ID

24515

Beschreibung

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

Stichworte

Versionen (1)
  1. 04.08.17 04.08.17 -
Hochgeladen am

4. August 2017

DOI

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Creative Commons BY 4.0
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Eligibility Leukemia, Lymphocytic, Chronic NCT00464633

Englisch

Eligibility Leukemia, Lymphocytic, Chronic NCT00464633

1 Formulare  
Inclusion Criteria
Beschreibung

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;
Beschreibung

Chronic Lymphocytic Leukemia Measurable | Prolymphocytic Leukemia Due to CLL

Datentyp

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;
Beschreibung

Progressive Disease Symptomatic

Datentyp

boolean

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

Alkylating Agents | Fludarabine refractory

Datentyp

boolean

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

Organ function

Datentyp

boolean

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

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient with de novo pll;
Beschreibung

Prolymphocytic Leukemia de novo

Datentyp

boolean

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

Secondary Malignant Neoplasm Limiting Continuance of life

Datentyp

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;
Beschreibung

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

Datentyp

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;
Beschreibung

Investigational New Drugs | Pharmaceutical Preparations Purpose Investigational

Datentyp

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;
Beschreibung

Deficiency of glucose-6-phosphate dehydrogenase

Datentyp

boolean

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

Autoimmune hemolytic anemia

Datentyp

boolean

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

Central Nervous System Involvement

Datentyp

boolean

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

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

Datentyp

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.
Beschreibung

Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
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Ähnliche Modelle

Eligibility Leukemia, Lymphocytic, Chronic NCT00464633

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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