ID

13168

Description

A Randomized Trial of Procrit vs. No Procrit in AML and High Risk MDS; ODM derived from: https://clinicaltrials.gov/show/NCT00656448

Link

https://clinicaltrials.gov/show/NCT00656448

Keywords

Versions (1)
  1. 1/21/16 1/21/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

January 21, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Acute Myelogenous Leukemia NCT00656448

English

Eligibility Acute Myelogenous Leukemia NCT00656448

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with a diagnosis of aml or high-risk mds (based on international prognostic scoring system (ipss): refractory anemia with excess of blasts (raeb) or raeb in transformation [raeb-t]) receiving frontline induction chemotherapy with any high dose or conventional dose cytarabine-containing regimen or clofarabine-containing regimen at md anderson cancer center.
Description

AML or MDS

Data type

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2]
C3463824
patients must be enrolled on the study within two weeks of the start of induction chemotherapy.
Description

induction chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
patients with documented iron, vitamin b12, or folate deficiency are eligible, but should receive replacement therapy while on study.
Description

iron, vitamin b12, or folate deficiency

Data type

boolean

Alias
UMLS CUI [1]
C0302583
UMLS CUI [2]
C0202252
UMLS CUI [3]
C0523631
understand and voluntarily sign an informed consent form.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with prior treatment with any form of erythropoietin within the previous month.
Description

erythropoietin

Data type

boolean

Alias
UMLS CUI [1]
C0014822
patients with uncontrolled hypertension (> or =140/90), uncontrolled, clinically significant cardiac arrhythmias, or history of pulmonary embolism or thrombosis within the last 5 years.
Description

hypertension (> or =140/90), uncontrolled, clinically significant cardiac arrhythmias, or history of pulmonary embolism or thrombosis

Data type

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C0003811
UMLS CUI [3]
C0034065
UMLS CUI [4]
C0040053
new onset (within 3 months prior to randomization) or poorly controlled seizures.
Description

seizures

Data type

boolean

Alias
UMLS CUI [1]
C0036572
patients with known hypersensitivity to the active substance or any of the excipients.
Description

hypersensitivity to the active substance

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0733467
pregnant or lactating women.
Description

pregnancy or lactation

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
acute erythroleukemia (m6 french-american-british (fab) classification)
Description

erythroleukemia

Data type

boolean

Alias
UMLS CUI [1]
C0023440
hemoglobin greater than or equal to 10g/dl
Description

hemoglobin

Data type

boolean

Alias
UMLS CUI [1]
C0019046
patients with head and neck cancer receiving radiation therapy when erythropoiesis-stimulating agents (esas) were given to maintain hemoglobin levels of more than 12 g/dl.
Description

head and neck cancer

Data type

boolean

Alias
UMLS CUI [1]
C0278996
patients with metastatic breast cancer receiving chemotherapy when esas were given to maintain hemoglobin levels of more than 12 g/dl.
Description

metastatic breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C0678222
patients with chronic kidney failure when esas were given to maintain hemoglobin levels of more than 12 g/dl.
Description

kidney failure

Data type

boolean

Alias
UMLS CUI [1]
C0035078
patients requiring major surgery would be taken off study due to a higher chance of blood clots being reported while taking esas.
Description

major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0543467
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Similar models

Eligibility Acute Myelogenous Leukemia NCT00656448

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
AML or MDS
Item
patients with a diagnosis of aml or high-risk mds (based on international prognostic scoring system (ipss): refractory anemia with excess of blasts (raeb) or raeb in transformation [raeb-t]) receiving frontline induction chemotherapy with any high dose or conventional dose cytarabine-containing regimen or clofarabine-containing regimen at md anderson cancer center.
boolean
C0023467 (UMLS CUI [1])
C3463824 (UMLS CUI [2])
induction chemotherapy
Item
patients must be enrolled on the study within two weeks of the start of induction chemotherapy.
boolean
C0392920 (UMLS CUI [1])
iron, vitamin b12, or folate deficiency
Item
patients with documented iron, vitamin b12, or folate deficiency are eligible, but should receive replacement therapy while on study.
boolean
C0302583 (UMLS CUI [1])
C0202252 (UMLS CUI [2])
C0523631 (UMLS CUI [3])
informed consent
Item
understand and voluntarily sign an informed consent form.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
erythropoietin
Item
patients with prior treatment with any form of erythropoietin within the previous month.
boolean
C0014822 (UMLS CUI [1])
hypertension (> or =140/90), uncontrolled, clinically significant cardiac arrhythmias, or history of pulmonary embolism or thrombosis
Item
patients with uncontrolled hypertension (> or =140/90), uncontrolled, clinically significant cardiac arrhythmias, or history of pulmonary embolism or thrombosis within the last 5 years.
boolean
C0020538 (UMLS CUI [1])
C0003811 (UMLS CUI [2])
C0034065 (UMLS CUI [3])
C0040053 (UMLS CUI [4])
seizures
Item
new onset (within 3 months prior to randomization) or poorly controlled seizures.
boolean
C0036572 (UMLS CUI [1])
hypersensitivity to the active substance
Item
patients with known hypersensitivity to the active substance or any of the excipients.
boolean
C0020517 (UMLS CUI [1,1])
C0733467 (UMLS CUI [1,2])
pregnancy or lactation
Item
pregnant or lactating women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
erythroleukemia
Item
acute erythroleukemia (m6 french-american-british (fab) classification)
boolean
C0023440 (UMLS CUI [1])
hemoglobin
Item
hemoglobin greater than or equal to 10g/dl
boolean
C0019046 (UMLS CUI [1])
head and neck cancer
Item
patients with head and neck cancer receiving radiation therapy when erythropoiesis-stimulating agents (esas) were given to maintain hemoglobin levels of more than 12 g/dl.
boolean
C0278996 (UMLS CUI [1])
metastatic breast cancer
Item
patients with metastatic breast cancer receiving chemotherapy when esas were given to maintain hemoglobin levels of more than 12 g/dl.
boolean
C0678222 (UMLS CUI [1])
kidney failure
Item
patients with chronic kidney failure when esas were given to maintain hemoglobin levels of more than 12 g/dl.
boolean
C0035078 (UMLS CUI [1])
major surgery
Item
patients requiring major surgery would be taken off study due to a higher chance of blood clots being reported while taking esas.
boolean
C0543467 (UMLS CUI [1])
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