ID

41052

Descrição

Study of Bendamustine Hydrochloride for the Treatment of Pediatric Patients With Relapsed or Refractory Acute Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01088984

Link

https://clinicaltrials.gov/show/NCT01088984

Palavras-chave

Versões (1)
  1. 17/06/2020 17/06/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

17 de junho de 2020

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Leukemia NCT01088984

Inglês

Eligibility Leukemia NCT01088984

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01088984
Criteria
Descrição

Criteria

the patient has histologically proven acute lymphocytic leukemia (all) or acute myeloid leukemia (aml) that has relapsed or is refractory to the last regimen, and the patient is without alternative curative therapy.
Descrição

Acute lymphocytic leukemia | Leukemia, Myelocytic, Acute | Recurrent disease | Unresponsive to Treatment | Curative treatment Alternative Lacking

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023449
UMLS CUI [2]
C0023467
UMLS CUI [3]
C0277556
UMLS CUI [4]
C0205269
UMLS CUI [5,1]
C1273390
UMLS CUI [5,2]
C1523987
UMLS CUI [5,3]
C0332268
the patient's last myelosuppression therapy ended at least 2 weeks before the first dose of study drug.
Descrição

Myelosuppressive Therapy Ended

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1513793
UMLS CUI [1,2]
C1272693
nonhematologic acute toxic effects of prior therapy have resolved to grade 2 or less according to national cancer institute (nci) common terminology criteria for adverse events (ctcae).
Descrição

Toxic effect Due to Prior Therapy | Toxic effect resolved CTCAE Grades

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C1514463
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C1514893
UMLS CUI [2,3]
C1516728
the patient has adequate liver function with bilirubin values less than or equal to 1.5 times the upper limit of normal (uln) and aspartate aminotransferase (ast) and alanine aminotransferase (alt) values less than or equal to 5 times the age-appropriate uln.
Descrição

Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
the patient has adequate renal function with serum creatinine values less than 2 times uln.
Descrição

Renal function | Creatinine measurement, serum

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
the patient has karnofsky or lansky performance status of 60 or greater. patients older than 16 years of age will be scored according to the karnofsky scale and patients 16 years of age or younger will be scored according to the lansky scale.
Descrição

Karnofsky Performance Status | Lansky Play-Performance Status | Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0206065
UMLS CUI [2]
C1522275
UMLS CUI [3]
C0001779
the patient may have had hematopoietic stem cell transplantation.
Descrição

Hemopoietic stem cell transplant

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0472699
women of childbearing potential (not surgically sterile) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of treatment and for 30 days after the end of treatment.
Descrição

Childbearing Potential Contraceptive methods

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
men not surgically sterile or who are capable of producing offspring must practice abstinence or use a barrier method of birth control, and must agree to continue use of this method for the duration of treatment and for 30 days after the end of treatment.
Descrição

Male sterilization Absent Sexual Abstinence | Male sterilization Absent Barrier Contraception | Male fertility Sexual Abstinence | Male fertility Barrier Contraception

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0024559
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0036899
UMLS CUI [2,1]
C0024559
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0004764
UMLS CUI [3,1]
C1955321
UMLS CUI [3,2]
C0036899
UMLS CUI [4,1]
C1955321
UMLS CUI [4,2]
C0004764
the patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and willing to return to the clinic for the follow-up evaluation as specified in this protocol.
Descrição

Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0525058
key exclusion criteria:
Descrição

Exclusion Criteria Main

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
the patient has any active, uncontrolled systemic infection, severe concurrent disease, or symptomatic untreated central nervous system (cns) involvement.
Descrição

Sepsis Uncontrolled | Comorbidity Severe | Central Nervous System Involvement Symptomatic Untreated

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0243026
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C4050309
UMLS CUI [3,2]
C0231220
UMLS CUI [3,3]
C0332155
the patient has evidence of active graft versus host disease.
Descrição

Graft-vs-Host Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0018133
the patient has a known human immunodeficiency virus (hiv) infection.
Descrição

HIV Infection

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019693
the patient has active hepatitis b or hepatitis c infection.
Descrição

Hepatitis B | Hepatitis C

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
the patient is a pregnant or lactating woman. any women becoming pregnant during the study will be withdrawn from the study immediately.
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
the patient has any serious uncontrolled medical or psychological disorder that would impair the ability of the patient to receive study drug.
Descrição

Disease Serious Uncontrolled | Mental disorders Serious Uncontrolled | Investigational New Drugs Receive Impaired

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0205318
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0205318
UMLS CUI [3,1]
C0013230
UMLS CUI [3,2]
C1514756
UMLS CUI [3,3]
C0221099
the patient has any condition that places the patient at unacceptable risk or confounds the ability of the investigators to interpret study data.
Descrição

Condition Study Subject Participation Status At risk | Condition Interferes with Interpretation Research data

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0459471
UMLS CUI [2,4]
C0681873
the patient has received any other investigational agent within 30 days of study entry.
Descrição

Investigational New Drugs Recent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0332185
the patient has known hypersensitivity to bendamustine or mannitol.
Descrição

Hypersensitivity Bendamustine | Mannitol allergy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0525079
UMLS CUI [2]
C0571922
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Similar models

Eligibility Leukemia NCT01088984

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01088984
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Acute lymphocytic leukemia | Leukemia, Myelocytic, Acute | Recurrent disease | Unresponsive to Treatment | Curative treatment Alternative Lacking
Item
the patient has histologically proven acute lymphocytic leukemia (all) or acute myeloid leukemia (aml) that has relapsed or is refractory to the last regimen, and the patient is without alternative curative therapy.
boolean
C0023449 (UMLS CUI [1])
C0023467 (UMLS CUI [2])
C0277556 (UMLS CUI [3])
C0205269 (UMLS CUI [4])
C1273390 (UMLS CUI [5,1])
C1523987 (UMLS CUI [5,2])
C0332268 (UMLS CUI [5,3])
Myelosuppressive Therapy Ended
Item
the patient's last myelosuppression therapy ended at least 2 weeks before the first dose of study drug.
boolean
C1513793 (UMLS CUI [1,1])
C1272693 (UMLS CUI [1,2])
Toxic effect Due to Prior Therapy | Toxic effect resolved CTCAE Grades
Item
nonhematologic acute toxic effects of prior therapy have resolved to grade 2 or less according to national cancer institute (nci) common terminology criteria for adverse events (ctcae).
boolean
C0600688 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
C0600688 (UMLS CUI [2,1])
C1514893 (UMLS CUI [2,2])
C1516728 (UMLS CUI [2,3])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
the patient has adequate liver function with bilirubin values less than or equal to 1.5 times the upper limit of normal (uln) and aspartate aminotransferase (ast) and alanine aminotransferase (alt) values less than or equal to 5 times the age-appropriate uln.
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
Renal function | Creatinine measurement, serum
Item
the patient has adequate renal function with serum creatinine values less than 2 times uln.
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Karnofsky Performance Status | Lansky Play-Performance Status | Age
Item
the patient has karnofsky or lansky performance status of 60 or greater. patients older than 16 years of age will be scored according to the karnofsky scale and patients 16 years of age or younger will be scored according to the lansky scale.
boolean
C0206065 (UMLS CUI [1])
C1522275 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Hemopoietic stem cell transplant
Item
the patient may have had hematopoietic stem cell transplantation.
boolean
C0472699 (UMLS CUI [1])
Childbearing Potential Contraceptive methods
Item
women of childbearing potential (not surgically sterile) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of treatment and for 30 days after the end of treatment.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Male sterilization Absent Sexual Abstinence | Male sterilization Absent Barrier Contraception | Male fertility Sexual Abstinence | Male fertility Barrier Contraception
Item
men not surgically sterile or who are capable of producing offspring must practice abstinence or use a barrier method of birth control, and must agree to continue use of this method for the duration of treatment and for 30 days after the end of treatment.
boolean
C0024559 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0036899 (UMLS CUI [1,3])
C0024559 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0004764 (UMLS CUI [2,3])
C1955321 (UMLS CUI [3,1])
C0036899 (UMLS CUI [3,2])
C1955321 (UMLS CUI [4,1])
C0004764 (UMLS CUI [4,2])
Protocol Compliance
Item
the patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and willing to return to the clinic for the follow-up evaluation as specified in this protocol.
boolean
C0525058 (UMLS CUI [1])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Sepsis Uncontrolled | Comorbidity Severe | Central Nervous System Involvement Symptomatic Untreated
Item
the patient has any active, uncontrolled systemic infection, severe concurrent disease, or symptomatic untreated central nervous system (cns) involvement.
boolean
C0243026 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C4050309 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C0332155 (UMLS CUI [3,3])
Graft-vs-Host Disease
Item
the patient has evidence of active graft versus host disease.
boolean
C0018133 (UMLS CUI [1])
HIV Infection
Item
the patient has a known human immunodeficiency virus (hiv) infection.
boolean
C0019693 (UMLS CUI [1])
Hepatitis B | Hepatitis C
Item
the patient has active hepatitis b or hepatitis c infection.
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
the patient is a pregnant or lactating woman. any women becoming pregnant during the study will be withdrawn from the study immediately.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Disease Serious Uncontrolled | Mental disorders Serious Uncontrolled | Investigational New Drugs Receive Impaired
Item
the patient has any serious uncontrolled medical or psychological disorder that would impair the ability of the patient to receive study drug.
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0205318 (UMLS CUI [2,3])
C0013230 (UMLS CUI [3,1])
C1514756 (UMLS CUI [3,2])
C0221099 (UMLS CUI [3,3])
Condition Study Subject Participation Status At risk | Condition Interferes with Interpretation Research data
Item
the patient has any condition that places the patient at unacceptable risk or confounds the ability of the investigators to interpret study data.
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0459471 (UMLS CUI [2,3])
C0681873 (UMLS CUI [2,4])
Investigational New Drugs Recent
Item
the patient has received any other investigational agent within 30 days of study entry.
boolean
C0013230 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Hypersensitivity Bendamustine | Mannitol allergy
Item
the patient has known hypersensitivity to bendamustine or mannitol.
boolean
C0020517 (UMLS CUI [1,1])
C0525079 (UMLS CUI [1,2])
C0571922 (UMLS CUI [2])
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