ID

37710

Beskrivning

Intergroup Randomized Trial for Children or Adolescents With B-Cell Non Hodgkin Lymphoma or B-Acute Leukemia: Rituximab Evaluation in High Risk Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01516580

Länk

https://clinicaltrials.gov/show/NCT01516580

Nyckelord

Versioner (1)
  1. 2019-08-19 2019-08-19 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

19 augusti 2019

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility B-cell Non Hodgkin Lymphoma NCT01516580

Engelsk

Eligibility B-cell Non Hodgkin Lymphoma NCT01516580

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically proven b-cell malignancies, either burkitt lymphoma or b-al (=burkitt leukaemia = l3-al) or diffuse large b-cell nhl or aggressive mature b-cell nhl non other specified or specifiable.
Beskrivning

B-cell Malignancies | Burkitt Lymphoma | Childhood Burkitt Leukemia FAB Classification | Diffuse Large B-Cell Lymphoma | Mature B-Cell Non-Hodgkin Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004561
UMLS CUI [1,2]
C0006826
UMLS CUI [2]
C0006413
UMLS CUI [3,1]
C0279582
UMLS CUI [3,2]
C2984084
UMLS CUI [4]
C0079744
UMLS CUI [5]
C1334634
stage iii with elevated ldh level ("b-high"), [ldh > twice the institutional upper limit of the adult normal values (> nx2)] or any stage iv or b-al.
Beskrivning

Ann Arbor lymphoma staging system | Serum LDH level elevated | Childhood Burkitt Leukemia

Datatyp

boolean

Alias
UMLS CUI [1]
C0432516
UMLS CUI [2]
C1275604
UMLS CUI [3]
C0279582
6 months to less than 18 years of age at the time of consent.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
males and females of reproductive potential must agree to use an effective contraceptive method during the treatment, and after the end of treatment: during twelve months for women, taking into account the characteristics of rituximab and during five months for men, taking into account the characteristics of methotrexate.
Beskrivning

Females & males of reproductive potential Contraceptive methods | Relationship Characteristics Rituximab | Relationship Characteristics Methotrexate

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C1521970
UMLS CUI [2,3]
C0393022
UMLS CUI [3,1]
C0439849
UMLS CUI [3,2]
C1521970
UMLS CUI [3,3]
C0025677
complete initial work-up within 8 days prior to treatment that allows definite staging.
Beskrivning

Work up Initial Complete

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0750430
UMLS CUI [1,2]
C0205265
UMLS CUI [1,3]
C0205197
able to comply with scheduled follow-up and with management of toxicity.
Beskrivning

Compliance Follow-up Scheduled | Compliance Management Toxicity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C3274571
UMLS CUI [1,3]
C0205539
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C1273870
UMLS CUI [2,3]
C0600688
signed informed consent from patients and/or their parents or legal guardians
Beskrivning

Informed Consent | Informed Consent Parent | Informed Consent Guardian

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030551
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C1274041
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
follicular lymphoma, malt and nodular marginal zone are not included into this therapeutic study
Beskrivning

Lymphoma, Follicular | MALT Lymphoma | Nodal marginal zone lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0024301
UMLS CUI [2]
C0242647
UMLS CUI [3]
C0855139
patients with congenital immunodeficiency, chromosomal breakage syndrome, prior organ transplantation, previous malignancy of any type, or known positive hiv serology.
Beskrivning

Immunodeficiency congenital | Nijmegen Breakage Syndrome | Organ Transplantation Previous | Malignant Neoplasms Previous | HIV Seropositivity

Datatyp

boolean

Alias
UMLS CUI [1]
C0853602
UMLS CUI [2]
C0398791
UMLS CUI [3,1]
C0029216
UMLS CUI [3,2]
C0205156
UMLS CUI [4,1]
C0006826
UMLS CUI [4,2]
C0205156
UMLS CUI [5]
C0019699
evidence of pregnancy or lactation period.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
there will be no exclusion criteria based on organ function.
Beskrivning

Exclusion Criteria Absent Organ function

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0678852
past or current anti-cancer treatment except corticosteroids during less than one week.
Beskrivning

Cancer treatment | Exception Adrenal Cortex Hormones

Datatyp

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0001617
tumor cell negative for cd20
Beskrivning

Neoplastic Cell CD20 Negative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0597032
UMLS CUI [1,2]
C4527200
prior exposure to rituximab.
Beskrivning

Exposure to Rituximab

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0393022
severe active viral infection, especially hepatitis b.
Beskrivning

Virus Disease Severe | Hepatitis B

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0042769
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0019163
hepatitis b carrier status history of hbv or positive serology.
Beskrivning

Hepatitis B carrier | Hepatitis B | HEPATITIS B SEROLOGY POSITIVE

Datatyp

boolean

Alias
UMLS CUI [1]
C0262505
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0744838
participation in another investigational drug clinical trial.
Beskrivning

Study Subject Participation Status | Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
patients who, for any reason, are not able to comply with the national legislation.
Beskrivning

Compliance Unable Legislation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C1299582
UMLS CUI [1,3]
C0023252
Tillbaka till toppen

Similar models

Eligibility B-cell Non Hodgkin Lymphoma NCT01516580

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
B-cell Malignancies | Burkitt Lymphoma | Childhood Burkitt Leukemia FAB Classification | Diffuse Large B-Cell Lymphoma | Mature B-Cell Non-Hodgkin Lymphoma
Item
histologically or cytologically proven b-cell malignancies, either burkitt lymphoma or b-al (=burkitt leukaemia = l3-al) or diffuse large b-cell nhl or aggressive mature b-cell nhl non other specified or specifiable.
boolean
C0004561 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0006413 (UMLS CUI [2])
C0279582 (UMLS CUI [3,1])
C2984084 (UMLS CUI [3,2])
C0079744 (UMLS CUI [4])
C1334634 (UMLS CUI [5])
Ann Arbor lymphoma staging system | Serum LDH level elevated | Childhood Burkitt Leukemia
Item
stage iii with elevated ldh level ("b-high"), [ldh > twice the institutional upper limit of the adult normal values (> nx2)] or any stage iv or b-al.
boolean
C0432516 (UMLS CUI [1])
C1275604 (UMLS CUI [2])
C0279582 (UMLS CUI [3])
Age
Item
6 months to less than 18 years of age at the time of consent.
boolean
C0001779 (UMLS CUI [1])
Females & males of reproductive potential Contraceptive methods | Relationship Characteristics Rituximab | Relationship Characteristics Methotrexate
Item
males and females of reproductive potential must agree to use an effective contraceptive method during the treatment, and after the end of treatment: during twelve months for women, taking into account the characteristics of rituximab and during five months for men, taking into account the characteristics of methotrexate.
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0439849 (UMLS CUI [2,1])
C1521970 (UMLS CUI [2,2])
C0393022 (UMLS CUI [2,3])
C0439849 (UMLS CUI [3,1])
C1521970 (UMLS CUI [3,2])
C0025677 (UMLS CUI [3,3])
Work up Initial Complete
Item
complete initial work-up within 8 days prior to treatment that allows definite staging.
boolean
C0750430 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Compliance Follow-up Scheduled | Compliance Management Toxicity
Item
able to comply with scheduled follow-up and with management of toxicity.
boolean
C1321605 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
C1321605 (UMLS CUI [2,1])
C1273870 (UMLS CUI [2,2])
C0600688 (UMLS CUI [2,3])
Informed Consent | Informed Consent Parent | Informed Consent Guardian
Item
signed informed consent from patients and/or their parents or legal guardians
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030551 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3,1])
C1274041 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Lymphoma, Follicular | MALT Lymphoma | Nodal marginal zone lymphoma
Item
follicular lymphoma, malt and nodular marginal zone are not included into this therapeutic study
boolean
C0024301 (UMLS CUI [1])
C0242647 (UMLS CUI [2])
C0855139 (UMLS CUI [3])
Immunodeficiency congenital | Nijmegen Breakage Syndrome | Organ Transplantation Previous | Malignant Neoplasms Previous | HIV Seropositivity
Item
patients with congenital immunodeficiency, chromosomal breakage syndrome, prior organ transplantation, previous malignancy of any type, or known positive hiv serology.
boolean
C0853602 (UMLS CUI [1])
C0398791 (UMLS CUI [2])
C0029216 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
C0006826 (UMLS CUI [4,1])
C0205156 (UMLS CUI [4,2])
C0019699 (UMLS CUI [5])
Pregnancy | Breast Feeding
Item
evidence of pregnancy or lactation period.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Exclusion Criteria Absent Organ function
Item
there will be no exclusion criteria based on organ function.
boolean
C0680251 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0678852 (UMLS CUI [1,3])
Cancer treatment | Exception Adrenal Cortex Hormones
Item
past or current anti-cancer treatment except corticosteroids during less than one week.
boolean
C0920425 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0001617 (UMLS CUI [2,2])
Neoplastic Cell CD20 Negative
Item
tumor cell negative for cd20
boolean
C0597032 (UMLS CUI [1,1])
C4527200 (UMLS CUI [1,2])
Exposure to Rituximab
Item
prior exposure to rituximab.
boolean
C0332157 (UMLS CUI [1,1])
C0393022 (UMLS CUI [1,2])
Virus Disease Severe | Hepatitis B
Item
severe active viral infection, especially hepatitis b.
boolean
C0042769 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0019163 (UMLS CUI [2])
Hepatitis B carrier | Hepatitis B | HEPATITIS B SEROLOGY POSITIVE
Item
hepatitis b carrier status history of hbv or positive serology.
boolean
C0262505 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0744838 (UMLS CUI [3])
Study Subject Participation Status | Investigational New Drugs
Item
participation in another investigational drug clinical trial.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Compliance Unable Legislation
Item
patients who, for any reason, are not able to comply with the national legislation.
boolean
C1321605 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0023252 (UMLS CUI [1,3])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial