ID

41078

Beskrivning

Consolidation Therapy With Autologous T Cells Genetically Targeted to the B Cell Specific Antigen CD19 in Patients With Chronic Lymphocytic Leukemia Following Upfront Chemotherapy With Pentostatin, Cyclophosphamide and Rituximab; ODM derived from: https://clinicaltrials.gov/show/NCT01416974

Länk

https://clinicaltrials.gov/show/NCT01416974

Nyckelord

Versioner (1)
  1. 2020-06-20 2020-06-20 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

20 juni 2020

DOI

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Creative Commons BY 4.0
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Eligibility Leukemia NCT01416974

Engelsk

Eligibility Leukemia NCT01416974

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01416974
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
cll patients with evidence of residual disease, who have achieved pr, npr or cr with detectable mrd following upfront therapy consisting of pentostatin, cyclophosphamide and rituximab.
Beskrivning

Chronic Lymphocytic Leukemia | Residual Tumor | partial response | Partial response Lymph nodes | In complete remission | MRD Following Neoadjuvant Therapy | Pentostatin | Cyclophosphamide | rituximab

Datatyp

boolean

Alias
UMLS CUI [1]
C0023434
UMLS CUI [2]
C0543478
UMLS CUI [3]
C1521726
UMLS CUI [4,1]
C1521726
UMLS CUI [4,2]
C0024204
UMLS CUI [5]
C0677874
UMLS CUI [6,1]
C0242596
UMLS CUI [6,2]
C0332282
UMLS CUI [6,3]
C0600558
UMLS CUI [7]
C0030896
UMLS CUI [8]
C0010583
UMLS CUI [9]
C0393022
the presence of mrd will be assessed by the flow cytometry and polymerasechain reaction at the mskcc diagnostic molecular pathology laboratory.
Beskrivning

MRD Flow Cytometry | MRD Polymerase Chain Reaction

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0242596
UMLS CUI [1,2]
C0016263
UMLS CUI [2,1]
C0242596
UMLS CUI [2,2]
C0032520
age ≥ 18 years of age.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
creatinine ≤2.0 mg/100 ml, bilirubin ≤2.0 mg/100 ml, ast and alt ≤3.0x normal, pt and ptt ≤2x normal outside the setting of stable chronic anticoagulation therapy, absolute neutrophil count ≥500/mm3, platelets ≥50,000/mm3, hemoglobin ≥8.0g/dl with transfusion support.
Beskrivning

Creatinine measurement, serum | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Prothrombin time assay | Activated Partial Thromboplastin Time measurement | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement | Support transfusion therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0033707
UMLS CUI [6]
C0030605
UMLS CUI [7]
C0948762
UMLS CUI [8]
C0032181
UMLS CUI [9]
C0518015
UMLS CUI [10]
C0436311
adequate pulmonary function as assessed by ≥92% oxygen saturation on room air by pulse oximetry.
Beskrivning

Pulmonary function | Oxygen saturation measurement on room air Pulse Oximetry

Datatyp

boolean

Alias
UMLS CUI [1]
C0231921
UMLS CUI [2,1]
C0523807
UMLS CUI [2,2]
C2709070
UMLS CUI [2,3]
C0034108
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
karnofsky performance status <70.
Beskrivning

Karnofsky Performance Status

Datatyp

boolean

Alias
UMLS CUI [1]
C0206065
pregnant or lactating women. women and men of childbearing age should use effective contraception while on this study and continue for 1 year after all treatment is finished.
Beskrivning

Pregnancy | Breast Feeding | Females & males of reproductive potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C4034483
UMLS CUI [3,2]
C0700589
impaired cardiac function (lvef <40%) as assessed by echo or muga scan.
Beskrivning

Decreased cardiac function | Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MUGA scan

Datatyp

boolean

Alias
UMLS CUI [1]
C0232166
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0013516
UMLS CUI [3,1]
C0428772
UMLS CUI [3,2]
C0521317
patients previously treated with allogeneic bone marrow or stem cell transplantation are ineligible.
Beskrivning

Allogeneic bone marrow transplantation | Allogeneic hematopoietic stem cell transplant

Datatyp

boolean

Alias
UMLS CUI [1]
C0149615
UMLS CUI [2]
C4255274
patients who are immediate candidates for allogeneic bone marrow or stem cell transplantation. patients who refuse this option remain eligible and need to be documented as such in patient medical record.
Beskrivning

Patients Appropriate Allogeneic bone marrow transplantation | Patients Appropriate Allogeneic hematopoietic stem cell transplant

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0149615
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548787
UMLS CUI [2,3]
C4255274
cll patients with transformed disease (richter's transformation) are ineligible for enrollment on this study.
Beskrivning

Chronic Lymphocytic Leukemia with Richter's syndrome

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023434
UMLS CUI [1,2]
C0332287
UMLS CUI [1,3]
C0349631
patients with following cardiac conditions will be excluded:
Beskrivning

Condition cardiac

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0018787
new york heart association (nyha) stage iii or iv congestive heart failure
Beskrivning

Congestive heart failure New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
myocardial infarction ≤6 months prior to enrollment
Beskrivning

Myocardial Infarction

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
history of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration
Beskrivning

Ventricular arrhythmia | Syncope Unexplained | Exception Vasovagal syncope | Exception Due to Dehydration

Datatyp

boolean

Alias
UMLS CUI [1]
C0085612
UMLS CUI [2,1]
C0039070
UMLS CUI [2,2]
C4288071
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0042420
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0678226
UMLS CUI [4,3]
C0011175
history of severe non-ischemic cardiomyopathy with ef ≤20%
Beskrivning

Non-ischemic cardiomyopathy Severe | Cardiac ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0877438
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0232174
patients with hiv and active hepatitis b or hepatitis c infection are ineligible.
Beskrivning

HIV Infection | Hepatitis B | Hepatitis C

Datatyp

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
patients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation, with the exception of squamous and basal cell carcinoma of skin.
Beskrivning

Cancer Other Treatment required for | Exception Patient observation | Exception Squamous cell carcinoma of skin | Exception Basal cell carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0332121
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0700325
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007117
step 2 registration (treatment):
Beskrivning

Step Registration | Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1261552
UMLS CUI [1,2]
C1514821
UMLS CUI [2]
C0087111
the following additional criteria must be met in order for a patient to be eligible to receive the modified t cell infusion. these labs are to be obtained within 2 weeks of t cell infusion.
Beskrivning

Criteria Fulfill | T-Lymphocyte Infusion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
UMLS CUI [2,1]
C0039194
UMLS CUI [2,2]
C0574032
creatinine ≤2.0 mg/100 ml, bilirubin ≤2.0 mg/100 ml, ast and alt ≤3.0x normal, pt and ptt ≤2x normal outside the setting of stable chronic anticoagulation therapy, absolute neutrophil count ≥500/mm3, platelets ≥50,000/mm3, hemoglobin ≥8.0g/dl with transfusion support.
Beskrivning

Creatinine measurement, serum | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Prothrombin time assay | Activated Partial Thromboplastin Time measurement | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement | Support transfusion therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0033707
UMLS CUI [6]
C0030605
UMLS CUI [7]
C0948762
UMLS CUI [8]
C0032181
UMLS CUI [9]
C0518015
UMLS CUI [10]
C0436311
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Similar models

Eligibility Leukemia NCT01416974

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01416974
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Lymphocytic Leukemia | Residual Tumor | partial response | Partial response Lymph nodes | In complete remission | MRD Following Neoadjuvant Therapy | Pentostatin | Cyclophosphamide | rituximab
Item
cll patients with evidence of residual disease, who have achieved pr, npr or cr with detectable mrd following upfront therapy consisting of pentostatin, cyclophosphamide and rituximab.
boolean
C0023434 (UMLS CUI [1])
C0543478 (UMLS CUI [2])
C1521726 (UMLS CUI [3])
C1521726 (UMLS CUI [4,1])
C0024204 (UMLS CUI [4,2])
C0677874 (UMLS CUI [5])
C0242596 (UMLS CUI [6,1])
C0332282 (UMLS CUI [6,2])
C0600558 (UMLS CUI [6,3])
C0030896 (UMLS CUI [7])
C0010583 (UMLS CUI [8])
C0393022 (UMLS CUI [9])
MRD Flow Cytometry | MRD Polymerase Chain Reaction
Item
the presence of mrd will be assessed by the flow cytometry and polymerasechain reaction at the mskcc diagnostic molecular pathology laboratory.
boolean
C0242596 (UMLS CUI [1,1])
C0016263 (UMLS CUI [1,2])
C0242596 (UMLS CUI [2,1])
C0032520 (UMLS CUI [2,2])
Age
Item
age ≥ 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Creatinine measurement, serum | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Prothrombin time assay | Activated Partial Thromboplastin Time measurement | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement | Support transfusion therapy
Item
creatinine ≤2.0 mg/100 ml, bilirubin ≤2.0 mg/100 ml, ast and alt ≤3.0x normal, pt and ptt ≤2x normal outside the setting of stable chronic anticoagulation therapy, absolute neutrophil count ≥500/mm3, platelets ≥50,000/mm3, hemoglobin ≥8.0g/dl with transfusion support.
boolean
C0201976 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0033707 (UMLS CUI [5])
C0030605 (UMLS CUI [6])
C0948762 (UMLS CUI [7])
C0032181 (UMLS CUI [8])
C0518015 (UMLS CUI [9])
C0436311 (UMLS CUI [10])
Pulmonary function | Oxygen saturation measurement on room air Pulse Oximetry
Item
adequate pulmonary function as assessed by ≥92% oxygen saturation on room air by pulse oximetry.
boolean
C0231921 (UMLS CUI [1])
C0523807 (UMLS CUI [2,1])
C2709070 (UMLS CUI [2,2])
C0034108 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Karnofsky Performance Status
Item
karnofsky performance status <70.
boolean
C0206065 (UMLS CUI [1])
Pregnancy | Breast Feeding | Females & males of reproductive potential Contraceptive methods
Item
pregnant or lactating women. women and men of childbearing age should use effective contraception while on this study and continue for 1 year after all treatment is finished.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C4034483 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Decreased cardiac function | Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MUGA scan
Item
impaired cardiac function (lvef <40%) as assessed by echo or muga scan.
boolean
C0232166 (UMLS CUI [1])
C0428772 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
C0428772 (UMLS CUI [3,1])
C0521317 (UMLS CUI [3,2])
Allogeneic bone marrow transplantation | Allogeneic hematopoietic stem cell transplant
Item
patients previously treated with allogeneic bone marrow or stem cell transplantation are ineligible.
boolean
C0149615 (UMLS CUI [1])
C4255274 (UMLS CUI [2])
Patients Appropriate Allogeneic bone marrow transplantation | Patients Appropriate Allogeneic hematopoietic stem cell transplant
Item
patients who are immediate candidates for allogeneic bone marrow or stem cell transplantation. patients who refuse this option remain eligible and need to be documented as such in patient medical record.
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0149615 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C4255274 (UMLS CUI [2,3])
Chronic Lymphocytic Leukemia with Richter's syndrome
Item
cll patients with transformed disease (richter's transformation) are ineligible for enrollment on this study.
boolean
C0023434 (UMLS CUI [1,1])
C0332287 (UMLS CUI [1,2])
C0349631 (UMLS CUI [1,3])
Condition cardiac
Item
patients with following cardiac conditions will be excluded:
boolean
C0348080 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
Congestive heart failure New York Heart Association Classification
Item
new york heart association (nyha) stage iii or iv congestive heart failure
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Myocardial Infarction
Item
myocardial infarction ≤6 months prior to enrollment
boolean
C0027051 (UMLS CUI [1])
Ventricular arrhythmia | Syncope Unexplained | Exception Vasovagal syncope | Exception Due to Dehydration
Item
history of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration
boolean
C0085612 (UMLS CUI [1])
C0039070 (UMLS CUI [2,1])
C4288071 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0042420 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C0011175 (UMLS CUI [4,3])
Non-ischemic cardiomyopathy Severe | Cardiac ejection fraction
Item
history of severe non-ischemic cardiomyopathy with ef ≤20%
boolean
C0877438 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0232174 (UMLS CUI [2])
HIV Infection | Hepatitis B | Hepatitis C
Item
patients with hiv and active hepatitis b or hepatitis c infection are ineligible.
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Cancer Other Treatment required for | Exception Patient observation | Exception Squamous cell carcinoma of skin | Exception Basal cell carcinoma
Item
patients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation, with the exception of squamous and basal cell carcinoma of skin.
boolean
C1707251 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0700325 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
Step Registration | Therapy
Item
step 2 registration (treatment):
boolean
C1261552 (UMLS CUI [1,1])
C1514821 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2])
Criteria Fulfill | T-Lymphocyte Infusion
Item
the following additional criteria must be met in order for a patient to be eligible to receive the modified t cell infusion. these labs are to be obtained within 2 weeks of t cell infusion.
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C0039194 (UMLS CUI [2,1])
C0574032 (UMLS CUI [2,2])
Creatinine measurement, serum | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Prothrombin time assay | Activated Partial Thromboplastin Time measurement | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement | Support transfusion therapy
Item
creatinine ≤2.0 mg/100 ml, bilirubin ≤2.0 mg/100 ml, ast and alt ≤3.0x normal, pt and ptt ≤2x normal outside the setting of stable chronic anticoagulation therapy, absolute neutrophil count ≥500/mm3, platelets ≥50,000/mm3, hemoglobin ≥8.0g/dl with transfusion support.
boolean
C0201976 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0033707 (UMLS CUI [5])
C0030605 (UMLS CUI [6])
C0948762 (UMLS CUI [7])
C0032181 (UMLS CUI [8])
C0518015 (UMLS CUI [9])
C0436311 (UMLS CUI [10])
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