ID

15930

Beschreibung

A Phase 1-2 Multi-Center Study Evaluating KTE-C19 in Subjects With Refractory Aggressive Non-Hodgkin Lymphoma (NHL); ODM derived from: https://clinicaltrials.gov/show/NCT02348216

Link

https://clinicaltrials.gov/show/NCT02348216

Stichworte

Versionen (1)
  1. 19.06.16 19.06.16 -
Hochgeladen am

19. Juni 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Refractory Diffuse Large B Cell Lymphoma NCT02348216

Englisch

Eligibility Refractory Diffuse Large B Cell Lymphoma NCT02348216

1 Formulare  
Criteria
Beschreibung

Criteria

1. histologically confirmed:
Beschreibung

Histology Procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0344441
diffuse large b cell lymphoma (dlbcl)
Beschreibung

Diffuse Large B-Cell Lymphoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0079744
primary mediastinal large b cell lymphoma (pmbcl)
Beschreibung

Mediastinal (Thymic) Large B-Cell Lymphoma

Datentyp

boolean

Alias
UMLS CUI [1]
C1292754
transformation follicular lymphoma (tfl)
Beschreibung

Follicular Lymphoma transformation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024301
UMLS CUI [1,2]
C0040682
2. chemotherapy-refractory disease, defined as one or more of the following:
Beschreibung

Chemotherapy Refractory Disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3665472
UMLS CUI [1,2]
C1514815
stable disease (duration of stable disease must be less than or equal to 12 months) or progressive disease as best response to most recent chemotherapy containing regimen
Beschreibung

Stable Disease | Disease Progression | Chemotherapy Best Overall Response

Datentyp

boolean

Alias
UMLS CUI [1]
C0677946
UMLS CUI [2]
C0242656
UMLS CUI [3,1]
C3665472
UMLS CUI [3,2]
C2986560
disease progression or recurrence less than or equal to 12 months of prior autologous sct
Beschreibung

Disease Progression | Disease recurrence | Transplantation of autologous hematopoietic stem cell

Datentyp

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2]
C0679254
UMLS CUI [3]
C1831743
3. subjects must have received adequate prior therapy including at a minimum:
Beschreibung

Prior Therapy | Minimum Following

Datentyp

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2,1]
C1524031
UMLS CUI [2,2]
C0332282
anti-cd20 monoclonal antibody unless investigator determines that tumor is cd20-negative and
Beschreibung

Anti-CD20 Antibody | Neoplasm CD20 Antigens Negative

Datentyp

boolean

Alias
UMLS CUI [1]
C3891557
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C0054946
UMLS CUI [2,3]
C0205160
an anthracycline containing chemotherapy regimen
Beschreibung

Chemotherapy Anthracycline Antibiotics

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0003234
for subjects with transformed fl must have received prior chemotherapy for follicular lymphoma and subsequently have chemorefractory disease after transformation to dlbcl
Beschreibung

Follicular Lymphoma transformation | Prior Chemotherapy Follicular Lymphoma | Refractory Disease | transformation Diffuse Large B-Cell Lymphoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024301
UMLS CUI [1,2]
C0040682
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C0024301
UMLS CUI [3]
C1514815
UMLS CUI [4,1]
C0040682
UMLS CUI [4,2]
C0079744
4. at least one measurable lesion per revised iwg response criteria
Beschreibung

Measurable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
5. age 18 or older
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
6. eastern cooperative oncology group (ecog) performance status of 0 or 1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
7. anc ≥ 1000/ul
Beschreibung

Absolute neutrophil count

Datentyp

boolean

Alias
UMLS CUI [1]
C0948762
8. platelet count ≥ 50,000/ul
Beschreibung

Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
9. adequate renal, hepatic, and cardiac function defined as:
Beschreibung

Renal function | Liver function | Cardiac function

Datentyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232164
serum creatinine ≤ 1.5 mg/dl
Beschreibung

Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
serum alt/ast ≤ 2.5 uln
Beschreibung

Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
total bilirubin ≤ 1.5 mg/dl, except in subjects with gilbert's syndrome.
Beschreibung

Bilirubin, total measurement | Gilbert Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0201913
UMLS CUI [2]
C0017551
cardiac ejection fraction ≥ 50% and no evidence of pericardial effusion as determined by an echo.
Beschreibung

Cardiac ejection fraction | Pericardial effusion No evidence of | Echocardiography

Datentyp

boolean

Alias
UMLS CUI [1]
C0232174
UMLS CUI [2,1]
C0031039
UMLS CUI [2,2]
C0332125
UMLS CUI [3]
C0013516
10. all subjects or legally appointed representatives/caregivers, must personally sign and date the irb/iec approved consent form before initiating any study specific procedures or activities.
Beschreibung

Informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
key exclusion criteria
Beschreibung

Exclusion Criteria Main

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
1. history of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) or follicular lymphoma unless disease free for at least 3 years
Beschreibung

Malignant Neoplasms | Skin carcinoma | Carcinoma in Situ | Carcinoma in situ of uterine cervix | Carcinoma in situ of bladder | Carcinoma in situ Breast | Lymphoma, Follicular | Disease Free of

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0699893
UMLS CUI [3]
C0007099
UMLS CUI [4]
C0851140
UMLS CUI [5]
C0154091
UMLS CUI [6]
C0154084
UMLS CUI [7]
C0024301
UMLS CUI [8,1]
C0012634
UMLS CUI [8,2]
C0332296
2. history of allogeneic stem cell transplantation
Beschreibung

Allogeneic Stem Cell Transplantation

Datentyp

boolean

Alias
UMLS CUI [1]
C2242529
3. prior car therapy or other genetically modified t cell therapy
Beschreibung

Prior Therapy Chimeric antigen receptor | T cell therapy Gene-Modified

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C4039583
UMLS CUI [2,1]
C0545322
UMLS CUI [2,2]
C1517476
4. clinically significant active infection (e.g. simple uti, bacterial pharyngitis allowed) or currently receiving iv antibiotics or have received iv antibiotics within 7 days prior to enrollment. prophylaxis antibiotics, antivirals and antifungals are permitted
Beschreibung

Communicable Diseases Clinical Significance | Urinary tract infection Simple | Pharyngitis bacterial | Antibiotics Intravenous | Prophylactic treatment Antibiotics | Prophylactic treatment Antiviral Agents | Prophylactic treatment Antifungal Agents

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C2826293
UMLS CUI [2,1]
C0042029
UMLS CUI [2,2]
C0205352
UMLS CUI [3]
C1141882
UMLS CUI [4,1]
C0003232
UMLS CUI [4,2]
C1522726
UMLS CUI [5,1]
C0199176
UMLS CUI [5,2]
C0003232
UMLS CUI [6,1]
C0199176
UMLS CUI [6,2]
C0003451
UMLS CUI [7,1]
C0199176
UMLS CUI [7,2]
C0003308
5. known history of infection with hiv or hepatitis b (hbsag positive) or hepatitis c virus (anti-hcv positive)
Beschreibung

HIV Infections | Hepatitis B | Hepatitis B surface antigen positive | Hepatitis C | Hepatitis C antibody positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0149709
UMLS CUI [4]
C0019196
UMLS CUI [5]
C0281863
6. subjects with detectable cerebrospinal fluid malignant cells or brain metastases or with a history of cerebrospinal fluid malignant cells or brain metastases
Beschreibung

Cerebrospinal Fluid Tumor cells, malignant | Metastatic malignant neoplasm to brain

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007806
UMLS CUI [1,2]
C0334227
UMLS CUI [2]
C0220650
7. history of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with cns involvement
Beschreibung

Seizures | Cerebral Ischemia | Cerebral Hemorrhage | Dementia | Cerebellar Diseases | Autoimmune Diseases Involvement with Central Nervous System

Datentyp

boolean

Alias
UMLS CUI [1]
C0036572
UMLS CUI [2]
C0917798
UMLS CUI [3]
C2937358
UMLS CUI [4]
C0497327
UMLS CUI [5]
C0007760
UMLS CUI [6,1]
C0004364
UMLS CUI [6,2]
C1314939
UMLS CUI [6,3]
C3714787
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Ähnliche Modelle

Eligibility Refractory Diffuse Large B Cell Lymphoma NCT02348216

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Histology Procedure
Item
1. histologically confirmed:
boolean
C0344441 (UMLS CUI [1])
Diffuse Large B-Cell Lymphoma
Item
diffuse large b cell lymphoma (dlbcl)
boolean
C0079744 (UMLS CUI [1])
Mediastinal (Thymic) Large B-Cell Lymphoma
Item
primary mediastinal large b cell lymphoma (pmbcl)
boolean
C1292754 (UMLS CUI [1])
Follicular Lymphoma transformation
Item
transformation follicular lymphoma (tfl)
boolean
C0024301 (UMLS CUI [1,1])
C0040682 (UMLS CUI [1,2])
Chemotherapy Refractory Disease
Item
2. chemotherapy-refractory disease, defined as one or more of the following:
boolean
C3665472 (UMLS CUI [1,1])
C1514815 (UMLS CUI [1,2])
Stable Disease | Disease Progression | Chemotherapy Best Overall Response
Item
stable disease (duration of stable disease must be less than or equal to 12 months) or progressive disease as best response to most recent chemotherapy containing regimen
boolean
C0677946 (UMLS CUI [1])
C0242656 (UMLS CUI [2])
C3665472 (UMLS CUI [3,1])
C2986560 (UMLS CUI [3,2])
Disease Progression | Disease recurrence | Transplantation of autologous hematopoietic stem cell
Item
disease progression or recurrence less than or equal to 12 months of prior autologous sct
boolean
C0242656 (UMLS CUI [1])
C0679254 (UMLS CUI [2])
C1831743 (UMLS CUI [3])
Prior Therapy | Minimum Following
Item
3. subjects must have received adequate prior therapy including at a minimum:
boolean
C1514463 (UMLS CUI [1])
C1524031 (UMLS CUI [2,1])
C0332282 (UMLS CUI [2,2])
Anti-CD20 Antibody | Neoplasm CD20 Antigens Negative
Item
anti-cd20 monoclonal antibody unless investigator determines that tumor is cd20-negative and
boolean
C3891557 (UMLS CUI [1])
C0027651 (UMLS CUI [2,1])
C0054946 (UMLS CUI [2,2])
C0205160 (UMLS CUI [2,3])
Chemotherapy Anthracycline Antibiotics
Item
an anthracycline containing chemotherapy regimen
boolean
C0392920 (UMLS CUI [1,1])
C0003234 (UMLS CUI [1,2])
Follicular Lymphoma transformation | Prior Chemotherapy Follicular Lymphoma | Refractory Disease | transformation Diffuse Large B-Cell Lymphoma
Item
for subjects with transformed fl must have received prior chemotherapy for follicular lymphoma and subsequently have chemorefractory disease after transformation to dlbcl
boolean
C0024301 (UMLS CUI [1,1])
C0040682 (UMLS CUI [1,2])
C1514457 (UMLS CUI [2,1])
C0024301 (UMLS CUI [2,2])
C1514815 (UMLS CUI [3])
C0040682 (UMLS CUI [4,1])
C0079744 (UMLS CUI [4,2])
Measurable Disease
Item
4. at least one measurable lesion per revised iwg response criteria
boolean
C1513041 (UMLS CUI [1])
Age
Item
5. age 18 or older
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
6. eastern cooperative oncology group (ecog) performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Absolute neutrophil count
Item
7. anc ≥ 1000/ul
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
8. platelet count ≥ 50,000/ul
boolean
C0032181 (UMLS CUI [1])
Renal function | Liver function | Cardiac function
Item
9. adequate renal, hepatic, and cardiac function defined as:
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232164 (UMLS CUI [3])
Creatinine measurement, serum
Item
serum creatinine ≤ 1.5 mg/dl
boolean
C0201976 (UMLS CUI [1])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
serum alt/ast ≤ 2.5 uln
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
Bilirubin, total measurement | Gilbert Disease
Item
total bilirubin ≤ 1.5 mg/dl, except in subjects with gilbert's syndrome.
boolean
C0201913 (UMLS CUI [1])
C0017551 (UMLS CUI [2])
Cardiac ejection fraction | Pericardial effusion No evidence of | Echocardiography
Item
cardiac ejection fraction ≥ 50% and no evidence of pericardial effusion as determined by an echo.
boolean
C0232174 (UMLS CUI [1])
C0031039 (UMLS CUI [2,1])
C0332125 (UMLS CUI [2,2])
C0013516 (UMLS CUI [3])
Informed consent
Item
10. all subjects or legally appointed representatives/caregivers, must personally sign and date the irb/iec approved consent form before initiating any study specific procedures or activities.
boolean
C0021430 (UMLS CUI [1])
Exclusion Criteria Main
Item
key exclusion criteria
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Malignant Neoplasms | Skin carcinoma | Carcinoma in Situ | Carcinoma in situ of uterine cervix | Carcinoma in situ of bladder | Carcinoma in situ Breast | Lymphoma, Follicular | Disease Free of
Item
1. history of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) or follicular lymphoma unless disease free for at least 3 years
boolean
C0006826 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
C0007099 (UMLS CUI [3])
C0851140 (UMLS CUI [4])
C0154091 (UMLS CUI [5])
C0154084 (UMLS CUI [6])
C0024301 (UMLS CUI [7])
C0012634 (UMLS CUI [8,1])
C0332296 (UMLS CUI [8,2])
Allogeneic Stem Cell Transplantation
Item
2. history of allogeneic stem cell transplantation
boolean
C2242529 (UMLS CUI [1])
Prior Therapy Chimeric antigen receptor | T cell therapy Gene-Modified
Item
3. prior car therapy or other genetically modified t cell therapy
boolean
C1514463 (UMLS CUI [1,1])
C4039583 (UMLS CUI [1,2])
C0545322 (UMLS CUI [2,1])
C1517476 (UMLS CUI [2,2])
Communicable Diseases Clinical Significance | Urinary tract infection Simple | Pharyngitis bacterial | Antibiotics Intravenous | Prophylactic treatment Antibiotics | Prophylactic treatment Antiviral Agents | Prophylactic treatment Antifungal Agents
Item
4. clinically significant active infection (e.g. simple uti, bacterial pharyngitis allowed) or currently receiving iv antibiotics or have received iv antibiotics within 7 days prior to enrollment. prophylaxis antibiotics, antivirals and antifungals are permitted
boolean
C0009450 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0042029 (UMLS CUI [2,1])
C0205352 (UMLS CUI [2,2])
C1141882 (UMLS CUI [3])
C0003232 (UMLS CUI [4,1])
C1522726 (UMLS CUI [4,2])
C0199176 (UMLS CUI [5,1])
C0003232 (UMLS CUI [5,2])
C0199176 (UMLS CUI [6,1])
C0003451 (UMLS CUI [6,2])
C0199176 (UMLS CUI [7,1])
C0003308 (UMLS CUI [7,2])
HIV Infections | Hepatitis B | Hepatitis B surface antigen positive | Hepatitis C | Hepatitis C antibody positive
Item
5. known history of infection with hiv or hepatitis b (hbsag positive) or hepatitis c virus (anti-hcv positive)
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0149709 (UMLS CUI [3])
C0019196 (UMLS CUI [4])
C0281863 (UMLS CUI [5])
Cerebrospinal Fluid Tumor cells, malignant | Metastatic malignant neoplasm to brain
Item
6. subjects with detectable cerebrospinal fluid malignant cells or brain metastases or with a history of cerebrospinal fluid malignant cells or brain metastases
boolean
C0007806 (UMLS CUI [1,1])
C0334227 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2])
Seizures | Cerebral Ischemia | Cerebral Hemorrhage | Dementia | Cerebellar Diseases | Autoimmune Diseases Involvement with Central Nervous System
Item
7. history of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with cns involvement
boolean
C0036572 (UMLS CUI [1])
C0917798 (UMLS CUI [2])
C2937358 (UMLS CUI [3])
C0497327 (UMLS CUI [4])
C0007760 (UMLS CUI [5])
C0004364 (UMLS CUI [6,1])
C1314939 (UMLS CUI [6,2])
C3714787 (UMLS CUI [6,3])
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