[c09aa8]: / clusters / final9knumclusters / clust_279.txt

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Grade ? 2 graft-versus-host disease (GvHD) per the Center for International Blood and Marrow Transplant Research (CIBMTR) consensus grading system at enrollment
Clinically significant graft versus host disease (GVHD) or GVHD requiring initiation of treatment or treatment escalation within 21 days, and/or > grade 1 persistent or clinically significant non-hematologic toxicity related to HSCT
Allogenic or autologous transplant for hematological malignancy with infusion of stem cells within 90 days before Cycle 1 Day 1, or on active immunosuppressive therapy for graft-versus-host disease (GVHD) or GVHD prophylaxis within 2 weeks of Cycle 1 Day 1.
Subject has active clinically significant graft versus host disease (GVHD) or is on treatment with systemic corticosteroids for GVHD (except grade 1 skin GVHD). At least 3 months must have elapsed since completion of allogeneic stem cell transplantation.
Graft-versus-host disease (GVHD) prophylaxis with any of the following agents: calcineurin inhibitor, short-course methotrexate steroids, mycophenolate mofetil, and sirolimus
Must be off all immunosuppressive medications (except steroids) for graft versus host disease (GVHD) for at least 2 weeks prior to study entry
Patients must be free from active graft versus host disease (GVHD) and off immunosuppressive GVHD therapy for 4 weeks prior to enrollment
At least 90 days have elapsed since bone marrow transplant and participant is off immune suppression for ? 2 weeks, if applicable with no evidence of active graft versus host disease (GVHD)
Patients with active graft-versus-host-disease (GVHD) status post stem cell transplant, i.e. patients requiring therapy more than chronic steroid immunosuppression and/or phototherapy for chronic skin GVHD will be excluded.
Requirement for systemic immunosuppressive therapy (e.g. graft-versus-host disease [GVHD] therapy within 12 weeks before the first dose of study drug)
Chronic graft versus host disease (GVHD) or on immunosuppressive therapy for the control of GVHD;
Subjects with active graft-vs-host disease (GVHD) requiring steroids or other immunosuppressive agents; history of >= grade II acute GVHD or extensive chronic GVHD
Requirement for systemic immunosuppressive therapy (e.g. graft-versus-host disease [GVHD] therapy within 12 weeks before the first dose of study drug)
Patients must be free from active graft versus host disease (GVHD) and off immunosuppressive GVHD therapy for 4 weeks prior to enrollment
Patients who have undergone allo-stem cell transplant (SCT) are eligible if they are at least 3 months post SCT, have relapsed AML, are not on treatment or prophylaxis for graft versus host disease (GVHD), and have no active GVHD.
Active graft-versus-host disease (GvHD), grade 2-4 according to the Glucksberg criteria, active chronic GvHD requiring systemic treatment or requirement for GvHD prophylaxis with cyclosporine or tacrolimus.
Active graft versus host disease (GVHD) or on immunosuppressive medication of GVHD
Patients with hematologic malignancies status post allogeneic SCT without evidence of disease relapse, active graft versus host disease (GVHD) or history of more than stage I skin acute GVHD; and off immunosuppression for at least 4 weeks; at least 60 days after allo-SCT
Patients who are < 90 days post allogeneic stem cell transplant will be excluded; patients beyond 90 days post-allogeneic stem cell transplant with active uncontrolled graft versus host disease (GVHD) > grade 1 will be excluded; patients who are on a stable dose of immunosuppressive therapy (tacrolimus, cyclosporine, or other) for > 2 weeks will be eligible but those with recent increase in the immunosuppressive medication dose within last 2 weeks to control GVHD will not be included; Note: subjects may be using systemic corticosteroids or topical or inhaled corticosteroids post allogeneic stem cell transplant; patients requiring >= 1 mg/kg prednisone for GVHD management at the time of screening will not be eligible until the prednisone can be weaned to < 1 mg/kg; such patients should be monitored for at least 14 days and if no flare of GVHD requiring re-escalation of steroids or additional interventions for the GVHD they will be eligible
No active graft-versus-host disease (GVHD) or on immunosuppressive medication for GVHD
Patients who have received any systemic corticosteroid therapy within 4 weeks prior to the start of therapy, or 12 weeks if given to treat graft versus host disease (GVHD), with the exception of physiological replacement doses of cortisone acetate or equivalent
Prior allogeneic transplant with graft-versus-host disease (GVHD) requiring ongoing immunosuppressive therapy
< grade 2 acute graft versus host disease (GVHD) at time of the first NK cell-enriched DLI; patients with treated acute GVHD must be on a stable dose of therapy (no increase in immunosuppressive therapy for the 2 weeks before planned NK cell-enriched DLIs); the dosage/level of immunosuppressive therapy at the time of NK-DLIs should be no greater than 20mg of prednisone daily or mycophenolate 500 mg bid daily or cyclosporine with a target level of 200 ng/mL or tacrolimus with a target level of 10 ng/ml
Patients must have no evidence of active graft-versus-host disease at the time of the CD8+ memory T-cell infusion; patients with a history of acute GVHD overall grade II based on skin only involvement or upper gastrointestinal (GI) tract involvement only will be eligible; patients with a history of liver or lower GI tract GVHD will not be eligible
Acute graft-versus-host disease (GVHD) ? Grade 1, either no signs of chronic GVHD or mild chronic GVHD graded as limited disease
Receipt of hematopoietic stem cell transplant (HSCT) within 60 days of the first dose of TAK-659; clinically significant graft-versus-host disease (GVHD) requiring ongoing immunosuppressive therapy post HSCT at the time of screening (use of topical steroids for ongoing skin GVHD is permitted).
Patients with chronic graft-versus-host disease (GVHD) if on prednisone equal to or less than 0.5 mg/kg and not receiving second-line GVHD treatments like pentostatin, infliximab, etanercept, etc
Prior allogeneic transplant with graft-versus-host disease (GVHD) requiring immunosuppressive therapy
No active graft versus host disease (GVHD) or immunosuppression for prevention or treatment of GVHD within two weeks of study entry
No active graft versus host disease (GVHD): patients with a history of stem cell transplant are eligible but cannot have evidence of active GVHD as determined by the investigator
Patients with active (grade 2-4) acute graft vs. host disease (GVHD), chronic GVHD or an overt autoimmune disease (e.g. hemolytic anemia) requiring high doses of glucocorticosteroid (> 0.5 mg/kg/day prednisone or its equivalent) as treatment
Patients with active (grade 2-4) acute graft versus host disease (GVHD), chronic GVHD, or an overt autoimmune disease (e.g. hemolytic anemia) requiring glucocorticosteroid treatment (> 0.5 mg/kg/day prednisone or its equivalent) as treatment
Grade 3 or higher Graft Versus Host Disease (GVHD), or GVHD on either a calcineurin inhibitor or prednisone more than 5 mg/day.
Have clinically significant graft versus host disease (GVHD), or GVHD requiring initiation or escalation of treatment within the last 21 days
greater than 5 years ago but has active graft versus host disease (GvHD) requiring systemic treatment.
Clinically significant graft versus host disease (GVHD) or active GVHD requiring initiation or escalation of treatment within 28-day screening period.
any active acute graft versus host disease (GvHD), grade 2- 4, according to the Glucksberg criteria or active chronic GvHD requiring systemic treatment
Graft-Versus-Host Disease (GVHD) therapy within 6 weeks before the first dose of study drug; low dose steroids (? 10mg) allowed
Recipients of previous allogeneic transplants who have rash involving more than 10% body surface area attributed to graft versus host disease (GVHD) (> grade 1 GVHD of skin); stem cell transplant recipients will be excluded if they are still receiving immunosuppression including steroids for GVHD or have active GVHD in any organ (except for grade 1 only of skin, not requiring treatment)
Active, uncontrolled graft vs. host disease (GVHD) following allogeneic transplant for non-AML condition (e.g. MDS, lymphoid malignancy, aplastic anemia); patients with GVHD controlled on stable doses of immunosuppressants are eligible
Patients with an allogeneic transplant must meet the following conditions: the transplant must have been performed more than 90 days before registration to this study, the patient must not have >= grade 2 acute graft versus host disease (GvHD) or either moderate or severe limited chronic GvHD, or extensive chronic GvHD of any severity; the patient must be off all immunosuppression for at least 2 weeks
Clinically significant graft versus host disease (GVHD) or GVHD requiring initiation of treatment or treatment escalation within 21 days, and/or > Grade 1 persistent or clinically significant non hematologic toxicity related to HSCT.
Subjects who have undergone hematopoietic stem cell transplant (HSCT) within 60 days of the first dose of AG-120, or subjects on immunosuppressive therapy post HSCT at the time of screening, or with clinically significant graft-versus-host disease (GVHD). (The use of a stable dose of oral steroids post HSCT and/or topical for ongoing skin GVHD is permitted.)
The patient is receiving immunosuppressive therapy - with the exception of low-dose prednisone (? 10 mg/day) - for treatment or prophylaxis of graft-versus-host disease (GVHD). If the patient has been on immunosuppressive treatment or prophylaxis for GVHD, the treatment(s) must have been discontinued at least 14 days prior to study treatment and there must be no evidence of Grade ? 2 GVHD.
Active graft versus host disease (GVHD) ? Grade 2 or extensive chronic GVHD requiring immunosuppressive therapy
EXCLUSION FOR TREATMENT: Patients with active (grade 2-4) acute graft versus host disease (GVHD), chronic GVHD or an overt autoimmune disease (e.g. hemolytic anemia) following allo-HSCT requiring glucocorticosteroid treatment (> 0.5 mg/kg/day prednisone or its equivalent) as treatment
Systemic immunosuppressive therapy post HSCT or with clinically significant graft-versus-host disease (GVHD).
Has chronic graft versus host disease (GVHD) or on immunosuppressive therapy for the control of GVHD
Subjects who have undergone hematopoietic stem cell transplant (HSCT) within 60 days of the first dose of AG-221, or subjects on immunosuppressive therapy post HSCT at the time of screening, or with clinically significant graft-versus-host disease (GVHD). (The use of a stable dose of oral steroids post GVHD and/or topical steroids for ongoing skin GVHD is permitted with Medical Monitor approval.)
Evidence of on-going graft versus-host disease (GVHD), or GVHD requiring immunosuppressive therapy
Patients with active (grade 2-4) acute graft versus (vs.) host disease (GVHD), chronic GVHD or an overt autoimmune disease (e.g. hemolytic anemia) requiring high doses of glucocorticosteroid (> 0.5 mg/kg/day prednisone or its equivalent) as treatment
Active graft versus host disease (GVHD) with other than grade 1 skin involvement or GVHD requiring immunosuppressive treatment.
Newly diagnosed acute graft-versus-host disease (GvHD), including lower Gastrointestinal (GI) involvement (modified International Bone Marrow Transplant Registry [IBMTR] Severity Stage 1 to 4 [>500 mL diarrhea/day]), with or without other organ system involvement.
Able to be off prednisone or other immunosuppressive medications for at least 3 days prior to Day 0 (excluding pre-medications); low dose prednisone (< 10 mg/day) is allowed if for indication other than graft-versus-host disease (GVHD)
< 60 days from ASCT; has chronic graft-versus host disease (GVHD) or requires continued treatment with systemic immunosuppressive agents
Clinically active or unstable graft-versus-host disease (GvHD) requiring treatment which precludes administration of chemotherapy as defined in this protocol
Patients is off or on a stable dose of immunosuppressive drugs for management or prophylaxis of graft-versus-host disease (GVHD) (defined as no escalation of therapy for GVHD) within 14 days prior to starting crenolanib
Active acute or extensive chronic graft-versus-host disease (GvHD) which included the administration of immunosuppressive agents to prevent or treat GvHD within 2 weeks before blinatumomab treatment
Allogeneic stem cell transplant within 60 days, active acute or chronic graft-versus-host disease (GvHD), or receiving immunosuppressive therapy as treatment for GvHD
Grade ? 2 graft-versus-host disease (GvHD) per the Center for International Blood and Marrow Transplant Research (CIBMTR) consensus grading system at enrollment
For both Parts 1 and 2, receipt of HSCT within 60 days of the first dose of PLX3397 is an exclusion criterion. Patients on immunosuppressive therapy post HSCT, or with clinically significant graft-versus-host disease are excluded from Part 1. (Use of topical steroids for ongoing skin GVHD is permitted). Patients for Part 1 must have a wash-out period of ?2 weeks or at least 4 half-lives from their last systemic immunosuppressive treatment for GVHD. Patients for Part 2 may be receiving systemic immunosuppressive treatment for management of GVHD at the time of screening and enrollment
=< grade 1 acute graft-versus-host disease (GVHD) at time of the CMV specific T cell infusion; patients with treated acute GVHD must be on a stable dose of therapy (no increase in immunosuppressive therapy for the 2 weeks before planned donor cell infusion); the dosage level of immunosuppressive therapy at the time of infusion should be no greater than 20 mg of prednisone daily or mycophenolate 1000 mg thrice daily (TID) or cyclosporine with a target level of 200 ng/ml or equivalent
For patients who have received prior HSCT, there can be no evidence of graft versus host disease (GVHD) and greater than 60 days must have elapsed since the HSCT
Patients with active, grade II-IV, acute graft versus (vs.) host disease (GVHD), chronic GVHD or any condition requiring high doses of glucocorticosteroid (> 0.5 mg/kg/day prednisone or its equivalent) as treatment
Patients with chronic, severe, generalized skin breakdown (such as generalized blistering, burns, severe graft versus host disease [GVHD] with open sores, etc.) are ineligible
If patients are on immunosuppressive therapy for treatment of graft versus host disease (GVHD), then only those on stable doses for at least 4 weeks (or on tapering doses) will be eligible
If patients are on immunosuppressive therapy for treatment of graft versus host disease (GVHD), then only those on stable doses for at least 4 weeks (or on tapering doses) will be eligible
Planned graft versus host disease (GVHD) prophylaxis consisting of tacrolimus (TAC)/methotrexate (MTX) or TAC/sirolimus (SRL)
The patient underwent autologous or allogeneic stem cell transplant within 60 days prior to receiving the first dose of omacetaxine and has any evidence of ongoing graft versus host disease (GVHD), or GVHD requiring immunosuppressive therapy.
Subjects on systemic immunosuppressive therapy post HSCT at the time of screening, or with clinically significant graft-versus-host disease (GVHD). The use of topical steroids for ongoing skin or ocular GVHD is permitted.