ID

41063

Descripción

Dasatinib Combination Therapy With the Smoothened (SMO) Inhibitor BMS-833923 in Chronic Myeloid Leukemia (CML); ODM derived from: https://clinicaltrials.gov/show/NCT01218477

Link

https://clinicaltrials.gov/show/NCT01218477

Palabras clave

Versiones (1)
  1. 18/6/20 18/6/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

18 de junio de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Leukemia NCT01218477

Inglés

Eligibility Leukemia NCT01218477

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01218477
Criteria
Descripción

Criteria

age ≥18 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis of chronic myeloid leukemia (cml) and cytogenetic positive for the philadelphia chromosome (ph+), documented ph+ cells on bone marrow assessment (bma)
Descripción

Philadelphia chromosome positive CML | Cells Philadelphia chromosome positive Bone Marrow Assessment

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0279543
UMLS CUI [2,1]
C0007634
UMLS CUI [2,2]
C0856536
UMLS CUI [2,3]
C0005953
UMLS CUI [2,4]
C1516048
≤6 weeks prior to treatment
Descripción

ID.3

Tipo de datos

boolean

either chronic-phase cml, with <15% blasts in peripheral blood and bone marrow, or advanced-phase cml, including ph+ acute lymphoblastic leukemia (all) (> 5% blasts) or hematologic progression with ≥15% blasts not in complete cytogenetic remission
Descripción

CML Chronic-Phase | Blasts Percentage Peripheral blood | Blasts Percentage Bone Marrow | CML Advanced phase | Philadelphia positive ALL | Blasts Percentage | Progression Hematologic | Cytogenetic Complete Response Absent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023474
UMLS CUI [2,1]
C0368761
UMLS CUI [2,2]
C0439165
UMLS CUI [2,3]
C0229664
UMLS CUI [3,1]
C0368761
UMLS CUI [3,2]
C0439165
UMLS CUI [3,3]
C0005953
UMLS CUI [4,1]
C0023473
UMLS CUI [4,2]
C0205179
UMLS CUI [5]
C4524071
UMLS CUI [6,1]
C0368761
UMLS CUI [6,2]
C0439165
UMLS CUI [7,1]
C0449258
UMLS CUI [7,2]
C0205488
UMLS CUI [8,1]
C4050364
UMLS CUI [8,2]
C0332197
resistance or suboptimal response to imatinib, dasatinib, or nilotinib and no known t315i/a abl-kinase mutation.
Descripción

Resistant to Imatinib | Partial response Imatinib | Resistant to Dasatinib | Partial response Dasatinib | Resistant to Nilotinib | Partial response Nilotinib | T315I mutation Unknown | Other Coding

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332325
UMLS CUI [1,2]
C0935989
UMLS CUI [2,1]
C1521726
UMLS CUI [2,2]
C0935989
UMLS CUI [3,1]
C0332325
UMLS CUI [3,2]
C1455147
UMLS CUI [4,1]
C1521726
UMLS CUI [4,2]
C1455147
UMLS CUI [5,1]
C0332325
UMLS CUI [5,2]
C1721377
UMLS CUI [6,1]
C1521726
UMLS CUI [6,2]
C1721377
UMLS CUI [7,1]
C3889036
UMLS CUI [7,2]
C0439673
UMLS CUI [8]
C3846158
key exclusion criteria
Descripción

Exclusion Criteria Main

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
known abl-kinase t315i or t315a mutation
Descripción

T315I mutation | Other Coding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3889036
UMLS CUI [2]
C3846158
ccyr at baseline
Descripción

CCyR

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4050364
any serious or uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy
Descripción

Disease Serious Impairing Investigational Therapy | Disease Uncontrolled Impairing Investigational Therapy | Communicable Disease Impairing Investigational Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0221099
UMLS CUI [1,4]
C0949266
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205318
UMLS CUI [2,3]
C0221099
UMLS CUI [2,4]
C0949266
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C0221099
UMLS CUI [3,3]
C0949266
uncontrolled or significant cardiovascular disease
Descripción

Cardiovascular Disease Uncontrolled | Cardiovascular Disease Significant

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0007222
UMLS CUI [2,2]
C0750502
grade 3 or higher peripheral blood counts
Descripción

Peripheral blood Count Grade

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0229664
UMLS CUI [1,2]
C0750480
UMLS CUI [1,3]
C0441800
serum calcium or phosphate below the lower limit of normal
Descripción

Serum calcium decreased | Serum phosphate concentration below normal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0595882
UMLS CUI [2]
C0595888
baseline hypomagnesemia and amylase or lipase at least grade 1 or higher
Descripción

Hypomagnesemia | Amylase measurement Grade | Lipase measurement Grade

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0151723
UMLS CUI [2,1]
C0201883
UMLS CUI [2,2]
C0441800
UMLS CUI [3,1]
C0373670
UMLS CUI [3,2]
C0441800
reduced renal function, defined as serum creatinine level >3*upper limit of normal
Descripción

Renal Insufficiency | Serum creatinine raised

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0700225
prior therapies for cml or ph+ all permitted, with the following restriction:
Descripción

Prior Therapy CML | Prior Therapy Philadelphia positive acute lymphocytic leukaemia | Restriction

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0023473
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C4524071
UMLS CUI [3]
C0443288
therapy permitted with corticosteroids, hydroxyurea, or anagrelide prior to starting treatment and during the first 4 weeks on study
Descripción

Therapy allowed | Steroid therapy | hydroxyurea | anagrelide

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0683607
UMLS CUI [2]
C0149783
UMLS CUI [3]
C0020402
UMLS CUI [4]
C0051809
6 months or longer after stem cell transplantation
Descripción

Stem cell transplant Previous

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1504389
UMLS CUI [1,2]
C0205156
28 days or longer after any investigational agent
Descripción

Investigational New Drugs Previous

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0205156
7 days or longer after any standard chemotherapy agent
Descripción

Standard Chemotherapeutic Agents Previous

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1442989
UMLS CUI [1,2]
C0003392
UMLS CUI [1,3]
C0205156
concomitant use of medications with a known risk of causing torsades de pointes
Descripción

Pharmaceutical Preparations At risk Torsades de Pointes

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0040479
concomitant use of strong inhibitors of the cyp3a4 isoenzyme
Descripción

CYP3A4 Inhibitors Strong

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3850053
UMLS CUI [1,2]
C0442821
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Similar models

Eligibility Leukemia NCT01218477

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01218477
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Age
Item
age ≥18 years
boolean
C0001779 (UMLS CUI [1])
Philadelphia chromosome positive CML | Cells Philadelphia chromosome positive Bone Marrow Assessment
Item
diagnosis of chronic myeloid leukemia (cml) and cytogenetic positive for the philadelphia chromosome (ph+), documented ph+ cells on bone marrow assessment (bma)
boolean
C0279543 (UMLS CUI [1])
C0007634 (UMLS CUI [2,1])
C0856536 (UMLS CUI [2,2])
C0005953 (UMLS CUI [2,3])
C1516048 (UMLS CUI [2,4])
ID.3
Item
≤6 weeks prior to treatment
boolean
CML Chronic-Phase | Blasts Percentage Peripheral blood | Blasts Percentage Bone Marrow | CML Advanced phase | Philadelphia positive ALL | Blasts Percentage | Progression Hematologic | Cytogenetic Complete Response Absent
Item
either chronic-phase cml, with <15% blasts in peripheral blood and bone marrow, or advanced-phase cml, including ph+ acute lymphoblastic leukemia (all) (> 5% blasts) or hematologic progression with ≥15% blasts not in complete cytogenetic remission
boolean
C0023474 (UMLS CUI [1])
C0368761 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0229664 (UMLS CUI [2,3])
C0368761 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
C0005953 (UMLS CUI [3,3])
C0023473 (UMLS CUI [4,1])
C0205179 (UMLS CUI [4,2])
C4524071 (UMLS CUI [5])
C0368761 (UMLS CUI [6,1])
C0439165 (UMLS CUI [6,2])
C0449258 (UMLS CUI [7,1])
C0205488 (UMLS CUI [7,2])
C4050364 (UMLS CUI [8,1])
C0332197 (UMLS CUI [8,2])
Resistant to Imatinib | Partial response Imatinib | Resistant to Dasatinib | Partial response Dasatinib | Resistant to Nilotinib | Partial response Nilotinib | T315I mutation Unknown | Other Coding
Item
resistance or suboptimal response to imatinib, dasatinib, or nilotinib and no known t315i/a abl-kinase mutation.
boolean
C0332325 (UMLS CUI [1,1])
C0935989 (UMLS CUI [1,2])
C1521726 (UMLS CUI [2,1])
C0935989 (UMLS CUI [2,2])
C0332325 (UMLS CUI [3,1])
C1455147 (UMLS CUI [3,2])
C1521726 (UMLS CUI [4,1])
C1455147 (UMLS CUI [4,2])
C0332325 (UMLS CUI [5,1])
C1721377 (UMLS CUI [5,2])
C1521726 (UMLS CUI [6,1])
C1721377 (UMLS CUI [6,2])
C3889036 (UMLS CUI [7,1])
C0439673 (UMLS CUI [7,2])
C3846158 (UMLS CUI [8])
Exclusion Criteria Main
Item
key exclusion criteria
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
T315I mutation | Other Coding
Item
known abl-kinase t315i or t315a mutation
boolean
C3889036 (UMLS CUI [1])
C3846158 (UMLS CUI [2])
CCyR
Item
ccyr at baseline
boolean
C4050364 (UMLS CUI [1])
Disease Serious Impairing Investigational Therapy | Disease Uncontrolled Impairing Investigational Therapy | Communicable Disease Impairing Investigational Therapy
Item
any serious or uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0221099 (UMLS CUI [1,3])
C0949266 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0221099 (UMLS CUI [2,3])
C0949266 (UMLS CUI [2,4])
C0009450 (UMLS CUI [3,1])
C0221099 (UMLS CUI [3,2])
C0949266 (UMLS CUI [3,3])
Cardiovascular Disease Uncontrolled | Cardiovascular Disease Significant
Item
uncontrolled or significant cardiovascular disease
boolean
C0007222 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
Peripheral blood Count Grade
Item
grade 3 or higher peripheral blood counts
boolean
C0229664 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
Serum calcium decreased | Serum phosphate concentration below normal
Item
serum calcium or phosphate below the lower limit of normal
boolean
C0595882 (UMLS CUI [1])
C0595888 (UMLS CUI [2])
Hypomagnesemia | Amylase measurement Grade | Lipase measurement Grade
Item
baseline hypomagnesemia and amylase or lipase at least grade 1 or higher
boolean
C0151723 (UMLS CUI [1])
C0201883 (UMLS CUI [2,1])
C0441800 (UMLS CUI [2,2])
C0373670 (UMLS CUI [3,1])
C0441800 (UMLS CUI [3,2])
Renal Insufficiency | Serum creatinine raised
Item
reduced renal function, defined as serum creatinine level >3*upper limit of normal
boolean
C1565489 (UMLS CUI [1])
C0700225 (UMLS CUI [2])
Prior Therapy CML | Prior Therapy Philadelphia positive acute lymphocytic leukaemia | Restriction
Item
prior therapies for cml or ph+ all permitted, with the following restriction:
boolean
C1514463 (UMLS CUI [1,1])
C0023473 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C4524071 (UMLS CUI [2,2])
C0443288 (UMLS CUI [3])
Therapy allowed | Steroid therapy | hydroxyurea | anagrelide
Item
therapy permitted with corticosteroids, hydroxyurea, or anagrelide prior to starting treatment and during the first 4 weeks on study
boolean
C0087111 (UMLS CUI [1,1])
C0683607 (UMLS CUI [1,2])
C0149783 (UMLS CUI [2])
C0020402 (UMLS CUI [3])
C0051809 (UMLS CUI [4])
Stem cell transplant Previous
Item
6 months or longer after stem cell transplantation
boolean
C1504389 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Investigational New Drugs Previous
Item
28 days or longer after any investigational agent
boolean
C0013230 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Standard Chemotherapeutic Agents Previous
Item
7 days or longer after any standard chemotherapy agent
boolean
C1442989 (UMLS CUI [1,1])
C0003392 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
Pharmaceutical Preparations At risk Torsades de Pointes
Item
concomitant use of medications with a known risk of causing torsades de pointes
boolean
C0013227 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0040479 (UMLS CUI [1,3])
CYP3A4 Inhibitors Strong
Item
concomitant use of strong inhibitors of the cyp3a4 isoenzyme
boolean
C3850053 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
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