Downloads: 1
| # | Blank 1 | Frequency | Blank 2 | Frequency | |
|---|---|---|---|---|---|
| 1 | 2 | patients who | 9 | eligible | 8 |
| 2 | 17 | 4 | ineligible | 6 | |
| 3 | 69 | and | 3 | allowed | 3 |
| 4 | 70 | patients who have undergone prior liver transplantation | 3 | eligible . | 2 |
| 5 | 1 | patients | 2 | not eligible within 60 days of therapy | 2 |
| 6 | 55 | they | 2 | candidates for allogeneic transplantation have a suitable donor | 2 |
| 7 | 62 | prior allogeneic stem cell transplant sct within 16 weeks or autologous sct within 8 weeks of initiation of therapy patients that require immunosuppressive therapy | 2 | willing to undergo transplantation | 2 |
| 8 | 3 | patients who have had an allogeneic hematopoietic stem cell transplantation | 1 | between t 40 and t 100 after allogeneic transplantation | 2 |
| 9 | 4 | subjects who have opted not to undergo allogeneic hematopoietic stem cell transplantation and who | 1 | considered to have failed available therapies or to be ineligible for or to not be interested in intensive chemotherapies including allogeneic hematopoietic stem cell transplantation | 1 |
| 10 | 5 | patients who have had a prior stem cell transplantation | 1 | candidates for allogeneic stem cell transplantation . | 1 |
| 11 | 6 | patients who have received allogeneic hematopoietic stem cell transplantation | 1 | not eligible . | 1 |
| 12 | 7 | patients will have completed induction therapy achieved 1st cr and will have completed any planned post remission therapy patients | 1 | not deemed eligible for high intensity chemotherapy . | 1 |
| 13 | 9 | patients that have received prior allogeneic stem cell transplantation | 1 | not eligible for participation | 1 |
| 14 | 10 | patients who have undergone autologous / allogeneic stem cell transplantation | 1 | not candidates for allogeneic stem cell transplantation for purposes of this study | 1 |
| 15 | 11 | there | 1 | not candidates for allogeneic stem cell transplantation shall be defined as 1 those who do not meet the eligibility criteria of an open allogeneic transplant protocol or 2 those who do not have a suitable available human leukocyte antigen hla matched donor available or 3 those who refuse to undergo stem cell transplantation or 4 those patients whose disease is characterized by good risk features for aml the following cytogenetic subtypes t 8 21 inv 16 | 1 |
| 16 | 12 | patients who have undergone either ablative or non myeloablative allogeneic stem cell transplantation | 1 | excluded from this study | 1 |
| 17 | 13 | patients who have undergone allogeneic stem cell transplantation for the treatment of any hematological malignancy | 1 | no liver function test criteria for non myeloablative allogeneic stem cell transplantation | 1 |
| 18 | 14 | b cell lymphoma classified as either of the following r / r fl after treatment with at least one prior chemoimmunotherapy regimen that included an anti cluster of differentiation 20 cd20 monoclonal antibody r / r dlbcl after treatment with at least one prior chemoimmunotherapy regimen that included an anti cd20 monoclonal antibody in participants who | 1 | not eligible for second line combination chemotherapy and autologous stem cell transplantation have failed second line combination chemotherapy | 1 |
| 19 | 15 | patients who completed single autologous stem cell transplant after completion of at most 2 induction regimens excluding dexamethasone alone and | 1 | in at least stable disease compared to pre induction in the first 100 days after stem cell transplantation | 1 |
| 20 | 16 | for rituximab in combination with polatuzumab vedotin and lenalidomide r pola len treatment group r / r dlbcl after treatment with at least one prior chemoimmunotherapy regimen that included an anti cd20 monoclonal antibody in patients who | 1 | not eligible for autologous stem cell transplantation or who have experienced disease progression following treatment with high dose chemotherapy plus autologous stem cell transplantation | 1 |
| 21 | 18 | patients who have ever received an autologous hematopoietic stem cell transplantation autohsct | 1 | schedmcLed to receive an autologous hematopoietic stem cell transplantation autohsct are not eligible | 1 |
| 22 | 20 | recipients of prior autologous hematopoietic stem cell transplantation | 1 | ineligible if disease recurrence occurred less than 6 months from their autologous stem cell transplant . | 1 |
| 23 | 21 | lymphoblastic leukemia lymphoma | 1 | included | 1 |
| 24 | 22 | autologous transplantation | 1 | candidate for an autologous or allogeneic stem cell transplantation sct will be allowed to receive the study drugs as a bridge to transplantation if candidates for transplant | 1 |
| 25 | 24 | patient participants who have undergone autologous stem cell transplantation autosct | 1 | eligible provided that they are > = 4 weeks from stem cell infusion | 1 |
| 26 | 26 | patients with b lineage all at least marrow cr in salvage 1 and beyond with molecmcLar failure at any time point after 1 month of salvage therapy | 1 | planned for treatment with high dose melphalan and autologous hematopoietic cell transplantation hct | 1 |
| 27 | 27 | patients must have relapsed after high dose therapy and autologous transplantation or be ineligible for high dose therapy and autologous transplantation patients that have failed autologous transplantation | 1 | allowed including patients who received prior allogeneic stem cell transplantation | 1 |
| 28 | 29 | persistent positron emission tomography pet positivity after chemotherapy | 1 | those with persistent disease > = 30 days after transplant those ineligible for autologous transplant include those with chemoresistant disease i . e . patients who have not achieved a partial response or better with their most recent chemotherapy regimen | 1 |
| 29 | 31 | have received or | 1 | expected to have a poor outcome from autologous transplant e . g . dlbcl relapsing within one year of rituximab | 1 |
| 30 | 32 | patients who have undergone autologous stem cell transplantation asct | 1 | unable to collect sufficient or tumor free autologous stem cells per seattle cancer care alliance scca standard practice | 1 |
| 31 | 33 | prior high dose chemotherapy and autologous hematopoietic cell transplantation hct s is | 1 | unable to tolerate the high dose autologous conditioning regimens or who refuse a high dose autologous transplant regimen | 1 |
| 32 | 34 | patients who have undergone autologous hematopoietic stem cell transplantation | 1 | ineligible for immediate established curative regimens including stem cell transplantation | 1 |
| 33 | 35 | subject must have documented diagnosis with previously untreated for cohort c the induction and consolidation treatment along with the first autologous stem cell transplantation asct | 1 | eligible provided that they are > = 4 weeks from stem cell infusion and meet other eligibility criteria | 1 |
| 34 | 36 | for rituximab atezo pola treatment group relapsed or refractory dlbcl after treatment with at least one prior chemoimmunotherapy regimen that included an anti cd20 monoclonal antibody in participants who | 1 | eligible once they have recovered from all toxicities from therapy | 1 |
| 35 | 37 | participants who | 1 | not eligible for second line combination immuno chemotherapy and autologous stem cell transplantation or who have failed second line combination immuno chemotherapy or experienced disease progression following autologous stem cell transplantation | 1 |
| 36 | 38 | patients for whom lenalidomide and dexamethasone treatment is appropriate and who | 1 | newly diagnosed and not considered candidate for high dose chemotherapy with stem cell transplantation sct due to being age > = 65 years or in participants < 65 years presence of important comorbid conditions likely to have a negative impact on tolerability of high dose chemotherapy with stem cell transplantation | 1 |
| 37 | 40 | patients with histologically confirmed cd20 positive b cell non hodgkin lymphoma nhl who | 1 | not eligible for high dose therapy followed by stem cell transplantation hdt sct for 1 or more of the following reasons | 1 |
| 38 | 41 | phase i patients with diagnosis of mmcLtiple myeloma at any stage of disease undergoing high dose chemotherapy and stem cell transplantation phase ii patients with myeloma undergoing a first high dose chemotherapy and stem cell transplantation after achieving at least stable disease following induction therapy any induction regimen prior to transplantation is allowed no more than 2 prior lines of therapy prior to transplantation | 1 | eligible for autologous transplantation | 1 |
| 39 | 42 | patients with relapsed mmcLtiple myeloma following autologous stem cell transplantation must have achieved at least partial response following additional chemotherapy cohort 1 r n patients | 1 | candidates for autologous stem cell transplantation sct | 1 |
| 40 | 43 | subjects with aml in their first relapse following a remission > = 12 months in duration who | 1 | eligible if relapse occurs with complex / high risk cytogenetics or occurs with normal cytogenetics but within 15 months following the autologous transplant | 1 |
| 41 | 45 | alkylating agent or corticosteroid subjects who | 1 | eligible for standard therapies e . g . chemotherapy or stem cell transplantation | 1 |
| 42 | 47 | prior allogeneic hematopoietic stem cell transplantation if evidence of donor chimerism persists patients with exclusively autologous hematopoiesis | 1 | candidates for autologous stem cell transplantation due to primary refractory or first relapse of disease | 1 |
| 43 | 48 | all patients must have a histologic or cytological diagnosis of all treated with stem cell transplantation there | 1 | not eligible for high dose chemotherapy and autologous stem cell transplantation hd asct are eligible with exposure to at least 1 prior therapy . waldstrom s macroglobmcLinemia dose expansion arm | 1 |
| 44 | 49 | dexamethasone cvad with or without auto sct r n bendamustine rituximab with or without auto sct r n please note r n patients | 1 | candidates for high dose chemotherapy and autologous stem cell transplantation with curative intent shomcLd not be enrolled | 1 |
| 45 | 50 | but no more than 120 days if a patient underwent auto sct he / she must demonstrate engraftment per treating investigator s discretion and meet all other hematological requirements as outlined below r n patients who progress during induction therapy | 1 | no restrictions on prior therapy | 1 |
| 46 | 51 | patients who have had a prior allogeneic stem cell transplant | 1 | allowed to receive combinations of the above regimens r n at the time of registration patients must be at least 14 days out from last dose of cytotoxic chemotherapy | 1 |
| 47 | 52 | with epstein barr virus ebv positive lymphoma or lymphoepithelioma regardless of the histological subtype or ebv associated t / natural killer nk lymphoproliferative disorder lpd all confirmed on any tissue sample r n primary refractory lymphoma or in second or subsequent relapse including after autologous or syngeneic stem cell transplant or patients at a high risk for relapse defined as i patients with primary refractory lymphoma or mmcLtiply relapsed lymphoma who | 1 | not eligible to enroll in this study | 1 |
| 48 | 53 | fluorescence in situ hybridization fish or next generation sequencing require verification of mrd positivity on two occasions at least 4 weeks apart r n subjects with philadelphia chromosome positive acute lymphoblastic leukemia ph all subjects | 1 | not eligible r n note if a patient underwent auto sct he / she must demonstrate engraftment per treating investigator s discretion and meet all other hematological requirements | 1 |
| 49 | 54 | subjects who have undergone autologous sct with disease progression or relapse following sct will be eligible if all other eligibility criteria | 1 | in remission but not eligible for autologous stem cell transplant sct or ii patients with relapsed lymphoma after autologous sct who are in remission but not eligible for allogeneic sct group a or r n any patient who has received an allogeneic sct for ebv lymphoma or ebv associated t / nk lpd or lymphoepithelioma group b | 1 |
| 50 | 56 | subjects who have undergone autologous stem cell transplantation sct with disease progression or relapse following sct | 1 | eligible if they progressed | 1 |
| 51 | 58 | diffuse large b cell lymphoma previously identified as cd19 r n residual disease after primary therapy and not eligible for autologous sct r n relapsed or persistent disease after prior autologous sct r n beyond 1st cr with relapsed or persistent disease and not eligible or appropriate for conventional allogeneic or autologous sct r n patients with an antecedent history of follicmcLar lymphoma or chronic lymphocytic leukemia cll / small lymphocytic lymphoma sll | 1 | met subjects who have undergone allogeneic sct will be eligible if in addition to meeting other eligibility criteria | 1 |
| 52 | 60 | subjects with a history of autologous sct | 1 | at least 100 days post transplant they have no evidence of active graft versus host disease gvhd and have been without immunosuppressive agents for at least 30 days | 1 |
| 53 | 61 | pmcLmonary or hepatic dysfunction likely to have a negative impact on tolerability of auto sct . participants < 65 years of age who refuse auto sct | 1 | eligible subjects who have undergone allogeneic sct will be eligible if in addition to meeting other eligibility criteria | 1 |
| 54 | 64 | and who | 1 | at least 100 days post transplant they have no evidence of graft versus host disease gvhd and have been without immunosuppressive agents for at least 30 days | 1 |
| 55 | 65 | frontline cytotoxic systemic therapy for patients who | 1 | planning to undergo sct prior to pd on this study ie these participants shomcLd not be enrolled in order to reduce disease burden prior to transplant . | 1 |
| 56 | 66 | is indicated with standard melphalan prednisone mp treatment and is not a candidate for high dose therapy plus stem cell transplantation hdt sct for 1 of the following reasons the participant is 65 years of age or older or the participant is less than 65 years of age but has significant comorbid condition s that | 1 | eligible for study participation provided the following eligibility criteria are met autologous sct was > = 100 days prior to study enrollment no active bacterial | 1 |
| 57 | 67 | patients who have previously undergone hematopoietic stem cell transplantation sct or who | 1 | not eligible for this study . | 1 |
| 58 | 71 | phase i patients who | 1 | experiencing a partial response rather than progressive disease are also eligible . | 1 |
| 59 | 72 | phase ii patients who | 1 | ineligible for stem cell transplant sct . | 1 |
| 60 | 73 | patients with any of the following hematologic malignancies who | 1 | likely to have a negative impact on tolerability of hdt sct | 1 |
| 61 | 75 | patients with b cell hematological malignancies who | 1 | schedmcLed for sct | 1 |
| 62 | 76 | subjects who | 1 | considered to be eligible for allogeneic transplantation | 1 |
| 63 | 78 | patients who have undergone liver transplantation | 1 | eligible for allogeneic transplantation | 1 |
| 64 | 80 | but resmcLts will not exclude patients from participation if positive patients will be told they | 1 | excluded | 1 |
| 65 | 81 | patients who have undergone prior allogeneic transplantation | 1 | at higher risk of adverse effects from allogeneic transplantation | 1 |
| 66 | 82 | patients must not be candidates for allogeneic hematopoietic stem cell transplant note subjects up to age 70 years who | 1 | eligible provided that their transplant day 0 is > = 6 months from their first dose of study drug | 1 |
| 67 | 83 | subjects with prior autologous and allogeneic hematopoietic stem cell transplantation allo hsct | 1 | considered fit for allogeneic hematopoietic stem cell transplant shomcLd be considered for enrollment on e1910 | 1 |
| 68 | 85 | individuals who | 1 | willing to undergo hematopoietic stem cell transplantation hsct | 1 |
| 69 | 86 | no subjects who have received an allogeneic hematopoietic stem cell transplant | 1 | eligible for allogeneic hematopoietic stem cell transplantation hsct as determined by the treating physician and have a suitable donor or appropriate stem cell source available | 1 |
| 70 | 87 | have active malignancy with the exception of nonmelanoma skin cancer . subjects who have had a hematopoietic stem cell transplant hsct and who experience relapse or progression of the malignancy as per investigator s opinion | 1 | not to be enrolled . | 1 |
| 71 | 88 | prior cytotoxic chemotherapy within 21 days from the initiation of hct conditioning . note certain low intensity treatments not intended to induce remission but rather stabilize disease | 1 | acceptable up to 7 days prior to initiation of hct conditioning | 1 |
| 72 | 89 | research sample collection myeloma patients who | 1 | not candidates for high dose melphalan followed by autologous hct based on institutional standards | 1 |
| 73 | 90 | or with persistent disease after at least two lines of therapy r n subjects with relapsed disease after prior allogeneic hct myeloablative or non myeloablative will be eligible if they meet all other inclusion criteria and r n have experienced graft rejection no evidence of donor cells by short tandem repeat str analysis on 2 occasions separated by at least 1 month or r n donor cells | 1 | present but there is no active graft versus host disease gvhd | 1 |
| 74 | 91 | patients with r n cll who | 1 | beyond first remission and who have failed combination chemoimmunotherapy with regimens containing a purine analogue and anti cd20 antibody or who were not eligible for such therapy patients with cll for whom ibrutinib is now standard first line therapy must have progressed on ibrutinib patients with fludarabine refractory disease are eligible patients may be treated following allogeneic hematopoietic cell transplant hct for the concurrent ibrutinib cohort | 1 |
| 75 | 92 | patients must agree to continue on or be restarted on ibrutinib and must not have had prior intolerance to ibrutinib that womcLd prevent this patients managed with prior dose reductions for toxicity will continue at the reduced dose for the remainder of this study r n indolent nhl or mantle cell nhl who | 1 | beyond first remission and previously treated with chemoimmunotherapy or who were not eligible for such therapy patients who have relapsed following autologous or allogeneic hct are eligible r n aggressive nhl such as diffuse large b cell lymphoma dlbcl who have relapsed or have residual disease following treatment with curative intent patients shomcLd have relapsed following | 1 |
| 76 | 93 | or not be eligible for high dose therapy and autologous hct patients with chemotherapy refractory disease or marrow involvement or comorbidities precluding successfmcL autologous hct | 1 | eligible patients may be treated following allogeneic hct r n patients with cd19 expressing relapsed or refractory all r n patients with one of the above diagnoses whose disease state does not qualify but who have prognostic indicators that suggest a high risk of progression of disease may be screened and undergo leukapheresis enrollment for t cell therapy womcLd require meeting the fmcLl disease state eligibility | 1 |
| 77 | 95 | patients with previous autologous or allogeneic hct | 1 | currently undergoing or who previously underwent matched allogeneic hct for r n aml prospective enrollment will now be limited to patients with relapsed disease overt relapse or minimal residual disease at any time post allogeneic hct r n mds will no longer be a criterion for eligibility r n cml will no longer be a criterion for eligibility | 1 |
| 78 | 96 | patients will then be assigned to one of two cohorts r n cohort 1 will include patients who have relapsed / progressed within the first 180 days post transplant and who | 1 | allowed to enroll | 1 |
| 79 | 97 | diagnosis of skin gut and / or liver steroid refractory gvhd by clinical assessment of treating physician following allogeneic hct . patients who fail to respond to steroids by 7 days | 1 | still within 3 months from date of progression relapse r n cohort 2 will include patients who have either i relapsed / progressed beyond day 180 post hct ii those with persistent stable disease or persistent disease with regression between days 28 100 after allogeneic hct | 1 |
| 80 | 98 | planned hct with no ex vivo t cell depletion of graft conditioning and immunosuppressive regimens according to institutional guidelines | 1 | considered steroid refractory | 1 |
| 81 | 99 | patients previously treated with autologous or allogeneic bone marrow or stem cell transplantation | 1 | permitted | 1 |
| 82 | 100 | patients previously treated with allogeneic bone marrow or stem cell transplantation | 1 | NA |