyelinating disease and/or Eaton-Lambert syndrome (para-neoplastic syndrome)
+Diagnosis of Waldenstrom’s macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome, plasma cell leukemia, myeloproliferative syndrome, or primary amyloidosis (with the exception of patients whose amyloidosis has been documented as a complication of MM, who will be evaluated on a case-by-case basis for trial participation)
+POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes)
+>= grade 3 neuropathy and/or polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes (POEMS syndrome)
+Malabsorption syndrome or other condition that precludes enteral route of administration
+Bilirubin ? 3.0 x ULN, unless due to Gilbert’s syndrome (unless considered due to leukemic organ involvement)
+Subject has received treatment with a hypomethylating agent and/or other chemotherapeutic agent either conventional or experimental for myelodysplastic syndrome (MDS) or AML
+Subject has a malabsorption syndrome or other condition that precludes enteral route of administration
+Any history of serotonin syndrome after receiving serotonergic drugs
+Documented history of carcinoid syndrome
+Patients with Gilbert's syndrome will be eligible for the study; the diagnosis of Gilbert's syndrome is suspected in people who have persistent, slightly elevated levels of unconjugated bilirubin without any other apparent cause; a diagnosis of Gilbert's syndrome will be based on the exclusion of other diseases based on the following criteria:\r\n* Unconjugated hyperbilirubinemia noted on several occasions\r\n* No evidence of hemolysis (normal hemoglobin, reticulocyte count, and lactate dehydrogenase [LDH])\r\n* Normal liver function tests\r\n* Absence of other diseases associated with unconjugated hyperbilirubinemia
+Subjects with history of or active symptoms of carcinoid syndrome
+Any history of serotonin syndrome (SS) after receiving serotonergic drugs
+Patients with a diagnosis of POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or plasma cell leukemia (> 2.0 x 10^9/L circulating plasma cells by standard differential)
+Bilirubin: =< 1.5 x ULN (except for subjects with Gilbert’s Syndrome or of non-hepatic cause)
+Malabsorption syndrome or other condition that precludes enteral route of administration
+Known reversible posterior leukoencephalopathy syndrome (RPLS)
+History of concomitant genetic syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome or any other known bone marrow failure syndrome
+History of multiple sclerosis or other demyelinating disease, Eaton-Lambert syndrome (para-neoplastic syndrome), history of hemorrhagic or ischemic stroke within the last 6 months, or alcoholic liver disease;
+A hypomethylating agent, venetoclax and/or chemo therapeutic agent for Myelodysplastic syndrome (MDS).
+Participant has a malabsorption syndrome or other condition that precludes enteral route of administration.
+History of Gilbert’s syndrome
+Direct bilirubin (bili) =< 40% if total bili > ULN in patients with Gilbert’s syndrome
+Any history of serotonin syndrome (SS) after receiving serotonergic drugs
+History of malabsorption syndrome or other condition that would interfere with enteral absorption
+POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein [M-protein] and skin changes)
+Diagnosis of amyloidosis, polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS), Waldenstrom’s macroglobulinemia
+History of sarcoidosis syndrome
+Patients with non-secretory multiple myeloma, active plasma cell leukemia, defined as either having 20% of peripheral white blood cells comprised of CD138+ plasma cells, or an absolute plasma cell count of 2 x 10^9/L, known amyloidosis, or known POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
+Patients with respiratory distress syndrome
+Has any history of serotonin syndrome after receiving 1 or more serotonergic drugs
+Diagnosis of smoldering MM, Waldenström's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome, plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome.
+Any other significant medical condition not under control, including any acute coronary syndrome within the past 6 months
+Has history of reversible posterior leukoencephalopathy syndrome
+Malabsorption syndrome or other condition that precludes enteral route of administration
+Histologic diagnosis of Richter’s syndrome (RS)
+History of sarcoidosis syndrome
+Total bilirubin =< 1.5 X upper limit of normal (ULN), for patients with congenital unconjugated hyperbilirubinemia (Crigler-Najjar syndrome type 1 and 2, Gilbert syndrome) that transient hyperbilirubinemia can occur due to physiological condition, as long as there is clear documentation of diagnosis, allowed to be enrolled if direct (conjugated) bilirubin is 1.5 X ULN
+• Bilirubin ? 1.5 times institutional ULN; does not apply to patients diagnosed with Gilbert's syndrome.
+Participant has a malabsorption syndrome or other condition that precludes enteral route of administration.
+Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes (POEMS) syndrome
+GROUP 6: Progressive gastrointestinal disease as defined by all of the following items:\r\n* Disease duration of scleroderma =< 2 years.\r\n* Documented severe malabsorption syndrome requiring nutritional support; severe malabsorption syndrome is > 10% weight loss and on total parenteral nutrition (TPN) or enteral feedings\r\n* High score on distention/ bloating scale (>= 1.60 out of 3.00) on gastrointestinal (GI) questionnaire
+>= grade 3 neuropathy and/or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
+Malabsorption syndrome or other condition that precludes enteral route of administration
+Patients with Gilbert's syndrome or other heritable diseases of bile processing.
+POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
+Has a paraneoplastic syndrome other than syndrome of inappropriate antidiuretic hormone secretion (SIADH) (hyponatremia)
+Bilirubin: =< 1.5 x ULN (except for subjects with Gilbert’s syndrome or of non-hepatic origin)
+POEMS syndrome requiring therapy, previously treated or untreated
+Known drug-related, inherited, or acquired procoagulant disorder including prothrombin gene mutation 20210, antithrombin III deficiency, protein C deficiency, protein S deficiency and antiphospholipid syndrome but not including heterozygosity for the Factor V Leiden mutation or the presence of a lupus anticoagulant in the absence of other criteria for the antiphospholipid syndrome
+Bilirubin =< 2 X ULN (3 X if known history of Gilbert's syndrome)
+Clonal cytogenetic abnormalities consistent with pre-myelodysplastic syndrome (pre-MDS) or MDS on marrow examination (e.g. monosomy 7)
+Known Gilbert’s syndrome
+History of sarcoidosis syndrome
+Patients with Gilbert’s syndrome will be eligible for the study; a diagnosis of Gilbert’s syndrome will be based on the exclusion of other diseases based on the following criteria:\r\n* Unconjugated hyperbilirubinemia noted on several occasions\r\n* No evidence of hemolysis (normal hemoglobin, reticulocyte count, and lactate dehydrogenase [LDH])\r\n* Normal liver function tests\r\n* Absence of other diseases associated with unconjugated hyperbilirubinemia
+Malabsorption syndrome or other condition that precludes enteral route of administration
+Patients with known Gilbert syndrome are not eligible
+history of erythema multiforme, toxic epidermal necrolysis or Stevens-Johnson syndrome;
+POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
+Has active cytokine release syndrome from CTL019 infusion
+Patients with known Gilbert's syndrome or reduced UGT1A1 activity.
+Malabsorption syndrome or other condition that precludes enteral route of administration
+Personal history of Gilbert’s syndrome
+Subjects with known polyneuropathy-organomegaly-endocrinopathy-M protein-skin lesions (POEMS) syndrome, and subjects with myeloma and amyloidosis will be eligible if they have measurable disease
+Malabsorption syndrome or other condition that would interfere with intestinal absorption are excluded
+Down syndrome
+Direct bilirubin must be < 2 mg/dL unless the elevation is known to be due to Gilbert's syndrome or acute GVHD (aGVHD) within 3 days of enrollment
+History of primary amyloidosis, hyperviscosity or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
+Individuals with Down syndrome
+Participants with malabsorption syndrome or any other condition that precludes enteral administration.
+Malabsorption syndrome or other condition that precludes enteral route of administration
+Malabsorption syndrome or other conditions that preclude enteral route of administration
+History of serotonergic syndrome
+Total bilirubin (T-Bil) =< 1.5 X ULN (prior diagnosis or past history consistent with Gilbert's syndrome is an exception)
+Any history of Stevens-Johnson syndrome
+Patients with an inherited cancer syndrome or a medical history suggestive of an inherited cancer syndrome remain eligible
+No prior history of myelodysplastic syndrome or other myeloid malignancy
+Patients with known Gilbert’s syndrome
+Subjects with Gorlin syndrome
+Prior treatment of myelodysplastic syndrome or myeloproliferative neoplasm with hypomethylating agent acceptable
+Bilirubin equal or less than 1.5 (unless Gilbert's syndrome)
+Patients with concomitant genetic syndrome: patients with Down syndrome, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome
+History of Gilbert's syndrome
+Malabsorption syndrome, such as Crohn’s disease
+No history of Steven’s Johnson’s syndrome, toxic epidermal necrolysis (TEN)s syndrome, or motor neuropathy
+RANDOMIZED PHASE II (ARMS K AND L): No history of Steven’s Johnson’s syndrome, TENs syndrome, or motor neuropathy
+History of Gilbert’s syndrome
+Patients with a diagnosis of myelodysplastic syndrome/myeloproliferative neoplasm, unclassifiable (MDS/MPN-U) that require therapy
+Acute IA defined as duration of clinical syndrome of <30 days.
+POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
+Patients with active Richter's syndrome (>10% large B-cells in marrow).
+Total bilirubin =< 2 X ULN (exceptions may apply to benign non-malignant indirect hyperbilirubinemia such as Gilbert syndrome)
+Known drug-related, inherited, or acquired procoagulant disorder including prothrombin gene mutation 20210, antithrombin III deficiency, protein C deficiency, protein S deficiency and antiphospholipid syndrome but not including heterozygosity for the factor V Leiden mutation or the presence of a lupus anticoagulant in the absence of other criteria for the antiphospholipid syndrome
+History of malabsorption syndrome e.g., pancreatic insufficiency, celiac disease, tropical sprue
+Patient with FA must have moderately severe aplastic anemia (AA) myelodysplastic syndrome (MDS) or acute leukemia with or without chromosomal abnormalities
+Myelodysplastic syndrome with multi-lineage dysplasia with or without chromosomal abnormalities
+Myelodysplastic syndrome
+History of multiple sclerosis or other demyelinating disease, Eaton-Lambert syndrome (para-neoplastic syndrome), history of hemorrhagic or ischemic stroke within the last 6 months, or alcoholic liver disease;
+Subject has gastric outlet syndrome or persistent/recurrent vomiting.
+Known history of myelodysplastic syndrome/leukemia at any time
+Patients with myelodysplastic syndrome, aplastic anemia or hemoglobinopathies will be eligible to participate regardless of disease status if plan is to proceed to HCT
+Criteria 3 POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
+Criteria 5 Myelodysplastic syndrome
+History of motor neuropathy considered to be of autoimmune origin (e.g., Guillain-Barre Syndrome, Myasthenia Gravis).
+Known presence of intermediate- or high-grade myelodysplastic syndrome.
+Subject has plasma cell leukemia or Waldenstrom’s macroglobulinemia or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or amyloidosis
+Myelodysplastic syndrome (MDS) or myelofibrosis;
+POEMS syndrome
+Myelodysplastic syndrome (MDS): primary or therapy related
+Difficulty with swallowing, or an active malabsorption syndrome.
+Difficulty with swallowing or an active malabsorption syndrome
+Patients with HNPCC (Lynch Syndrome)
+Symptomatic amyloidosis, active 'polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes' (POEMS) syndrome, active plasma cell leukemia at the time of screening.
+Diagnosis of myelodysplastic syndrome.
+History of myelodysplastic syndrome or organ transplantation
+POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
+Subject has plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloidosis
+History of Gilbert syndrome
+Has any history of serotonin syndrome after receiving serotonergic drugs
+Down syndrome
+Kostmann syndrome
+Shwachman syndrome
+No known Gilbert’s syndrome or known homozygosity for UGAT1A1*28 polymorphism
+History of Gilbert's syndrome
+Have received a hypomethylating agent for myelodysplastic syndrome (MDS).
+POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes)
+Patient has a history of Stevens-Johnson-Syndrome (SJS) or Toxic Epidermal Necroloysis (TEN)
+POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
+Patients with plasma cell leukemia, polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome, or amyloidosis are excluded from this trial
+Subject has Acute Respiratory Distress Syndrome (ARDS)
+Patient with and without Down syndrome are eligible and must have one of the following:\r\n* Second or greater relapse;\r\n* Primary refractory disease with at least 2 prior induction attempts;\r\n* First relapse refractory to at least one prior re-induction attempt\r\n* Any relapse after HSCT\r\n* First relapse with no prior re-induction attempt in setting of Down syndrome\r\n* Note: Patients with Down syndrome are eligible with any disease status including first relapse with no prior re-induction attempt; patients without Down syndrome are NOT eligible if in first relapse with no prior re-induction attempt
+Patients known to have one of the following concomitant genetic syndromes: Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndrome
+Documented Gilbert’s syndrome
+Diagnosis of Down syndrome (Trisomy 21)
+History of Gilbert’s syndrome
+Patients with a history of myelodysplastic syndrome (MDS)
+Patients with any of the following diagnoses:\r\n* Acute promyelocytic leukemia (APL)\r\n* Down syndrome\r\n* Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome\r\n* Wilson's disease and any other disorder of copper metabolism\r\n* Juvenile myelomonocytic leukemia (JMML)
+Patients with Li Fraumeni syndrome are excluded from the study
+Direct bilirubin ?2 X institutional ULN (unless due to known Gilbert's syndrome or compensated hemolysis directly attributable to CLL)
+Radiosensitivity syndrome (scleroderma, dermatomyositis, other genetic syndrome that predisposes to adverse radiotherapy complications)
+Total bilirubin =< 2 x ULN (patients with Gilbert syndrome may be included at the discretion of the principal investigator [PI] or where hemolysis has been excluded)
+Patients with a family history or Li-Fraumeni syndrome will not be eligible
+History of posterior reversible encephalopathy syndrome
+Patients with Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or other inherited bone marrow failure syndromes are not eligible
+Patients who have experienced bowel perforation, neurologic involvement, Guillain Barré syndrome, Myasthenia Gravis, Steven Johnson syndrome and other intractable events or grade 4 non-laboratory toxicity
+Patients must not have > grade 2 neuropathy and/or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
+MDS, myelodysplastic syndrome/myeloproliferative neoplasia overlap disorders (including chronic myelomonocytic leukemia [CMML], and MDS/myeloproliferative neoplasm [MPN] unclassifiable syndromes)
+Diagnosis of polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome
+Malabsorption syndrome or other condition that would interfere with intestinal absorption
+Patients with malabsorption syndrome or other condition that would interfere with intestinal absorption
+Patients with a history of toxic epidermal necrolysis (TEN) or Stevens-Johnson syndrome are excluded
+Pre-existing nephritic syndrome
+History of another primary invasive cancer, hematologic malignancy, or myelodysplastic syndrome that has not been in remission for at least 1 year
+Subject has Down syndrome.
+Presence of GVHD overlap syndrome as per NIH guidelines.
+For Cohort A: Has myelodysplastic syndrome
+Patients with concomitant genetic syndrome: such as patients with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Patients with Down Syndrome will not be excluded.
+History of Stevens-Johnson syndrome or toxic epidermal necrolysis syndrome.
+Known prolymphocytic leukemia or history of, or currently suspected, Richter's syndrome.
+Known prolymphocytic leukemia or history of, or currently suspected, Richter's syndrome.
+Richter syndrome
+POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
+Patients with peripheral arterial disease with intermittent claudication or Leriches Syndrome
+Subjects who have history of toxic epidermal necrolysis or Stevens-Johnson syndrome;
+Had prior serotonin syndrome
+Patients with concomitant genetic syndrome: such as patients with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Patients with Down Syndrome will not be excluded.
+Presence of known intermediate- or high-grade myelodysplastic syndrome
+Patients must not have known Gilbert’s syndrome
+Known history or presence of Sweet Syndrome at screening
+Plasma cell leukemia or POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) syndrome
+Presence of a malabsorption syndrome possibly affecting drug absorption (e.g., Crohn’s disease or chronic pancreatitis)
+History of Steven's Johnson's syndrome or toxic epidermal necrolysis syndrome.
+History of posterior reversible encephalopathy syndrome.
+Known Gilbert's syndrome
+No history of erythema multiforme, toxic epidermal necrolysis or Stevens-Johnson syndrome
+POEMS syndrome
+Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition
+Patients must not have POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
+Any history of serotonin syndrome after receiving serotonergic drugs.
+History of sarcoidosis syndrome
+Have ongoing or recent (?6 months) hepatorenal syndrome.
+Subjects with monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), primary amyloidosis, Waldenstrom's macroglobulinemia, or POEMS syndrome (plasma cell dyscrasia with poly neuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
+Malabsorption syndrome or poor upper gastrointestinal integrity
+History of malabsorption syndrome or other condition that would interfere with enteral absorption
+POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
+Myelodysplastic syndrome
+Gastrointestinal tract disease or defect with associated malabsorption syndrome
+Patients who have a known inherited syndrome as the cause for hormone over secretion.
+Patients with Cushing's syndrome due to ectopic ACTH secretion or ACTH-independent (adrenal) Cushing's syndrome.
+Patients must not have a known history of Gilbert’s syndrome or known homozygosity for the UDP glucuronosyltransferase 1 family, polypeptide A1 (UGT1A1)*28 allele
+Have active metabolic or digestive illnesses such as malabsorptive disorders (Crohn’s, Celiac disease, irritable bowel syndrome [IBS]), renal insufficiency, hepatic insufficiency, cachexia, or short bowel syndrome
+History of Osler-Weber-Rendu syndrome or hereditary hemorrhagic telangiectasia
+Known history of myelodysplastic syndrome (MDS).
+Patients must not have been diagnosed with myelodysplastic syndrome or with any malignancy other than neuroblastoma
+History of motor neuropathy considered to be of autoimmune origin (e.g., Guillain-Barre syndrome, myasthenia gravis)
+Known to have a hypercoagulability syndrome (e.g.: antithrombin III, deficiency, anticardiolipin syndrome etc)
+Patients with Down syndrome, acute promyelocytic leukemia, juvenile myelomonocytic leukemia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or other bone marrow failure syndromes are not eligible
+History of concomitant genetic syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome or any other known bone marrow failure syndrome
+Patients with active tumor lysis syndrome (TLS) either from laboratory or clinical changes
+Malabsorption syndrome or other condition that precludes enteral route of administration
+Wolff-Parkinson White syndrome or the presence of an intra-cardiac defibrillator
+Pre-existing renal disease including glomerulonephritis, nephritic syndrome, Fanconi syndrome or renal tubular acidosis
+Maldigestion/malabsorption syndrome pre-dating the diagnosis of pancreatic cancer.
+Cushing’s syndrome
+POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein [M-protein] and skin changes)
+Serum glutamate pyruvate transaminase (SGPT) =< 200 IU/ml (unless Gilbert's syndrome)
+POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
+Myelodysplastic syndrome
+Diagnosed with smoldering MM, monoclonal gammopathy of undetermined significance, Waldenstrom macroglobulinemia, plasma cell leukemia, polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome or amyloidosis
+Evidence of Gilbert’s syndrome or known homozygosity for the UGT1A1*28 allele (special screening not required)
+Participant has a malabsorption syndrome or other condition that precludes enteral route of administration.
+Patients who have a history of myelodysplastic syndrome
+Li-Fraumeni Syndrome
+Diagnosis of Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome, plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome.
+Subject has malabsorption syndrome or other condition that precludes enteral route of administration
+Subjects with a significant history of malabsorption (e.g. celiac sprue, short bowel syndrome, or other, as determined by the treating physician) are excluded
+Active gastrointestinal tract disease with malabsorption syndrome
+Patients must have a confirmed diagnosis of non-M3 AML; antecedent myelodysplastic syndrome (MDS) is acceptable
+History of reversible posterior leukoencephalopathy syndrome (RPLS)
+History of Gilbert’s syndrome
+Malabsorption syndrome or other condition that precludes enteral route of administration
+Known history of Gilbert's Syndrome or any current hyperbilirubinemia of any cause
+History of malabsorption syndrome or other condition that would interfere with enteral absorption Exclusion Criteria Related to Medications:
+History of sarcoidosis syndrome.
+Patients with myelodysplastic syndrome/acute myeloid leukaemia.
+POEMS syndrome (plasma cell dyscrasias with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein [M-protein] and skin changes) or amyloid light-chain (AL) amyloidoses
+Down Syndrome
+Subject has active malignant tumors other than AML or myelodysplastic syndrome (MDS).
+Malabsorption syndrome or other conditions that would interfere with intestinal absorption
+Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin (POEMS) syndrome
+Has a known history of Gilbert's Syndrome
+Diagnosis of Myelodysplastic Syndrome.
+Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome
+Clinical evidence of nephrotic syndrome prior to enrollment
+History of Gilbert’s syndrome
+History of Gilbert's syndrome
+Presence of chronic diarrhea (> grade 1 by Common Toxicity Criteria [CTC] criteria), short bowel syndrome, pancreatic insufficiency, or malabsorption
+History of Gilbert’s syndrome
+Participants with known disorders due to a deficiency in bilirubin glucuronidation (e.g. Gilbert’s syndrome)
+History of sarcoidosis syndrome
+Diagnosis of Waldenstrom's macroglobulinemia, POEMS syndrome, plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome
+History of Gilbert's syndrome.
+Total bilirubin =< 2 x ULN (except for patients with uridine diphosphate glucuronosyltransferase 1A1 [UGT1A1] promoter polymorphism, i.e. Gilbert syndrome, confirmed by genotyping or invader UGT1A1 molecular assay prior to study enrollment; patients enrolled with Gilbert syndrome must have total bilirubin < 3 ULN)
+POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
+Participants with known disorders due to a deficiency in bilirubin glucuronidation (e.g. Gilbert’s syndrome)
+History of Gilbert's syndrome
+Patients with history of Down's syndrome, Fanconi anemia or other known marrow failure condition
+Serum bilirubin =< 1.5 x ULN (unless Gilbert’s syndrome and evidence of hemolysis)
+History of immune system abnormalities such as hyperimmunity (e.g., autoimmune diseases) that required systemic immunosuppression therapy and hypoimmunity (e.g., myelodysplastic disorders, marrow failures, acquired immunodeficiency syndrome (AIDS), ongoing pregnancy, transplant immunosuppression)
+Any active or chronic corneal disorder and Sjogren's syndrome.
+Diagnosis of Waldenstrom's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome, plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome.
+Individuals with Down syndrome
+Bilirubin < to 2.0 x normal (except Gilbert’s Syndrome)
+Prior treatment of myelodysplastic syndrome or myeloproliferative neoplasm acceptable
+History of immune system abnormalities such as hyperimmunity (e.g., autoimmune diseases) and hypoimmunity (e.g., myelodysplastic disorders, marrow failures, acquired immune deficiency syndrome [AIDS], ongoing pregnancy, transplant immunosuppression)
+Any other significant medical condition not under control, including any acute coronary syndrome within the past 6 months
+History of Gilbert’s syndrome
+Myelodysplastic syndrome with fibrosis (MF 3)
+Total bilirubin =< 2.0 (exceptions may apply to benign non-malignant indirect hyperbilirubinemia such as Gilbert syndrome)
+Carcinoid Syndrome
+Has a known history of, or active, neurologic paraneoplastic syndrome
+Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome
+Nephrotic syndrome
+Bilirubin =< 2 mg/dL (exceptions may apply to benign non-malignant indirect hyperbilirubinemia such as Gilbert syndrome)
+No known malabsorption syndrome
+Patients with a known mutation in p53 (Li Fraumeni syndrome)
+Known procoagulant disorder including prothrombin gene mutation 20210, antithrombin III deficiency, protein C deficiency, protein S deficiency and antiphospholipid syndrome but not including heterozygosity for the Factor V Leiden mutation or the presence of a lupus anticoagulant in the absence of other criteria for the antiphospholipid syndrome
+Down syndrome
+Kostmann syndrome
+Shwachman syndrome
+A pathologically confirmed diagnosis of leukemia or myelodysplastic syndrome (MDS)
+Myelodysplastic syndrome (MDS): primary or therapy related; or
+Patients with Down syndrome and deoxyribonucleic acid (DNA) fragility syndromes (such as Fanconi anemia, Bloom syndrome) are excluded
+Received prior treatment with HMA or chemotherapy for antecedent myelodysplastic syndrome (MDS)
+Presence of chronic GvHD at Screening (including acute-chronic overlap syndrome).
+Previously untreated for Myelodysplastic Syndrome (MDS)
+Known presence of myelodysplastic syndrome
+Concomitant genetic syndrome or other known bone marrow failure syndrome
+Down syndrome
+Serum bilirubin ? 2 x ULN unless due to Gilbert's syndrome or hemolysis or considered to be related to leukemia;
+Known presence of myelodysplastic syndrome
+History of Gilbert's syndrome.
+Patients with Down syndrome are excluded.
+Bilirubin ? 2.0 times ULN, unless subject has known Gilbert's syndrome
+Neurologic disease including multiple sclerosis, Eaton-Lambert syndrome, demyelination
+Myelodysplastic Syndrome (MDS) at any stage.
+Patients with nevoid BCC syndrome (Gorlin syndrome) may enroll in this study but must meet the criteria for locally advanced or metastatic disease listed above
+Prior treatment with decitabine for myelodysplastic syndrome (MDS) or AML
+History of Gilbert’s syndrome
+Known history of Gilbert’s syndrome
+Known presence of myelodysplastic syndrome
+Patients with a known history of Gilbert’s syndrome
+4. Known history of Gilbert's Syndrome.
+Sézary syndrome
+History of malabsorption syndrome or other condition that would interfere with enteral absorption
+Active disease transformation (ie, Richter's Syndrome); subjects with Richter's Syndrome that has resolved > 2 years from signing the ICD are eligible.
+History of Stevens-Johnson syndrome characterized by a desquamating rash while taking thalidomide or similar drugs.
+Myelodysplastic syndrome\r\n* =< 55 years of age and >= 10% blasts, not responsive to hypomethylating agents and/or conventional therapy
+Subjects with posterior leukoencephalopathy syndrome
+Bilirubin greater than 1.5 mg/dl (>26 µmol/L) unless elevation is thought to be due to hepatic infiltration by AML, Gilbert syndrome, or hemolysis.
+History of neurological conditions that would confound assessment of treatment-emergent neuropathy other than =< grade 1 peripheral neuropathy including multiple sclerosis or other demyelinating disease and/or Eaton-Lambert syndrome (para-neoplastic syndrome); diabetes is allowed
+Diagnosis of myelodysplastic syndrome (MDS) or a hematologic malignancy.
+Subjects who have Gorlin syndrome
+Malabsorption syndrome or other condition that would interfere with enteric absorption
+History of hereditary hemorrhagic telangiectasia (HHT, Osler-Weber-Rendu syndrome)
+Patients with low- and Int-1-risk myelodysplastic syndrome
+Documented diagnosis of the following: Myelodysplastic syndrome lasting ? 3 months and < 3 years Disease must not be secondary to treatment with radiotherapy, chemotherapy, and/or immunotherapy for malignant or autoimmune diseases
+Any pre-excitation syndromes, e.g., Wolff-Parkinson-White syndrome;
+History of sarcoidosis syndrome
+Patients with a family history or Li-Fraumeni syndrome will not be eligible
+Patient has Down syndrome
+POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes).
+POEMS (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein [M-protein] and skin changes) syndrome
+History of Gilbert’s syndrome
+Subject has active malignant tumors other than AML or Myelodysplastic syndrome (MDS).
+POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes).
+Plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein), and skin changes (POEMS) syndrome
+Patients with myelodysplastic syndrome
+POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
+Patients with myelodysplastic syndrome
+Nephrotic syndrome
+Diagnosis of Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome, plasma cell leukemia, myeloproliferative syndrome, or primary amyloidosis (with the exception of patients in whom amyloidosis has been documented as a complication of MM, who will be evaluated on a case-by-case basis for trial participation)
+Patients with a known germline mutation of PTPN11 (Noonan’s Syndrome) are not eligible
+POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
+POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
+Immediate family member with a known or suspected Familial Cancer Syndrome (including but not limited to hereditary breast and ovarian cancer syndrome, hereditary non-polyposis colorectal cancer syndrome and familial adenomatous polyposis).
+Subject has acute chest syndrome
+total bilirubin ?1.5 X institutional ULN unless due to Gilbert's syndrome, controlled autoimmune hemolytic anemia or immune thrombocytopenia
+History of congenital platelet function defect (e.g., Bernard-Soulier syndrome, Chediak-Higashi syndrome, Glanzmann thrombasthenia, storage pool defect)
+History of hepatic sinusoid obstructive syndrome (venoocculsive disease) within the prior 3 months.
+History of malabsorption syndrome or other condition that would interfere with enteral absorption or results in the inability or unwillingness to swallow pills
+Known primary immunodeficiencies, either cellular (e.g., DiGeorge syndrome, T-negative severe combined immunodeficiency [SCID]) or combined T- and B-cell immunodeficiencies (e.g., T- and B-negative SCID, Wiskott Aldrich syndrome, ataxia telangiectasia, common variable immunodeficiency)
+Participants with malabsorption syndrome or any other condition that precludes enteral administration.
+POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
+Patients with myelodysplastic syndrome.
+Malabsorption syndrome
+History of malabsorption syndrome or other condition that would interfere with enteral absorption
+Myelodysplastic syndrome (MDS)
+POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
+Diagnosis of smoldering multiple myeloma, Waldenstrom's macroglobulinemia, POEMS syndrome, plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome
+Has known gastrointestinal condition or procedure that could interfere with swallowing or the oral absorption of tolerance of IXAZOMIB - Diagnosis of smoldering multiple myeloma, Waldenstrom's macroglobulinemia, POEMS syndrome, plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome
+Patients with a history of hereditary hemorrhagic telangiectasia (Osler-Weber-Rendu syndrome)
+Patients with an immunodeficiency syndrome
+POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
+Total bilirubin < 1.5 x upper limit of reference range (ULRR), unless the patient meets the criteria for Gilbert’s syndrome
+Total bilirubin > 1.5 x ULN (unless due to lymphoma or isolated, predominantly indirect hyperbilirubinemia due to Gilbert's syndrome)
+POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
+Bilirubin equal or less than 1.5 (unless Gilbert's Syndrome)
+History of malabsorption syndrome or other condition that would interfere with enteral absorption
+hyperviscosity syndrome due to monoclonal gammopathy
+Acute coronary syndrome
+Patients diagnosed with Sezary syndrome; Sezary syndrome is equivalent to mycosis fungoides that develops to stage IVA/B with B2 (high blood tumor burden) involvement, and as such requires a more aggressive treatment regimen than Valchlor or TSEBT
+Patients with any of the following diagnoses are not eligible:\r\n* Acute promyelocytic leukemia (APL)\r\n* Down syndrome\r\n* Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome\r\n* Wilson's disease and any other disorder of copper metabolism\r\n* Juvenile myelomonocytic leukemia (JMML)
+Active polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome.
+Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome
+History of Gilbert’s syndrome
+Active or a history of Tourette’s syndrome or tic disorder
+Have a confirmed diagnosis of sleep apnea or restless leg syndrome
+Patients with Down syndrome
+Known malabsorption syndrome, short bowel or chologenic diarrhea not controlled by specific therapeutic means
+Patients with Down syndrome, acute promyelocytic leukemia, juvenile myelomonocytic leukemia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or other bone marrow failure syndromes are not eligible
+Malabsorption syndrome or other condition that would interfere with enteral absorption
+Known myelodysplastic syndrome
+Known myelodysplastic syndrome.
+Acute Coronary Syndrome (ACS) (angina or MI) in last 6 months.
+Diagnosis of myelodysplastic syndrome (MDS).
+All patients who present for an initial consultation at the Dana Farber Cancer Institute (DFCI) for myelodysplastic syndrome (MDS) or a hematologic malignancy (transplantation consultation excluded)
+Sleep apnea or restless leg syndrome (RLS)
+Acute coronary syndrome as defined by active chest pain, dynamic electrocardiogram (ECG) changes, troponin greater than 2.5
+Co-morbidity with immunosuppressive disease such as acquired immune deficiency syndrome (AIDS)
+Known Mirizzi syndrome.
+History of irritable bowel syndrome (IBS)
+Delayed gastric emptying syndrome
+Patients with Sjogren's syndrome
+Has difficulty swallowing medications, or known history of malabsorption syndrome;
+Ongoing or recent hepatorenal syndrome.
+Current Myelodysplastic syndrome only subjects
+History of neuroleptic malignant syndrome
+Patients with diagnosis of chronic fatigue syndrome (CFS)
+POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein [M-protein] and skin changes)
+Patients with a diagnosis of obesity hypoventilation syndrome
+POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
+Subjects with a history of myelodysplastic syndrome
+Subjects who have currently active hepatic or biliary disease (with the exception of patients with Gilbert's syndrome)
+Diagnosed with hematological malignancy or marrow failure syndrome such as but not limited to: aplastic anemia, myelodysplastic syndrome or leukemia
+Have a clinical diagnosis of sleep apnea or restless leg syndrome
+Patients with acute/chronic GVHD overlap syndrome
+History of irritable bowel syndrome (IBS)
+Myelodysplatic Syndrome
+History of Guillain-Barre syndrome
+History of Guillain-Barre syndrome
+History of malabsorption syndrome (e.g., pancreatic insufficiency, celiac disease, or tropical sprue)
+Have a history of Guillain-Barre syndrome (GBS)
+Bone marrow failure disorders:\r\n* Paroxysmal nocturnal hemoglobinuria (PNH)\r\n* Hereditary bone marrow failure disorders include Diamond-Blackfan anemia, Shwachman- Diamond syndrome, Kostmann syndrome, and congenital amegakaryocytic thrombocytopenia\r\n* Other non-malignant hematologic or immunologic disorders that require transplantation:\r\n** Quantitative or qualitative congenital platelet disorders (including but not limited to congenital megakaryocytopenia, absent-radii syndrome, Glanzmann’s thrombasthenia)\r\n** Quantitative or qualitative congenital neutrophil disorders (including but not limited to chronic granulomatous disease, congenital neutropenia)\r\n** Congenital primary immunodeficiencies (including but not limited to severe combined immunodeficiency syndrome, Wiskott-Aldrich syndrome, CD40 ligand deficiency, T-cell deficiencies)\r\n** Hemoglobinopathies (including sickle cell disease and thalassemia)
+Patients with known or suspected Gilbert’s syndrome at the time of study enrollment
+Down syndrome
+Short gut syndrome
+Any malabsorption disease/syndrome
+History of atrophic gastritis, pernicious anemia, or Zollinger-Ellison syndrome
+Subjects who have Gorlins syndrome
+Subjects with treatment-related myelodysplastic syndrome.
+Solitary bone or extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia, or monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), primary amyloidosis, Waldenstrom's macroglobulinemia, POEMS syndrome or active plasma cell leukemia
+POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
+A defined myelodysplastic syndrome(s) (MDS)
+History of malabsorption syndrome (e.g., pancreatic insufficiency, celiac disease, or tropical sprue)
+Diagnosis of Down's Syndrome
+Histologic confirmation of leukemia or myelodysplatic syndrome (MDS) at the time of diagnosis or recurrence
+Individuals with “Li Fraumeni syndrome” defined as one of the following:\r\n* Carriers of a germline protein 53 (p53) mutation\r\n* Members of families meeting classic Li-Fraumeni syndrome (LFS) criteria by family history without an identifiable p53 mutation\r\n* Obligate carrier by pedigree (these individuals can be offered testing but are still eligible if they defer); the following examples describe “obligate carriers by pedigree”\r\n** A child of a parent with known p53 mutation that is diagnosed with cancer\r\n** An individual with a sibling and a child who are p53 positive OR\r\n* Individuals with an inherited cancer predisposition syndrome as defined by one of the following:\r\n** Hereditary retinoblastoma with a germline retinoblastoma (Rb) mutation\r\n** Diagnosis of hereditary paraganglioma/pheochromocytoma syndrome with a germline succinate dehydrogenase (SDH) mutation\r\n** Diagnosis of multiple endocrine neoplasia, type 1 or 2, with a germline multiple endocrine neoplasia (MEN) mutation\r\n** New diagnosis of opsoclonus-myoclonus with a negative cancer work-up upon presentation of symptoms\r\n** Familial neuroblastoma with a germline anaplastic lymphoma kinase (ALK) mutation\r\n** Rapid-onset obesity with hypothalamic dysfunction, hypoventilation and autonomic dysregulation (ROHHAD syndrome) or congenital central hypoventilation syndrome (CCHS) with or without a germline paired–like homeobox 2B (PHOX 2B) mutation\r\n** Von Hippel-Lindau with a Von Hippel-Lindau (VHL) mutation\r\n** Women with an abnormal cell-free deoxyribonucleic acid (DNA) test (i.e. a non-invasive prenatal test [NIPT] to detect chromosomal abnormalities) and no cancer diagnosis\r\n** Other rare cancer predisposition syndromes at the discretion of the treating physician and study physicians\r\n* IF APPLICABLE: individuals with any of the above-listed cancer predisposition syndromes (apart from Li Fraumeni syndrome) are likewise eligible in the absence of a known mutation if they are an obligate carrier by pedigree
+Individuals with “Li Fraumeni syndrome” defined as one of the following:\r\n* Carriers of a germline p53 mutation OR\r\n* Members of families meeting classic LFS criteria by family history without an identifiable p53 mutation OR\r\n* Obligate carrier by pedigree (these individuals can be offered testing but are still eligible if they defer); the following examples describe “obligate carriers by pedigree”\r\n** A child of a parent with known p53 mutation that is diagnosed with cancer\r\n** An individual with a sibling and a child who are p53 positive OR\r\n* Individuals with an inherited cancer predisposition syndrome as defined by one of the following:\r\n** Hereditary retinoblastoma with a germline Rb mutation\r\n** Diagnosis of hereditary paraganglioma/pheochromocytoma syndrome with a germline SDH mutation\r\n** Diagnosis of multiple endocrine neoplasia, type 1 or 2, with a germline MEN mutation\r\n** New diagnosis of opsoclonus-myoclonus with a negative cancer work-up upon presentation of symptoms\r\n** Familial neuroblastoma with a germline ALK mutation\r\n** Rapid-onset obesity with hypothalamic dysfunction, hypoventilation and autonomic dysregulation (ROHHAD syndrome) or congenital central hypoventilation syndrome (CCHS) with or without a germline PHOX 2B mutation\r\n** Von Hippel-Lindau with a VHL mutation\r\n** Other rare cancer predisposition syndrome at the discretion of the treating physician and study physicians\r\n* IF APPLICABLE: individuals with any of the above-listed cancer predisposition syndromes (apart from Li Fraumeni syndrome) are likewise eligible in the absence of a known mutation if they are an obligate carrier by pedigree
+History of Stevens-Johnson syndrome
+History of Stevens-Johnson syndrome
+Subject has plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloidosis
+Patients with respiratory distress syndrome
+Patients who have experienced an acute coronary syndrome or angina in the past 6 months
+PATIENT: Patients with respiratory distress syndrome
+Has been diagnosis of active acquired immunodeficiency syndrome (AIDS) or hepatitis B/C and other significant disease or disorders
+Patients with unstable cardiopulmonary conditions or respiratory distress syndrome
+History of Steven’s Johnson’s syndrome, toxic epidermal necrolysis syndrome (TENs) or motor neuropathy
+Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome.
+Pre-existing renal disease including glomerulonephritis, nephritic syndrome, Fanconi syndrome or renal tubular acidosis
+Subjects with Gilbert's syndrome or resolving autoimmune hemolytic anemia may have a bilirubin up to 3.0 x ULN and are still eligible
+POEMS syndrome [plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes]
+POEMs syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
+Patients with respiratory distress syndrome
+Patients with respiratory distress syndrome
+History of Crohn's disease, celiac sprue or other malabsorption syndrome which may interfere with digestion and absorption of broccoli sprout extract
+POEMS (Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin changes) syndrome, monoclonal gammopathy of unknown significance, smoldering myeloma, solitary plasmacytoma, amyloidosis, Waldenström macroglobulinemia, or IgM myeloma.
+POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
+Myelodysplastic Syndrome
+Bilirubin >1.5 x ULN, unless prior diagnosis and documentation of leukemic organ involvement, ongoing hemolysis, or Gilbert's syndrome
+History of Stevens-Johnson syndrome or toxic epidermal necrolysis syndrome.
+History of Guillain-Barre syndrome or Stevens-Johnson syndrome