ID

36295

Beschrijving

Lonquek for Autologous Stem Cell Mobilization; ODM derived from: https://clinicaltrials.gov/show/NCT02488382

Link

https://clinicaltrials.gov/show/NCT02488382

Trefwoorden

  1. 30-04-19 30-04-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

30 april 2019

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Lymphoma NCT02488382

Eligibility Lymphoma NCT02488382

  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT02488382
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with confirmed multiple myeloma or hodgkins or non hodgkin lymphoma at need of autologous stem cell transplantation.
Beschrijving

Multiple Myeloma | Hodgkin lymphoma | Lymphoma, Non-Hodgkin | Patient need for Transplantation of autologous hematopoietic stem cell

Datatype

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2]
C0019829
UMLS CUI [3]
C0024305
UMLS CUI [4,1]
C0686904
UMLS CUI [4,2]
C1831743
disease must be chemosensitive or stable status to prior therapy before transplant.
Beschrijving

Chemosensitive malignant neoplastic disease | Stable status Prior Therapy | Status pre- Transplantation

Datatype

boolean

Alias
UMLS CUI [1]
C4520514
UMLS CUI [2,1]
C0205360
UMLS CUI [2,2]
C1514463
UMLS CUI [3,1]
C0332152
UMLS CUI [3,2]
C0040732
age between 18 and 65 years inclusive.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status 0, 1 or 2.
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
written informed consent.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
adequate birth control in fertile patients.
Beschrijving

Patients Fertile Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0015895
UMLS CUI [1,3]
C0700589
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
lymphoma patients that did not fulfill the inclusion criteria.
Beschrijving

Inclusion criteria failed

Datatype

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0231175
patients with factors predicting poor mobilization including >3 lines of previous chemotherapy, extensive irradiation, patients that received stem cell toxicity drugs like melphalan, fludarabine, >2 courses of revlimid, age >65 years, platelets counts <100x109/l, wbc<2.5x109/l or wbc > 35x109/l.
Beschrijving

Factor Mobilization Poor | Chemotherapy cycle Quantity | Therapeutic radiology procedure Extensive | Pharmaceutical Preparations Stem cell Toxicity | Melphalan | fludarabine | Revlimid | Age | Platelet Count measurement | White Blood Cell Count procedure

Datatype

boolean

Alias
UMLS CUI [1,1]
C1521761
UMLS CUI [1,2]
C0300926
UMLS CUI [1,3]
C0542537
UMLS CUI [2,1]
C1302181
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0205231
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C0038250
UMLS CUI [4,3]
C0600688
UMLS CUI [5]
C0025241
UMLS CUI [6]
C0059985
UMLS CUI [7]
C1135145
UMLS CUI [8]
C0001779
UMLS CUI [9]
C0032181
UMLS CUI [10]
C0023508
previous autologous stem cell transplantation.
Beschrijving

Transplantation of autologous hematopoietic stem cell

Datatype

boolean

Alias
UMLS CUI [1]
C1831743
inability to tolerate peripheral blood stem cell harvest.
Beschrijving

Harvesting of peripheral blood stem cells Receive Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0457411
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
peripheral venous access not possible.
Beschrijving

Peripheral venous access Unsuccessful

Datatype

boolean

Alias
UMLS CUI [1,1]
C4489703
UMLS CUI [1,2]
C1272705

Similar models

Eligibility Lymphoma NCT02488382

  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT02488382
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma | Hodgkin lymphoma | Lymphoma, Non-Hodgkin | Patient need for Transplantation of autologous hematopoietic stem cell
Item
patients with confirmed multiple myeloma or hodgkins or non hodgkin lymphoma at need of autologous stem cell transplantation.
boolean
C0026764 (UMLS CUI [1])
C0019829 (UMLS CUI [2])
C0024305 (UMLS CUI [3])
C0686904 (UMLS CUI [4,1])
C1831743 (UMLS CUI [4,2])
Chemosensitive malignant neoplastic disease | Stable status Prior Therapy | Status pre- Transplantation
Item
disease must be chemosensitive or stable status to prior therapy before transplant.
boolean
C4520514 (UMLS CUI [1])
C0205360 (UMLS CUI [2,1])
C1514463 (UMLS CUI [2,2])
C0332152 (UMLS CUI [3,1])
C0040732 (UMLS CUI [3,2])
Age
Item
age between 18 and 65 years inclusive.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0, 1 or 2.
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
written informed consent.
boolean
C0021430 (UMLS CUI [1])
Patients Fertile Contraceptive methods
Item
adequate birth control in fertile patients.
boolean
C0030705 (UMLS CUI [1,1])
C0015895 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Inclusion criteria failed
Item
lymphoma patients that did not fulfill the inclusion criteria.
boolean
C1512693 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Factor Mobilization Poor | Chemotherapy cycle Quantity | Therapeutic radiology procedure Extensive | Pharmaceutical Preparations Stem cell Toxicity | Melphalan | fludarabine | Revlimid | Age | Platelet Count measurement | White Blood Cell Count procedure
Item
patients with factors predicting poor mobilization including >3 lines of previous chemotherapy, extensive irradiation, patients that received stem cell toxicity drugs like melphalan, fludarabine, >2 courses of revlimid, age >65 years, platelets counts <100x109/l, wbc<2.5x109/l or wbc > 35x109/l.
boolean
C1521761 (UMLS CUI [1,1])
C0300926 (UMLS CUI [1,2])
C0542537 (UMLS CUI [1,3])
C1302181 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C0205231 (UMLS CUI [3,2])
C0013227 (UMLS CUI [4,1])
C0038250 (UMLS CUI [4,2])
C0600688 (UMLS CUI [4,3])
C0025241 (UMLS CUI [5])
C0059985 (UMLS CUI [6])
C1135145 (UMLS CUI [7])
C0001779 (UMLS CUI [8])
C0032181 (UMLS CUI [9])
C0023508 (UMLS CUI [10])
Transplantation of autologous hematopoietic stem cell
Item
previous autologous stem cell transplantation.
boolean
C1831743 (UMLS CUI [1])
Harvesting of peripheral blood stem cells Receive Unable
Item
inability to tolerate peripheral blood stem cell harvest.
boolean
C0457411 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Peripheral venous access Unsuccessful
Item
peripheral venous access not possible.
boolean
C4489703 (UMLS CUI [1,1])
C1272705 (UMLS CUI [1,2])

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