ID

34873

Description

A Dose Escalation Study of JNJ-64052781 in Participants With Relapsed or Refractory B-cell Malignancies; ODM derived from: https://clinicaltrials.gov/show/NCT02454270

Link

https://clinicaltrials.gov/show/NCT02454270

Keywords

  1. 2/1/19 2/1/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 1, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility B-Cell Chronic Lymphocytic Leukemia NCT02454270

Eligibility B-Cell Chronic Lymphocytic Leukemia NCT02454270

Inclusion Criteria
Description

Inclusion Criteria

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

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
participants must meet protocol specified hematology and chemistry lab parameters criteria
Description

Hematology Criteria Fulfill | Chemistry Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0200627
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C1550543
UMLS CUI [2,1]
C0201682
UMLS CUI [2,2]
C0243161
UMLS CUI [2,3]
C1550543
histological confirmation of disease with documented disease relapse after the last therapy requiring treatment per the treating physician. participants with lymphoma must have at least 1 measurable site of disease. in addition, b-cell malignancy disease-specific criteria specified in the protocol must also be met
Description

Chronic Lymphocytic Leukemia | Recurrent Chronic Lymphoid Leukemia Treatment required for | Lymphoma Measurable Disease Site Quantity | Inclusion criteria Study Protocol Fulfill

Data type

boolean

Alias
UMLS CUI [1]
C0023434
UMLS CUI [2,1]
C0854802
UMLS CUI [2,2]
C0332121
UMLS CUI [3,1]
C0024299
UMLS CUI [3,2]
C1513041
UMLS CUI [3,3]
C1515974
UMLS CUI [3,4]
C1265611
UMLS CUI [4,1]
C1512693
UMLS CUI [4,2]
C2348563
UMLS CUI [4,3]
C1550543
a woman of childbearing potential must have a negative serum [beta-human chorionic gonadotropin (β-hcg)] or urine pregnancy test at (minimum sensitivity 25 international units (iu)/ liter (l) or equivalent units of hcg) prior to the first dose of study drug
Description

Childbearing Potential Serum pregnancy test (B-HCG) Negative | Childbearing Potential Urine pregnancy test Negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430060
UMLS CUI [1,3]
C1513916
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430056
UMLS CUI [2,3]
C1513916
a woman must agree to use 2 effective methods of birth control and agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 3 months after receiving the last dose of study drug
Description

Gender Contraceptive methods | Gender Ovum Donation Absent | Gender Oocyte Donation Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0242812
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0242813
UMLS CUI [3,3]
C0332197
a man who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control example, either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository during the study and for 3 months after receiving the last dose of study drug. all men must also not donate sperm during the study and for 3 months after receiving the last dose of study drug
Description

Gender Sexually active Childbearing Potential Barrier Contraception | Condoms, Male | Spermatocidal Agents | Partner Vaginal contraceptive diaphragm | Partner Cervical contraceptive cap | Partner Vaginal Spermicides | Gender Sperm donation Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0241028
UMLS CUI [1,3]
C3831118
UMLS CUI [1,4]
C0004764
UMLS CUI [2]
C0009653
UMLS CUI [3]
C0037862
UMLS CUI [4,1]
C0682323
UMLS CUI [4,2]
C0042241
UMLS CUI [5,1]
C0682323
UMLS CUI [5,2]
C0493327
UMLS CUI [6,1]
C0682323
UMLS CUI [6,2]
C0087145
UMLS CUI [7,1]
C0079399
UMLS CUI [7,2]
C0871414
UMLS CUI [7,3]
C0332197
each participant (or their legally acceptable representative) must sign an informed consent form (icf) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study. consent is to be obtained prior to the initiation of any study-related tests or procedures that are not part of standard-of-care for the participant's disease
Description

Informed Consent | Informed Consent Patient Representative

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of, or known central nervous system (cns) involvement caused by the underlying b-cell malignancy or prior history of national cancer institute common terminology criteria for adverse events (nci ctcae) grade greater than or equal to >= 3 drug-related cns toxicity. participants with signs or symptoms of cns involvement should have a computed tomography (ct) or magnetic resonance imaging (mri) and lumbar puncture to specifically exclude the presence of cns disease
Description

CNS Involvement caused by Chronic Lymphocytic Leukemia | CNS toxicity Drug-induced CTCAE Grades | Sign or Symptom CNS Involvement CT | Sign or Symptom CNS Involvement MRI | Sign or Symptom CNS Involvement Lumbar Puncture

Data type

boolean

Alias
UMLS CUI [1,1]
C4050309
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C0023434
UMLS CUI [2,1]
C3160947
UMLS CUI [2,2]
C0458082
UMLS CUI [2,3]
C1516728
UMLS CUI [3,1]
C3540840
UMLS CUI [3,2]
C4050309
UMLS CUI [3,3]
C0040405
UMLS CUI [4,1]
C3540840
UMLS CUI [4,2]
C4050309
UMLS CUI [4,3]
C0024485
UMLS CUI [5,1]
C3540840
UMLS CUI [5,2]
C4050309
UMLS CUI [5,3]
C0037943
history of or known or suspected autoimmune disease (exception: vitiligo, resolved childhood atopic dermatitis, and history of grave's disease that is euthyroid clinically and by laboratory testing at screening)
Description

Autoimmune Disease | Autoimmune Disease Suspected | Exception Vitiligo | Exception Childhood atopic dermatitis resolved | Exception GRAVE DISEASE EUTHYROID

Data type

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2,1]
C0004364
UMLS CUI [2,2]
C0750491
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0042900
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1276071
UMLS CUI [4,3]
C1514893
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0744480
prior allogeneic hematopoietic stem-cell transplant
Description

Allogeneic Hematopoietic Stem Cell Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C1705576
prior solid organ transplantation
Description

Solid organ transplant

Data type

boolean

Alias
UMLS CUI [1]
C0730400
prior treatment with a therapeutic agent targeting cd19 and/or cd3
Description

Therapeutic agent Targeting CD19 | Therapeutic agent Targeting CD3

Data type

boolean

Alias
UMLS CUI [1,1]
C0304231
UMLS CUI [1,2]
C1521840
UMLS CUI [1,3]
C0108748
UMLS CUI [2,1]
C0304231
UMLS CUI [2,2]
C1521840
UMLS CUI [2,3]
C0108779

Similar models

Eligibility B-Cell Chronic Lymphocytic Leukemia NCT02454270

Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Hematology Criteria Fulfill | Chemistry Criteria Fulfill
Item
participants must meet protocol specified hematology and chemistry lab parameters criteria
boolean
C0200627 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
C0201682 (UMLS CUI [2,1])
C0243161 (UMLS CUI [2,2])
C1550543 (UMLS CUI [2,3])
Chronic Lymphocytic Leukemia | Recurrent Chronic Lymphoid Leukemia Treatment required for | Lymphoma Measurable Disease Site Quantity | Inclusion criteria Study Protocol Fulfill
Item
histological confirmation of disease with documented disease relapse after the last therapy requiring treatment per the treating physician. participants with lymphoma must have at least 1 measurable site of disease. in addition, b-cell malignancy disease-specific criteria specified in the protocol must also be met
boolean
C0023434 (UMLS CUI [1])
C0854802 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
C0024299 (UMLS CUI [3,1])
C1513041 (UMLS CUI [3,2])
C1515974 (UMLS CUI [3,3])
C1265611 (UMLS CUI [3,4])
C1512693 (UMLS CUI [4,1])
C2348563 (UMLS CUI [4,2])
C1550543 (UMLS CUI [4,3])
Childbearing Potential Serum pregnancy test (B-HCG) Negative | Childbearing Potential Urine pregnancy test Negative
Item
a woman of childbearing potential must have a negative serum [beta-human chorionic gonadotropin (β-hcg)] or urine pregnancy test at (minimum sensitivity 25 international units (iu)/ liter (l) or equivalent units of hcg) prior to the first dose of study drug
boolean
C3831118 (UMLS CUI [1,1])
C0430060 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0430056 (UMLS CUI [2,2])
C1513916 (UMLS CUI [2,3])
Gender Contraceptive methods | Gender Ovum Donation Absent | Gender Oocyte Donation Absent
Item
a woman must agree to use 2 effective methods of birth control and agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 3 months after receiving the last dose of study drug
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0242812 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0079399 (UMLS CUI [3,1])
C0242813 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Gender Sexually active Childbearing Potential Barrier Contraception | Condoms, Male | Spermatocidal Agents | Partner Vaginal contraceptive diaphragm | Partner Cervical contraceptive cap | Partner Vaginal Spermicides | Gender Sperm donation Absent
Item
a man who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control example, either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository during the study and for 3 months after receiving the last dose of study drug. all men must also not donate sperm during the study and for 3 months after receiving the last dose of study drug
boolean
C0079399 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C3831118 (UMLS CUI [1,3])
C0004764 (UMLS CUI [1,4])
C0009653 (UMLS CUI [2])
C0037862 (UMLS CUI [3])
C0682323 (UMLS CUI [4,1])
C0042241 (UMLS CUI [4,2])
C0682323 (UMLS CUI [5,1])
C0493327 (UMLS CUI [5,2])
C0682323 (UMLS CUI [6,1])
C0087145 (UMLS CUI [6,2])
C0079399 (UMLS CUI [7,1])
C0871414 (UMLS CUI [7,2])
C0332197 (UMLS CUI [7,3])
Informed Consent | Informed Consent Patient Representative
Item
each participant (or their legally acceptable representative) must sign an informed consent form (icf) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study. consent is to be obtained prior to the initiation of any study-related tests or procedures that are not part of standard-of-care for the participant's disease
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
CNS Involvement caused by Chronic Lymphocytic Leukemia | CNS toxicity Drug-induced CTCAE Grades | Sign or Symptom CNS Involvement CT | Sign or Symptom CNS Involvement MRI | Sign or Symptom CNS Involvement Lumbar Puncture
Item
history of, or known central nervous system (cns) involvement caused by the underlying b-cell malignancy or prior history of national cancer institute common terminology criteria for adverse events (nci ctcae) grade greater than or equal to >= 3 drug-related cns toxicity. participants with signs or symptoms of cns involvement should have a computed tomography (ct) or magnetic resonance imaging (mri) and lumbar puncture to specifically exclude the presence of cns disease
boolean
C4050309 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0023434 (UMLS CUI [1,3])
C3160947 (UMLS CUI [2,1])
C0458082 (UMLS CUI [2,2])
C1516728 (UMLS CUI [2,3])
C3540840 (UMLS CUI [3,1])
C4050309 (UMLS CUI [3,2])
C0040405 (UMLS CUI [3,3])
C3540840 (UMLS CUI [4,1])
C4050309 (UMLS CUI [4,2])
C0024485 (UMLS CUI [4,3])
C3540840 (UMLS CUI [5,1])
C4050309 (UMLS CUI [5,2])
C0037943 (UMLS CUI [5,3])
Autoimmune Disease | Autoimmune Disease Suspected | Exception Vitiligo | Exception Childhood atopic dermatitis resolved | Exception GRAVE DISEASE EUTHYROID
Item
history of or known or suspected autoimmune disease (exception: vitiligo, resolved childhood atopic dermatitis, and history of grave's disease that is euthyroid clinically and by laboratory testing at screening)
boolean
C0004364 (UMLS CUI [1])
C0004364 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0042900 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C1276071 (UMLS CUI [4,2])
C1514893 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0744480 (UMLS CUI [5,2])
Allogeneic Hematopoietic Stem Cell Transplantation
Item
prior allogeneic hematopoietic stem-cell transplant
boolean
C1705576 (UMLS CUI [1])
Solid organ transplant
Item
prior solid organ transplantation
boolean
C0730400 (UMLS CUI [1])
Therapeutic agent Targeting CD19 | Therapeutic agent Targeting CD3
Item
prior treatment with a therapeutic agent targeting cd19 and/or cd3
boolean
C0304231 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0108748 (UMLS CUI [1,3])
C0304231 (UMLS CUI [2,1])
C1521840 (UMLS CUI [2,2])
C0108779 (UMLS CUI [2,3])

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