ID

24501

Descrição

Treatment of Relapsed or Chemotherapy Refractory Chronic Lymphocytic Leukemia or Indolent B Cell Lymphoma Using Autologous T Cells Genetically Targeted to the B Cell Specific Antigen CD19; ODM derived from: https://clinicaltrials.gov/show/NCT00466531

Link

https://clinicaltrials.gov/show/NCT00466531

Palavras-chave

Versões (2)
  1. 03/08/2017 03/08/2017 -
  2. 03/08/2017 03/08/2017 -
Transferido a

3 de agosto de 2017

DOI

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Licença

Creative Commons BY-NC 3.0
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Eligibility Leukemia NCT00466531

Inglês

Eligibility Leukemia NCT00466531

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00466531
Criteria
Descrição

Criteria

• patients must have the following cd19+ b cell leukemia or lymphoma either with relapsed or chemotherapy-refractory disease or with evidence of residual disease following therapy.
Descrição

Chronic Lymphocytic Leukemia CD19 positive | B-Cell Lymphomas CD19 positive | Recurrent disease | Chemotherapy refractory | Residual disease Post Therapeutic procedure

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0023434
UMLS CUI [1,2]
C0882808
UMLS CUI [2,1]
C0079731
UMLS CUI [2,2]
C0882808
UMLS CUI [3]
C0277556
UMLS CUI [4,1]
C0392920
UMLS CUI [4,2]
C0205269
UMLS CUI [5,1]
C0543478
UMLS CUI [5,2]
C0687676
UMLS CUI [5,3]
C0087111
in all cases, patient's disease must be confirmed at mskcc.
Descrição

Disease Confirmed

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521093
cll: patients must have a diagnosis of cll as evidenced by flow cytometry, bone marrow histology, and/or cytogenetics.
Descrição

Chronic Lymphocytic Leukemia Flow Cytometry | Chronic Lymphocytic Leukemia Bone Marrow Histology | Chronic Lymphocytic Leukemia Cytogenetic Analysis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0023434
UMLS CUI [1,2]
C0016263
UMLS CUI [2,1]
C0023434
UMLS CUI [2,2]
C0005953
UMLS CUI [2,3]
C0344441
UMLS CUI [3,1]
C0023434
UMLS CUI [3,2]
C0752095
other low grade b-cell neoplasms are eligible for study, such as small lymphocytic lymphoma (sll), follicular lymphoma, waldenstrom's macroglobulinemia, hairy cell leukemia, marginal zone lymphomas, and mantle cell lymphomas.
Descrição

Low grade B-cell lymphoma | Small Lymphocytic Lymphoma | Lymphoma, Follicular | Waldenstrom Macroglobulinemia | Hairy Cell Leukemia | Marginal zone lymphoma | Mantle cell lymphoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0456861
UMLS CUI [2]
C0855095
UMLS CUI [3]
C0024301
UMLS CUI [4]
C0024419
UMLS CUI [5]
C0023443
UMLS CUI [6]
C0242647
UMLS CUI [7]
C0334634
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, granulocytes ≥1,000/mm3, platelets ≥50,000/mm3, hemoglobin ≥8.0g/dl with transfusion support
Descrição

Creatinine measurement, serum | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Prothrombin time assay | Activated Partial Thromboplastin Time measurement | Anticoagulation Therapy chronic stable | Granulocyte count | Platelet Count measurement | Hemoglobin measurement | Support transfusion therapy

Tipo de dados

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 [7,1]
C0003281
UMLS CUI [7,2]
C0205191
UMLS CUI [7,3]
C0205360
UMLS CUI [8]
C0857490
UMLS CUI [9]
C0032181
UMLS CUI [10]
C0518015
UMLS CUI [11]
C0436311
adequate cardiac function (lvef ≥40%) as assessed by echo or muga scan performed within 1 month of treatment.
Descrição

Cardiac function | Left ventricular ejection fraction | Echocardiography | Multiple gated acquisition scanning

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232164
UMLS CUI [2]
C0428772
UMLS CUI [3]
C0013516
UMLS CUI [4]
C0521317
adequate pulmonary function as assessed by ≥92% oxygen saturation on room air by pulse oximetry.
Descrição

Pulmonary function | Oxygen saturation on room air Pulse oximetry

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0231921
UMLS CUI [2]
C2923807
life expectancy of > 3 months.
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
exclusion:
Descrição

Exclusion Criteria

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0680251
karnofsky performance status <70.
Descrição

Karnofsky Performance Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0206065
cll patients with active transformed disease (richter's transformation) are ineligible for enrollment on this study.
Descrição

Chronic Lymphocytic Leukemia | Richter's syndrome

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023434
UMLS CUI [2]
C0349631
patients with following cardiac conditions will be excluded:
Descrição

Heart condition

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3842523
new york heart association (nyha) stage iii or iv congestive heart failure
Descrição

Congestive heart failure New York Heart Association Classification

Tipo de dados

boolean

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

Myocardial Infarction

Tipo de dados

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
Descrição

Ventricular arrhythmia | Syncope Etiology unknown | Vasovagal syncope Unlikely | Syncope Due to Dehydration Unlikely

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0085612
UMLS CUI [2,1]
C0039070
UMLS CUI [2,2]
C0743626
UMLS CUI [3,1]
C0042420
UMLS CUI [3,2]
C0750558
UMLS CUI [4,1]
C0039070
UMLS CUI [4,2]
C0678226
UMLS CUI [4,3]
C0011175
UMLS CUI [4,4]
C0750558
history of severe non-ischemic cardiomyopathy with ef ≤20%
Descrição

Cardiomyopathy severe | Non-ischemic cardiomyopathy | Cardiac ejection fraction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1833442
UMLS CUI [2]
C0877438
UMLS CUI [3]
C0232174
patients with hiv, hepatitis b or hepatitis c infection are ineligible.
Descrição

HIV Infection | Hepatitis B | Hepatitis C

Tipo de dados

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.
Descrição

Malignant Neoplasms Treatment required for

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332121
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Similar models

Eligibility Leukemia NCT00466531

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00466531
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Chronic Lymphocytic Leukemia CD19 positive | B-Cell Lymphomas CD19 positive | Recurrent disease | Chemotherapy refractory | Residual disease Post Therapeutic procedure
Item
• patients must have the following cd19+ b cell leukemia or lymphoma either with relapsed or chemotherapy-refractory disease or with evidence of residual disease following therapy.
boolean
C0023434 (UMLS CUI [1,1])
C0882808 (UMLS CUI [1,2])
C0079731 (UMLS CUI [2,1])
C0882808 (UMLS CUI [2,2])
C0277556 (UMLS CUI [3])
C0392920 (UMLS CUI [4,1])
C0205269 (UMLS CUI [4,2])
C0543478 (UMLS CUI [5,1])
C0687676 (UMLS CUI [5,2])
C0087111 (UMLS CUI [5,3])
Disease Confirmed
Item
in all cases, patient's disease must be confirmed at mskcc.
boolean
C0012634 (UMLS CUI [1,1])
C0521093 (UMLS CUI [1,2])
Chronic Lymphocytic Leukemia Flow Cytometry | Chronic Lymphocytic Leukemia Bone Marrow Histology | Chronic Lymphocytic Leukemia Cytogenetic Analysis
Item
cll: patients must have a diagnosis of cll as evidenced by flow cytometry, bone marrow histology, and/or cytogenetics.
boolean
C0023434 (UMLS CUI [1,1])
C0016263 (UMLS CUI [1,2])
C0023434 (UMLS CUI [2,1])
C0005953 (UMLS CUI [2,2])
C0344441 (UMLS CUI [2,3])
C0023434 (UMLS CUI [3,1])
C0752095 (UMLS CUI [3,2])
Low grade B-cell lymphoma | Small Lymphocytic Lymphoma | Lymphoma, Follicular | Waldenstrom Macroglobulinemia | Hairy Cell Leukemia | Marginal zone lymphoma | Mantle cell lymphoma
Item
other low grade b-cell neoplasms are eligible for study, such as small lymphocytic lymphoma (sll), follicular lymphoma, waldenstrom's macroglobulinemia, hairy cell leukemia, marginal zone lymphomas, and mantle cell lymphomas.
boolean
C0456861 (UMLS CUI [1])
C0855095 (UMLS CUI [2])
C0024301 (UMLS CUI [3])
C0024419 (UMLS CUI [4])
C0023443 (UMLS CUI [5])
C0242647 (UMLS CUI [6])
C0334634 (UMLS CUI [7])
Creatinine measurement, serum | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Prothrombin time assay | Activated Partial Thromboplastin Time measurement | Anticoagulation Therapy chronic stable | Granulocyte 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, granulocytes ≥1,000/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])
C0003281 (UMLS CUI [7,1])
C0205191 (UMLS CUI [7,2])
C0205360 (UMLS CUI [7,3])
C0857490 (UMLS CUI [8])
C0032181 (UMLS CUI [9])
C0518015 (UMLS CUI [10])
C0436311 (UMLS CUI [11])
Cardiac function | Left ventricular ejection fraction | Echocardiography | Multiple gated acquisition scanning
Item
adequate cardiac function (lvef ≥40%) as assessed by echo or muga scan performed within 1 month of treatment.
boolean
C0232164 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
C0013516 (UMLS CUI [3])
C0521317 (UMLS CUI [4])
Pulmonary function | Oxygen saturation 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])
C2923807 (UMLS CUI [2])
Life Expectancy
Item
life expectancy of > 3 months.
boolean
C0023671 (UMLS CUI [1])
Exclusion Criteria
Item
exclusion:
boolean
C0680251 (UMLS CUI [1])
Karnofsky Performance Status
Item
karnofsky performance status <70.
boolean
C0206065 (UMLS CUI [1])
Chronic Lymphocytic Leukemia | Richter's syndrome
Item
cll patients with active transformed disease (richter's transformation) are ineligible for enrollment on this study.
boolean
C0023434 (UMLS CUI [1])
C0349631 (UMLS CUI [2])
Heart condition
Item
patients with following cardiac conditions will be excluded:
boolean
C3842523 (UMLS CUI [1])
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 Etiology unknown | Vasovagal syncope Unlikely | Syncope Due to Dehydration Unlikely
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])
C0743626 (UMLS CUI [2,2])
C0042420 (UMLS CUI [3,1])
C0750558 (UMLS CUI [3,2])
C0039070 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C0011175 (UMLS CUI [4,3])
C0750558 (UMLS CUI [4,4])
Cardiomyopathy severe | Non-ischemic cardiomyopathy | Cardiac ejection fraction
Item
history of severe non-ischemic cardiomyopathy with ef ≤20%
boolean
C1833442 (UMLS CUI [1])
C0877438 (UMLS CUI [2])
C0232174 (UMLS CUI [3])
HIV Infection | Hepatitis B | Hepatitis C
Item
patients with hiv, hepatitis b or hepatitis c infection are ineligible.
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Malignant Neoplasms Treatment required for
Item
patients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation.
boolean
C0006826 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
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