ID

30329

Beschrijving

Flavopiridol to Treat Relapsed Mantle Cell Lymphoma or Diffuse Large B-Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00445341

Link

https://clinicaltrials.gov/show/NCT00445341

Trefwoorden

Versies (1)
  1. 29-05-18 29-05-18 -
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See clinicaltrials.gov

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29 mei 2018

DOI

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Creative Commons BY 4.0
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Eligibility Lymphoma NCT00445341

Engels

Eligibility Lymphoma NCT00445341

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00445341
Criteria
Beschrijving

Criteria

previously treated mantle cell lymphoma or diffuse large b-cell lymphoma (to include mediastinal (thymic) large b-cell lymphoma; transformed large b-cell lymphoma; follicular grade iiib large b-cell lymphoma; intravascular large b-cell lymphoma).
Beschrijving

Prior Therapy Mantle cell lymphoma | Prior Therapy Diffuse Large B-Cell Lymphoma | Mediastinal (Thymic) Large B-Cell Lymphoma | Diffuse Large B-Cell Lymphoma Transformed | Diffuse Large B-Cell Lymphoma Follicular Ann Arbor lymphoma staging system | Intravascular large b-cell lymphoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0334634
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0079744
UMLS CUI [3]
C1292754
UMLS CUI [4,1]
C0079744
UMLS CUI [4,2]
C0457344
UMLS CUI [5,1]
C0079744
UMLS CUI [5,2]
C0439682
UMLS CUI [5,3]
C0432516
UMLS CUI [6]
C0334660
confirmed pathological diagnosis at the national cancer institute, national institutes of health (nih).
Beschrijving

Diagnosis Pathological

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0205469
recurrent measurable disease (measurable disease in 2 dimensions or leukemic disease which can be quantified and followed).
Beschrijving

Measurable Disease 2-Dimensional Recurrent | Leukemia Measurable

Datatype

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1705052
UMLS CUI [1,3]
C2945760
UMLS CUI [2,1]
C0023418
UMLS CUI [2,2]
C1513040
prior anthracycline-based treatment for patients with diffuse large b-cell lymphoma (dlbcl).
Beschrijving

Prior anthracycline therapy Diffuse Large B-Cell Lymphoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0278941
UMLS CUI [1,2]
C0079744
age greater than 18 years.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
eastern cooperative oncology group (ecog) performance 2 or better.
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
major organ function: absolute neutrophil count (anc) greater than 1000/mcl, platelet greater than 50,000/mcl, creatinine less than 1.5 mg/dl or creatinine clearance greater than 60 ml/min; serum glutamic pyruvic transaminase (sgpt) less than 5 x upper limit of normal; bilirubin less than 2 mg/dl (total) except less than 5 mg/dl in patients with gilbert's syndrome as defined by greater than 80% unconjugated. anc and platelet requirements must be met independent of transfusion.
Beschrijving

Organ function | Absolute neutrophil count | Platelet Count measurement | Creatinine measurement, serum | Creatinine clearance measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement | Exception Gilbert Disease | Unconjugated bilirubin

Datatype

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0201976
UMLS CUI [5]
C0373595
UMLS CUI [6]
C0201836
UMLS CUI [7]
C1278039
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0017551
UMLS CUI [9]
C0857544
informed consent and willingness to use contraception by both men and women.
Beschrijving

Informed Consent | Contraceptive methods Willing

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C0600109
both male and female patients must be willing to use adequate contraception (to include effective barrier methods of contraception) or to completely abstain from heterosexual intercourse while on protocol treatment.
Beschrijving

Contraceptive methods Willing | Contraception, Barrier | Sexual Abstinence

Datatype

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0600109
UMLS CUI [2]
C0004764
UMLS CUI [3]
C0036899
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or nursing because of an unknown potential for teratogenic or abortifacient effects.
Beschrijving

Pregnancy | Breast Feeding | Potential Unknown Teratogeniic effect | Potential Unknown Abortifacient Effect

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3245505
UMLS CUI [3,2]
C0439673
UMLS CUI [3,3]
C0232910
UMLS CUI [4,1]
C3245505
UMLS CUI [4,2]
C0439673
UMLS CUI [4,3]
C3179338
human immunodeficiency virus (hiv) serology negative. hiv positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with flavopiridol. additionally, the biology of hiv associated dlbcl's is often quite different from hiv negative disease due to involvement of epstein barr virus (ebv).
Beschrijving

Serology negative HIV | Exclusion Antiretroviral therapy HIV Seropositivity | Drug Interaction alvocidib Possible

Datatype

boolean

Alias
UMLS CUI [1,1]
C0919674
UMLS CUI [1,2]
C0019682
UMLS CUI [2,1]
C2828389
UMLS CUI [2,2]
C1963724
UMLS CUI [2,3]
C0019699
UMLS CUI [3,1]
C0687133
UMLS CUI [3,2]
C0281603
UMLS CUI [3,3]
C0332149
hepatitis b surface antigen negative.
Beschrijving

Hepatitis B surface antigen negative

Datatype

boolean

Alias
UMLS CUI [1]
C0919711
active central nervous system (cns) lymphoma. these patients have a poor prognosis and because they frequently develop progressive neurological dysfunction that would confound the evaluation of neurological and other adverse events.
Beschrijving

Central nervous system lymphoma | Prognosis bad | Development Progressive Neurologic dysfunction Frequently | Progressive Neurologic dysfunction Interferes with Evaluation Neurological event | Progressive Neurologic dysfunction Interferes with Evaluation Adverse event

Datatype

boolean

Alias
UMLS CUI [1]
C0742472
UMLS CUI [2]
C0278252
UMLS CUI [3,1]
C0243107
UMLS CUI [3,2]
C4013375
UMLS CUI [3,3]
C0332183
UMLS CUI [4,1]
C4013375
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C1261322
UMLS CUI [4,4]
C1320718
UMLS CUI [5,1]
C4013375
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C1261322
UMLS CUI [5,4]
C0877248
history of inflammatory bowel disease unless this has been inactive for a period of 2 or more years.
Beschrijving

Inflammatory Bowel Disease | Exception Disease remission

Datatype

boolean

Alias
UMLS CUI [1]
C0021390
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0544452
recovery from toxicity of prior therapy to a grade 1 or less.
Beschrijving

Prior Therapy Toxicity | Recovery Toxicity CTCAE Grades

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0600688
UMLS CUI [2,1]
C2004454
UMLS CUI [2,2]
C0600688
UMLS CUI [2,3]
C1516728
systemic cytotoxic or experimental treatments within 4 weeks of treatment.
Beschrijving

Cytotoxic therapy Systemic | Investigational Therapies Systemic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C0205373
UMLS CUI [2,1]
C0949266
UMLS CUI [2,2]
C0205373
white blood cell (wbc) greater than 100,000 cells/mcl.
Beschrijving

White Blood Cell Count procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0023508
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Similar models

Eligibility Lymphoma NCT00445341

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00445341
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Prior Therapy Mantle cell lymphoma | Prior Therapy Diffuse Large B-Cell Lymphoma | Mediastinal (Thymic) Large B-Cell Lymphoma | Diffuse Large B-Cell Lymphoma Transformed | Diffuse Large B-Cell Lymphoma Follicular Ann Arbor lymphoma staging system | Intravascular large b-cell lymphoma
Item
previously treated mantle cell lymphoma or diffuse large b-cell lymphoma (to include mediastinal (thymic) large b-cell lymphoma; transformed large b-cell lymphoma; follicular grade iiib large b-cell lymphoma; intravascular large b-cell lymphoma).
boolean
C1514463 (UMLS CUI [1,1])
C0334634 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0079744 (UMLS CUI [2,2])
C1292754 (UMLS CUI [3])
C0079744 (UMLS CUI [4,1])
C0457344 (UMLS CUI [4,2])
C0079744 (UMLS CUI [5,1])
C0439682 (UMLS CUI [5,2])
C0432516 (UMLS CUI [5,3])
C0334660 (UMLS CUI [6])
Diagnosis Pathological
Item
confirmed pathological diagnosis at the national cancer institute, national institutes of health (nih).
boolean
C0011900 (UMLS CUI [1,1])
C0205469 (UMLS CUI [1,2])
Measurable Disease 2-Dimensional Recurrent | Leukemia Measurable
Item
recurrent measurable disease (measurable disease in 2 dimensions or leukemic disease which can be quantified and followed).
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
C2945760 (UMLS CUI [1,3])
C0023418 (UMLS CUI [2,1])
C1513040 (UMLS CUI [2,2])
Prior anthracycline therapy Diffuse Large B-Cell Lymphoma
Item
prior anthracycline-based treatment for patients with diffuse large b-cell lymphoma (dlbcl).
boolean
C0278941 (UMLS CUI [1,1])
C0079744 (UMLS CUI [1,2])
Age
Item
age greater than 18 years.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance 2 or better.
boolean
C1520224 (UMLS CUI [1])
Organ function | Absolute neutrophil count | Platelet Count measurement | Creatinine measurement, serum | Creatinine clearance measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement | Exception Gilbert Disease | Unconjugated bilirubin
Item
major organ function: absolute neutrophil count (anc) greater than 1000/mcl, platelet greater than 50,000/mcl, creatinine less than 1.5 mg/dl or creatinine clearance greater than 60 ml/min; serum glutamic pyruvic transaminase (sgpt) less than 5 x upper limit of normal; bilirubin less than 2 mg/dl (total) except less than 5 mg/dl in patients with gilbert's syndrome as defined by greater than 80% unconjugated. anc and platelet requirements must be met independent of transfusion.
boolean
C0678852 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0201976 (UMLS CUI [4])
C0373595 (UMLS CUI [5])
C0201836 (UMLS CUI [6])
C1278039 (UMLS CUI [7])
C1705847 (UMLS CUI [8,1])
C0017551 (UMLS CUI [8,2])
C0857544 (UMLS CUI [9])
Informed Consent | Contraceptive methods Willing
Item
informed consent and willingness to use contraception by both men and women.
boolean
C0021430 (UMLS CUI [1])
C0700589 (UMLS CUI [2,1])
C0600109 (UMLS CUI [2,2])
Contraceptive methods Willing | Contraception, Barrier | Sexual Abstinence
Item
both male and female patients must be willing to use adequate contraception (to include effective barrier methods of contraception) or to completely abstain from heterosexual intercourse while on protocol treatment.
boolean
C0700589 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C0004764 (UMLS CUI [2])
C0036899 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Potential Unknown Teratogeniic effect | Potential Unknown Abortifacient Effect
Item
pregnant or nursing because of an unknown potential for teratogenic or abortifacient effects.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3245505 (UMLS CUI [3,1])
C0439673 (UMLS CUI [3,2])
C0232910 (UMLS CUI [3,3])
C3245505 (UMLS CUI [4,1])
C0439673 (UMLS CUI [4,2])
C3179338 (UMLS CUI [4,3])
Serology negative HIV | Exclusion Antiretroviral therapy HIV Seropositivity | Drug Interaction alvocidib Possible
Item
human immunodeficiency virus (hiv) serology negative. hiv positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with flavopiridol. additionally, the biology of hiv associated dlbcl's is often quite different from hiv negative disease due to involvement of epstein barr virus (ebv).
boolean
C0919674 (UMLS CUI [1,1])
C0019682 (UMLS CUI [1,2])
C2828389 (UMLS CUI [2,1])
C1963724 (UMLS CUI [2,2])
C0019699 (UMLS CUI [2,3])
C0687133 (UMLS CUI [3,1])
C0281603 (UMLS CUI [3,2])
C0332149 (UMLS CUI [3,3])
Hepatitis B surface antigen negative
Item
hepatitis b surface antigen negative.
boolean
C0919711 (UMLS CUI [1])
Central nervous system lymphoma | Prognosis bad | Development Progressive Neurologic dysfunction Frequently | Progressive Neurologic dysfunction Interferes with Evaluation Neurological event | Progressive Neurologic dysfunction Interferes with Evaluation Adverse event
Item
active central nervous system (cns) lymphoma. these patients have a poor prognosis and because they frequently develop progressive neurological dysfunction that would confound the evaluation of neurological and other adverse events.
boolean
C0742472 (UMLS CUI [1])
C0278252 (UMLS CUI [2])
C0243107 (UMLS CUI [3,1])
C4013375 (UMLS CUI [3,2])
C0332183 (UMLS CUI [3,3])
C4013375 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C1261322 (UMLS CUI [4,3])
C1320718 (UMLS CUI [4,4])
C4013375 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C1261322 (UMLS CUI [5,3])
C0877248 (UMLS CUI [5,4])
Inflammatory Bowel Disease | Exception Disease remission
Item
history of inflammatory bowel disease unless this has been inactive for a period of 2 or more years.
boolean
C0021390 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0544452 (UMLS CUI [2,2])
Prior Therapy Toxicity | Recovery Toxicity CTCAE Grades
Item
recovery from toxicity of prior therapy to a grade 1 or less.
boolean
C1514463 (UMLS CUI [1,1])
C0600688 (UMLS CUI [1,2])
C2004454 (UMLS CUI [2,1])
C0600688 (UMLS CUI [2,2])
C1516728 (UMLS CUI [2,3])
Cytotoxic therapy Systemic | Investigational Therapies Systemic
Item
systemic cytotoxic or experimental treatments within 4 weeks of treatment.
boolean
C0677881 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0949266 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
White Blood Cell Count procedure
Item
white blood cell (wbc) greater than 100,000 cells/mcl.
boolean
C0023508 (UMLS CUI [1])
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