ID

17913

Descripción

AG-858 in Patients Who Are Cytogenetically Positive After Treatment With Gleevec™; ODM derived from: https://clinicaltrials.gov/show/NCT00058747

Link

https://clinicaltrials.gov/show/NCT00058747

Palabras clave

Versiones (1)
  1. 8/10/16 8/10/16 -
Subido en

8 de octubre de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Leukemia, Myeloid, Chronic NCT00058747

Inglés

Eligibility Leukemia, Myeloid, Chronic NCT00058747

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
must be philadelphia chromosome positive chronic myelogenous leukemia in first chronic phase
Descripción

Philadelphia chromosome positive chronic myelogenous leukemia Chronic phase First

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0279543
UMLS CUI [1,2]
C0457343
UMLS CUI [1,3]
C0205435
must have a complete hematologic response
Descripción

Complete Hematologic Response

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4050175
must have received gleevec™, ifn-α, cytarabine, busulfan, hydroxyurea, homoharringtonine (hht) or any combination thereof as long as the combination has been discontinued and the dosing of gleevec™ has been stable for 6 months or greater
Descripción

Gleevec | Interferon-alpha | Cytarabine | Busulfan | hydroxyurea | omacetaxine mepesuccinate | Combination Drug Therapy Discontinued

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0935987
UMLS CUI [2]
C0002199
UMLS CUI [3]
C0010711
UMLS CUI [4]
C0006463
UMLS CUI [5]
C0020402
UMLS CUI [6]
C0062941
UMLS CUI [7,1]
C0013218
UMLS CUI [7,2]
C1444662
must have one of the following cytogenetic statuses:
Descripción

Cytogenetic Analysis Status

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0752095
UMLS CUI [1,2]
C0449438
(a) less than a ccr after receiving gleevec™ for at least one year at a minimum dose of 400 mg/day. a stable dose of gleevec™ must have been maintained for the last six months prior to eligibility testing or (b) stable cytogenetic status without ccr (no cytogenic response or progression) in three consecutive determinations over six months while on a stable dose of gleevec™ (at a minimum of 400mg/day) for at least 6 months or (c) cytogenetic progression while on a stable dose of gleevec™ (at a minimum dose of 400mg/day)for at least 2 consecutive evaluations at least one month apart
Descripción

Gleevec Dosage Duration | Cytogenetic Complete Response Less Than | Cytogenetic Analysis Stable status | Cytogenetic Complete Response Lacking | Cytogenetic Analysis Disease Progression | Evaluation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0935987
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0449238
UMLS CUI [2,1]
C4050364
UMLS CUI [2,2]
C0439092
UMLS CUI [3,1]
C0752095
UMLS CUI [3,2]
C0205360
UMLS CUI [4,1]
C4050364
UMLS CUI [4,2]
C0332268
UMLS CUI [5,1]
C0752095
UMLS CUI [5,2]
C0242656
UMLS CUI [6]
C1261322
ecog performance score of 0 or 1
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
must be at least 18 years old
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
not pregnant or breastfeeding and agree to use contraception during the course of the study
Descripción

Pregnancy | Breast Feeding | Contraceptive methods Agree

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C3641827
no prior allogeneic bone marrow transplant or be candidates for curative bmt
Descripción

Allogeneic bone marrow transplantation | Indication Bone Marrow Transplantation curative

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0149615
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0005961
UMLS CUI [2,3]
C1273390
no immunodeficiency or other serious illness
Descripción

Immunologic Deficiency Syndromes | Illness Serious

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021051
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0205404
no current use of immunosuppressive medications
Descripción

Immunosuppressive Agents

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021081
no other cancer within the last five years, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin
Descripción

Malignant Neoplasms | Carcinoma in situ of uterine cervix Treated Adequate | Carcinoma in situ of uterine cervix Conization | Basal cell carcinoma | Squamous cell carcinoma of skin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0851140
UMLS CUI [2,2]
C1522326
UMLS CUI [2,3]
C0205411
UMLS CUI [3,1]
C0851140
UMLS CUI [3,2]
C0195324
UMLS CUI [4]
C0007117
UMLS CUI [5]
C0553723
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Similar models

Eligibility Leukemia, Myeloid, Chronic NCT00058747

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Philadelphia chromosome positive chronic myelogenous leukemia Chronic phase First
Item
must be philadelphia chromosome positive chronic myelogenous leukemia in first chronic phase
boolean
C0279543 (UMLS CUI [1,1])
C0457343 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
Complete Hematologic Response
Item
must have a complete hematologic response
boolean
C4050175 (UMLS CUI [1])
Gleevec | Interferon-alpha | Cytarabine | Busulfan | hydroxyurea | omacetaxine mepesuccinate | Combination Drug Therapy Discontinued
Item
must have received gleevec™, ifn-α, cytarabine, busulfan, hydroxyurea, homoharringtonine (hht) or any combination thereof as long as the combination has been discontinued and the dosing of gleevec™ has been stable for 6 months or greater
boolean
C0935987 (UMLS CUI [1])
C0002199 (UMLS CUI [2])
C0010711 (UMLS CUI [3])
C0006463 (UMLS CUI [4])
C0020402 (UMLS CUI [5])
C0062941 (UMLS CUI [6])
C0013218 (UMLS CUI [7,1])
C1444662 (UMLS CUI [7,2])
Cytogenetic Analysis Status
Item
must have one of the following cytogenetic statuses:
boolean
C0752095 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Gleevec Dosage Duration | Cytogenetic Complete Response Less Than | Cytogenetic Analysis Stable status | Cytogenetic Complete Response Lacking | Cytogenetic Analysis Disease Progression | Evaluation
Item
(a) less than a ccr after receiving gleevec™ for at least one year at a minimum dose of 400 mg/day. a stable dose of gleevec™ must have been maintained for the last six months prior to eligibility testing or (b) stable cytogenetic status without ccr (no cytogenic response or progression) in three consecutive determinations over six months while on a stable dose of gleevec™ (at a minimum of 400mg/day) for at least 6 months or (c) cytogenetic progression while on a stable dose of gleevec™ (at a minimum dose of 400mg/day)for at least 2 consecutive evaluations at least one month apart
boolean
C0935987 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C4050364 (UMLS CUI [2,1])
C0439092 (UMLS CUI [2,2])
C0752095 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
C4050364 (UMLS CUI [4,1])
C0332268 (UMLS CUI [4,2])
C0752095 (UMLS CUI [5,1])
C0242656 (UMLS CUI [5,2])
C1261322 (UMLS CUI [6])
ECOG performance status
Item
ecog performance score of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Age
Item
must be at least 18 years old
boolean
C0001779 (UMLS CUI [1])
Pregnancy | Breast Feeding | Contraceptive methods Agree
Item
not pregnant or breastfeeding and agree to use contraception during the course of the study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C3641827 (UMLS CUI [3,2])
Allogeneic bone marrow transplantation | Indication Bone Marrow Transplantation curative
Item
no prior allogeneic bone marrow transplant or be candidates for curative bmt
boolean
C0149615 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0005961 (UMLS CUI [2,2])
C1273390 (UMLS CUI [2,3])
Immunologic Deficiency Syndromes | Illness Serious
Item
no immunodeficiency or other serious illness
boolean
C0021051 (UMLS CUI [1])
C0221423 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Immunosuppressive Agents
Item
no current use of immunosuppressive medications
boolean
C0021081 (UMLS CUI [1])
Malignant Neoplasms | Carcinoma in situ of uterine cervix Treated Adequate | Carcinoma in situ of uterine cervix Conization | Basal cell carcinoma | Squamous cell carcinoma of skin
Item
no other cancer within the last five years, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin
boolean
C0006826 (UMLS CUI [1])
C0851140 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0205411 (UMLS CUI [2,3])
C0851140 (UMLS CUI [3,1])
C0195324 (UMLS CUI [3,2])
C0007117 (UMLS CUI [4])
C0553723 (UMLS CUI [5])
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