ID

37008

Beschreibung

Brentuximab Vedotin in Patients With Relapsed or Refractory EBV-and CD30-positive Lymphomas; ODM derived from: https://clinicaltrials.gov/show/NCT02388490

Link

https://clinicaltrials.gov/show/NCT02388490

Stichworte

Versionen (1)
  1. 29.06.19 29.06.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

29. Juni 2019

DOI

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Lizenz

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Eligibility Relapsed or Refractory EBV-and CD30-positive Lymphomas NCT02388490

Englisch

Eligibility Relapsed or Refractory EBV-and CD30-positive Lymphomas NCT02388490

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with relapsed or refractory ebv- and cd30-positive lymphomas
Beschreibung

Recurrent Lymphoma EBV Positive CD30 positive | Refractory Lymphoma EBV Positive CD30 positive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4525062
UMLS CUI [1,2]
C4329796
UMLS CUI [1,3]
C3888910
UMLS CUI [2,1]
C4525060
UMLS CUI [2,2]
C4329796
UMLS CUI [2,3]
C3888910
2. age ≥ 18 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
3. ecog performance status 0-2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
4. at least one measurable lesion based on revised cheson's or modified swat criteria
Beschreibung

Measurable lesion Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
5. provision archival tumor tissues (4 μm thickness x 5 unstained slides) and blood samples
Beschreibung

Tumor tissue sample Thickness | Tumor tissue sample Unstained Specimen Quantity | Blood specimen

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C1280412
UMLS CUI [2,1]
C0475358
UMLS CUI [2,2]
C1883469
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C0178913
6. voluntary written informed consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
7. female patient is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.
Beschreibung

Postmenopausal state | Female Sterilization | Childbearing Potential Contraceptive methods Quantity | Childbearing Potential Sexual Abstinence Coitus

Datentyp

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C1265611
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0036899
UMLS CUI [4,3]
C0009253
8. male patients, even if surgically sterilized, (i.e., status post vasectomy) agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.
Beschreibung

Gender Barrier Contraception | Male sterilization | Status post Vasectomy | Gender Sexual Abstinence Coitus

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0004764
UMLS CUI [2]
C0024559
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0042387
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0036899
UMLS CUI [4,3]
C0009253
9. adequate hematologic function: absolute neutrophil count (anc) ≥1,500/µl, platelet count ≥ 75,000/µl, and hemoglobin ≥8.0 g/dl unless there is known hematologic tumor marrow involvement (anc ≥ 1,000/µl and platelet count ≥ 50,000/µl if there is known bone marrow involvement)
Beschreibung

Hematologic function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement | Exception Hematologic Neoplasm Bone Marrow Involvement | Exception Bone Marrow Involvement

Datentyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0518015
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0376545
UMLS CUI [5,3]
C1517677
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C1517677
10. adequate liver function: total bilirubin < 1.5 x the upper limit of the normal (uln) unless the elevation is known to be due to gilbert syndrome and alt or ast < 3 x uln (ast and ast < 5 x uln if their elevation can be reasonably ascribed to the presence of hematologic tumor in liver)
Beschreibung

Liver function | Serum total bilirubin measurement | Exception Relationship Gilbert Disease | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Relationship Hematologic Neoplasm Liver

Datentyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0439849
UMLS CUI [3,3]
C0017551
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0201899
UMLS CUI [6,1]
C0439849
UMLS CUI [6,2]
C0376545
UMLS CUI [6,3]
C0023884
11. adequate renal function: serum creatinine < 2.0 mg/dl and/or creatinine clearance or calculated creatinine clearance > 40 ml/minute.
Beschreibung

Renal function | Creatinine measurement, serum | Creatinine clearance measurement | Estimation of creatinine clearance by Cockcroft-Gault formula

Datentyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0373595
UMLS CUI [4]
C2711451
12. expected survival > 3 months
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. female patient who are both lactating and breast-feeding or have a positive serum pregnancy test
Beschreibung

Lactation | Breast Feeding | Serum pregnancy test positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0022925
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0430063
2. any serious medical or psychiatric illness
Beschreibung

Illness Serious | Mental disorder Serious

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0205404
3. known cerebral or meningeal involvement (ebv- and cd30-positive lymphoma or any other etiology), including signs or symptoms of pml
Beschreibung

Involvement cerebral | Involvement meningeal | Lymphoma EBV Positive CD30 positive | Sign or Symptom Progressive Multifocal Leukoencephalopathy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1314939
UMLS CUI [1,2]
C0006104
UMLS CUI [2,1]
C1314939
UMLS CUI [2,2]
C0521400
UMLS CUI [3,1]
C0024299
UMLS CUI [3,2]
C4329796
UMLS CUI [3,3]
C3888910
UMLS CUI [4,1]
C3540840
UMLS CUI [4,2]
C0023524
4. symptomatic neurologic disease compromising normal activities or requiring medication
Beschreibung

Nervous system disorder Symptomatic compromises Activity | Nervous system disorder Symptomatic Requirement Pharmaceutical Preparations

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C2945640
UMLS CUI [1,4]
C0026606
UMLS CUI [2,1]
C0027765
UMLS CUI [2,2]
C0231220
UMLS CUI [2,3]
C1514873
UMLS CUI [2,4]
C0013227
5. any sensory or motor peripheral neuropathy greater than or equal to grade 2
Beschreibung

Peripheral sensory neuropathy CTCAE Grades | Peripheral motor neuropathy CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0151313
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C0235025
UMLS CUI [2,2]
C1516728
6. known history of myocardial infarction within 1 year, nyha class iii/iv heart failure, or uncontrolled cardiovascular conditions including cardiac arrhythmias, congestive heart failure (chf), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. recent evidence (within 6 months before first dose of study drug) of a left-ventricular ejection fraction <50%.
Beschreibung

Myocardial Infarction | Heart failure New York Heart Association Classification | Cardiovascular Disease Uncontrolled | Cardiac Arrhythmia | Congestive heart failure | Angina Pectoris | Ischemia Electrocardiography | Cardiac conduction abnormality Electrocardiography | Left ventricular ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C1275491
UMLS CUI [3,1]
C0007222
UMLS CUI [3,2]
C0205318
UMLS CUI [4]
C0003811
UMLS CUI [5]
C0018802
UMLS CUI [6]
C0002962
UMLS CUI [7,1]
C0022116
UMLS CUI [7,2]
C1623258
UMLS CUI [8,1]
C1842820
UMLS CUI [8,2]
C1623258
UMLS CUI [9]
C0428772
7. any active systemic viral, bacterial, or fungal infection within 2 weeks prior to first study drug dose
Beschreibung

Systemic viral infection | Systemic bacterial infection | Systemic mycosis

Datentyp

boolean

Alias
UMLS CUI [1]
C4285789
UMLS CUI [2]
C4285778
UMLS CUI [3]
C0553576
8. any prior chemotherapy and/or other investigational agents within at least 5 half-lives of last dose
Beschreibung

Prior Chemotherapy | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2]
C0013230
9. prior stem cell transplantation within 100 days or radioimmunotherapy within 8 weeks
Beschreibung

Stem cell transplant | Radioimmunotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C1504389
UMLS CUI [2]
C0085101
10. prior exposure to cd30-targeted agents
Beschreibung

Pharmaceutical agents Targeting CD30

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1254351
UMLS CUI [1,2]
C1521840
UMLS CUI [1,3]
C0054950
11. known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin
Beschreibung

Hypersensitivity Recombinant Proteins | Hypersensitivity Murine protein | Hypersensitivity Brentuximab vedotin Excipient

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0034861
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1699668
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C2973446
UMLS CUI [3,3]
C0015237
12. known human immunodeficiency virus (hiv) positive
Beschreibung

HIV Seropositivity

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
13. known hepatitis b surface antigen-positive, or known or suspected active hepatitis c infection
Beschreibung

Hepatitis B surface antigen positive | Hepatitis C | Hepatitis C Suspected

Datentyp

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0019196
UMLS CUI [3,1]
C0019196
UMLS CUI [3,2]
C0750491
14. another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have evidence of residual disease. patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
Beschreibung

Cancer Other | Residual Tumor | Exception Complete excision Skin carcinoma | Exception Complete excision Carcinoma in Situ

Datentyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2]
C0543478
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0015250
UMLS CUI [3,3]
C0699893
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0015250
UMLS CUI [4,3]
C0007099
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Ähnliche Modelle

Eligibility Relapsed or Refractory EBV-and CD30-positive Lymphomas NCT02388490

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Recurrent Lymphoma EBV Positive CD30 positive | Refractory Lymphoma EBV Positive CD30 positive
Item
1. patients with relapsed or refractory ebv- and cd30-positive lymphomas
boolean
C4525062 (UMLS CUI [1,1])
C4329796 (UMLS CUI [1,2])
C3888910 (UMLS CUI [1,3])
C4525060 (UMLS CUI [2,1])
C4329796 (UMLS CUI [2,2])
C3888910 (UMLS CUI [2,3])
Age
Item
2. age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
3. ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Measurable lesion Quantity
Item
4. at least one measurable lesion based on revised cheson's or modified swat criteria
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Tumor tissue sample Thickness | Tumor tissue sample Unstained Specimen Quantity | Blood specimen
Item
5. provision archival tumor tissues (4 μm thickness x 5 unstained slides) and blood samples
boolean
C0475358 (UMLS CUI [1,1])
C1280412 (UMLS CUI [1,2])
C0475358 (UMLS CUI [2,1])
C1883469 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0178913 (UMLS CUI [3])
Informed Consent
Item
6. voluntary written informed consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
boolean
C0021430 (UMLS CUI [1])
Postmenopausal state | Female Sterilization | Childbearing Potential Contraceptive methods Quantity | Childbearing Potential Sexual Abstinence Coitus
Item
7. female patient is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C3831118 (UMLS CUI [4,1])
C0036899 (UMLS CUI [4,2])
C0009253 (UMLS CUI [4,3])
Gender Barrier Contraception | Male sterilization | Status post Vasectomy | Gender Sexual Abstinence Coitus
Item
8. male patients, even if surgically sterilized, (i.e., status post vasectomy) agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.
boolean
C0079399 (UMLS CUI [1,1])
C0004764 (UMLS CUI [1,2])
C0024559 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C0042387 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0036899 (UMLS CUI [4,2])
C0009253 (UMLS CUI [4,3])
Hematologic function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement | Exception Hematologic Neoplasm Bone Marrow Involvement | Exception Bone Marrow Involvement
Item
9. adequate hematologic function: absolute neutrophil count (anc) ≥1,500/µl, platelet count ≥ 75,000/µl, and hemoglobin ≥8.0 g/dl unless there is known hematologic tumor marrow involvement (anc ≥ 1,000/µl and platelet count ≥ 50,000/µl if there is known bone marrow involvement)
boolean
C0221130 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0376545 (UMLS CUI [5,2])
C1517677 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C1517677 (UMLS CUI [6,2])
Liver function | Serum total bilirubin measurement | Exception Relationship Gilbert Disease | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Relationship Hematologic Neoplasm Liver
Item
10. adequate liver function: total bilirubin < 1.5 x the upper limit of the normal (uln) unless the elevation is known to be due to gilbert syndrome and alt or ast < 3 x uln (ast and ast < 5 x uln if their elevation can be reasonably ascribed to the presence of hematologic tumor in liver)
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0439849 (UMLS CUI [3,2])
C0017551 (UMLS CUI [3,3])
C0201836 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
C0439849 (UMLS CUI [6,1])
C0376545 (UMLS CUI [6,2])
C0023884 (UMLS CUI [6,3])
Renal function | Creatinine measurement, serum | Creatinine clearance measurement | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
11. adequate renal function: serum creatinine < 2.0 mg/dl and/or creatinine clearance or calculated creatinine clearance > 40 ml/minute.
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
C2711451 (UMLS CUI [4])
Life Expectancy
Item
12. expected survival > 3 months
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Lactation | Breast Feeding | Serum pregnancy test positive
Item
1. female patient who are both lactating and breast-feeding or have a positive serum pregnancy test
boolean
C0022925 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0430063 (UMLS CUI [3])
Illness Serious | Mental disorder Serious
Item
2. any serious medical or psychiatric illness
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Involvement cerebral | Involvement meningeal | Lymphoma EBV Positive CD30 positive | Sign or Symptom Progressive Multifocal Leukoencephalopathy
Item
3. known cerebral or meningeal involvement (ebv- and cd30-positive lymphoma or any other etiology), including signs or symptoms of pml
boolean
C1314939 (UMLS CUI [1,1])
C0006104 (UMLS CUI [1,2])
C1314939 (UMLS CUI [2,1])
C0521400 (UMLS CUI [2,2])
C0024299 (UMLS CUI [3,1])
C4329796 (UMLS CUI [3,2])
C3888910 (UMLS CUI [3,3])
C3540840 (UMLS CUI [4,1])
C0023524 (UMLS CUI [4,2])
Nervous system disorder Symptomatic compromises Activity | Nervous system disorder Symptomatic Requirement Pharmaceutical Preparations
Item
4. symptomatic neurologic disease compromising normal activities or requiring medication
boolean
C0027765 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C2945640 (UMLS CUI [1,3])
C0026606 (UMLS CUI [1,4])
C0027765 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
C0013227 (UMLS CUI [2,4])
Peripheral sensory neuropathy CTCAE Grades | Peripheral motor neuropathy CTCAE Grades
Item
5. any sensory or motor peripheral neuropathy greater than or equal to grade 2
boolean
C0151313 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0235025 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
Myocardial Infarction | Heart failure New York Heart Association Classification | Cardiovascular Disease Uncontrolled | Cardiac Arrhythmia | Congestive heart failure | Angina Pectoris | Ischemia Electrocardiography | Cardiac conduction abnormality Electrocardiography | Left ventricular ejection fraction
Item
6. known history of myocardial infarction within 1 year, nyha class iii/iv heart failure, or uncontrolled cardiovascular conditions including cardiac arrhythmias, congestive heart failure (chf), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. recent evidence (within 6 months before first dose of study drug) of a left-ventricular ejection fraction <50%.
boolean
C0027051 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0007222 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0003811 (UMLS CUI [4])
C0018802 (UMLS CUI [5])
C0002962 (UMLS CUI [6])
C0022116 (UMLS CUI [7,1])
C1623258 (UMLS CUI [7,2])
C1842820 (UMLS CUI [8,1])
C1623258 (UMLS CUI [8,2])
C0428772 (UMLS CUI [9])
Systemic viral infection | Systemic bacterial infection | Systemic mycosis
Item
7. any active systemic viral, bacterial, or fungal infection within 2 weeks prior to first study drug dose
boolean
C4285789 (UMLS CUI [1])
C4285778 (UMLS CUI [2])
C0553576 (UMLS CUI [3])
Prior Chemotherapy | Investigational New Drugs
Item
8. any prior chemotherapy and/or other investigational agents within at least 5 half-lives of last dose
boolean
C1514457 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Stem cell transplant | Radioimmunotherapy
Item
9. prior stem cell transplantation within 100 days or radioimmunotherapy within 8 weeks
boolean
C1504389 (UMLS CUI [1])
C0085101 (UMLS CUI [2])
Pharmaceutical agents Targeting CD30
Item
10. prior exposure to cd30-targeted agents
boolean
C1254351 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0054950 (UMLS CUI [1,3])
Hypersensitivity Recombinant Proteins | Hypersensitivity Murine protein | Hypersensitivity Brentuximab vedotin Excipient
Item
11. known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin
boolean
C0020517 (UMLS CUI [1,1])
C0034861 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1699668 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C2973446 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
HIV Seropositivity
Item
12. known human immunodeficiency virus (hiv) positive
boolean
C0019699 (UMLS CUI [1])
Hepatitis B surface antigen positive | Hepatitis C | Hepatitis C Suspected
Item
13. known hepatitis b surface antigen-positive, or known or suspected active hepatitis c infection
boolean
C0149709 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0019196 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
Cancer Other | Residual Tumor | Exception Complete excision Skin carcinoma | Exception Complete excision Carcinoma in Situ
Item
14. another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have evidence of residual disease. patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
boolean
C1707251 (UMLS CUI [1])
C0543478 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0015250 (UMLS CUI [3,2])
C0699893 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0015250 (UMLS CUI [4,2])
C0007099 (UMLS CUI [4,3])
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