ID

30414

Beschreibung

Trial to Define the Safety and Tolerability of SGN-40, Rituximab, and Gemcitabine in Patients With DLBCL; ODM derived from: https://clinicaltrials.gov/show/NCT00655837

Link

https://clinicaltrials.gov/show/NCT00655837

Stichworte

Versionen (1)
  1. 03.06.18 03.06.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

3. Juni 2018

DOI

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Creative Commons BY 4.0
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Eligibility Lymphoma, Large B-Cell, Diffuse NCT00655837

Englisch

Eligibility Lymphoma, Large B-Cell, Diffuse NCT00655837

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
have a histologic diagnosis of dlbcl, including transformed histology and follicular grade 3 disease.
Beschreibung

Diffuse Large B-Cell Lymphoma | Lymphoma transformation | Follicular Lymphoma Ann Arbor lymphoma staging system

Datentyp

boolean

Alias
UMLS CUI [1]
C0079744
UMLS CUI [2]
C1536010
UMLS CUI [3,1]
C0024301
UMLS CUI [3,2]
C0432516
must have at least one site of biopsy-proven disease demonstrating both of the following: bidimensional measurable disease with the longest axis >= 1.5cm by radiographic imaging or positive fdg-pet scan at baseline.
Beschreibung

Disease Site Quantity Biopsy | Measurable Disease 2-Dimensional | Disease Axis Size Radiographic imaging | FDG-PET Positive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0005558
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C1705052
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C1522496
UMLS CUI [3,3]
C0456389
UMLS CUI [3,4]
C0457276
UMLS CUI [4,1]
C3641247
UMLS CUI [4,2]
C1514241
patients with dlbcl and who have either relapsed, refractory, or progressive disease following salvage therapy, or relapsed, refractory, or progressive disease following initial therapy and be medically unfit to receive aggressive therapy.
Beschreibung

Diffuse Large B-Cell Lymphoma | Recurrent disease Post Salvage Therapy | Refractory Disease Post Salvage Therapy | Progressive Disease Post Salvage Therapy | Recurrent disease Post First line treatment | Refractory Disease Post First line treatment | Progressive Disease Post First line treatment | Medically unfit Therapy Aggressive

Datentyp

boolean

Alias
UMLS CUI [1]
C0079744
UMLS CUI [2,1]
C0277556
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0085405
UMLS CUI [3,1]
C1514815
UMLS CUI [3,2]
C0687676
UMLS CUI [3,3]
C0085405
UMLS CUI [4,1]
C1335499
UMLS CUI [4,2]
C0687676
UMLS CUI [4,3]
C0085405
UMLS CUI [5,1]
C0277556
UMLS CUI [5,2]
C0687676
UMLS CUI [5,3]
C1708063
UMLS CUI [6,1]
C1514815
UMLS CUI [6,2]
C0687676
UMLS CUI [6,3]
C1708063
UMLS CUI [7,1]
C1335499
UMLS CUI [7,2]
C0687676
UMLS CUI [7,3]
C1708063
UMLS CUI [8,1]
C3841806
UMLS CUI [8,2]
C0087111
UMLS CUI [8,3]
C0580822
either fresh or archived tumor specimen must be available.
Beschreibung

Availability of Tumor sample Fresh | Availability of Tumor sample Stored

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0475358
UMLS CUI [1,3]
C0443224
UMLS CUI [2,1]
C0470187
UMLS CUI [2,2]
C0475358
UMLS CUI [2,3]
C1698986
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
documented history within 6 months of registration of a cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms.
Beschreibung

Event Cerebrovascular | Angina, Unstable | Myocardial Infarction | Cardiac symptoms

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C1880018
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0741933
patients who have received allogeneic stem cell transplant.
Beschreibung

Allogeneic Stem Cell Transplantation

Datentyp

boolean

Alias
UMLS CUI [1]
C2242529
patients with evidence of another invasive primary malignancy within the past three years other than non-melanoma skin cancer, cervical carcinoma in situ, in situ carcinoma of the breast, or fully resected prostate cancer with normal psa within 8 weeks of registration.
Beschreibung

Invasive cancer Primary | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Carcinoma in situ of female breast | Exception Prostate carcinoma Resected | Exception PSA normal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0677898
UMLS CUI [1,2]
C0205225
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0686288
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0600139
UMLS CUI [5,3]
C1521996
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0580554
patients with any active systemic viral, bacterial, or fungal infection requiring intravenous anti-infectives within 4 weeks prior to first dose of study drug.
Beschreibung

Systemic viral infection | Systemic bacterial infection | Systemic mycosis | Requirement Anti-Infective Agents Intravenous

Datentyp

boolean

Alias
UMLS CUI [1]
C4285789
UMLS CUI [2]
C4285778
UMLS CUI [3]
C0553576
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C0003204
UMLS CUI [4,3]
C1522726
patients with a history or clinical evidence of leptomeningeal or central nervous system (cns) lymphoma.
Beschreibung

Leptomeningeal Lymphoma | Central nervous system lymphoma

Datentyp

boolean

Alias
UMLS CUI [1]
C2213017
UMLS CUI [2]
C0742472
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Ähnliche Modelle

Eligibility Lymphoma, Large B-Cell, Diffuse NCT00655837

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Diffuse Large B-Cell Lymphoma | Lymphoma transformation | Follicular Lymphoma Ann Arbor lymphoma staging system
Item
have a histologic diagnosis of dlbcl, including transformed histology and follicular grade 3 disease.
boolean
C0079744 (UMLS CUI [1])
C1536010 (UMLS CUI [2])
C0024301 (UMLS CUI [3,1])
C0432516 (UMLS CUI [3,2])
Disease Site Quantity Biopsy | Measurable Disease 2-Dimensional | Disease Axis Size Radiographic imaging | FDG-PET Positive
Item
must have at least one site of biopsy-proven disease demonstrating both of the following: bidimensional measurable disease with the longest axis >= 1.5cm by radiographic imaging or positive fdg-pet scan at baseline.
boolean
C0012634 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0005558 (UMLS CUI [1,4])
C1513041 (UMLS CUI [2,1])
C1705052 (UMLS CUI [2,2])
C0012634 (UMLS CUI [3,1])
C1522496 (UMLS CUI [3,2])
C0456389 (UMLS CUI [3,3])
C0457276 (UMLS CUI [3,4])
C3641247 (UMLS CUI [4,1])
C1514241 (UMLS CUI [4,2])
Diffuse Large B-Cell Lymphoma | Recurrent disease Post Salvage Therapy | Refractory Disease Post Salvage Therapy | Progressive Disease Post Salvage Therapy | Recurrent disease Post First line treatment | Refractory Disease Post First line treatment | Progressive Disease Post First line treatment | Medically unfit Therapy Aggressive
Item
patients with dlbcl and who have either relapsed, refractory, or progressive disease following salvage therapy, or relapsed, refractory, or progressive disease following initial therapy and be medically unfit to receive aggressive therapy.
boolean
C0079744 (UMLS CUI [1])
C0277556 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0085405 (UMLS CUI [2,3])
C1514815 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C0085405 (UMLS CUI [3,3])
C1335499 (UMLS CUI [4,1])
C0687676 (UMLS CUI [4,2])
C0085405 (UMLS CUI [4,3])
C0277556 (UMLS CUI [5,1])
C0687676 (UMLS CUI [5,2])
C1708063 (UMLS CUI [5,3])
C1514815 (UMLS CUI [6,1])
C0687676 (UMLS CUI [6,2])
C1708063 (UMLS CUI [6,3])
C1335499 (UMLS CUI [7,1])
C0687676 (UMLS CUI [7,2])
C1708063 (UMLS CUI [7,3])
C3841806 (UMLS CUI [8,1])
C0087111 (UMLS CUI [8,2])
C0580822 (UMLS CUI [8,3])
Availability of Tumor sample Fresh | Availability of Tumor sample Stored
Item
either fresh or archived tumor specimen must be available.
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C0443224 (UMLS CUI [1,3])
C0470187 (UMLS CUI [2,1])
C0475358 (UMLS CUI [2,2])
C1698986 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Event Cerebrovascular | Angina, Unstable | Myocardial Infarction | Cardiac symptoms
Item
documented history within 6 months of registration of a cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms.
boolean
C0441471 (UMLS CUI [1,1])
C1880018 (UMLS CUI [1,2])
C0002965 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0741933 (UMLS CUI [4])
Allogeneic Stem Cell Transplantation
Item
patients who have received allogeneic stem cell transplant.
boolean
C2242529 (UMLS CUI [1])
Invasive cancer Primary | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Carcinoma in situ of female breast | Exception Prostate carcinoma Resected | Exception PSA normal
Item
patients with evidence of another invasive primary malignancy within the past three years other than non-melanoma skin cancer, cervical carcinoma in situ, in situ carcinoma of the breast, or fully resected prostate cancer with normal psa within 8 weeks of registration.
boolean
C0677898 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0686288 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0600139 (UMLS CUI [5,2])
C1521996 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0580554 (UMLS CUI [6,2])
Systemic viral infection | Systemic bacterial infection | Systemic mycosis | Requirement Anti-Infective Agents Intravenous
Item
patients with any active systemic viral, bacterial, or fungal infection requiring intravenous anti-infectives within 4 weeks prior to first dose of study drug.
boolean
C4285789 (UMLS CUI [1])
C4285778 (UMLS CUI [2])
C0553576 (UMLS CUI [3])
C1514873 (UMLS CUI [4,1])
C0003204 (UMLS CUI [4,2])
C1522726 (UMLS CUI [4,3])
Leptomeningeal Lymphoma | Central nervous system lymphoma
Item
patients with a history or clinical evidence of leptomeningeal or central nervous system (cns) lymphoma.
boolean
C2213017 (UMLS CUI [1])
C0742472 (UMLS CUI [2])
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