ID

17964

Description

Campath-1H and EPOCH to Treat Non-Hodgkin's T- and NK-Cell Lymphomas; ODM derived from: https://clinicaltrials.gov/show/NCT00069238

Link

https://clinicaltrials.gov/show/NCT00069238

Keywords

Versions (1)
  1. 10/12/16 10/12/16 -
Uploaded on

October 12, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Lymphoma NCT00069238

English

Eligibility Lymphoma NCT00069238

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00069238
Criteria
Description

Criteria

cd52-expressing lymphoid malignancy, confirmed by pathology or flow cytometry staff of the hematopathology section, laboratory of pathology, nci. patients with t & nk cell malignancy without accessible tissue for flow cytometry analysis may be treated on this study.
Description

Malignant lymphoid neoplasm CD52 gene Expression | Flow Cytometry | T-Cell Lymphoma | NK-cell lymphoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0746336
UMLS CUI [1,2]
C1539083
UMLS CUI [1,3]
C0017262
UMLS CUI [2]
C0016263
UMLS CUI [3]
C0079772
UMLS CUI [4]
C3647364
patients with chemotherapy naive aggressive t & nk lymphomas, including but not limited to peripheral t cell lymphoma (nos), gamma-delta hepatosplenic t cell lymphoma, subcutaneous panniculitis-like t cell, nk-t cell lymphoma confirmed by pathology or flow cytometry staff of the hematopathology section, laboratory of pathology, nci. patients with alk-positive anaplastic large cell lymphoma and patients with t cell precursor disease are not eligible.
Description

Chemotherapy naive | T-Cell Lymphoma Aggressive | NK-cell lymphoma Aggressive | Peripheral T-Cell Lymphoma | Hepatosplenic T-cell lymphoma | Subcutaneous panniculitis-like T-cell lymphoma | Flow Cytometry | alk-positive anaplastic large cell lymphoma | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Data type

boolean

Alias
UMLS CUI [1,1]
C3665472
UMLS CUI [1,2]
C0919936
UMLS CUI [2,1]
C0079772
UMLS CUI [2,2]
C0580822
UMLS CUI [3,1]
C3647364
UMLS CUI [3,2]
C0580822
UMLS CUI [4]
C0079774
UMLS CUI [5]
C1333984
UMLS CUI [6]
C0522624
UMLS CUI [7]
C0016263
UMLS CUI [8]
C1332079
UMLS CUI [9]
C1961099
age greater than or equal to 17 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
laboratory tests: creatinine less than or equal to 1.5 mg/dl or creatinine clearance greater than or equal to 60 ml/min; bilirubin less than 2.0 mg/dl unless due to gilbert's, ast and alt less than or equal to 3 times uln (ast and alt is less than or equal to 6 times uln for patients on hyperalimentation for whom these abnormalities are felt to be due to the hyperalimentation) and; anc is greater than or equal to 1000/mm(3), platelet greater than or equal to 75,000/mm(3); unless impairment due to respective organ involvement by tumor.
Description

Laboratory Procedures | Creatinine measurement, serum | Creatinine clearance measurement | Serum total bilirubin measurement | Gilbert Disease | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Hyperphagia | Absolute neutrophil count | Platelet Count measurement | Impairment Due to Neoplasm organ involvement

Data type

boolean

Alias
UMLS CUI [1]
C0022885
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0373595
UMLS CUI [4]
C1278039
UMLS CUI [5]
C0017551
UMLS CUI [6]
C0201899
UMLS CUI [7]
C0201836
UMLS CUI [8]
C0020505
UMLS CUI [9]
C0948762
UMLS CUI [10]
C0032181
UMLS CUI [11,1]
C0221099
UMLS CUI [11,2]
C0678226
UMLS CUI [11,3]
C0027651
UMLS CUI [11,4]
C0457576
no active symptomatic ischemic heart disease, myocardial infarction or congestive heart failure within the past year.
Description

Myocardial Ischemia Symptomatic | Myocardial Infarction | Congestive heart failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0151744
UMLS CUI [1,2]
C0231220
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0018802
hiv negative, because of the unknown effects of combined therapy with chemotherapy and an immunosuppressive agent on hiv progression.
Description

HIV negative | Combined Modality Therapy | Chemotherapy | Immunosuppressive Agents | effects Unknown HIV disease progression

Data type

boolean

Alias
UMLS CUI [1]
C0481430
UMLS CUI [2]
C0009429
UMLS CUI [3]
C0392920
UMLS CUI [4]
C0021081
UMLS CUI [5,1]
C0001688
UMLS CUI [5,2]
C0439673
UMLS CUI [5,3]
C1141957
signed informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
willing to use contraception.
Description

Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0700589
not pregnant or nursing, because of the unknown effects of alemtuzumab on the developing fetus and infant.
Description

Pregnancy | Breast Feeding | alemtuzumab | effects Unknown Fetus | effects Unknown Infant

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0383429
UMLS CUI [4,1]
C0001688
UMLS CUI [4,2]
C0439673
UMLS CUI [4,3]
C0015965
UMLS CUI [5,1]
C0001688
UMLS CUI [5,2]
C0439673
UMLS CUI [5,3]
C0021270
no serious underlying medical condition or infection that would contraindicate treatment. patients with cns involvement are eligible for treatment on this study.
Description

medical condition Serious Medical contraindication Therapeutic procedure | Communicable Disease Serious Medical contraindication Therapeutic procedure | Central Nervous System Involvement

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C1301624
UMLS CUI [1,4]
C0087111
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C1301624
UMLS CUI [2,4]
C0087111
UMLS CUI [3]
C4050309
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Similar models

Eligibility Lymphoma NCT00069238

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00069238
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Malignant lymphoid neoplasm CD52 gene Expression | Flow Cytometry | T-Cell Lymphoma | NK-cell lymphoma
Item
cd52-expressing lymphoid malignancy, confirmed by pathology or flow cytometry staff of the hematopathology section, laboratory of pathology, nci. patients with t & nk cell malignancy without accessible tissue for flow cytometry analysis may be treated on this study.
boolean
C0746336 (UMLS CUI [1,1])
C1539083 (UMLS CUI [1,2])
C0017262 (UMLS CUI [1,3])
C0016263 (UMLS CUI [2])
C0079772 (UMLS CUI [3])
C3647364 (UMLS CUI [4])
Chemotherapy naive | T-Cell Lymphoma Aggressive | NK-cell lymphoma Aggressive | Peripheral T-Cell Lymphoma | Hepatosplenic T-cell lymphoma | Subcutaneous panniculitis-like T-cell lymphoma | Flow Cytometry | alk-positive anaplastic large cell lymphoma | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Item
patients with chemotherapy naive aggressive t & nk lymphomas, including but not limited to peripheral t cell lymphoma (nos), gamma-delta hepatosplenic t cell lymphoma, subcutaneous panniculitis-like t cell, nk-t cell lymphoma confirmed by pathology or flow cytometry staff of the hematopathology section, laboratory of pathology, nci. patients with alk-positive anaplastic large cell lymphoma and patients with t cell precursor disease are not eligible.
boolean
C3665472 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
C0079772 (UMLS CUI [2,1])
C0580822 (UMLS CUI [2,2])
C3647364 (UMLS CUI [3,1])
C0580822 (UMLS CUI [3,2])
C0079774 (UMLS CUI [4])
C1333984 (UMLS CUI [5])
C0522624 (UMLS CUI [6])
C0016263 (UMLS CUI [7])
C1332079 (UMLS CUI [8])
C1961099 (UMLS CUI [9])
Age
Item
age greater than or equal to 17 years.
boolean
C0001779 (UMLS CUI [1])
Laboratory Procedures | Creatinine measurement, serum | Creatinine clearance measurement | Serum total bilirubin measurement | Gilbert Disease | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Hyperphagia | Absolute neutrophil count | Platelet Count measurement | Impairment Due to Neoplasm organ involvement
Item
laboratory tests: creatinine less than or equal to 1.5 mg/dl or creatinine clearance greater than or equal to 60 ml/min; bilirubin less than 2.0 mg/dl unless due to gilbert's, ast and alt less than or equal to 3 times uln (ast and alt is less than or equal to 6 times uln for patients on hyperalimentation for whom these abnormalities are felt to be due to the hyperalimentation) and; anc is greater than or equal to 1000/mm(3), platelet greater than or equal to 75,000/mm(3); unless impairment due to respective organ involvement by tumor.
boolean
C0022885 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C0017551 (UMLS CUI [5])
C0201899 (UMLS CUI [6])
C0201836 (UMLS CUI [7])
C0020505 (UMLS CUI [8])
C0948762 (UMLS CUI [9])
C0032181 (UMLS CUI [10])
C0221099 (UMLS CUI [11,1])
C0678226 (UMLS CUI [11,2])
C0027651 (UMLS CUI [11,3])
C0457576 (UMLS CUI [11,4])
Myocardial Ischemia Symptomatic | Myocardial Infarction | Congestive heart failure
Item
no active symptomatic ischemic heart disease, myocardial infarction or congestive heart failure within the past year.
boolean
C0151744 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
HIV negative | Combined Modality Therapy | Chemotherapy | Immunosuppressive Agents | effects Unknown HIV disease progression
Item
hiv negative, because of the unknown effects of combined therapy with chemotherapy and an immunosuppressive agent on hiv progression.
boolean
C0481430 (UMLS CUI [1])
C0009429 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C0021081 (UMLS CUI [4])
C0001688 (UMLS CUI [5,1])
C0439673 (UMLS CUI [5,2])
C1141957 (UMLS CUI [5,3])
Informed Consent
Item
signed informed consent.
boolean
C0021430 (UMLS CUI [1])
Contraceptive methods
Item
willing to use contraception.
boolean
C0700589 (UMLS CUI [1])
Pregnancy | Breast Feeding | alemtuzumab | effects Unknown Fetus | effects Unknown Infant
Item
not pregnant or nursing, because of the unknown effects of alemtuzumab on the developing fetus and infant.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0383429 (UMLS CUI [3])
C0001688 (UMLS CUI [4,1])
C0439673 (UMLS CUI [4,2])
C0015965 (UMLS CUI [4,3])
C0001688 (UMLS CUI [5,1])
C0439673 (UMLS CUI [5,2])
C0021270 (UMLS CUI [5,3])
medical condition Serious Medical contraindication Therapeutic procedure | Communicable Disease Serious Medical contraindication Therapeutic procedure | Central Nervous System Involvement
Item
no serious underlying medical condition or infection that would contraindicate treatment. patients with cns involvement are eligible for treatment on this study.
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1301624 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C0009450 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C1301624 (UMLS CUI [2,3])
C0087111 (UMLS CUI [2,4])
C4050309 (UMLS CUI [3])
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