ID

41074

Beschreibung

Hyper CVAD Plus Ofatumumab in CD - 20 Positive Acute Lymphoblastic Leukemia (ALL); ODM derived from: https://clinicaltrials.gov/show/NCT01363128

Link

https://clinicaltrials.gov/show/NCT01363128

Stichworte

Versionen (1)
  1. 19.06.20 19.06.20 -
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See clinicaltrials.gov

Hochgeladen am

19. Juni 2020

DOI

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Eligibility Leukemia NCT01363128

Englisch

Eligibility Leukemia NCT01363128

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01363128
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients of all ages with newly diagnosed, previously untreated cd-20+ all, or lymphoblastic lymphoma, burkitt leukemia/lymphoma or having achieved cr with one course of induction chemotherapy.
Beschreibung

Age | Acute lymphocytic leukemia CD20 positive Untreated | Lymphoblastic Lymphoma | Burkitt Lymphoma | In complete remission Due to Induction Chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0023449
UMLS CUI [2,2]
C3888518
UMLS CUI [2,3]
C0332155
UMLS CUI [3]
C0855146
UMLS CUI [4]
C0006413
UMLS CUI [5,1]
C0677874
UMLS CUI [5,2]
C0678226
UMLS CUI [5,3]
C3179010
2. failure to one induction course of chemotherapy (these patients will be analyzed separately).
Beschreibung

Induction Chemotherapy failed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3179010
UMLS CUI [1,2]
C0231175
3. performance status of 0, 1, or 2.
Beschreibung

Performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1518965
4. adequate organ function with creatinine less than or equal to 3.0 mg/dl (unless considered tumor related), bilirubin less than or equal to 3.0 mg/dl (unless considered tumor related).
Beschreibung

Organ function | Creatinine measurement, serum | Exception Neoplasm Related | Serum total bilirubin measurement | Exception Neoplasm Related

Datentyp

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C0201976
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0027651
UMLS CUI [3,3]
C0439849
UMLS CUI [4]
C1278039
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0027651
UMLS CUI [5,3]
C0439849
5. adequate cardiac function defined as no history of arrhythmia, history of mi or clinically significant abnormal ekg, as determined by the pi and/or the treating physician, within 3 months prior to study enrollment. cardiac function will be assessed by history and physical examination.
Beschreibung

Cardiac function | Cardiac Arrhythmia Absent | Myocardial Infarction Absent | Electrocardiogram abnormal Absent | Cardiac function Medical History | Cardiac function Physical Examination

Datentyp

boolean

Alias
UMLS CUI [1]
C0232164
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0027051
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0522055
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0232164
UMLS CUI [5,2]
C0262926
UMLS CUI [6,1]
C0232164
UMLS CUI [6,2]
C0031809
6. no active or co-existing malignancy(other than all or lymphoblastic lymphoma) with life expectancy less than 12 months due to that malignancy.
Beschreibung

Malignant Neoplasm Absent | Cancer Other Absent | Exception Acute lymphocytic leukemia | Exception Lymphoblastic Lymphoma | Life Expectancy Due to Malignant Neoplasm

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1707251
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0023449
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0855146
UMLS CUI [5,1]
C0023671
UMLS CUI [5,2]
C0678226
UMLS CUI [5,3]
C0006826
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pregnant or nursing women.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
2. known to be hiv+
Beschreibung

HIV Seropositivity

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
3. ph+ all
Beschreibung

Philadelphia positive acute lymphocytic leukaemia

Datentyp

boolean

Alias
UMLS CUI [1]
C4524071
4. active and uncontrolled disease/infection as judged by the treating physician
Beschreibung

Disease Uncontrolled | Communicable Disease Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205318
5. unable or unwilling to sign the consent form
Beschreibung

Informed Consent Unable | Informed Consent Unwilling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080
6. subjects who have current active hepatic or biliary disease (with exception of patients with gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
Beschreibung

Liver disease | Biliary System Disorder | Exception Gilbert Disease | Exception Cholelithiasis Asymptomatic | Exception Secondary malignant neoplasm of liver | Exception Chronic liver disease Stable

Datentyp

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C3275124
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0017551
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0008350
UMLS CUI [4,3]
C0231221
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0494165
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0341439
UMLS CUI [6,3]
C0205360
7. treatment with any known non - marketed drug substance or experimental therapy within 5 terminal half lives (calculated by multiplying the reported terminal half life by 5) or 4 weeks prior to enrollment, whichever is longer, or currently participating in any other interventional clinical study.
Beschreibung

Drugs, Non-Prescription | Therapy, Investigational | Study Subject Participation Status | Interventional Study

Datentyp

boolean

Alias
UMLS CUI [1]
C0013231
UMLS CUI [2]
C0949266
UMLS CUI [3]
C2348568
UMLS CUI [4]
C3274035
8. history of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae
Beschreibung

Cerebrovascular Disorder | Event with Symptoms | Event with Sequelae

Datentyp

boolean

Alias
UMLS CUI [1]
C0007820
UMLS CUI [2,1]
C0441471
UMLS CUI [2,2]
C0332287
UMLS CUI [2,3]
C1457887
UMLS CUI [3,1]
C0441471
UMLS CUI [3,2]
C0332287
UMLS CUI [3,3]
C0543419
9. positive serology for hepatitis b (hb) defined as a positive test for hbsag. in addition, if negative for hbsag but hbcab positive (regardless of hbsab status), a hb dna test will be performed and if positive the subject will be excluded. consult with a physician experienced in care & management of subjects with hepatitis b to manage/treat subjects who are anti-hbc positive.
Beschreibung

Serology positive Hepatitis B | Hepatitis B surface antigen positive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0242089
UMLS CUI [1,2]
C0019163
UMLS CUI [2]
C0149709
10. positive serology for hepatitis c (hc) defined as a positive test for hcab, in which case reflexively perform a hc riba immunoblot assay on the same sample to confirm the result.
Beschreibung

Serology positive Hepatitis C | Hepatitis C antibody positive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0242089
UMLS CUI [1,2]
C0019196
UMLS CUI [2]
C0281863
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Ähnliche Modelle

Eligibility Leukemia NCT01363128

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01363128
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Acute lymphocytic leukemia CD20 positive Untreated | Lymphoblastic Lymphoma | Burkitt Lymphoma | In complete remission Due to Induction Chemotherapy
Item
1. patients of all ages with newly diagnosed, previously untreated cd-20+ all, or lymphoblastic lymphoma, burkitt leukemia/lymphoma or having achieved cr with one course of induction chemotherapy.
boolean
C0001779 (UMLS CUI [1])
C0023449 (UMLS CUI [2,1])
C3888518 (UMLS CUI [2,2])
C0332155 (UMLS CUI [2,3])
C0855146 (UMLS CUI [3])
C0006413 (UMLS CUI [4])
C0677874 (UMLS CUI [5,1])
C0678226 (UMLS CUI [5,2])
C3179010 (UMLS CUI [5,3])
Induction Chemotherapy failed
Item
2. failure to one induction course of chemotherapy (these patients will be analyzed separately).
boolean
C3179010 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Performance status
Item
3. performance status of 0, 1, or 2.
boolean
C1518965 (UMLS CUI [1])
Organ function | Creatinine measurement, serum | Exception Neoplasm Related | Serum total bilirubin measurement | Exception Neoplasm Related
Item
4. adequate organ function with creatinine less than or equal to 3.0 mg/dl (unless considered tumor related), bilirubin less than or equal to 3.0 mg/dl (unless considered tumor related).
boolean
C0678852 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0027651 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
C1278039 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0027651 (UMLS CUI [5,2])
C0439849 (UMLS CUI [5,3])
Cardiac function | Cardiac Arrhythmia Absent | Myocardial Infarction Absent | Electrocardiogram abnormal Absent | Cardiac function Medical History | Cardiac function Physical Examination
Item
5. adequate cardiac function defined as no history of arrhythmia, history of mi or clinically significant abnormal ekg, as determined by the pi and/or the treating physician, within 3 months prior to study enrollment. cardiac function will be assessed by history and physical examination.
boolean
C0232164 (UMLS CUI [1])
C0003811 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0522055 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0232164 (UMLS CUI [5,1])
C0262926 (UMLS CUI [5,2])
C0232164 (UMLS CUI [6,1])
C0031809 (UMLS CUI [6,2])
Malignant Neoplasm Absent | Cancer Other Absent | Exception Acute lymphocytic leukemia | Exception Lymphoblastic Lymphoma | Life Expectancy Due to Malignant Neoplasm
Item
6. no active or co-existing malignancy(other than all or lymphoblastic lymphoma) with life expectancy less than 12 months due to that malignancy.
boolean
C0006826 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1707251 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0023449 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0855146 (UMLS CUI [4,2])
C0023671 (UMLS CUI [5,1])
C0678226 (UMLS CUI [5,2])
C0006826 (UMLS CUI [5,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
1. pregnant or nursing women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HIV Seropositivity
Item
2. known to be hiv+
boolean
C0019699 (UMLS CUI [1])
Philadelphia positive acute lymphocytic leukaemia
Item
3. ph+ all
boolean
C4524071 (UMLS CUI [1])
Disease Uncontrolled | Communicable Disease Uncontrolled
Item
4. active and uncontrolled disease/infection as judged by the treating physician
boolean
C0012634 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Informed Consent Unable | Informed Consent Unwilling
Item
5. unable or unwilling to sign the consent form
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Liver disease | Biliary System Disorder | Exception Gilbert Disease | Exception Cholelithiasis Asymptomatic | Exception Secondary malignant neoplasm of liver | Exception Chronic liver disease Stable
Item
6. subjects who have current active hepatic or biliary disease (with exception of patients with gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
boolean
C0023895 (UMLS CUI [1])
C3275124 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0017551 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0008350 (UMLS CUI [4,2])
C0231221 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0494165 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0341439 (UMLS CUI [6,2])
C0205360 (UMLS CUI [6,3])
Drugs, Non-Prescription | Therapy, Investigational | Study Subject Participation Status | Interventional Study
Item
7. treatment with any known non - marketed drug substance or experimental therapy within 5 terminal half lives (calculated by multiplying the reported terminal half life by 5) or 4 weeks prior to enrollment, whichever is longer, or currently participating in any other interventional clinical study.
boolean
C0013231 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
C2348568 (UMLS CUI [3])
C3274035 (UMLS CUI [4])
Cerebrovascular Disorder | Event with Symptoms | Event with Sequelae
Item
8. history of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae
boolean
C0007820 (UMLS CUI [1])
C0441471 (UMLS CUI [2,1])
C0332287 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
C0441471 (UMLS CUI [3,1])
C0332287 (UMLS CUI [3,2])
C0543419 (UMLS CUI [3,3])
Serology positive Hepatitis B | Hepatitis B surface antigen positive
Item
9. positive serology for hepatitis b (hb) defined as a positive test for hbsag. in addition, if negative for hbsag but hbcab positive (regardless of hbsab status), a hb dna test will be performed and if positive the subject will be excluded. consult with a physician experienced in care & management of subjects with hepatitis b to manage/treat subjects who are anti-hbc positive.
boolean
C0242089 (UMLS CUI [1,1])
C0019163 (UMLS CUI [1,2])
C0149709 (UMLS CUI [2])
Serology positive Hepatitis C | Hepatitis C antibody positive
Item
10. positive serology for hepatitis c (hc) defined as a positive test for hcab, in which case reflexively perform a hc riba immunoblot assay on the same sample to confirm the result.
boolean
C0242089 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
C0281863 (UMLS CUI [2])
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