ID

41238

Beskrivning

A Study of DCDT2980S in Combination With MabThera/Rituxan or DCDS4501A in Combination With MabThera/Rituxan and Evaluation of Combination DCDS4501A and Obinutuzumab in Patients With Non-Hodgkin's Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01691898

Länk

https://clinicaltrials.gov/show/NCT01691898

Nyckelord

Versioner (1)
  1. 2020-07-22 2020-07-22 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

22 juli 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Lymphoma, B-Cell, Lymphoma, Follicular NCT01691898

Engelsk

Eligibility Lymphoma, B-Cell, Lymphoma, Follicular NCT01691898

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
eastern cooperative oncology group (ecog) performance status of 0, 1, or 2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy of at least 12 weeks
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
history of histologically documented relapsed or refractory grades 1-3a follicular lymphoma, or relapsed or refractory diffuse large b-cell lymphoma
Beskrivning

Recurrent Follicular Lymphoma Ann Arbor lymphoma staging system | Refractory Follicular Lymphoma Ann Arbor lymphoma staging system | Diffuse large B-cell lymphoma recurrent | Diffuse large B-cell lymphoma refractory

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1335701
UMLS CUI [1,2]
C0432516
UMLS CUI [2,1]
C1335723
UMLS CUI [2,2]
C0432516
UMLS CUI [3]
C0855111
UMLS CUI [4]
C0855112
availability of an archival or freshly biopsied tumor tissue sample must be confirmed for study enrollment
Beskrivning

Availability of Tumor tissue sample

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0475358
have a clinical indication for treatment as determined by the investigator
Beskrivning

Indication Therapeutic procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0087111
must have at least one bi-dimensionally measurable lesion (>1.5 cm in its largest dimension by ct scan or mri)
Beskrivning

Measurable Disease 2-Dimensional Quantity | Lesion size, largest dimension CT scan | Lesion size, largest dimension MRI

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1705052
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C1275593
UMLS CUI [2,2]
C0040405
UMLS CUI [3,1]
C1275593
UMLS CUI [3,2]
C0024485
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior use of any monoclonal antibody, radioimmuno-conjugate or antibody drug conjugate within 4 weeks before study start
Beskrivning

Monoclonal Antibodies | Other Coding | Antibody conjugate

Datatyp

boolean

Alias
UMLS CUI [1]
C0003250
UMLS CUI [2]
C3846158
UMLS CUI [3]
C0598658
treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational anti-cancer agent within 2 weeks prior study start
Beskrivning

Therapeutic radiology procedure | Chemotherapy | Immunotherapy | Therapeutic immunosuppression | Antineoplastic Agents Investigational

Datatyp

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C0392920
UMLS CUI [3]
C0021083
UMLS CUI [4]
C0021079
UMLS CUI [5,1]
C0003392
UMLS CUI [5,2]
C1517586
adverse events except for sensory neuropathy from any previous treatments must be resolved or stabilized to grade </=2 prior study start
Beskrivning

Adverse event Due to Prior Therapy | Exception Sensory neuropathy | Requirement Recovery CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C1514463
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0151313
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C2004454
UMLS CUI [3,3]
C1516728
completion of autologous stem cell transplant within 100 days prior study start
Beskrivning

Autologous hematopoietic stem cell transplant Completion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2193200
UMLS CUI [1,2]
C0205197
prior allogeneic stem cell transplant
Beskrivning

Allogeneic Stem Cell Transplantation

Datatyp

boolean

Alias
UMLS CUI [1]
C2242529
eligibility for autologous sct (patients with relapsed or refractory dlbcl)
Beskrivning

Patients Eligible Autologous hematopoietic stem cell transplant | Diffuse large B-cell lymphoma recurrent | Diffuse large B-cell lymphoma refractory

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548635
UMLS CUI [1,3]
C2193200
UMLS CUI [2]
C0855111
UMLS CUI [3]
C0855112
history of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
Beskrivning

Allergic Reaction Severe Monoclonal Antibody Therapy | Anaphylaxis Severe Monoclonal Antibody Therapy | Allergic Reaction Recombinant Fusion Proteins Antibody Related | Anaphylaxis Recombinant Fusion Proteins Antibody Related

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0279694
UMLS CUI [2,1]
C0002792
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0279694
UMLS CUI [3,1]
C1527304
UMLS CUI [3,2]
C0034857
UMLS CUI [3,3]
C0003241
UMLS CUI [3,4]
C0439849
UMLS CUI [4,1]
C0002792
UMLS CUI [4,2]
C0034857
UMLS CUI [4,3]
C0003241
UMLS CUI [4,4]
C0439849
history of other malignancy that could affect compliance with the protocol or interpretation of results
Beskrivning

Cancer Other Affecting Protocol Compliance | Cancer Other Affecting Interpretation Research results

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C1707251
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0459471
UMLS CUI [2,4]
C0683954
current or past history of cns lymphoma
Beskrivning

Primary central nervous system lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0280803
current grade > 1 peripheral neuropathy
Beskrivning

Peripheral Neuropathy CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
Tillbaka till toppen

Similar models

Eligibility Lymphoma, B-Cell, Lymphoma, Follicular NCT01691898

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0, 1, or 2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of at least 12 weeks
boolean
C0023671 (UMLS CUI [1])
Recurrent Follicular Lymphoma Ann Arbor lymphoma staging system | Refractory Follicular Lymphoma Ann Arbor lymphoma staging system | Diffuse large B-cell lymphoma recurrent | Diffuse large B-cell lymphoma refractory
Item
history of histologically documented relapsed or refractory grades 1-3a follicular lymphoma, or relapsed or refractory diffuse large b-cell lymphoma
boolean
C1335701 (UMLS CUI [1,1])
C0432516 (UMLS CUI [1,2])
C1335723 (UMLS CUI [2,1])
C0432516 (UMLS CUI [2,2])
C0855111 (UMLS CUI [3])
C0855112 (UMLS CUI [4])
Availability of Tumor tissue sample
Item
availability of an archival or freshly biopsied tumor tissue sample must be confirmed for study enrollment
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
Indication Therapeutic procedure
Item
have a clinical indication for treatment as determined by the investigator
boolean
C3146298 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Measurable Disease 2-Dimensional Quantity | Lesion size, largest dimension CT scan | Lesion size, largest dimension MRI
Item
must have at least one bi-dimensionally measurable lesion (>1.5 cm in its largest dimension by ct scan or mri)
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1275593 (UMLS CUI [2,1])
C0040405 (UMLS CUI [2,2])
C1275593 (UMLS CUI [3,1])
C0024485 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Monoclonal Antibodies | Other Coding | Antibody conjugate
Item
prior use of any monoclonal antibody, radioimmuno-conjugate or antibody drug conjugate within 4 weeks before study start
boolean
C0003250 (UMLS CUI [1])
C3846158 (UMLS CUI [2])
C0598658 (UMLS CUI [3])
Therapeutic radiology procedure | Chemotherapy | Immunotherapy | Therapeutic immunosuppression | Antineoplastic Agents Investigational
Item
treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational anti-cancer agent within 2 weeks prior study start
boolean
C1522449 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C0021079 (UMLS CUI [4])
C0003392 (UMLS CUI [5,1])
C1517586 (UMLS CUI [5,2])
Adverse event Due to Prior Therapy | Exception Sensory neuropathy | Requirement Recovery CTCAE Grades
Item
adverse events except for sensory neuropathy from any previous treatments must be resolved or stabilized to grade </=2 prior study start
boolean
C0877248 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0151313 (UMLS CUI [2,2])
C1514873 (UMLS CUI [3,1])
C2004454 (UMLS CUI [3,2])
C1516728 (UMLS CUI [3,3])
Autologous hematopoietic stem cell transplant Completion
Item
completion of autologous stem cell transplant within 100 days prior study start
boolean
C2193200 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Allogeneic Stem Cell Transplantation
Item
prior allogeneic stem cell transplant
boolean
C2242529 (UMLS CUI [1])
Patients Eligible Autologous hematopoietic stem cell transplant | Diffuse large B-cell lymphoma recurrent | Diffuse large B-cell lymphoma refractory
Item
eligibility for autologous sct (patients with relapsed or refractory dlbcl)
boolean
C0030705 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C2193200 (UMLS CUI [1,3])
C0855111 (UMLS CUI [2])
C0855112 (UMLS CUI [3])
Allergic Reaction Severe Monoclonal Antibody Therapy | Anaphylaxis Severe Monoclonal Antibody Therapy | Allergic Reaction Recombinant Fusion Proteins Antibody Related | Anaphylaxis Recombinant Fusion Proteins Antibody Related
Item
history of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
boolean
C1527304 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0279694 (UMLS CUI [1,3])
C0002792 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0279694 (UMLS CUI [2,3])
C1527304 (UMLS CUI [3,1])
C0034857 (UMLS CUI [3,2])
C0003241 (UMLS CUI [3,3])
C0439849 (UMLS CUI [3,4])
C0002792 (UMLS CUI [4,1])
C0034857 (UMLS CUI [4,2])
C0003241 (UMLS CUI [4,3])
C0439849 (UMLS CUI [4,4])
Cancer Other Affecting Protocol Compliance | Cancer Other Affecting Interpretation Research results
Item
history of other malignancy that could affect compliance with the protocol or interpretation of results
boolean
C1707251 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C1707251 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0459471 (UMLS CUI [2,3])
C0683954 (UMLS CUI [2,4])
Primary central nervous system lymphoma
Item
current or past history of cns lymphoma
boolean
C0280803 (UMLS CUI [1])
Peripheral Neuropathy CTCAE Grades
Item
current grade > 1 peripheral neuropathy
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Tillbaka till toppen 

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