ID

28064

Description

Study of ABT-263 When Administered in Combination With Either Fludarabine/Cyclophosphamide/Rituximab or Bendamustine/Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00868413

Lien

https://clinicaltrials.gov/show/NCT00868413

Mots-clés

Versions (1)
  1. 14/12/2017 14/12/2017 -
Détendeur de droits

See clinicaltrials.gov

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14 décembre 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Chronic Lymphocytic Leukemia NCT00868413

Anglais

Eligibility Chronic Lymphocytic Leukemia NCT00868413

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
must have relapsed or refractory chronic lymphocytic leukemia (cll), received no more than 5 prior myelosuppressive/chemotherapy regimens and must be a candidate for treatment with either fludarabine/cyclophosphamide/rituximab (fcr) or bendamustine/rituximab (br);
Description

Recurrent Chronic Lymphoid Leukemia | Chronic lymphocytic leukaemia refractory | Myelosuppressive Therapy Quantity | Chemotherapy Regimen Quantity | FCR Regimen Scheduled | Bendamustine/rituximab Scheduled

Type de données

boolean

Alias
UMLS CUI [1]
C0854802
UMLS CUI [2]
C0278791
UMLS CUI [3,1]
C1513793
UMLS CUI [3,2]
C1265611
UMLS CUI [4,1]
C0392920
UMLS CUI [4,2]
C1265611
UMLS CUI [5,1]
C1880650
UMLS CUI [5,2]
C0205539
UMLS CUI [6,1]
C1328232
UMLS CUI [6,2]
C0205539
subject has an eastern cooperative oncology group (ecog) performance score of </=1;
Description

ECOG performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
must have adequate bone marrow independent of growth factor support (with the exception of subjects with bone marrow heavily infiltrated with underlying disease [80% or more] who may use growth factor support to achieve absolute neutrophil count (anc) eligibility criteria), per local laboratory reference range at screening as follows: anc >/=1000/mcl, platelets>/= 100,000/mm3 (entry platelet count must be independent of transfusion within 14 days of screening),hemoglobin >/= 9.0 g/dl.
Description

Bone Marrow Independent of Growth Factor Support | Exception Bone Marrow Infiltration Percentage Comorbidity | Absolute neutrophil count | Platelet Count measurement | Platelet Count measurement Independent of Transfusion | Hemoglobin measurement

Type de données

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0332291
UMLS CUI [1,3]
C0018284
UMLS CUI [1,4]
C1521721
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0005953
UMLS CUI [2,3]
C0332448
UMLS CUI [2,4]
C0439165
UMLS CUI [2,5]
C0009488
UMLS CUI [3]
C0948762
UMLS CUI [4]
C0032181
UMLS CUI [5,1]
C0032181
UMLS CUI [5,2]
C0332291
UMLS CUI [5,3]
C1879316
UMLS CUI [6]
C0518015
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject has history or is clinically suspicious for cancer-related central nervous system disease;
Description

CNS disorder Relationship Malignant Neoplasm

Type de données

boolean

Alias
UMLS CUI [1,1]
C0007682
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0006826
has history of severe allergic or anaphylactic reactions to human, humanized, chimeric or murine monoclonal antibodies;
Description

Allergic Reaction Severe Human Monoclonal Antibodies | Allergic Reaction Severe Humanized Monoclonal Antibodies | Allergic Reaction Severe Chimeric monoclonal antibody | Allergic Reaction Severe Murine Monoclonal Antibodies | Anaphylactic reaction Severe Human Monoclonal Antibodies | Anaphylactic reaction Severe Humanized Monoclonal Antibodies | Anaphylactic reaction Severe Chimeric monoclonal antibody | Anaphylactic reaction Severe Murine Monoclonal Antibodies

Type de données

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0003250
UMLS CUI [1,4]
C0086418
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C2985546
UMLS CUI [3,1]
C1527304
UMLS CUI [3,2]
C0205082
UMLS CUI [3,3]
C0598622
UMLS CUI [3,4]
C0746619
UMLS CUI [4,1]
C1527304
UMLS CUI [4,2]
C0205082
UMLS CUI [4,3]
C2916903
UMLS CUI [5,1]
C0002792
UMLS CUI [5,2]
C0205082
UMLS CUI [5,3]
C0003250
UMLS CUI [5,4]
C0086418
UMLS CUI [6,1]
C0002792
UMLS CUI [6,2]
C0205082
UMLS CUI [6,3]
C2985546
UMLS CUI [7,1]
C0002792
UMLS CUI [7,2]
C0205082
UMLS CUI [7,3]
C0598622
UMLS CUI [7,4]
C0746619
UMLS CUI [8,1]
C0002792
UMLS CUI [8,2]
C0205082
UMLS CUI [8,3]
C2916903
has undergone an allogeneic stem cell transplant; exhibits evidence of other uncontrolled condition(s) including, but not limited to: uncontrolled systemic infection, diagnosis of fever and neutropenia within 1 week prior to study drug administration;
Description

Allogeneic Stem Cell Transplantation | Condition Uncontrolled | Sepsis Uncontrolled | Fever | Neutropenia

Type de données

boolean

Alias
UMLS CUI [1]
C2242529
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0243026
UMLS CUI [3,2]
C0205318
UMLS CUI [4]
C0015967
UMLS CUI [5]
C0027947
has underlying, predisposing condition of bleeding or currently exhibits signs of bleeding; has a recent history of non-chemotherapy induced thrombocytopenic associated bleeding;
Description

Bleeding tendency | Signs Hemorrhage | Hemorrhage Associated with Thrombocytopenia | Chemotherapy Absent

Type de données

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2,1]
C0220912
UMLS CUI [2,2]
C0019080
UMLS CUI [3,1]
C0019080
UMLS CUI [3,2]
C0332281
UMLS CUI [3,3]
C0040034
UMLS CUI [4,1]
C0392920
UMLS CUI [4,2]
C0332197
currently receiving or requires anticoagulation therapy;
Description

Anticoagulation Therapy

Type de données

boolean

Alias
UMLS CUI [1]
C0003281
has active immune thrombocytopenic purpura (itp) or a history of being refractory to platelet transfusions (within 1 year prior to 1st dose of study drug);
Description

Immune thrombocytopenic purpura | Platelet Transfusion Unresponsive to Treatment

Type de données

boolean

Alias
UMLS CUI [1]
C0398650
UMLS CUI [2,1]
C0086818
UMLS CUI [2,2]
C0205269
has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis.
Description

Peptic Ulcer | Hemorrhagic esophagitis | Hemorrhagic gastritis

Type de données

boolean

Alias
UMLS CUI [1]
C0030920
UMLS CUI [2]
C0520560
UMLS CUI [3]
C2010560
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Similar models

Eligibility Chronic Lymphocytic Leukemia NCT00868413

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Recurrent Chronic Lymphoid Leukemia | Chronic lymphocytic leukaemia refractory | Myelosuppressive Therapy Quantity | Chemotherapy Regimen Quantity | FCR Regimen Scheduled | Bendamustine/rituximab Scheduled
Item
must have relapsed or refractory chronic lymphocytic leukemia (cll), received no more than 5 prior myelosuppressive/chemotherapy regimens and must be a candidate for treatment with either fludarabine/cyclophosphamide/rituximab (fcr) or bendamustine/rituximab (br);
boolean
C0854802 (UMLS CUI [1])
C0278791 (UMLS CUI [2])
C1513793 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0392920 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C1880650 (UMLS CUI [5,1])
C0205539 (UMLS CUI [5,2])
C1328232 (UMLS CUI [6,1])
C0205539 (UMLS CUI [6,2])
ECOG performance status
Item
subject has an eastern cooperative oncology group (ecog) performance score of </=1;
boolean
C1520224 (UMLS CUI [1])
Bone Marrow Independent of Growth Factor Support | Exception Bone Marrow Infiltration Percentage Comorbidity | Absolute neutrophil count | Platelet Count measurement | Platelet Count measurement Independent of Transfusion | Hemoglobin measurement
Item
must have adequate bone marrow independent of growth factor support (with the exception of subjects with bone marrow heavily infiltrated with underlying disease [80% or more] who may use growth factor support to achieve absolute neutrophil count (anc) eligibility criteria), per local laboratory reference range at screening as follows: anc >/=1000/mcl, platelets>/= 100,000/mm3 (entry platelet count must be independent of transfusion within 14 days of screening),hemoglobin >/= 9.0 g/dl.
boolean
C0005953 (UMLS CUI [1,1])
C0332291 (UMLS CUI [1,2])
C0018284 (UMLS CUI [1,3])
C1521721 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C0005953 (UMLS CUI [2,2])
C0332448 (UMLS CUI [2,3])
C0439165 (UMLS CUI [2,4])
C0009488 (UMLS CUI [2,5])
C0948762 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C0032181 (UMLS CUI [5,1])
C0332291 (UMLS CUI [5,2])
C1879316 (UMLS CUI [5,3])
C0518015 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
CNS disorder Relationship Malignant Neoplasm
Item
subject has history or is clinically suspicious for cancer-related central nervous system disease;
boolean
C0007682 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
Allergic Reaction Severe Human Monoclonal Antibodies | Allergic Reaction Severe Humanized Monoclonal Antibodies | Allergic Reaction Severe Chimeric monoclonal antibody | Allergic Reaction Severe Murine Monoclonal Antibodies | Anaphylactic reaction Severe Human Monoclonal Antibodies | Anaphylactic reaction Severe Humanized Monoclonal Antibodies | Anaphylactic reaction Severe Chimeric monoclonal antibody | Anaphylactic reaction Severe Murine Monoclonal Antibodies
Item
has history of severe allergic or anaphylactic reactions to human, humanized, chimeric or murine monoclonal antibodies;
boolean
C1527304 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0003250 (UMLS CUI [1,3])
C0086418 (UMLS CUI [1,4])
C1527304 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C2985546 (UMLS CUI [2,3])
C1527304 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0598622 (UMLS CUI [3,3])
C0746619 (UMLS CUI [3,4])
C1527304 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C2916903 (UMLS CUI [4,3])
C0002792 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0003250 (UMLS CUI [5,3])
C0086418 (UMLS CUI [5,4])
C0002792 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C2985546 (UMLS CUI [6,3])
C0002792 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C0598622 (UMLS CUI [7,3])
C0746619 (UMLS CUI [7,4])
C0002792 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
C2916903 (UMLS CUI [8,3])
Allogeneic Stem Cell Transplantation | Condition Uncontrolled | Sepsis Uncontrolled | Fever | Neutropenia
Item
has undergone an allogeneic stem cell transplant; exhibits evidence of other uncontrolled condition(s) including, but not limited to: uncontrolled systemic infection, diagnosis of fever and neutropenia within 1 week prior to study drug administration;
boolean
C2242529 (UMLS CUI [1])
C0348080 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0243026 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0015967 (UMLS CUI [4])
C0027947 (UMLS CUI [5])
Bleeding tendency | Signs Hemorrhage | Hemorrhage Associated with Thrombocytopenia | Chemotherapy Absent
Item
has underlying, predisposing condition of bleeding or currently exhibits signs of bleeding; has a recent history of non-chemotherapy induced thrombocytopenic associated bleeding;
boolean
C1458140 (UMLS CUI [1])
C0220912 (UMLS CUI [2,1])
C0019080 (UMLS CUI [2,2])
C0019080 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C0040034 (UMLS CUI [3,3])
C0392920 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Anticoagulation Therapy
Item
currently receiving or requires anticoagulation therapy;
boolean
C0003281 (UMLS CUI [1])
Immune thrombocytopenic purpura | Platelet Transfusion Unresponsive to Treatment
Item
has active immune thrombocytopenic purpura (itp) or a history of being refractory to platelet transfusions (within 1 year prior to 1st dose of study drug);
boolean
C0398650 (UMLS CUI [1])
C0086818 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
Peptic Ulcer | Hemorrhagic esophagitis | Hemorrhagic gastritis
Item
has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis.
boolean
C0030920 (UMLS CUI [1])
C0520560 (UMLS CUI [2])
C2010560 (UMLS CUI [3])
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