ID

22424

Description

The Effectiveness of Alemtuzumab Given in Combination With CHOP and ESHAP in Patients Newly Diagnosed With Peripheral T-Cell Lymphoma (PTCL); ODM derived from: https://clinicaltrials.gov/show/NCT00930605

Link

https://clinicaltrials.gov/show/NCT00930605

Keywords

Versions (1)
  1. 6/2/17 6/2/17 -
Uploaded on

June 2, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Peripheral T-cell Lymphoma NCT00930605

English

Eligibility Peripheral T-cell Lymphoma NCT00930605

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients must have a diagnosis of one of the following histologic types according to the who classification:
Description

WHO tumor classification

Data type

boolean

Alias
UMLS CUI [1]
C1301142
angioimmunoblastic t-cell lymphoma
Description

Angioimmunoblastic Lymphadenopathy

Data type

boolean

Alias
UMLS CUI [1]
C0020981
extranodal nk/t-cell lymphoma, nasal type
Description

Nasal Type Extranodal NK/T-Cell Lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0392788
enteropathy-type t-cell lymphoma
Description

Enteropathy-Associated T-Cell Lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0456889
hepatosplenic gamma-delta t-cell lymphoma
Description

Hepatosplenic T-cell lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C1333984
subcutaneous panniculitis-like t-cell lymphoma
Description

Subcutaneous panniculitis-like T-cell lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0522624
anaplastic large-cell lymphoma, t/null cell, primary systemic type
Description

Anaplastic large cell lymphoma, T/Null cell, primary systemic type

Data type

boolean

Alias
UMLS CUI [1]
C1531540
peripheral t-cell lymphoma, not otherwise characterized
Description

Peripheral T-Cell Lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0079774
all biopsy specimens including patients whose diagnosis have been made outside king chulalongkorn memorial hospital will be reviewed by an expert hematopathologist at department of pathology, king chulalongkorn memorial hospital.
Description

Biopsy sample Hematologist review

Data type

boolean

Alias
UMLS CUI [1,1]
C0677862
UMLS CUI [1,2]
C2923847
2. newly diagnosed, age 15 - 65 years.
Description

Newly Diagnosed | Age

Data type

boolean

Alias
UMLS CUI [1]
C1518321
UMLS CUI [2]
C0001779
3. complete work up for baseline evaluation and measurement (appendix b).
Description

Work up Complete | Evaluation | Measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0750430
UMLS CUI [1,2]
C0205197
UMLS CUI [2]
C1261322
UMLS CUI [3]
C0242485
4. patient's free written inform consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with a known hypersensitivity to murine proteins or to any component of alemtuzumab.
Description

Hypersensitivity murine protein | Hypersensitivity Alemtuzumab Component

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1699668
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0383429
UMLS CUI [2,3]
C1705248
2. patients who have received prior antilymphoma treatment with chemotherapy or radiotherapy.
Description

Chemotherapy Lymphoma | Therapeutic radiology procedure Lymphoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0024299
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0024299
3. patients with poor performance status (ps; ecog criteria of 3-4)(appendix c).
Description

poor performance status ECOG performance status

Data type

boolean

Alias
UMLS CUI [1,1]
C1831741
UMLS CUI [1,2]
C1520224
4. serologic evidence of human immunodeficiency virus exposure.
Description

HIV Exposure Evidence Serologic

Data type

boolean

Alias
UMLS CUI [1,1]
C0019682
UMLS CUI [1,2]
C0332157
UMLS CUI [1,3]
C3887511
UMLS CUI [1,4]
C0205473
5. patients with history of impaired cardiac status or myocardial infarction.
Description

Cardiac Status Impaired | Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1,1]
C1999091
UMLS CUI [1,2]
C0221099
UMLS CUI [2]
C0027051
6. patients with serum creatinine > 1.8 mg/dl, bilirubin > 1.5 times upper limit of normal range, sgot or sgpt > 3 times upper limit of normal range, unless due to tumor involvement.
Description

Creatinine measurement, serum | Elevated total bilirubin | Aspartate aminotransferase increased | Alanine aminotransferase increased | Serum creatinine level Due to Involvement with Malignant Neoplasm | Elevated total bilirubin Due to Involvement with Malignant Neoplasm | Aspartate aminotransferase increased Due to Involvement with Malignant Neoplasm | Alanine aminotransferase increased Due to Involvement with Malignant Neoplasm

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0741494
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0151905
UMLS CUI [5,1]
C0600061
UMLS CUI [5,2]
C0678226
UMLS CUI [5,3]
C1314939
UMLS CUI [5,4]
C0006826
UMLS CUI [6,1]
C0741494
UMLS CUI [6,2]
C0678226
UMLS CUI [6,3]
C1314939
UMLS CUI [6,4]
C0006826
UMLS CUI [7,1]
C0151904
UMLS CUI [7,2]
C0678226
UMLS CUI [7,3]
C1314939
UMLS CUI [7,4]
C0006826
UMLS CUI [8,1]
C0151905
UMLS CUI [8,2]
C0678226
UMLS CUI [8,3]
C1314939
UMLS CUI [8,4]
C0006826
7. patients with active uncontrolled infection, active non-malignant gastric or duodenal ulcer, uncontrolled diabetes mellitus or other severe medical conditions which would preclude aggressive cytotoxic chemotherapy.
Description

Communicable Disease Uncontrolled | Gastric ulcer | Duodenal Ulcer | Diabetic - poor control | Medical condition Severe Exclude Cytotoxic Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0038358
UMLS CUI [3]
C0013295
UMLS CUI [4]
C0421258
UMLS CUI [5,1]
C3843040
UMLS CUI [5,2]
C0205082
UMLS CUI [5,3]
C0332196
UMLS CUI [5,4]
C0677881
8. pregnant or lactating women.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
9. serious medical or psychiatric illness which prevent informed consent.
Description

Illness Serious Preventing Informed Consent | Mental disorder Serious Preventing Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C1292733
UMLS CUI [1,4]
C0021430
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C1292733
UMLS CUI [2,4]
C0021430
10. patients who are likely to lost to follow up (e.g., unwilling or difficult to return, cannot be contacted).
Description

Clinical Study Follow-up Patient Availability Unlikely

Data type

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C0030705
UMLS CUI [1,3]
C0470187
UMLS CUI [1,4]
C0750558
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Similar models

Eligibility Peripheral T-cell Lymphoma NCT00930605

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
WHO tumor classification
Item
1. patients must have a diagnosis of one of the following histologic types according to the who classification:
boolean
C1301142 (UMLS CUI [1])
Angioimmunoblastic Lymphadenopathy
Item
angioimmunoblastic t-cell lymphoma
boolean
C0020981 (UMLS CUI [1])
Nasal Type Extranodal NK/T-Cell Lymphoma
Item
extranodal nk/t-cell lymphoma, nasal type
boolean
C0392788 (UMLS CUI [1])
Enteropathy-Associated T-Cell Lymphoma
Item
enteropathy-type t-cell lymphoma
boolean
C0456889 (UMLS CUI [1])
Hepatosplenic T-cell lymphoma
Item
hepatosplenic gamma-delta t-cell lymphoma
boolean
C1333984 (UMLS CUI [1])
Subcutaneous panniculitis-like T-cell lymphoma
Item
subcutaneous panniculitis-like t-cell lymphoma
boolean
C0522624 (UMLS CUI [1])
Anaplastic large cell lymphoma, T/Null cell, primary systemic type
Item
anaplastic large-cell lymphoma, t/null cell, primary systemic type
boolean
C1531540 (UMLS CUI [1])
Peripheral T-Cell Lymphoma
Item
peripheral t-cell lymphoma, not otherwise characterized
boolean
C0079774 (UMLS CUI [1])
Biopsy sample Hematologist review
Item
all biopsy specimens including patients whose diagnosis have been made outside king chulalongkorn memorial hospital will be reviewed by an expert hematopathologist at department of pathology, king chulalongkorn memorial hospital.
boolean
C0677862 (UMLS CUI [1,1])
C2923847 (UMLS CUI [1,2])
Newly Diagnosed | Age
Item
2. newly diagnosed, age 15 - 65 years.
boolean
C1518321 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Work up Complete | Evaluation | Measurement
Item
3. complete work up for baseline evaluation and measurement (appendix b).
boolean
C0750430 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C1261322 (UMLS CUI [2])
C0242485 (UMLS CUI [3])
Informed Consent
Item
4. patient's free written inform consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity murine protein | Hypersensitivity Alemtuzumab Component
Item
1. patients with a known hypersensitivity to murine proteins or to any component of alemtuzumab.
boolean
C0020517 (UMLS CUI [1,1])
C1699668 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0383429 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
Chemotherapy Lymphoma | Therapeutic radiology procedure Lymphoma
Item
2. patients who have received prior antilymphoma treatment with chemotherapy or radiotherapy.
boolean
C0392920 (UMLS CUI [1,1])
C0024299 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0024299 (UMLS CUI [2,2])
poor performance status ECOG performance status
Item
3. patients with poor performance status (ps; ecog criteria of 3-4)(appendix c).
boolean
C1831741 (UMLS CUI [1,1])
C1520224 (UMLS CUI [1,2])
HIV Exposure Evidence Serologic
Item
4. serologic evidence of human immunodeficiency virus exposure.
boolean
C0019682 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C3887511 (UMLS CUI [1,3])
C0205473 (UMLS CUI [1,4])
Cardiac Status Impaired | Myocardial Infarction
Item
5. patients with history of impaired cardiac status or myocardial infarction.
boolean
C1999091 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
Creatinine measurement, serum | Elevated total bilirubin | Aspartate aminotransferase increased | Alanine aminotransferase increased | Serum creatinine level Due to Involvement with Malignant Neoplasm | Elevated total bilirubin Due to Involvement with Malignant Neoplasm | Aspartate aminotransferase increased Due to Involvement with Malignant Neoplasm | Alanine aminotransferase increased Due to Involvement with Malignant Neoplasm
Item
6. patients with serum creatinine > 1.8 mg/dl, bilirubin > 1.5 times upper limit of normal range, sgot or sgpt > 3 times upper limit of normal range, unless due to tumor involvement.
boolean
C0201976 (UMLS CUI [1])
C0741494 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0151905 (UMLS CUI [4])
C0600061 (UMLS CUI [5,1])
C0678226 (UMLS CUI [5,2])
C1314939 (UMLS CUI [5,3])
C0006826 (UMLS CUI [5,4])
C0741494 (UMLS CUI [6,1])
C0678226 (UMLS CUI [6,2])
C1314939 (UMLS CUI [6,3])
C0006826 (UMLS CUI [6,4])
C0151904 (UMLS CUI [7,1])
C0678226 (UMLS CUI [7,2])
C1314939 (UMLS CUI [7,3])
C0006826 (UMLS CUI [7,4])
C0151905 (UMLS CUI [8,1])
C0678226 (UMLS CUI [8,2])
C1314939 (UMLS CUI [8,3])
C0006826 (UMLS CUI [8,4])
Communicable Disease Uncontrolled | Gastric ulcer | Duodenal Ulcer | Diabetic - poor control | Medical condition Severe Exclude Cytotoxic Chemotherapy
Item
7. patients with active uncontrolled infection, active non-malignant gastric or duodenal ulcer, uncontrolled diabetes mellitus or other severe medical conditions which would preclude aggressive cytotoxic chemotherapy.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0038358 (UMLS CUI [2])
C0013295 (UMLS CUI [3])
C0421258 (UMLS CUI [4])
C3843040 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0332196 (UMLS CUI [5,3])
C0677881 (UMLS CUI [5,4])
Pregnancy | Breast Feeding
Item
8. pregnant or lactating women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Illness Serious Preventing Informed Consent | Mental disorder Serious Preventing Informed Consent
Item
9. serious medical or psychiatric illness which prevent informed consent.
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1292733 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,4])
C0004936 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C1292733 (UMLS CUI [2,3])
C0021430 (UMLS CUI [2,4])
Clinical Study Follow-up Patient Availability Unlikely
Item
10. patients who are likely to lost to follow up (e.g., unwilling or difficult to return, cannot be contacted).
boolean
C3274571 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
C0750558 (UMLS CUI [1,4])
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