ID

13731

Description

Clofarabine, Idarubicin, and Cytarabine Combination in Acute Myeloid Leukemia (AML) Induction; ODM derived from: https://clinicaltrials.gov/show/NCT01025154

Link

https://clinicaltrials.gov/show/NCT01025154

Keywords

Versions (1)
  1. 3/1/16 3/1/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

March 1, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia NCT01025154

English

Eligibility Acute Myeloid Leukemia NCT01025154

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. diagnosis of aml (world health organization (who) classification)
Description

1. diagnosis of aml (world health organization (who) classification)

Data type

boolean

Alias
UMLS CUI [1]
C0023467
2. patients must be chemotherapy-naïve, i.e. not have received any prior cytotoxic chemotherapy for aml (with the exception of hydroxyurea). they could have received prior therapy with hypomethylating agents, targeted, or biological agents.
Description

2. patients must be chemotherapy-naïve, i.e. not have received any prior cytotoxic chemotherapy for aml (with the exception of hydroxyurea). they could have received prior therapy with hypomethylating agents, targeted, or biological agents.

Data type

boolean

Alias
UMLS CUI [1]
C1514463
3. age 18 to 60 years.
Description

3. age 18 to 60 years.

Data type

boolean

Alias
UMLS CUI [1]
C0001779
4. eastern cooperative oncology group (ecog) performance status </= 2.
Description

4. eastern cooperative oncology group (ecog) performance status </= 2.

Data type

boolean

Alias
UMLS CUI [1]
C1520224
5. serum creatinine </= 1.0 mg/dl; if serum creatinine > 1.0 mg/dl, then the estimated glomerular filtration rate (gfr) must be > 60 ml/min/1.73m^2 as calculated by the modification of diet in renal disease equation where predicted gfr (ml/min/1.73m^2)=186 * (serum creatinine)^-1.154 x (age in years)^-0.023 * (0.742 if patient is female) * (1.212 if patient is black), where scr is serum creatinine measured in mg/dl. serum bilirubin </= 1.5 * upper limit of normal (uln) (unless increase is due to hemolysis or a congenital disorder); serum transaminases (sgpt and/or sgot) </= 2.5 * uln.
Description

5. serum creatinine </= 1.0 mg/dl; if serum creatinine > 1.0 mg/dl, then the estimated glomerular filtration rate (gfr) must be > 60 ml/min/1.73m^2 as calculated by the modification of diet in renal disease equation where predicted gfr (ml/min/1.73m^2)=186 * (serum creatinine)^-1.154 x (age in years)^-0.023 * (0.742 if patient is female) * (1.212 if patient is black), where scr is serum creatinine measured in mg/dl. serum bilirubin </= 1.5 * upper limit of normal (uln) (unless increase is due to hemolysis or a congenital disorder); serum transaminases (sgpt and/or sgot) </= 2.5 * uln.

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0017654
6. cardiac ejection fraction >/= 45% (by either echocardiography or muga scan).
Description

6. cardiac ejection fraction >/= 45% (by either echocardiography or muga scan).

Data type

boolean

Alias
UMLS CUI [1]
C0232174
7. ability to understand and provide signed informed consent.
Description

7. ability to understand and provide signed informed consent.

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with acute promyelocytic leukemia (apl).
Description

1. patients with acute promyelocytic leukemia (apl).

Data type

boolean

Alias
UMLS CUI [1]
C0023487
2. any coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or results.
Description

2. any coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or results.

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
3. nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception (such as birth control pills, intrauterine device (iud), diaphragm, abstinence, or condoms by their partner) over the entire course of therapy.
Description

3. nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception (such as birth control pills, intrauterine device (iud), diaphragm, abstinence, or condoms by their partner) over the entire course of therapy.

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0430056
UMLS CUI [3]
C0700589
4. active and uncontrolled infection requiring therapy with iv antibiotics or antifungal therapy. prior or concurrent history of one or more opportunistic infections (e.g., cytomegalovirus, pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than tb).
Description

4. active and uncontrolled infection requiring therapy with iv antibiotics or antifungal therapy. prior or concurrent history of one or more opportunistic infections (e.g., cytomegalovirus, pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than tb).

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0029118
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Similar models

Eligibility Acute Myeloid Leukemia NCT01025154

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
AML
Item
1. diagnosis of aml (world health organization (who) classification)
boolean
C0023467 (UMLS CUI [1])
prior therapy
Item
2. patients must be chemotherapy-naïve, i.e. not have received any prior cytotoxic chemotherapy for aml (with the exception of hydroxyurea). they could have received prior therapy with hypomethylating agents, targeted, or biological agents.
boolean
C1514463 (UMLS CUI [1])
age
Item
3. age 18 to 60 years.
boolean
C0001779 (UMLS CUI [1])
ECOG
Item
4. eastern cooperative oncology group (ecog) performance status </= 2.
boolean
C1520224 (UMLS CUI [1])
creatinine, gfr, bilirubin, transaminases
Item
5. serum creatinine </= 1.0 mg/dl; if serum creatinine > 1.0 mg/dl, then the estimated glomerular filtration rate (gfr) must be > 60 ml/min/1.73m^2 as calculated by the modification of diet in renal disease equation where predicted gfr (ml/min/1.73m^2)=186 * (serum creatinine)^-1.154 x (age in years)^-0.023 * (0.742 if patient is female) * (1.212 if patient is black), where scr is serum creatinine measured in mg/dl. serum bilirubin </= 1.5 * upper limit of normal (uln) (unless increase is due to hemolysis or a congenital disorder); serum transaminases (sgpt and/or sgot) </= 2.5 * uln.
boolean
C0201976 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0017654 (UMLS CUI [5])
cardiac ejection fraction
Item
6. cardiac ejection fraction >/= 45% (by either echocardiography or muga scan).
boolean
C0232174 (UMLS CUI [1])
signed informed consent
Item
7. ability to understand and provide signed informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
APL
Item
1. patients with acute promyelocytic leukemia (apl).
boolean
C0023487 (UMLS CUI [1])
any coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or results
Item
2. any coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or results.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
breastfeeding, positive pregnancy test, contraception
Item
3. nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception (such as birth control pills, intrauterine device (iud), diaphragm, abstinence, or condoms by their partner) over the entire course of therapy.
boolean
C0006147 (UMLS CUI [1])
C0430056 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
active and uncontrolled infection, opportunistic infections
Item
4. active and uncontrolled infection requiring therapy with iv antibiotics or antifungal therapy. prior or concurrent history of one or more opportunistic infections (e.g., cytomegalovirus, pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than tb).
boolean
C0009450 (UMLS CUI [1])
C0029118 (UMLS CUI [2])
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