ID

37710

Description

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

Link

https://clinicaltrials.gov/show/NCT01516580

Keywords

Versions (1)
  1. 8/19/19 8/19/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 19, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility B-cell Non Hodgkin Lymphoma NCT01516580

English

Eligibility B-cell Non Hodgkin Lymphoma NCT01516580

1 forms  
Inclusion Criteria
Description

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.
Description

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

Data type

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.
Description

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

Data type

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.
Description

Age

Data type

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.
Description

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

Data type

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.
Description

Work up Initial Complete

Data type

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.
Description

Compliance Follow-up Scheduled | Compliance Management Toxicity

Data type

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
Description

Informed Consent | Informed Consent Parent | Informed Consent Guardian

Data type

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
Description

Exclusion Criteria

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

Lymphoma, Follicular | MALT Lymphoma | Nodal marginal zone lymphoma

Data type

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.
Description

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

Data type

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.
Description

Pregnancy | Breast Feeding

Data type

boolean

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

Exclusion Criteria Absent Organ function

Data type

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.
Description

Cancer treatment | Exception Adrenal Cortex Hormones

Data type

boolean

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

Neoplastic Cell CD20 Negative

Data type

boolean

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

Exposure to Rituximab

Data type

boolean

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

Virus Disease Severe | Hepatitis B

Data type

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.
Description

Hepatitis B carrier | Hepatitis B | HEPATITIS B SEROLOGY POSITIVE

Data type

boolean

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

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

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

Compliance Unable Legislation

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C1299582
UMLS CUI [1,3]
C0023252
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Similar models

Eligibility B-cell Non Hodgkin Lymphoma NCT01516580

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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