ID

17379

Beschreibung

Bortezomib and Flavopiridol in Treating Patients With Recurrent or Refractory Indolent B-Cell Neoplasms; ODM derived from: https://clinicaltrials.gov/show/NCT00082784

Link

https://clinicaltrials.gov/show/NCT00082784

Stichworte

Versionen (1)
  1. 10.09.16 10.09.16 -
Hochgeladen am

10. September 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue NCT00082784

Englisch

Eligibility Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue NCT00082784

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
wbc < 50,000/mm^3 for patients with circulating tumor cells
Beschreibung

Circulating Neoplastic Cells | White Blood Cell Count

Datentyp

boolean

Alias
UMLS CUI [1]
C0027625
UMLS CUI [2]
C0023508
no prior allergic reaction to compounds of similar chemical or biological composition to and presumably able to tolerated bortezomib, flavopiridol, allopurinol, sodium polystyrene sulfonate, or dexamethasone
Beschreibung

Allergic Reaction bortezomib | Allergic Reaction alvocidib | Allergic Reaction Allopurinol | Allergic Reaction Sodium polystyrene sulfonate | Allergic Reaction Dexamethasone

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1176309
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0281603
UMLS CUI [3,1]
C1527304
UMLS CUI [3,2]
C0002144
UMLS CUI [4,1]
C1527304
UMLS CUI [4,2]
C0142915
UMLS CUI [5,1]
C1527304
UMLS CUI [5,2]
C0011777
no neuropathy >= grade 2
Beschreibung

Neuropathy | CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1]
C0442874
UMLS CUI [2]
C1516728
no other condition that would preclude study participation
Beschreibung

Condition Study Subject Participation Status Exclusion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C2828389
not pregnant or nursing
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
fertile patients must use effective contraception during and for 3 months after study participation
Beschreibung

Fertility Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
prior autologous stem cell transplantation is allowed
Beschreibung

Transplantation of autologous hematopoietic stem cell

Datentyp

boolean

Alias
UMLS CUI [1]
C1831743
no prior allogeneic stem cell transplantation
Beschreibung

Allogeneic Stem Cell Transplantation

Datentyp

boolean

Alias
UMLS CUI [1]
C2242529
no other concurrent anticancer agents
Beschreibung

Antineoplastic Agents

Datentyp

boolean

Alias
UMLS CUI [1]
C0003392
no other concurrent investigational agents
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
hemoglobin >= 8 g/dl
Beschreibung

Hemoglobin

Datentyp

boolean

Alias
UMLS CUI [1]
C0019046
platelet count >= 100,000/mm^3
Beschreibung

Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
absolute neutrophil count >= 1,500/mm^3
Beschreibung

Absolute neutrophil count

Datentyp

boolean

Alias
UMLS CUI [1]
C0948762
bilirubin =< 2 times upper limit of normal (uln)
Beschreibung

Serum total bilirubin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
ast/alt =< 3 times uln
Beschreibung

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
creatinine =< 2 times uln or creatinine clearance >= 50 ml/min
Beschreibung

Creatinine measurement, serum | Creatinine clearance measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
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Ähnliche Modelle

Eligibility Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue NCT00082784

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Circulating Neoplastic Cells | White Blood Cell Count
Item
wbc < 50,000/mm^3 for patients with circulating tumor cells
boolean
C0027625 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
Allergic Reaction bortezomib | Allergic Reaction alvocidib | Allergic Reaction Allopurinol | Allergic Reaction Sodium polystyrene sulfonate | Allergic Reaction Dexamethasone
Item
no prior allergic reaction to compounds of similar chemical or biological composition to and presumably able to tolerated bortezomib, flavopiridol, allopurinol, sodium polystyrene sulfonate, or dexamethasone
boolean
C1527304 (UMLS CUI [1,1])
C1176309 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0281603 (UMLS CUI [2,2])
C1527304 (UMLS CUI [3,1])
C0002144 (UMLS CUI [3,2])
C1527304 (UMLS CUI [4,1])
C0142915 (UMLS CUI [4,2])
C1527304 (UMLS CUI [5,1])
C0011777 (UMLS CUI [5,2])
Neuropathy | CTCAE Grades
Item
no neuropathy >= grade 2
boolean
C0442874 (UMLS CUI [1])
C1516728 (UMLS CUI [2])
Condition Study Subject Participation Status Exclusion
Item
no other condition that would preclude study participation
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C2828389 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
not pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Fertility Contraceptive methods
Item
fertile patients must use effective contraception during and for 3 months after study participation
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Transplantation of autologous hematopoietic stem cell
Item
prior autologous stem cell transplantation is allowed
boolean
C1831743 (UMLS CUI [1])
Allogeneic Stem Cell Transplantation
Item
no prior allogeneic stem cell transplantation
boolean
C2242529 (UMLS CUI [1])
Antineoplastic Agents
Item
no other concurrent anticancer agents
boolean
C0003392 (UMLS CUI [1])
Investigational New Drugs
Item
no other concurrent investigational agents
boolean
C0013230 (UMLS CUI [1])
Hemoglobin
Item
hemoglobin >= 8 g/dl
boolean
C0019046 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count >= 100,000/mm^3
boolean
C0032181 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count >= 1,500/mm^3
boolean
C0948762 (UMLS CUI [1])
Serum total bilirubin measurement
Item
bilirubin =< 2 times upper limit of normal (uln)
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
ast/alt =< 3 times uln
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Creatinine measurement, serum | Creatinine clearance measurement
Item
creatinine =< 2 times uln or creatinine clearance >= 50 ml/min
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
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