ID

36266

Beskrivning

Augmented Berlin-Frankfurt-Munster Therapy Plus Ofatumumab for Young Adults With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT02419469

Länk

https://clinicaltrials.gov/show/NCT02419469

Nyckelord

Versioner (1)
  1. 2019-04-26 2019-04-26 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

26 april 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Leukemia NCT02419469

Engelsk

Eligibility Leukemia NCT02419469

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT02419469
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients must have precursor-b lymphoblastic leukemia or lymphoma.
Beskrivning

Precursor B-cell lymphoblastic leukemia | B-precursor Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C1292769
UMLS CUI [2]
C1390945
2. patients must be untreated or have had only one prior chemotherapy regimen for all or ll . previously treated patients will be analyzed separately.
Beskrivning

Patients Untreated | Prior Chemotherapy Quantity Acute lymphocytic leukemia | Prior Chemotherapy Quantity Lymphoid leukemia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0023449
UMLS CUI [3,1]
C1514457
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0023448
3. age between 12 to 30 years old
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
4. patients with cns disease or testicular disease are eligible.
Beskrivning

CNS disorder | Testicular Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0007682
UMLS CUI [2]
C0039584
5. intrathecal therapy with cytarabine is allowed prior to registration for patient convenience. this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture. systemic chemotherapy must begin within 72 hours of the first intrathecal treatment.
Beskrivning

Cytarabine Intrathecal | Diagnostic bone marrow | Venous line insertion | Systemic Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0010711
UMLS CUI [1,2]
C0677897
UMLS CUI [2]
C4523377
UMLS CUI [3]
C0398266
UMLS CUI [4]
C1883256
6. signed informed consent prior to the start of systemic therapy. in the event of enrollment of a minor patient, an attempt to obtain assent from the patient must be documented, and parental consent must be signed.
Beskrivning

Informed Consent | Assent Minor | Informed Consent Parent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C1879749
UMLS CUI [2,2]
C0026193
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C0030551
7. echocardiogram should be done within 7 days of starting therapy if there are cardiac risk factors (e.g., history of hypertension or of myocardial infarction)
Beskrivning

Cardiac risk factors | Echocardiography Required | Hypertensive disease | Myocardial Infarction

Datatyp

boolean

Alias
UMLS CUI [1]
C2024776
UMLS CUI [2,1]
C0013516
UMLS CUI [2,2]
C1514873
UMLS CUI [3]
C0020538
UMLS CUI [4]
C0027051
8. creatinine should be < 3 mg/dl bilirubin < 3 mg/dl unless due to disease
Beskrivning

Creatinine measurement, serum | Serum total bilirubin measurement | Exception Due to Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C1278039
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0012634
9. zubrod performance status of <3
Beskrivning

Zubrod Performance Status

Datatyp

boolean

Alias
UMLS CUI [1]
C3714786
10. patients who received steroids more than 72 hours prior to study enrollment are eligible but will be analyzed separately.
Beskrivning

Steroids

Datatyp

boolean

Alias
UMLS CUI [1]
C0038317
11. lymphoblasts may have any positive expression of cd20 for ofatumumab administration.
Beskrivning

Lymphoblast positive for CD20 antigen | ofatumumab

Datatyp

boolean

Alias
UMLS CUI [1]
C1267889
UMLS CUI [2]
C1832027
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. age less than twelve years of age or greater than 30 years.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. more than one prior treatment regimen for all or ll.
Beskrivning

Prior Therapy Quantity Acute lymphocytic leukemia | Prior Therapy Quantity Lymphoid leukemia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0023449
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0023448
3. the patient is pregnant or unwilling to practice appropriate birth control.
Beskrivning

Pregnancy | Contraceptive methods Unwilling

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C0558080
4. presence of the philadelphia chromosome t(9;22)
Beskrivning

Presence of Philadelphia Chromosome t(9;22)

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0150312
UMLS CUI [1,2]
C0031526
UMLS CUI [1,3]
C3897138
5. laboratory or clinical evidence of active infectious hepatitis.
Beskrivning

Infectious hepatitis

Datatyp

boolean

Alias
UMLS CUI [1]
C0151325
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Similar models

Eligibility Leukemia NCT02419469

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT02419469
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Precursor B-cell lymphoblastic leukemia | B-precursor Lymphoma
Item
1. patients must have precursor-b lymphoblastic leukemia or lymphoma.
boolean
C1292769 (UMLS CUI [1])
C1390945 (UMLS CUI [2])
Patients Untreated | Prior Chemotherapy Quantity Acute lymphocytic leukemia | Prior Chemotherapy Quantity Lymphoid leukemia
Item
2. patients must be untreated or have had only one prior chemotherapy regimen for all or ll . previously treated patients will be analyzed separately.
boolean
C0030705 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C1514457 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0023449 (UMLS CUI [2,3])
C1514457 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0023448 (UMLS CUI [3,3])
Age
Item
3. age between 12 to 30 years old
boolean
C0001779 (UMLS CUI [1])
CNS disorder | Testicular Disease
Item
4. patients with cns disease or testicular disease are eligible.
boolean
C0007682 (UMLS CUI [1])
C0039584 (UMLS CUI [2])
Cytarabine Intrathecal | Diagnostic bone marrow | Venous line insertion | Systemic Chemotherapy
Item
5. intrathecal therapy with cytarabine is allowed prior to registration for patient convenience. this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture. systemic chemotherapy must begin within 72 hours of the first intrathecal treatment.
boolean
C0010711 (UMLS CUI [1,1])
C0677897 (UMLS CUI [1,2])
C4523377 (UMLS CUI [2])
C0398266 (UMLS CUI [3])
C1883256 (UMLS CUI [4])
Informed Consent | Assent Minor | Informed Consent Parent
Item
6. signed informed consent prior to the start of systemic therapy. in the event of enrollment of a minor patient, an attempt to obtain assent from the patient must be documented, and parental consent must be signed.
boolean
C0021430 (UMLS CUI [1])
C1879749 (UMLS CUI [2,1])
C0026193 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3,1])
C0030551 (UMLS CUI [3,2])
Cardiac risk factors | Echocardiography Required | Hypertensive disease | Myocardial Infarction
Item
7. echocardiogram should be done within 7 days of starting therapy if there are cardiac risk factors (e.g., history of hypertension or of myocardial infarction)
boolean
C2024776 (UMLS CUI [1])
C0013516 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0020538 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
Creatinine measurement, serum | Serum total bilirubin measurement | Exception Due to Disease
Item
8. creatinine should be < 3 mg/dl bilirubin < 3 mg/dl unless due to disease
boolean
C0201976 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0012634 (UMLS CUI [3,3])
Zubrod Performance Status
Item
9. zubrod performance status of <3
boolean
C3714786 (UMLS CUI [1])
Steroids
Item
10. patients who received steroids more than 72 hours prior to study enrollment are eligible but will be analyzed separately.
boolean
C0038317 (UMLS CUI [1])
Lymphoblast positive for CD20 antigen | ofatumumab
Item
11. lymphoblasts may have any positive expression of cd20 for ofatumumab administration.
boolean
C1267889 (UMLS CUI [1])
C1832027 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Age
Item
1. age less than twelve years of age or greater than 30 years.
boolean
C0001779 (UMLS CUI [1])
Prior Therapy Quantity Acute lymphocytic leukemia | Prior Therapy Quantity Lymphoid leukemia
Item
2. more than one prior treatment regimen for all or ll.
boolean
C1514463 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0023449 (UMLS CUI [1,3])
C1514463 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0023448 (UMLS CUI [2,3])
Pregnancy | Contraceptive methods Unwilling
Item
3. the patient is pregnant or unwilling to practice appropriate birth control.
boolean
C0032961 (UMLS CUI [1])
C0700589 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Presence of Philadelphia Chromosome t(9;22)
Item
4. presence of the philadelphia chromosome t(9;22)
boolean
C0150312 (UMLS CUI [1,1])
C0031526 (UMLS CUI [1,2])
C3897138 (UMLS CUI [1,3])
Infectious hepatitis
Item
5. laboratory or clinical evidence of active infectious hepatitis.
boolean
C0151325 (UMLS CUI [1])
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