ID

18024

Beschreibung

BBR 2778 for Relapsed, Aggressive Non-Hodgkin's Lymphoma (NHL); ODM derived from: https://clinicaltrials.gov/show/NCT00088530

Link

https://clinicaltrials.gov/show/NCT00088530

Stichworte

Versionen (1)
  1. 14.10.16 14.10.16 -
Hochgeladen am

14. Oktober 2016

DOI

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Creative Commons BY 4.0
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Eligibility Lymphoma, Non-Hodgkin NCT00088530

Englisch

Eligibility Lymphoma, Non-Hodgkin NCT00088530

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed aggressive [de novo or transformed] nhl according to real/who classification.
Beschreibung

Aggressive Non-Hodgkin Lymphoma de novo | Aggressive Non-Hodgkin Lymphoma Transformed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1332225
UMLS CUI [1,2]
C1515568
UMLS CUI [2,1]
C1332225
UMLS CUI [2,2]
C0457344
at least one objectively measurable lesion as demonstrated by ct, spiral ct, or mri and plain radiograph of the chest (chest x-ray, for chest lesions only) that can be followed for response as target lesion.
Beschreibung

Measurable Disease Quantity | X-Ray Computed Tomography | Tomography, Spiral Computed | Magnetic Resonance Imaging | Plain chest X-ray | Target Lesion Related Response

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0040405
UMLS CUI [3]
C0860888
UMLS CUI [4]
C0024485
UMLS CUI [5]
C0039985
UMLS CUI [6,1]
C2986546
UMLS CUI [6,2]
C0439849
UMLS CUI [6,3]
C1704632
relapse after 2 or more prior regimens of chemotherapy
Beschreibung

Prior Chemotherapy Quantity | Recurrent disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0277556
ecog performance status of 0, 1, or 2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate hematologic, renal and hepatic function
Beschreibung

Hematologic function | Renal function | Liver function

Datentyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
lvef ≥50% determined by muga scan
Beschreibung

Left ventricular ejection fraction | Multiple gated acquisition scanning

Datentyp

boolean

Alias
UMLS CUI [1]
C0428772
UMLS CUI [2]
C0521317
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior treatment with a cumulative dose of doxorubicin or equivalent exceeding 450 mg/m²
Beschreibung

Doxorubicin Cumulative Dose | Doxorubicin Equivalent Cumulative Dose

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013089
UMLS CUI [1,2]
C2986497
UMLS CUI [2,1]
C0013089
UMLS CUI [2,2]
C0205163
UMLS CUI [2,3]
C2986497
prior allogenic stem cell transplant
Beschreibung

Allogeneic Stem Cell Transplantation

Datentyp

boolean

Alias
UMLS CUI [1]
C2242529
histological diagnosis of burkitt lymphoma, lymphoblastic lymphoma or mantle cell lymphoma
Beschreibung

Burkitt Lymphoma | Precursor cell lymphoblastic lymphoma | Mantle cell lymphoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0006413
UMLS CUI [2]
C0079748
UMLS CUI [3]
C0334634
active cns lymphoma or hiv-related lymphoma.
Beschreibung

Central nervous system lymphoma | Lymphoma, AIDS-Related

Datentyp

boolean

Alias
UMLS CUI [1]
C0742472
UMLS CUI [2]
C0085090
any chemotherapy, radiotherapy, or other anticancer treatment (including corticosteroid, 10 or more mg/day of prednisone or equivalent) within the 2 weeks before randomization
Beschreibung

Chemotherapy | Therapeutic radiology procedure | cancer treatment | Adrenal Cortex Hormones | Prednisone | Prednisone Equivalent

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0920425
UMLS CUI [4]
C0001617
UMLS CUI [5]
C0032952
UMLS CUI [6,1]
C0032952
UMLS CUI [6,2]
C0205163
pregnant women or nursing mothers
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Ähnliche Modelle

Eligibility Lymphoma, Non-Hodgkin NCT00088530

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Aggressive Non-Hodgkin Lymphoma de novo | Aggressive Non-Hodgkin Lymphoma Transformed
Item
histologically confirmed aggressive [de novo or transformed] nhl according to real/who classification.
boolean
C1332225 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C1332225 (UMLS CUI [2,1])
C0457344 (UMLS CUI [2,2])
Measurable Disease Quantity | X-Ray Computed Tomography | Tomography, Spiral Computed | Magnetic Resonance Imaging | Plain chest X-ray | Target Lesion Related Response
Item
at least one objectively measurable lesion as demonstrated by ct, spiral ct, or mri and plain radiograph of the chest (chest x-ray, for chest lesions only) that can be followed for response as target lesion.
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0040405 (UMLS CUI [2])
C0860888 (UMLS CUI [3])
C0024485 (UMLS CUI [4])
C0039985 (UMLS CUI [5])
C2986546 (UMLS CUI [6,1])
C0439849 (UMLS CUI [6,2])
C1704632 (UMLS CUI [6,3])
Prior Chemotherapy Quantity | Recurrent disease
Item
relapse after 2 or more prior regimens of chemotherapy
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0277556 (UMLS CUI [2])
ECOG performance status
Item
ecog performance status of 0, 1, or 2
boolean
C1520224 (UMLS CUI [1])
Hematologic function | Renal function | Liver function
Item
adequate hematologic, renal and hepatic function
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Left ventricular ejection fraction | Multiple gated acquisition scanning
Item
lvef ≥50% determined by muga scan
boolean
C0428772 (UMLS CUI [1])
C0521317 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Doxorubicin Cumulative Dose | Doxorubicin Equivalent Cumulative Dose
Item
prior treatment with a cumulative dose of doxorubicin or equivalent exceeding 450 mg/m²
boolean
C0013089 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
C0013089 (UMLS CUI [2,1])
C0205163 (UMLS CUI [2,2])
C2986497 (UMLS CUI [2,3])
Allogeneic Stem Cell Transplantation
Item
prior allogenic stem cell transplant
boolean
C2242529 (UMLS CUI [1])
Burkitt Lymphoma | Precursor cell lymphoblastic lymphoma | Mantle cell lymphoma
Item
histological diagnosis of burkitt lymphoma, lymphoblastic lymphoma or mantle cell lymphoma
boolean
C0006413 (UMLS CUI [1])
C0079748 (UMLS CUI [2])
C0334634 (UMLS CUI [3])
Central nervous system lymphoma | Lymphoma, AIDS-Related
Item
active cns lymphoma or hiv-related lymphoma.
boolean
C0742472 (UMLS CUI [1])
C0085090 (UMLS CUI [2])
Chemotherapy | Therapeutic radiology procedure | cancer treatment | Adrenal Cortex Hormones | Prednisone | Prednisone Equivalent
Item
any chemotherapy, radiotherapy, or other anticancer treatment (including corticosteroid, 10 or more mg/day of prednisone or equivalent) within the 2 weeks before randomization
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0920425 (UMLS CUI [3])
C0001617 (UMLS CUI [4])
C0032952 (UMLS CUI [5])
C0032952 (UMLS CUI [6,1])
C0205163 (UMLS CUI [6,2])
Pregnancy | Breast Feeding
Item
pregnant women or nursing mothers
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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