ID

28417

Beskrivning

Combination Chemotherapy and Rituximab in Treating Patients With Untreated Mantle Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00433537

Länk

https://clinicaltrials.gov/show/NCT00433537

Nyckelord

Versioner (1)
  1. 2018-01-11 2018-01-11 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

11 januari 2018

DOI

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Creative Commons BY 4.0
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Eligibility Contiguous Stage II Mantle Cell Lymphoma NCT00433537

Engelsk

Eligibility Contiguous Stage II Mantle Cell Lymphoma NCT00433537

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have a histologically confirmed diagnosis of mantle cell lymphoma by demonstrating appropriate morphology plus at least one of the following on the biopsy specimen: nuclear cyclin d1+ by immunohistochemistry; t(11;14) by fluorescence in situ hybridization (fish), polymerase chain reaction (pcr), or conventional karyotyping
Beskrivning

Mantle cell lymphoma | Morphology Appropriate | Biopsy sample | CCND1 Positive Immunohistochemistry | t(11;14)(q13;q32) FISH | t(11;14)(q13;q32) PCR | t(11;14)(q13;q32) Karyotyping

Datatyp

boolean

Alias
UMLS CUI [1]
C0334634
UMLS CUI [2,1]
C0332437
UMLS CUI [2,2]
C1548787
UMLS CUI [3]
C0677862
UMLS CUI [4,1]
C1741716
UMLS CUI [4,2]
C1514241
UMLS CUI [4,3]
C0021044
UMLS CUI [5,1]
C1515705
UMLS CUI [5,2]
C0162789
UMLS CUI [6,1]
C1515705
UMLS CUI [6,2]
C0032520
UMLS CUI [7,1]
C1515705
UMLS CUI [7,2]
C0022526
no prior chemotherapy, immunotherapy or radiotherapy for mantle cell lymphoma; a brief course of steroids (< 14 days) for symptom relief or steroids for other indications are allowed
Beskrivning

Prior Chemotherapy Absent Mantle cell lymphoma | Prior Immunotherapy Absent Mantle cell lymphoma | Prior radiation therapy Absent Mantle cell lymphoma | Steroids Course Brief allowed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0334634
UMLS CUI [2,1]
C1514461
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0334634
UMLS CUI [3,1]
C0279134
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0334634
UMLS CUI [4,1]
C0038317
UMLS CUI [4,2]
C0750729
UMLS CUI [4,3]
C1879313
UMLS CUI [4,4]
C0683607
patients must have measurable disease; ct scans at baseline are required to define the extent of measurable disease; the scans must be obtained within 6 weeks prior to registration; combined ct/pet scans may be used for the baseline and subsequent evaluations if accurate tumor measurements can be obtained from the ct component
Beskrivning

Measurable Disease CT scan | PET/CT scan Evaluation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0040405
UMLS CUI [2,1]
C1699633
UMLS CUI [2,2]
C1261322
eastern cooperative oncology group (ecog) performance status 0-2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
absolute neutrophil count (anc) > 1500 mm^3 (unless low count due to marrow involvement or splenomegaly)
Beskrivning

Absolute neutrophil count | Relationship Bone Marrow Involvement | Relationship Splenomegaly

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C1517677
UMLS CUI [3,1]
C0439849
UMLS CUI [3,2]
C0038002
platelets > 100,000 mm^3 (unless low counts due to marrow involvement or splenomegaly)
Beskrivning

Platelet Count measurement | Relationship Bone Marrow Involvement | Relationship Splenomegaly

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C1517677
UMLS CUI [3,1]
C0439849
UMLS CUI [3,2]
C0038002
creatinine < 2 mg/dl
Beskrivning

Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
bilirubin < 2 mg/dl (may be up to 3.0 mg/dl if due to gilbert's disease or due to liver involvement by lymphoma)
Beskrivning

Serum total bilirubin measurement | Relationship Gilbert Disease | Relationship Liver Involvement with Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C0017551
UMLS CUI [3,1]
C0439849
UMLS CUI [3,2]
C0023884
UMLS CUI [3,3]
C1314939
UMLS CUI [3,4]
C0024299
patients over the age of 45 must have a left ventricular ejection fraction (lvef) of greater than 45% documented within 90 days prior to registration
Beskrivning

Age | Left ventricular ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0428772
patients must be tested for hepatitis b surface antigen (hbs ag) within 4 weeks prior to registration note: hbs ag positive patients are not excluded but will have more stringent monitoring of liver function tests
Beskrivning

Serum Hepatitis B Surface Antigen Test | Hepatitis B surface antigen positive Requirement Liver Function Tests

Datatyp

boolean

Alias
UMLS CUI [1]
C1254699
UMLS CUI [2,1]
C0149709
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0023901
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
known hiv disease; an hiv test is not required for entry on study but is required if the patient is perceived to be at risk; patients with a history of intravenous drug use or any other behavior with an increased risk for hiv infection should be tested for exposure to the hiv virus; patients with known hiv are excluded since the immunocompromised state of patients with hiv infection or the concomitant use of highly active antiretroviral therapy (haart) may result in more extensive dose modifications than intended for the intensive therapeutic regimen used in this study
Beskrivning

HIV Infection | Patients At risk Requirement HIV test | Intravenous drug use HIV test | Behavior Risk Increased HIV test | Antiretroviral Therapy, Highly Active

Datatyp

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C1514873
UMLS CUI [2,4]
C1321876
UMLS CUI [3,1]
C0699778
UMLS CUI [3,2]
C1321876
UMLS CUI [4,1]
C0004927
UMLS CUI [4,2]
C0035647
UMLS CUI [4,3]
C0205217
UMLS CUI [4,4]
C1321876
UMLS CUI [5]
C0887947
pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy; women of childbearing potential and sexually active males must use an accepted and effective method of contraception
Beskrivning

Pregnancy | Breast Feeding | Childbearing Potential Hematologic Test | Childbearing Potential Urinalysis | Childbearing Potential Contraceptive methods | Gender Sexually active Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0018941
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0042014
UMLS CUI [5,1]
C3831118
UMLS CUI [5,2]
C0700589
UMLS CUI [6,1]
C0079399
UMLS CUI [6,2]
C0241028
UMLS CUI [6,3]
C0700589
grade 2 or higher baseline peripheral neuropathy
Beskrivning

Peripheral Neuropathy CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
known hypersensitivity to boron or mannitol
Beskrivning

Hypersensitivity Boron | Mannitol allergy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0006030
UMLS CUI [2]
C0571922
history of prior malignancy unless at least one of the following conditions are met:
Beskrivning

Malignant Neoplasms

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
malignancy was in-situ
Beskrivning

Exception Carcinoma in Situ

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0007099
malignancy was treated surgically or with local radiation therapy with curative intent and the patient has been disease free for > 3 years
Beskrivning

Exception Operative Surgical Procedures Malignant Neoplasms | Exception Therapeutic radiology procedure Local Curative Malignant Neoplasms | Exception Disease Free of

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1522449
UMLS CUI [2,3]
C0205276
UMLS CUI [2,4]
C1276305
UMLS CUI [2,5]
C0006826
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C0332296
any adjuvant hormonal therapy must have been discontinued > 3 months prior to registration
Beskrivning

Hormone Therapy Adjuvant To be stopped

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C1522673
UMLS CUI [1,3]
C1272691
known central nervous system (cns) involvement
Beskrivning

Central Nervous System Involvement

Datatyp

boolean

Alias
UMLS CUI [1]
C4050309
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Similar models

Eligibility Contiguous Stage II Mantle Cell Lymphoma NCT00433537

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Mantle cell lymphoma | Morphology Appropriate | Biopsy sample | CCND1 Positive Immunohistochemistry | t(11;14)(q13;q32) FISH | t(11;14)(q13;q32) PCR | t(11;14)(q13;q32) Karyotyping
Item
patients must have a histologically confirmed diagnosis of mantle cell lymphoma by demonstrating appropriate morphology plus at least one of the following on the biopsy specimen: nuclear cyclin d1+ by immunohistochemistry; t(11;14) by fluorescence in situ hybridization (fish), polymerase chain reaction (pcr), or conventional karyotyping
boolean
C0334634 (UMLS CUI [1])
C0332437 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C0677862 (UMLS CUI [3])
C1741716 (UMLS CUI [4,1])
C1514241 (UMLS CUI [4,2])
C0021044 (UMLS CUI [4,3])
C1515705 (UMLS CUI [5,1])
C0162789 (UMLS CUI [5,2])
C1515705 (UMLS CUI [6,1])
C0032520 (UMLS CUI [6,2])
C1515705 (UMLS CUI [7,1])
C0022526 (UMLS CUI [7,2])
Prior Chemotherapy Absent Mantle cell lymphoma | Prior Immunotherapy Absent Mantle cell lymphoma | Prior radiation therapy Absent Mantle cell lymphoma | Steroids Course Brief allowed
Item
no prior chemotherapy, immunotherapy or radiotherapy for mantle cell lymphoma; a brief course of steroids (< 14 days) for symptom relief or steroids for other indications are allowed
boolean
C1514457 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0334634 (UMLS CUI [1,3])
C1514461 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0334634 (UMLS CUI [2,3])
C0279134 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0334634 (UMLS CUI [3,3])
C0038317 (UMLS CUI [4,1])
C0750729 (UMLS CUI [4,2])
C1879313 (UMLS CUI [4,3])
C0683607 (UMLS CUI [4,4])
Measurable Disease CT scan | PET/CT scan Evaluation
Item
patients must have measurable disease; ct scans at baseline are required to define the extent of measurable disease; the scans must be obtained within 6 weeks prior to registration; combined ct/pet scans may be used for the baseline and subsequent evaluations if accurate tumor measurements can be obtained from the ct component
boolean
C1513041 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
C1699633 (UMLS CUI [2,1])
C1261322 (UMLS CUI [2,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Absolute neutrophil count | Relationship Bone Marrow Involvement | Relationship Splenomegaly
Item
absolute neutrophil count (anc) > 1500 mm^3 (unless low count due to marrow involvement or splenomegaly)
boolean
C0948762 (UMLS CUI [1])
C0439849 (UMLS CUI [2,1])
C1517677 (UMLS CUI [2,2])
C0439849 (UMLS CUI [3,1])
C0038002 (UMLS CUI [3,2])
Platelet Count measurement | Relationship Bone Marrow Involvement | Relationship Splenomegaly
Item
platelets > 100,000 mm^3 (unless low counts due to marrow involvement or splenomegaly)
boolean
C0032181 (UMLS CUI [1])
C0439849 (UMLS CUI [2,1])
C1517677 (UMLS CUI [2,2])
C0439849 (UMLS CUI [3,1])
C0038002 (UMLS CUI [3,2])
Creatinine measurement, serum
Item
creatinine < 2 mg/dl
boolean
C0201976 (UMLS CUI [1])
Serum total bilirubin measurement | Relationship Gilbert Disease | Relationship Liver Involvement with Lymphoma
Item
bilirubin < 2 mg/dl (may be up to 3.0 mg/dl if due to gilbert's disease or due to liver involvement by lymphoma)
boolean
C1278039 (UMLS CUI [1])
C0439849 (UMLS CUI [2,1])
C0017551 (UMLS CUI [2,2])
C0439849 (UMLS CUI [3,1])
C0023884 (UMLS CUI [3,2])
C1314939 (UMLS CUI [3,3])
C0024299 (UMLS CUI [3,4])
Age | Left ventricular ejection fraction
Item
patients over the age of 45 must have a left ventricular ejection fraction (lvef) of greater than 45% documented within 90 days prior to registration
boolean
C0001779 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
Serum Hepatitis B Surface Antigen Test | Hepatitis B surface antigen positive Requirement Liver Function Tests
Item
patients must be tested for hepatitis b surface antigen (hbs ag) within 4 weeks prior to registration note: hbs ag positive patients are not excluded but will have more stringent monitoring of liver function tests
boolean
C1254699 (UMLS CUI [1])
C0149709 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0023901 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
HIV Infection | Patients At risk Requirement HIV test | Intravenous drug use HIV test | Behavior Risk Increased HIV test | Antiretroviral Therapy, Highly Active
Item
known hiv disease; an hiv test is not required for entry on study but is required if the patient is perceived to be at risk; patients with a history of intravenous drug use or any other behavior with an increased risk for hiv infection should be tested for exposure to the hiv virus; patients with known hiv are excluded since the immunocompromised state of patients with hiv infection or the concomitant use of highly active antiretroviral therapy (haart) may result in more extensive dose modifications than intended for the intensive therapeutic regimen used in this study
boolean
C0019693 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
C1321876 (UMLS CUI [2,4])
C0699778 (UMLS CUI [3,1])
C1321876 (UMLS CUI [3,2])
C0004927 (UMLS CUI [4,1])
C0035647 (UMLS CUI [4,2])
C0205217 (UMLS CUI [4,3])
C1321876 (UMLS CUI [4,4])
C0887947 (UMLS CUI [5])
Pregnancy | Breast Feeding | Childbearing Potential Hematologic Test | Childbearing Potential Urinalysis | Childbearing Potential Contraceptive methods | Gender Sexually active Contraceptive methods
Item
pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy; women of childbearing potential and sexually active males must use an accepted and effective method of contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0018941 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0042014 (UMLS CUI [4,2])
C3831118 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
C0079399 (UMLS CUI [6,1])
C0241028 (UMLS CUI [6,2])
C0700589 (UMLS CUI [6,3])
Peripheral Neuropathy CTCAE Grades
Item
grade 2 or higher baseline peripheral neuropathy
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Hypersensitivity Boron | Mannitol allergy
Item
known hypersensitivity to boron or mannitol
boolean
C0020517 (UMLS CUI [1,1])
C0006030 (UMLS CUI [1,2])
C0571922 (UMLS CUI [2])
Malignant Neoplasms
Item
history of prior malignancy unless at least one of the following conditions are met:
boolean
C0006826 (UMLS CUI [1])
Exception Carcinoma in Situ
Item
malignancy was in-situ
boolean
C1705847 (UMLS CUI [1,1])
C0007099 (UMLS CUI [1,2])
Exception Operative Surgical Procedures Malignant Neoplasms | Exception Therapeutic radiology procedure Local Curative Malignant Neoplasms | Exception Disease Free of
Item
malignancy was treated surgically or with local radiation therapy with curative intent and the patient has been disease free for > 3 years
boolean
C1705847 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
C0205276 (UMLS CUI [2,3])
C1276305 (UMLS CUI [2,4])
C0006826 (UMLS CUI [2,5])
C1705847 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0332296 (UMLS CUI [3,3])
Hormone Therapy Adjuvant To be stopped
Item
any adjuvant hormonal therapy must have been discontinued > 3 months prior to registration
boolean
C0279025 (UMLS CUI [1,1])
C1522673 (UMLS CUI [1,2])
C1272691 (UMLS CUI [1,3])
Central Nervous System Involvement
Item
known central nervous system (cns) involvement
boolean
C4050309 (UMLS CUI [1])
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