ID

24515

Description

Alvocidib in Patients With Previously Treated Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia Arising From Chronic Lymphocytic Leukemia (CLL); ODM derived from: https://clinicaltrials.gov/show/NCT00464633

Link

https://clinicaltrials.gov/show/NCT00464633

Keywords

  1. 8/4/17 8/4/17 -
Uploaded on

August 4, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Leukemia, Lymphocytic, Chronic NCT00464633

Eligibility Leukemia, Lymphocytic, Chronic NCT00464633

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient must have documentation of histologically confirmed and measurable chronic lymphocytic leukemia (cll) or prolymphocytic leukemia (pll) arising from cll;
Description

Chronic Lymphocytic Leukemia Measurable | Prolymphocytic Leukemia Due to CLL

Data type

boolean

Alias
UMLS CUI [1,1]
C0023434
UMLS CUI [1,2]
C1513040
UMLS CUI [2,1]
C0023486
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0023434
patient must have symptomatic and progressive disease;
Description

Progressive Disease Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C1335499
UMLS CUI [1,2]
C0231220
patient must have received prior alkylating agent(s) and be fludarabine refractory;
Description

Alkylating Agents | Fludarabine refractory

Data type

boolean

Alias
UMLS CUI [1]
C0002073
UMLS CUI [2,1]
C0059985
UMLS CUI [2,2]
C0205269
patient must have the adequate organ functions;
Description

Organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
patient's eastern cooperative oncology group performance (ecog) status must be 0-2;
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient with de novo pll;
Description

Prolymphocytic Leukemia de novo

Data type

boolean

Alias
UMLS CUI [1,1]
C0023486
UMLS CUI [1,2]
C1515568
patient with secondary malignancy that will limit survival ≤5 years;
Description

Secondary Malignant Neoplasm Limiting Continuance of life

Data type

boolean

Alias
UMLS CUI [1,1]
C3266877
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0038952
patient with prior allogenic or autologous bone marrow transplant or peripheral blood stem cell transplant ≤12 months;
Description

Allogeneic bone marrow transplantation | Autologous bone marrow transplant | Peripheral Stem Cell Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0149615
UMLS CUI [2]
C0194037
UMLS CUI [3]
C0242602
patient receiving an investigational agent or an approved agent for an investigational purpose within last 4 weeks prior to study entry;
Description

Investigational New Drugs | Pharmaceutical Preparations Purpose Investigational

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1285529
UMLS CUI [2,3]
C1517586
patient with known history of glucose-6-phosphate dehydrogenase deficiency;
Description

Deficiency of glucose-6-phosphate dehydrogenase

Data type

boolean

Alias
UMLS CUI [1]
C2939465
patient with autoimmune hemolytic anemia;
Description

Autoimmune hemolytic anemia

Data type

boolean

Alias
UMLS CUI [1]
C0002880
patient with known central nervous system involvement;
Description

Central Nervous System Involvement

Data type

boolean

Alias
UMLS CUI [1]
C4050309
patient with active, uncontrolled serious bacterial, viral or fungal infections
Description

Bacterial Infections Serious Uncontrolled | Virus Diseases Serious Uncontrolled | Mycoses Serious Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0004623
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0205318
UMLS CUI [2,1]
C0042769
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0205318
UMLS CUI [3,1]
C0026946
UMLS CUI [3,2]
C0205404
UMLS CUI [3,3]
C0205318
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568

Similar models

Eligibility Leukemia, Lymphocytic, Chronic NCT00464633

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Lymphocytic Leukemia Measurable | Prolymphocytic Leukemia Due to CLL
Item
patient must have documentation of histologically confirmed and measurable chronic lymphocytic leukemia (cll) or prolymphocytic leukemia (pll) arising from cll;
boolean
C0023434 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
C0023486 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0023434 (UMLS CUI [2,3])
Progressive Disease Symptomatic
Item
patient must have symptomatic and progressive disease;
boolean
C1335499 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Alkylating Agents | Fludarabine refractory
Item
patient must have received prior alkylating agent(s) and be fludarabine refractory;
boolean
C0002073 (UMLS CUI [1])
C0059985 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
Organ function
Item
patient must have the adequate organ functions;
boolean
C0678852 (UMLS CUI [1])
ECOG performance status
Item
patient's eastern cooperative oncology group performance (ecog) status must be 0-2;
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prolymphocytic Leukemia de novo
Item
patient with de novo pll;
boolean
C0023486 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
Secondary Malignant Neoplasm Limiting Continuance of life
Item
patient with secondary malignancy that will limit survival ≤5 years;
boolean
C3266877 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0038952 (UMLS CUI [1,3])
Allogeneic bone marrow transplantation | Autologous bone marrow transplant | Peripheral Stem Cell Transplantation
Item
patient with prior allogenic or autologous bone marrow transplant or peripheral blood stem cell transplant ≤12 months;
boolean
C0149615 (UMLS CUI [1])
C0194037 (UMLS CUI [2])
C0242602 (UMLS CUI [3])
Investigational New Drugs | Pharmaceutical Preparations Purpose Investigational
Item
patient receiving an investigational agent or an approved agent for an investigational purpose within last 4 weeks prior to study entry;
boolean
C0013230 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C1285529 (UMLS CUI [2,2])
C1517586 (UMLS CUI [2,3])
Deficiency of glucose-6-phosphate dehydrogenase
Item
patient with known history of glucose-6-phosphate dehydrogenase deficiency;
boolean
C2939465 (UMLS CUI [1])
Autoimmune hemolytic anemia
Item
patient with autoimmune hemolytic anemia;
boolean
C0002880 (UMLS CUI [1])
Central Nervous System Involvement
Item
patient with known central nervous system involvement;
boolean
C4050309 (UMLS CUI [1])
Bacterial Infections Serious Uncontrolled | Virus Diseases Serious Uncontrolled | Mycoses Serious Uncontrolled
Item
patient with active, uncontrolled serious bacterial, viral or fungal infections
boolean
C0004623 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0042769 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0205318 (UMLS CUI [2,3])
C0026946 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0205318 (UMLS CUI [3,3])
Study Subject Participation Status
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1])

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