ID

20621

Descrição

Phase 2 Study of Temozolomide to Treat Poor Risk / Refractory Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00611247

Link

https://clinicaltrials.gov/show/NCT00611247

Palavras-chave

Versões (1)
  1. 07/03/2017 07/03/2017 -
Transferido a

7 de março de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Leukemia, Myeloid NCT00611247

Inglês

Eligibility Leukemia, Myeloid NCT00611247

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients must have histologically or cytologically confirmed acute myeloid leukemia, as defined by the who classification.
Descrição

aml histologically or cytologically confirmed

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0679557
UMLS CUI [1,3]
C1298647
2. patients must be considered unfit for conventional induction chemotherapy, unwilling to receive such treatment or have evidence of disease relapse or refractory disease.
Descrição

Medical contraindication; Induction Chemotherapy | refusing treatment; Chemotherapy | Recurrent disease | Refractory Disease

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C3179010
UMLS CUI [2,1]
C0749657
UMLS CUI [2,2]
C3665472
UMLS CUI [3]
C0277556
UMLS CUI [4]
C1514815
3. for patients who have received no prior conventional chemotherapy, one of the following must be present:
Descrição

prior chemotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1514457
poor risk cytogenetics (complex abnormalities, deletions of chromosome 7 or 5, 11q23 abnormalities, inv[3])
Descrição

poor risk cytogenetics

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0752095
UMLS CUI [1,2]
C2826176
secondary leukemia (prior hematologic disorder or therapy-related leukemia).
Descrição

secondary leukemia (prior hematologic disorder or therapy-related leukemia)

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0280449
UMLS CUI [2]
C0863127
UMLS CUI [3,1]
C0376545
UMLS CUI [3,2]
C0332132
4. age > 60 years of age.
Descrição

age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
5. life expectancy of greater than 3 months.
Descrição

life expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
6. ecog performance status greater than 2.
Descrição

ecog

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
7. patients must have normal organ and marrow function as defined below:
Descrição

patients must have normal organ and marrow function

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C0005953
8. adequate hepatic function: total bilirubin 1.5mg/dl, ast(sgot)/alt(sgpt) 2.5 x institutional upper limit of normal.
Descrição

bilirubin, ast, alt

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
9. adequate renal function: serum creatinine within normal institutional limits or calculated creatinine clearance > 60 ml/min/1.73 m2 for patients with creatinine levels above institutional normal.
Descrição

creatinine, calculated creatinine clearance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
10. ability to understand and the willingness to sign a written informed consent document.
Descrição

informed consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin c) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
Descrição

Prior Chemotherapy | prior radiation therapy | Nitrosoureas, antineoplastic alkylating agents | Mitomycin | Adverse effect of radiation therapy | Antineoplastic adverse reaction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2]
C0279134
UMLS CUI [3]
C3540781
UMLS CUI [4]
C0002475
UMLS CUI [5]
C0392615
UMLS CUI [6]
C0569491
2. patients may not be receiving any other investigational agents.
Descrição

patients may not be receiving any other investigational agents

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C2348568
3. history of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or dtic
Descrição

Hypersensitivity; temozolomide; Compound (substance) | Hypersensitivity; Dacarbazine; Compound (substance)

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0076080
UMLS CUI [1,3]
C1706082
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0010927
UMLS CUI [2,3]
C1706082
4. history of gastrointestinal disease or significant bowel resection that could interfere with drug absorption.
Descrição

gastrointestinal disease, bowel resection, drug absorption

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0678745
UMLS CUI [2,1]
C0741614
UMLS CUI [2,2]
C0678745
5. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Descrição

Comorbidity | Limited (extensiveness); Protocol Compliance | Communicable Diseases; Active | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2,1]
C0439801
UMLS CUI [2,2]
C0525058
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C0205177
UMLS CUI [4]
C0742758
UMLS CUI [5]
C0002965
UMLS CUI [6]
C0003811
UMLS CUI [7]
C0004936
6. prior allogeneic stem cell transplantation.
Descrição

prior allogeneic stem cell transplantation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C2242529
7. inability to swallow tablets
Descrição

ability to swallow tablet

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0566355
UMLS CUI [1,2]
C0039225
8. prior radiation up to more than 25% of bone marrow.
Descrição

prior radiation up to more than 25% of bone marrow

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0005953
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Similar models

Eligibility Leukemia, Myeloid NCT00611247

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
aml histologically or cytologically confirmed
Item
1. patients must have histologically or cytologically confirmed acute myeloid leukemia, as defined by the who classification.
boolean
C0023467 (UMLS CUI [1,1])
C0679557 (UMLS CUI [1,2])
C1298647 (UMLS CUI [1,3])
Medical contraindication; Induction Chemotherapy | refusing treatment; Chemotherapy | Recurrent disease | Refractory Disease
Item
2. patients must be considered unfit for conventional induction chemotherapy, unwilling to receive such treatment or have evidence of disease relapse or refractory disease.
boolean
C1301624 (UMLS CUI [1,1])
C3179010 (UMLS CUI [1,2])
C0749657 (UMLS CUI [2,1])
C3665472 (UMLS CUI [2,2])
C0277556 (UMLS CUI [3])
C1514815 (UMLS CUI [4])
prior chemotherapy
Item
3. for patients who have received no prior conventional chemotherapy, one of the following must be present:
boolean
C1514457 (UMLS CUI [1])
poor risk cytogenetics
Item
poor risk cytogenetics (complex abnormalities, deletions of chromosome 7 or 5, 11q23 abnormalities, inv[3])
boolean
C0752095 (UMLS CUI [1,1])
C2826176 (UMLS CUI [1,2])
secondary leukemia (prior hematologic disorder or therapy-related leukemia)
Item
secondary leukemia (prior hematologic disorder or therapy-related leukemia).
boolean
C0280449 (UMLS CUI [1])
C0863127 (UMLS CUI [2])
C0376545 (UMLS CUI [3,1])
C0332132 (UMLS CUI [3,2])
age
Item
4. age > 60 years of age.
boolean
C0001779 (UMLS CUI [1])
life expectancy
Item
5. life expectancy of greater than 3 months.
boolean
C0023671 (UMLS CUI [1])
ecog
Item
6. ecog performance status greater than 2.
boolean
C1520224 (UMLS CUI [1])
patients must have normal organ and marrow function
Item
7. patients must have normal organ and marrow function as defined below:
boolean
C0678852 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
bilirubin, ast, alt
Item
8. adequate hepatic function: total bilirubin 1.5mg/dl, ast(sgot)/alt(sgpt) 2.5 x institutional upper limit of normal.
boolean
C1278039 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
creatinine, calculated creatinine clearance
Item
9. adequate renal function: serum creatinine within normal institutional limits or calculated creatinine clearance > 60 ml/min/1.73 m2 for patients with creatinine levels above institutional normal.
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
informed consent
Item
10. ability to understand and the willingness to sign a written informed consent document.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior Chemotherapy | prior radiation therapy | Nitrosoureas, antineoplastic alkylating agents | Mitomycin | Adverse effect of radiation therapy | Antineoplastic adverse reaction
Item
1. patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin c) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
boolean
C1514457 (UMLS CUI [1])
C0279134 (UMLS CUI [2])
C3540781 (UMLS CUI [3])
C0002475 (UMLS CUI [4])
C0392615 (UMLS CUI [5])
C0569491 (UMLS CUI [6])
patients may not be receiving any other investigational agents
Item
2. patients may not be receiving any other investigational agents.
boolean
C0013230 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
Hypersensitivity; temozolomide; Compound (substance) | Hypersensitivity; Dacarbazine; Compound (substance)
Item
3. history of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or dtic
boolean
C0020517 (UMLS CUI [1,1])
C0076080 (UMLS CUI [1,2])
C1706082 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0010927 (UMLS CUI [2,2])
C1706082 (UMLS CUI [2,3])
gastrointestinal disease, bowel resection, drug absorption
Item
4. history of gastrointestinal disease or significant bowel resection that could interfere with drug absorption.
boolean
C0017178 (UMLS CUI [1,1])
C0678745 (UMLS CUI [1,2])
C0741614 (UMLS CUI [2,1])
C0678745 (UMLS CUI [2,2])
Comorbidity | Limited (extensiveness); Protocol Compliance | Communicable Diseases; Active | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders
Item
5. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
boolean
C0009488 (UMLS CUI [1])
C0439801 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
C0009450 (UMLS CUI [3,1])
C0205177 (UMLS CUI [3,2])
C0742758 (UMLS CUI [4])
C0002965 (UMLS CUI [5])
C0003811 (UMLS CUI [6])
C0004936 (UMLS CUI [7])
prior allogeneic stem cell transplantation
Item
6. prior allogeneic stem cell transplantation.
boolean
C1514463 (UMLS CUI [1,1])
C2242529 (UMLS CUI [1,2])
ability to swallow tablet
Item
7. inability to swallow tablets
boolean
C0566355 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
prior radiation up to more than 25% of bone marrow
Item
8. prior radiation up to more than 25% of bone marrow.
boolean
C0279134 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
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