ID

30389

Beschrijving

Donor Stem Cell Transplant in Treating Patients With Mantle Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00720447

Link

https://clinicaltrials.gov/show/NCT00720447

Trefwoorden

Versies (2)
  1. 01-06-18 01-06-18 -
  2. 01-06-18 01-06-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

1 juni 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Lymphoma NCT00720447

Engels

Eligibility Lymphoma NCT00720447

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00720447
Criteria
Beschrijving

Criteria

histologically confirmed diagnosis of mantle cell lymphoma
Beschrijving

Mantle cell lymphoma

Datatype

boolean

Alias
UMLS CUI [1]
C0334634
no relapsed or progressive disease
Beschrijving

Exclusion Criteria | Recurrent disease | Progressive Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0277556
UMLS CUI [3]
C1335499
achieved at least a partial remission following induction chemotherapy
Beschrijving

Partial response Post Induction Chemotherapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C1521726
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C3179010
hla-matched donor available
Beschrijving

HLA Match Donor Available

Datatype

boolean

Alias
UMLS CUI [1,1]
C4330149
UMLS CUI [1,2]
C0013018
UMLS CUI [1,3]
C0470187
blood samples from both patient and donor available for chimerism studies
Beschrijving

Blood specimen Patient Chimerism Study | Blood specimen Donor Chimerism Study

Datatype

boolean

Alias
UMLS CUI [1,1]
C0178913
UMLS CUI [1,2]
C0030705
UMLS CUI [1,3]
C0333678
UMLS CUI [1,4]
C2603343
UMLS CUI [2,1]
C0178913
UMLS CUI [2,2]
C0013018
UMLS CUI [2,3]
C0333678
UMLS CUI [2,4]
C2603343
no central nervous system involvement
Beschrijving

Exclusion Central Nervous System Involvement

Datatype

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C4050309
patient characteristics:
Beschrijving

Client Characteristics

Datatype

boolean

Alias
UMLS CUI [1]
C0815172
ecog performance status 2-4
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
considered fit for transplant by treating physician
Beschrijving

Patient Eligible Transplantation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548635
UMLS CUI [1,3]
C0040732
serum bilirubin ≤ 1.5 times upper limit of normal
Beschrijving

Serum total bilirubin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
alkaline phosphatase ≤ 2 times normal
Beschrijving

Alkaline phosphatase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201850
creatinine clearance ≥ 50 ml/min
Beschrijving

Creatinine clearance measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0373595
ejection fraction > 50% (no inadequate cardiac function)
Beschrijving

Cardiac ejection fraction | Exclusion Cardiac function Inadequate

Datatype

boolean

Alias
UMLS CUI [1]
C0232174
UMLS CUI [2,1]
C2828389
UMLS CUI [2,2]
C0232164
UMLS CUI [2,3]
C0205412
not pregnant or nursing
Beschrijving

Pregnancy Absent | Breast Feeding Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
negative pregnancy test
Beschrijving

Pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1]
C0427780
no symptomatic respiratory compromise
Beschrijving

Exclusion Airway compromise Symptomatic

Datatype

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C4055482
UMLS CUI [1,3]
C0231220
no serious concurrent disease which would preclude allograft
Beschrijving

Exclusion | Comorbidity Preventing Allograft

Datatype

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0040739
no known serological positivity for hepatitis b, hepatitis c, or hiv
Beschrijving

Exclusion Criteria | Serology positive Hepatitis B | Serology positive Hepatitis C | HIV Seropositivity

Datatype

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0242089
UMLS CUI [2,2]
C0019163
UMLS CUI [3,1]
C0242089
UMLS CUI [3,2]
C0019196
UMLS CUI [4]
C0019699
no history of a psychological illness or condition that would affect compliance
Beschrijving

Exclusion Criteria | Mental disorders Affecting Compliance behavior | Mental condition Affecting Compliance behavior

Datatype

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C1321605
UMLS CUI [3,1]
C3840291
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C1321605
no previous malignancy within the past 5 years except nonmelanoma skin tumors or stage 0 (in situ) cervical carcinoma
Beschrijving

Exclusion Malignant Neoplasms Previous | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix

Datatype

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0006826
UMLS CUI [1,3]
C0205156
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
prior concurrent therapy:
Beschrijving

Therapeutic procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0087111
see disease characteristics
Beschrijving

ID.22

Datatype

boolean

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Similar models

Eligibility Lymphoma NCT00720447

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00720447
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Mantle cell lymphoma
Item
histologically confirmed diagnosis of mantle cell lymphoma
boolean
C0334634 (UMLS CUI [1])
Exclusion Criteria | Recurrent disease | Progressive Disease
Item
no relapsed or progressive disease
boolean
C0680251 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
C1335499 (UMLS CUI [3])
Partial response Post Induction Chemotherapy
Item
achieved at least a partial remission following induction chemotherapy
boolean
C1521726 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C3179010 (UMLS CUI [1,3])
HLA Match Donor Available
Item
hla-matched donor available
boolean
C4330149 (UMLS CUI [1,1])
C0013018 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
Blood specimen Patient Chimerism Study | Blood specimen Donor Chimerism Study
Item
blood samples from both patient and donor available for chimerism studies
boolean
C0178913 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0333678 (UMLS CUI [1,3])
C2603343 (UMLS CUI [1,4])
C0178913 (UMLS CUI [2,1])
C0013018 (UMLS CUI [2,2])
C0333678 (UMLS CUI [2,3])
C2603343 (UMLS CUI [2,4])
Exclusion Central Nervous System Involvement
Item
no central nervous system involvement
boolean
C2828389 (UMLS CUI [1,1])
C4050309 (UMLS CUI [1,2])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 2-4
boolean
C1520224 (UMLS CUI [1])
Patient Eligible Transplantation
Item
considered fit for transplant by treating physician
boolean
C0030705 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C0040732 (UMLS CUI [1,3])
Serum total bilirubin measurement
Item
serum bilirubin ≤ 1.5 times upper limit of normal
boolean
C1278039 (UMLS CUI [1])
Alkaline phosphatase measurement
Item
alkaline phosphatase ≤ 2 times normal
boolean
C0201850 (UMLS CUI [1])
Creatinine clearance measurement
Item
creatinine clearance ≥ 50 ml/min
boolean
C0373595 (UMLS CUI [1])
Cardiac ejection fraction | Exclusion Cardiac function Inadequate
Item
ejection fraction > 50% (no inadequate cardiac function)
boolean
C0232174 (UMLS CUI [1])
C2828389 (UMLS CUI [2,1])
C0232164 (UMLS CUI [2,2])
C0205412 (UMLS CUI [2,3])
Pregnancy Absent | Breast Feeding Absent
Item
not pregnant or nursing
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Pregnancy test negative
Item
negative pregnancy test
boolean
C0427780 (UMLS CUI [1])
Exclusion Airway compromise Symptomatic
Item
no symptomatic respiratory compromise
boolean
C2828389 (UMLS CUI [1,1])
C4055482 (UMLS CUI [1,2])
C0231220 (UMLS CUI [1,3])
Exclusion | Comorbidity Preventing Allograft
Item
no serious concurrent disease which would preclude allograft
boolean
C2828389 (UMLS CUI [1])
C0009488 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0040739 (UMLS CUI [2,3])
Exclusion Criteria | Serology positive Hepatitis B | Serology positive Hepatitis C | HIV Seropositivity
Item
no known serological positivity for hepatitis b, hepatitis c, or hiv
boolean
C0680251 (UMLS CUI [1])
C0242089 (UMLS CUI [2,1])
C0019163 (UMLS CUI [2,2])
C0242089 (UMLS CUI [3,1])
C0019196 (UMLS CUI [3,2])
C0019699 (UMLS CUI [4])
Exclusion Criteria | Mental disorders Affecting Compliance behavior | Mental condition Affecting Compliance behavior
Item
no history of a psychological illness or condition that would affect compliance
boolean
C0680251 (UMLS CUI [1])
C0004936 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C1321605 (UMLS CUI [2,3])
C3840291 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C1321605 (UMLS CUI [3,3])
Exclusion Malignant Neoplasms Previous | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix
Item
no previous malignancy within the past 5 years except nonmelanoma skin tumors or stage 0 (in situ) cervical carcinoma
boolean
C2828389 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
ID.22
Item
see disease characteristics
boolean
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