ID

30561

Beskrivning

A Study to Determine the Efficacy and Safety of Lenalidomide in Patients With Mantle Cell NHL Who Have Relapsed or Progressed After Treatment With Bortezomib or Are Refractory to Bortezomib. The "EMERGE" Trial; ODM derived from: https://clinicaltrials.gov/show/NCT00737529

Länk

https://clinicaltrials.gov/show/NCT00737529

Nyckelord

Versioner (1)
  1. 2018-06-14 2018-06-14 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

14 juni 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Mantle Cell Lymphoma NCT00737529

Engelsk

Eligibility Mantle Cell Lymphoma NCT00737529

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
biopsy proven mantle cell lymphoma
Beskrivning

Mantle cell lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0334634
patients must have documents relapsed, refractory or pd after treatment with bortezomib
Beskrivning

Bortezomib | Recurrent disease | Refractory Disease | Progressive Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1176309
UMLS CUI [2]
C0277556
UMLS CUI [3]
C1514815
UMLS CUI [4]
C1335499
must have measureable disease on cross sectional imaging by ct
Beskrivning

Measurable Disease Cross-sectional imaging CT

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C3824793
UMLS CUI [1,3]
C0040405
eastern cooperative oncology group (ecog) performance score 0,1 or 2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
willing to follow pregnancy precautions
Beskrivning

Contraceptive methods Willing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0600109
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
any of the following laboratory abnormalities
Beskrivning

Laboratory test result abnormal

Datatyp

boolean

Alias
UMLS CUI [1]
C0438215
absolute neutrophil count (anc) < 1,500 cells/mm3 (1.5 x 109/l)
Beskrivning

Absolute neutrophil count

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
platelet count < 60,000/mm3 (60 x 109/l)
Beskrivning

Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
serum aspartate transaminase/serum glutamic oxaloacetic transaminase(ast/sgot) or alanine transaminase/serum glutamic pyruvic transaminase (alt/sgpt) > 3.0 x upper limit of normal (uln), except in patients with documented liver involvement by lymphoma.
Beskrivning

Aspartate aminotransferase increased | Alanine aminotransferase increased | Exception Liver Involvement with Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0023884
UMLS CUI [3,3]
C1314939
UMLS CUI [3,4]
C0024299
serum total bilirubin > 1.5 x uln, except in cases of gilbert's syndrome and documented liver involvement by lymphoma.
Beskrivning

Elevated total bilirubin | Exception Gilbert Disease | Exception Liver Involvement with Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0741494
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0017551
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0023884
UMLS CUI [3,3]
C1314939
UMLS CUI [3,4]
C0024299
calculated creatinine clearance (cockcroft-gault formula) of < 30 ml /min
Beskrivning

Estimation of creatinine clearance by Cockcroft-Gault formula

Datatyp

boolean

Alias
UMLS CUI [1]
C2711451
patients who are candidates for high dose chemotherapy/allogeneic stem cell transplant are not eligible
Beskrivning

Patient need for High-dose chemotherapy | Patient need for Allogeneic Stem Cell Transplantation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C1328050
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C2242529
history of active central nervous system (cns) lymphoma within the previous 3 months
Beskrivning

Central nervous system lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0742472
subjects not willing or unable to take deep vein thrombosis (dvt) prophylaxis
Beskrivning

DVT prophylaxis Unwilling | DVT prophylaxis Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0853245
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0853245
UMLS CUI [2,2]
C1299582
prior history of malignancies, other than mcl, unless the patient has been free of the disease for ≥ 3 years
Beskrivning

Malignant Neoplasms | Exception Mantle cell lymphoma | Exception Disease Free of

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0334634
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C0332296
positive human immunodeficiency virus (hiv) or active hepatitis b or c
Beskrivning

HIV Seropositivity | Hepatitis B | Hepatitis C

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
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Similar models

Eligibility Mantle Cell Lymphoma NCT00737529

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Mantle cell lymphoma
Item
biopsy proven mantle cell lymphoma
boolean
C0334634 (UMLS CUI [1])
Bortezomib | Recurrent disease | Refractory Disease | Progressive Disease
Item
patients must have documents relapsed, refractory or pd after treatment with bortezomib
boolean
C1176309 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
C1514815 (UMLS CUI [3])
C1335499 (UMLS CUI [4])
Measurable Disease Cross-sectional imaging CT
Item
must have measureable disease on cross sectional imaging by ct
boolean
C1513041 (UMLS CUI [1,1])
C3824793 (UMLS CUI [1,2])
C0040405 (UMLS CUI [1,3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance score 0,1 or 2
boolean
C1520224 (UMLS CUI [1])
Contraceptive methods Willing
Item
willing to follow pregnancy precautions
boolean
C0700589 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Laboratory test result abnormal
Item
any of the following laboratory abnormalities
boolean
C0438215 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count (anc) < 1,500 cells/mm3 (1.5 x 109/l)
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count < 60,000/mm3 (60 x 109/l)
boolean
C0032181 (UMLS CUI [1])
Aspartate aminotransferase increased | Alanine aminotransferase increased | Exception Liver Involvement with Lymphoma
Item
serum aspartate transaminase/serum glutamic oxaloacetic transaminase(ast/sgot) or alanine transaminase/serum glutamic pyruvic transaminase (alt/sgpt) > 3.0 x upper limit of normal (uln), except in patients with documented liver involvement by lymphoma.
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0023884 (UMLS CUI [3,2])
C1314939 (UMLS CUI [3,3])
C0024299 (UMLS CUI [3,4])
Elevated total bilirubin | Exception Gilbert Disease | Exception Liver Involvement with Lymphoma
Item
serum total bilirubin > 1.5 x uln, except in cases of gilbert's syndrome and documented liver involvement by lymphoma.
boolean
C0741494 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0017551 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0023884 (UMLS CUI [3,2])
C1314939 (UMLS CUI [3,3])
C0024299 (UMLS CUI [3,4])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
calculated creatinine clearance (cockcroft-gault formula) of < 30 ml /min
boolean
C2711451 (UMLS CUI [1])
Patient need for High-dose chemotherapy | Patient need for Allogeneic Stem Cell Transplantation
Item
patients who are candidates for high dose chemotherapy/allogeneic stem cell transplant are not eligible
boolean
C0686904 (UMLS CUI [1,1])
C1328050 (UMLS CUI [1,2])
C0686904 (UMLS CUI [2,1])
C2242529 (UMLS CUI [2,2])
Central nervous system lymphoma
Item
history of active central nervous system (cns) lymphoma within the previous 3 months
boolean
C0742472 (UMLS CUI [1])
DVT prophylaxis Unwilling | DVT prophylaxis Unable
Item
subjects not willing or unable to take deep vein thrombosis (dvt) prophylaxis
boolean
C0853245 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0853245 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Malignant Neoplasms | Exception Mantle cell lymphoma | Exception Disease Free of
Item
prior history of malignancies, other than mcl, unless the patient has been free of the disease for ≥ 3 years
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0334634 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0332296 (UMLS CUI [3,3])
HIV Seropositivity | Hepatitis B | Hepatitis C
Item
positive human immunodeficiency virus (hiv) or active hepatitis b or c
boolean
C0019699 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
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