ID

24502

Beschreibung

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

Stichworte

Versionen (2)
  1. 03.08.17 03.08.17 -
  2. 03.08.17 03.08.17 -
Hochgeladen am

3. August 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Leukemia NCT00466531

Englisch

Eligibility Leukemia NCT00466531

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00466531
Criteria
Beschreibung

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Disease Confirmed

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Pulmonary function | Oxygen saturation on room air Pulse oximetry

Datentyp

boolean

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

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
exclusion:
Beschreibung

Exclusion Criteria

Datentyp

boolean

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

Karnofsky Performance Status

Datentyp

boolean

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

Chronic Lymphocytic Leukemia | Richter's syndrome

Datentyp

boolean

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

Heart condition

Datentyp

boolean

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

Congestive heart failure New York Heart Association Classification

Datentyp

boolean

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

Myocardial Infarction

Datentyp

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
Beschreibung

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

Datentyp

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%
Beschreibung

Cardiomyopathy severe | Non-ischemic cardiomyopathy | Cardiac ejection fraction

Datentyp

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.
Beschreibung

HIV Infection | Hepatitis B | Hepatitis C

Datentyp

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.
Beschreibung

Malignant Neoplasms Treatment required for

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332121
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Ähnliche Modelle

Eligibility Leukemia NCT00466531

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00466531
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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