ID

22005

Description

Augmented Berlin-Frankfurt-Munster (BFM) Therapy for Adolescent/Young Adults With Acute Lymphoblastic Leukemia or Acute Lymphoblastic Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00866749

Link

https://clinicaltrials.gov/show/NCT00866749

Keywords

  1. 5/14/17 5/14/17 -
Uploaded on

May 14, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Lymphoblastic Leukemia NCT00866749

Eligibility Lymphoblastic Leukemia NCT00866749

Inclusion Criteria
Description

Inclusion Criteria

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

lymphoblastic leukemia, lymphoblastic lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0023448
UMLS CUI [2]
C0079748
2. patients must be untreated or have had only one prior chemotherapy regimen for all or ll . previously treated patients will be analyzed separately.
Description

prior chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1514457
3. age between 12 to 40 years old
Description

age

Data type

boolean

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

cns, testicular disease

Data type

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.
Description

cytarabine intrathecal therapy, systemic chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1831734
UMLS CUI [1,2]
C0010711
UMLS CUI [2]
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.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
7. echocardiogram should be done within 72 hours of starting therapy if there are cardiac risk factors (e.g., history of hypertension or of myocardial infarction)
Description

ecg, cardiac risk factors

Data type

boolean

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C2024776
8. creatinine should be < 3 mg/dl bilirubin < 3 mg/dl unless felt to be due to disease
Description

creatinine, bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C1278039
9. zubrod performance status of <3
Description

zubrod performance status

Data type

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
Description

steroids

Data type

boolean

Alias
UMLS CUI [1]
C0038317
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. age less than twelve years of age or greater than 40 years.
Description

age

Data type

boolean

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

prior chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1514457
3. the patient is pregnant or unwilling to practice appropriate birth control.
Description

pregnancy, effective contraception

Data type

boolean

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

philadelphia chromosome

Data type

boolean

Alias
UMLS CUI [1]
C0031526

Similar models

Eligibility Lymphoblastic Leukemia NCT00866749

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
lymphoblastic leukemia, lymphoblastic lymphoma
Item
1. patients must have precursor-b or t-lymphoblastic leukemia or lymphoblastic lymphoma.
boolean
C0023448 (UMLS CUI [1])
C0079748 (UMLS CUI [2])
prior chemotherapy
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
C1514457 (UMLS CUI [1])
age
Item
3. age between 12 to 40 years old
boolean
C0001779 (UMLS CUI [1])
cns, testicular disease
Item
4. patients with cns disease or testicular disease are eligible.
boolean
C0007682 (UMLS CUI [1])
C0039584 (UMLS CUI [2])
cytarabine intrathecal therapy, 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
C1831734 (UMLS CUI [1,1])
C0010711 (UMLS CUI [1,2])
C1883256 (UMLS CUI [2])
informed consent
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])
ecg, cardiac risk factors
Item
7. echocardiogram should be done within 72 hours of starting therapy if there are cardiac risk factors (e.g., history of hypertension or of myocardial infarction)
boolean
C1623258 (UMLS CUI [1,1])
C2024776 (UMLS CUI [1,2])
creatinine, bilirubin
Item
8. creatinine should be < 3 mg/dl bilirubin < 3 mg/dl unless felt to be due to disease
boolean
C0201976 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
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])
Item Group
C0680251 (UMLS CUI)
age
Item
1. age less than twelve years of age or greater than 40 years.
boolean
C0001779 (UMLS CUI [1])
prior chemotherapy
Item
2. more than one prior treatment regimen for all or ll.
boolean
C1514457 (UMLS CUI [1])
pregnancy, effective contraception
Item
3. the patient is pregnant or unwilling to practice appropriate birth control.
boolean
C0032961 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
philadelphia chromosome
Item
4. presence of the philadelphia chromosome t(9;22)
boolean
C0031526 (UMLS CUI [1])

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