ID

39626

Beskrivning

Epigenetic Modulation in Relapsed/Refractory Follicular Lymphoma and Marginal Zone Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01121757

Länk

https://clinicaltrials.gov/show/NCT01121757

Nyckelord

Versioner (1)
  1. 2020-02-05 2020-02-05 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

5 februari 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Follicular Lymphoma NCT01121757

Engelsk

Eligibility Follicular Lymphoma NCT01121757

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically or cytologically confirmed follicular or marginal zone lymphoma
Beskrivning

Lymphoma, Follicular | Marginal Zone Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0024301
UMLS CUI [2]
C1367654
2. refractory disease defined as persistence of evaluable disease after therapy or have relapsed disease to at least one prior treatment regimen
Beskrivning

Refractory Disease | Evaluable Disease Persistent post treatment | Recurrent disease | Prior Therapy Quantity

Datatyp

boolean

Alias
UMLS CUI [1]
C1514815
UMLS CUI [2,1]
C1516986
UMLS CUI [2,2]
C0205322
UMLS CUI [2,3]
C2709088
UMLS CUI [3]
C0277556
UMLS CUI [4,1]
C1514463
UMLS CUI [4,2]
C1265611
3. understand and voluntarily sign an informed consent form
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
4. age > or = to 18 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
5. able to adhere to the study requirements
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
6. a frozen tumor sample must be available for microarray analysis. this may either be a previously collected sample if it was properly prepared or a new biopsy may be obtained.
Beskrivning

Availability of Tumor tissue sample Frozen | Microarray Analysis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0475358
UMLS CUI [1,3]
C0016701
UMLS CUI [2]
C1449575
o at least 1 core biopsy specimen using at least a 16 gauge needle, which corresponds to roughly 25 mg of tissue. an equivalent amount of biopsy material from previously performed procedures, as long as it was fresh frozen, can be used. sample obtained with leukapheresis is acceptable in subjects with a white blood cell count (wbc) of 100,000 or greater.
Beskrivning

Specimen obtained by core needle biopsy | Leukapheresis Acceptable | White Blood Cell Count procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C1960700
UMLS CUI [2,1]
C0023416
UMLS CUI [2,2]
C1879533
UMLS CUI [3]
C0023508
7. eastern cooperative oncology group (ecog) performance status of < or = to 2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
8. laboratory test results within ranges specified by the protocol.
Beskrivning

Laboratory test result Consistent with Study Protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0587081
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C2348563
9. disease free of prior malignancies for > or = to 3 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast or superficial melanoma only requiring excision or prostate cancer with a prostate specific antigen (psa) that has not increased for at least 3 months.
Beskrivning

Malignant Neoplasms Disease Free of Duration | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Carcinoma in situ of female breast Treated | Exception Superficial spreading melanoma Requirement Excision | Exception Prostate carcinoma Prostate specific antigen measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0332296
UMLS CUI [1,4]
C0449238
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0686288
UMLS CUI [5,3]
C1522326
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0334438
UMLS CUI [6,3]
C1514873
UMLS CUI [6,4]
C0728940
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0600139
UMLS CUI [7,3]
C0201544
10. all study participants must be willing to be registered into the mandatory revassist®
Beskrivning

Study Subject All | Registration Risk Reduction Program

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0444868
UMLS CUI [2,1]
C1514821
UMLS CUI [2,2]
C1137094
UMLS CUI [2,3]
C3484370
program, and comply with the requirements of revassist®.
Beskrivning

Compliance behavior Risk Reduction Program

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C1137094
UMLS CUI [1,3]
C3484370
11. females of childbearing potential (fcbp) must comply with pregnancy testing requirements. men and women must use approved birth control methods during the study.
Beskrivning

Childbearing Potential Pregnancy Tests | Gender Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0032976
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
12. women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with azacitidine.
Beskrivning

Childbearing Potential Contraceptive methods | Gender Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
13. if at high risk for thrombotic event (such as on steroids or history of deep vein thrombosis), subjects must be able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid may use warfarin or low molecular weight heparin)
Beskrivning

High risk of Thrombosis | Steroid therapy | Deep Vein Thrombosis | Anticoagulation Prophylactic treatment | Aspirin U/day | Warfarin | Heparin, Low-Molecular-Weight

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C0040053
UMLS CUI [2]
C0149783
UMLS CUI [3]
C0149871
UMLS CUI [4,1]
C0003281
UMLS CUI [4,2]
C0199176
UMLS CUI [5,1]
C0004057
UMLS CUI [5,2]
C0456683
UMLS CUI [6]
C0043031
UMLS CUI [7]
C0019139
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
Beskrivning

Medical condition Serious Preventing Informed Consent | Laboratory test result abnormal Preventing Informed Consent | Mental disorders Preventing Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C1292733
UMLS CUI [1,4]
C0021430
UMLS CUI [2,1]
C0438215
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0021430
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C1292733
UMLS CUI [3,3]
C0021430
2. pregnant or breast feeding females. (lactating females must agree not to breast feed while taking lenalidomide).
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
3. any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
Beskrivning

Condition Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk | Condition Interferes with Interpretation Research data | Laboratory test result abnormal Interferes with Interpretation Research data

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
UMLS CUI [2,1]
C0438215
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1444641
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0459471
UMLS CUI [3,4]
C0681873
UMLS CUI [4,1]
C0438215
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0459471
UMLS CUI [4,4]
C0681873
4. use of any other experimental drug or therapy within 28 days of baseline.
Beskrivning

Investigational New Drugs | Therapies, Investigational

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0949266
5. known hypersensitivity to thalidomide or mannitol.
Beskrivning

Hypersensitivity Thalidomide | Mannitol allergy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0039736
UMLS CUI [2]
C0571922
6. the development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
Beskrivning

Erythema Nodosum | Rash desquamating | Intake Thalidomide | Intake Pharmaceutical Preparations Similar

Datatyp

boolean

Alias
UMLS CUI [1]
C0014743
UMLS CUI [2]
C0542171
UMLS CUI [3,1]
C1512806
UMLS CUI [3,2]
C0039736
UMLS CUI [4,1]
C1512806
UMLS CUI [4,2]
C0013227
UMLS CUI [4,3]
C2348205
7. any prior use of lenalidomide or azacitidine
Beskrivning

lenalidomide | Azacitidine

Datatyp

boolean

Alias
UMLS CUI [1]
C1144149
UMLS CUI [2]
C0004475
8. concurrent use of other anti-cancer agents or treatments
Beskrivning

Antineoplastic Agents Other | Cancer treatment Other

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003392
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C0920425
UMLS CUI [2,2]
C0205394
9. known positive for hiv or infectious hepatitis, type b or c
Beskrivning

HIV Seropositivity | Hepatitis B positive | Hepatitis C positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0856706
UMLS CUI [3]
C1112419
10. no chemotherapy, biologics or immunotherapy within 2 weeks prior to registration as specified in the protocol. subjects must have recovered from all therapy-related non-hematological toxicities to < grade 1 or to baseline if patient started with > grade 1 toxicity. there is no time limit with regards to radiation prior to registration.
Beskrivning

Chemotherapy | Biological Agents | Immunotherapy | Toxicity Therapy Related | Patient recovered | Toxicity CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0005515
UMLS CUI [3]
C0021083
UMLS CUI [4,1]
C0600688
UMLS CUI [4,2]
C0087111
UMLS CUI [4,3]
C0439849
UMLS CUI [5]
C1115804
UMLS CUI [6,1]
C0600688
UMLS CUI [6,2]
C1516728
11. no radioimmunotherapy within 2 months prior to registration. subjects must have recovered from all therapy-related toxicities to < grade 1 or to baseline if patient started with > grade 1 toxicity.
Beskrivning

Radioimmunotherapy | Toxicity Therapy Related | Patient recovered | Toxicity CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1]
C0085101
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0439849
UMLS CUI [3]
C1115804
UMLS CUI [4,1]
C0600688
UMLS CUI [4,2]
C1516728
12. no prior allogeneic stem cell transplantation unless allogeneic engraftment is <2%
Beskrivning

Allogeneic Stem Cell Transplantation | Exception Graft acceptance Allogeneic Percentage

Datatyp

boolean

Alias
UMLS CUI [1]
C2242529
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0301944
UMLS CUI [2,3]
C1515895
UMLS CUI [2,4]
C0439165
13. subjects receiving chronic, systemic treatment with corticosteroids equivalent to >20mg of prednisone per day
Beskrivning

CORTICOSTEROIDS FOR SYSTEMIC USE chronic | Equivalent Prednisolone U/day

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3653708
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0205163
UMLS CUI [2,2]
C0032950
UMLS CUI [2,3]
C0456683
Tillbaka till toppen

Similar models

Eligibility Follicular Lymphoma NCT01121757

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Lymphoma, Follicular | Marginal Zone Lymphoma
Item
1. histologically or cytologically confirmed follicular or marginal zone lymphoma
boolean
C0024301 (UMLS CUI [1])
C1367654 (UMLS CUI [2])
Refractory Disease | Evaluable Disease Persistent post treatment | Recurrent disease | Prior Therapy Quantity
Item
2. refractory disease defined as persistence of evaluable disease after therapy or have relapsed disease to at least one prior treatment regimen
boolean
C1514815 (UMLS CUI [1])
C1516986 (UMLS CUI [2,1])
C0205322 (UMLS CUI [2,2])
C2709088 (UMLS CUI [2,3])
C0277556 (UMLS CUI [3])
C1514463 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
Informed Consent
Item
3. understand and voluntarily sign an informed consent form
boolean
C0021430 (UMLS CUI [1])
Age
Item
4. age > or = to 18 years
boolean
C0001779 (UMLS CUI [1])
Protocol Compliance
Item
5. able to adhere to the study requirements
boolean
C0525058 (UMLS CUI [1])
Availability of Tumor tissue sample Frozen | Microarray Analysis
Item
6. a frozen tumor sample must be available for microarray analysis. this may either be a previously collected sample if it was properly prepared or a new biopsy may be obtained.
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C0016701 (UMLS CUI [1,3])
C1449575 (UMLS CUI [2])
Specimen obtained by core needle biopsy | Leukapheresis Acceptable | White Blood Cell Count procedure
Item
o at least 1 core biopsy specimen using at least a 16 gauge needle, which corresponds to roughly 25 mg of tissue. an equivalent amount of biopsy material from previously performed procedures, as long as it was fresh frozen, can be used. sample obtained with leukapheresis is acceptable in subjects with a white blood cell count (wbc) of 100,000 or greater.
boolean
C1960700 (UMLS CUI [1])
C0023416 (UMLS CUI [2,1])
C1879533 (UMLS CUI [2,2])
C0023508 (UMLS CUI [3])
ECOG performance status
Item
7. eastern cooperative oncology group (ecog) performance status of < or = to 2
boolean
C1520224 (UMLS CUI [1])
Laboratory test result Consistent with Study Protocol
Item
8. laboratory test results within ranges specified by the protocol.
boolean
C0587081 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Malignant Neoplasms Disease Free of Duration | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Carcinoma in situ of female breast Treated | Exception Superficial spreading melanoma Requirement Excision | Exception Prostate carcinoma Prostate specific antigen measurement
Item
9. disease free of prior malignancies for > or = to 3 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast or superficial melanoma only requiring excision or prostate cancer with a prostate specific antigen (psa) that has not increased for at least 3 months.
boolean
C0006826 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0332296 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0686288 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0334438 (UMLS CUI [6,2])
C1514873 (UMLS CUI [6,3])
C0728940 (UMLS CUI [6,4])
C1705847 (UMLS CUI [7,1])
C0600139 (UMLS CUI [7,2])
C0201544 (UMLS CUI [7,3])
Study Subject All | Registration Risk Reduction Program
Item
10. all study participants must be willing to be registered into the mandatory revassist®
boolean
C0681850 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
C1514821 (UMLS CUI [2,1])
C1137094 (UMLS CUI [2,2])
C3484370 (UMLS CUI [2,3])
Compliance behavior Risk Reduction Program
Item
program, and comply with the requirements of revassist®.
boolean
C1321605 (UMLS CUI [1,1])
C1137094 (UMLS CUI [1,2])
C3484370 (UMLS CUI [1,3])
Childbearing Potential Pregnancy Tests | Gender Contraceptive methods
Item
11. females of childbearing potential (fcbp) must comply with pregnancy testing requirements. men and women must use approved birth control methods during the study.
boolean
C3831118 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Childbearing Potential Contraceptive methods | Gender Contraceptive methods
Item
12. women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with azacitidine.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
High risk of Thrombosis | Steroid therapy | Deep Vein Thrombosis | Anticoagulation Prophylactic treatment | Aspirin U/day | Warfarin | Heparin, Low-Molecular-Weight
Item
13. if at high risk for thrombotic event (such as on steroids or history of deep vein thrombosis), subjects must be able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid may use warfarin or low molecular weight heparin)
boolean
C0332167 (UMLS CUI [1,1])
C0040053 (UMLS CUI [1,2])
C0149783 (UMLS CUI [2])
C0149871 (UMLS CUI [3])
C0003281 (UMLS CUI [4,1])
C0199176 (UMLS CUI [4,2])
C0004057 (UMLS CUI [5,1])
C0456683 (UMLS CUI [5,2])
C0043031 (UMLS CUI [6])
C0019139 (UMLS CUI [7])
Item Group
C0680251 (UMLS CUI)
Medical condition Serious Preventing Informed Consent | Laboratory test result abnormal Preventing Informed Consent | Mental disorders Preventing Informed Consent
Item
1. any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1292733 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,4])
C0438215 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
Pregnancy | Breast Feeding
Item
2. pregnant or breast feeding females. (lactating females must agree not to breast feed while taking lenalidomide).
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Condition Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk | Condition Interferes with Interpretation Research data | Laboratory test result abnormal Interferes with Interpretation Research data
Item
3. any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0438215 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0459471 (UMLS CUI [3,3])
C0681873 (UMLS CUI [3,4])
C0438215 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0459471 (UMLS CUI [4,3])
C0681873 (UMLS CUI [4,4])
Investigational New Drugs | Therapies, Investigational
Item
4. use of any other experimental drug or therapy within 28 days of baseline.
boolean
C0013230 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
Hypersensitivity Thalidomide | Mannitol allergy
Item
5. known hypersensitivity to thalidomide or mannitol.
boolean
C0020517 (UMLS CUI [1,1])
C0039736 (UMLS CUI [1,2])
C0571922 (UMLS CUI [2])
Erythema Nodosum | Rash desquamating | Intake Thalidomide | Intake Pharmaceutical Preparations Similar
Item
6. the development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
boolean
C0014743 (UMLS CUI [1])
C0542171 (UMLS CUI [2])
C1512806 (UMLS CUI [3,1])
C0039736 (UMLS CUI [3,2])
C1512806 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
C2348205 (UMLS CUI [4,3])
lenalidomide | Azacitidine
Item
7. any prior use of lenalidomide or azacitidine
boolean
C1144149 (UMLS CUI [1])
C0004475 (UMLS CUI [2])
Antineoplastic Agents Other | Cancer treatment Other
Item
8. concurrent use of other anti-cancer agents or treatments
boolean
C0003392 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0920425 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
HIV Seropositivity | Hepatitis B positive | Hepatitis C positive
Item
9. known positive for hiv or infectious hepatitis, type b or c
boolean
C0019699 (UMLS CUI [1])
C0856706 (UMLS CUI [2])
C1112419 (UMLS CUI [3])
Chemotherapy | Biological Agents | Immunotherapy | Toxicity Therapy Related | Patient recovered | Toxicity CTCAE Grades
Item
10. no chemotherapy, biologics or immunotherapy within 2 weeks prior to registration as specified in the protocol. subjects must have recovered from all therapy-related non-hematological toxicities to < grade 1 or to baseline if patient started with > grade 1 toxicity. there is no time limit with regards to radiation prior to registration.
boolean
C0392920 (UMLS CUI [1])
C0005515 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C0600688 (UMLS CUI [4,1])
C0087111 (UMLS CUI [4,2])
C0439849 (UMLS CUI [4,3])
C1115804 (UMLS CUI [5])
C0600688 (UMLS CUI [6,1])
C1516728 (UMLS CUI [6,2])
Radioimmunotherapy | Toxicity Therapy Related | Patient recovered | Toxicity CTCAE Grades
Item
11. no radioimmunotherapy within 2 months prior to registration. subjects must have recovered from all therapy-related toxicities to < grade 1 or to baseline if patient started with > grade 1 toxicity.
boolean
C0085101 (UMLS CUI [1])
C0600688 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C1115804 (UMLS CUI [3])
C0600688 (UMLS CUI [4,1])
C1516728 (UMLS CUI [4,2])
Allogeneic Stem Cell Transplantation | Exception Graft acceptance Allogeneic Percentage
Item
12. no prior allogeneic stem cell transplantation unless allogeneic engraftment is <2%
boolean
C2242529 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0301944 (UMLS CUI [2,2])
C1515895 (UMLS CUI [2,3])
C0439165 (UMLS CUI [2,4])
CORTICOSTEROIDS FOR SYSTEMIC USE chronic | Equivalent Prednisolone U/day
Item
13. subjects receiving chronic, systemic treatment with corticosteroids equivalent to >20mg of prednisone per day
boolean
C3653708 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0205163 (UMLS CUI [2,1])
C0032950 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])
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