ID

24733

Description

Phase I Trial of Clofarabine in Combo w/ HD Etoposide & Cyclophosphamide and APBSCT for Pts w/ High-Risk or Refractory NHL; ODM derived from: https://clinicaltrials.gov/show/NCT00477945

Lien

https://clinicaltrials.gov/show/NCT00477945

Mots-clés

Versions (1)
  1. 15/08/2017 15/08/2017 -
Téléchargé le

15 août 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Non Hodgkin's Lymphoma NCT00477945

Anglais

Eligibility Non Hodgkin's Lymphoma NCT00477945

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. documentation of disease. patients must have one of the following disease types:
Description

types of diseases

Type de données

boolean

Alias
UMLS CUI [1]
C0457464
diffuse large cell non-hodgkin's lymphoma, mediastinal b-cell lymphoma, or peripheral t-cell lymphoma that is:
Description

Diffuse Large B-Cell Lymphoma | Mediastinal (Thymic) Large B-Cell Lymphoma | Peripheral T-Cell Lymphoma

Type de données

boolean

Alias
UMLS CUI [1]
C0079744
UMLS CUI [2]
C1292754
UMLS CUI [3]
C0079774
primary refractory (achievement less than complete response)
Description

Primary Refractory | Complete response Less Than

Type de données

boolean

Alias
UMLS CUI [1]
C2347678
UMLS CUI [2,1]
C0677874
UMLS CUI [2,2]
C0439092
relapsed and refractory (achievement less than a partial response) to at least a single salvage therapy
Description

Salvage Therapy Quantity Recurrent disease | Salvage Therapy Quantity Refractory | Partial response Less Than

Type de données

boolean

Alias
UMLS CUI [1,1]
C0085405
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0277556
UMLS CUI [2,1]
C0085405
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0205269
UMLS CUI [3,1]
C1521726
UMLS CUI [3,2]
C0439092
relapsed or primary refractory follicular lymphoma (fl) with a high fl international prognostic index.
Description

Recurrent Follicular Lymphoma | Refractory Follicular Lymphoma Primary | Follicular Lymphoma International Prognostic Index High

Type de données

boolean

Alias
UMLS CUI [1]
C1335701
UMLS CUI [2,1]
C1335723
UMLS CUI [2,2]
C0205225
UMLS CUI [3,1]
C4040298
UMLS CUI [3,2]
C0205250
large cell transformation of lymphoma from a more indolent lymphoma (e.g., follicular, marginal zone, etc.)
Description

Indolent lymphoma | Lymphoma, Follicular | Marginal zone lymphoma | Lymphoma transformation | Large cell lymphoma

Type de données

boolean

Alias
UMLS CUI [1]
C1334170
UMLS CUI [2]
C0024301
UMLS CUI [3]
C0242647
UMLS CUI [4]
C1536010
UMLS CUI [5]
C0024302
mantle cell lymphoma that is:
Description

Mantle cell lymphoma

Type de données

boolean

Alias
UMLS CUI [1]
C0334634
primary refractory (achievement less than complete response)
Description

Primary Refractory | Complete response Less Than

Type de données

boolean

Alias
UMLS CUI [1]
C2347678
UMLS CUI [2,1]
C0677874
UMLS CUI [2,2]
C0439092
relapsed (regardless of chemosensitivity of relapsed disease)
Description

Recurrent disease | Chemosensitivity Independent of

Type de données

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2,1]
C2347610
UMLS CUI [2,2]
C0332291
2. patients who received prior autologous stem cell transplantation are not eligible.
Description

Transplantation of autologous hematopoietic stem cell Exclusion

Type de données

boolean

Alias
UMLS CUI [1,1]
C1831743
UMLS CUI [1,2]
C2828389
3. patient age 18-70 years
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
4. performance status ecog 0-1
Description

ECOG performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
5. required baseline laboratory values:
Description

Laboratory Results Patient need for

Type de données

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0686904
lvef > 45% corrected
Description

Left ventricular ejection fraction Corrected

Type de données

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0205202
dlco > 50% of predicted value (corrected for hemoglobin)
Description

Carbon Monoxide Diffusing Capability Test | Hemoglobin measurement Corrected

Type de données

boolean

Alias
UMLS CUI [1]
C1516251
UMLS CUI [2,1]
C0518015
UMLS CUI [2,2]
C0205202
serum creatinine ≤ 2.0 mg/dl or estimated creatinine clearance of ≥60 ml/min
Description

Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula

Type de données

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C2711451
bilirubin < 1 x upper limit of normal value.
Description

Serum total bilirubin measurement

Type de données

boolean

Alias
UMLS CUI [1]
C1278039
ast and alt < 1 x upper limit of normal value.
Description

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
6. signed written informed consent. patient must be capable of understanding the investigational nature of the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. no active infection. patients with active infections requiring oral or intravenous antibiotics are not eligible for enrollment until resolution of infection.
Description

Communicable Disease | Antibiotics Oral Patient need for | Antibiotics Intravenous Patient need for

Type de données

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2,1]
C0003232
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C0686904
UMLS CUI [3,1]
C0003232
UMLS CUI [3,2]
C1522726
UMLS CUI [3,3]
C0686904
2. no hiv disease. patients with immune dysfunction are at a significantly higher risk of infection from intensive immunosuppressive therapies.
Description

HIV Infection | Immune System Disease High risk of Infection | Therapeutic immunosuppression intense Causing Infection

Type de données

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2,1]
C0021053
UMLS CUI [2,2]
C0332167
UMLS CUI [2,3]
C3714514
UMLS CUI [3,1]
C0021079
UMLS CUI [3,2]
C0522510
UMLS CUI [3,3]
C0678227
UMLS CUI [3,4]
C3714514
3. non-pregnant and non-nursing. treatment under this protocol would expose a fetus to significant risks. women of childbearing potential should have a negative pregnancy test prior to study entry. women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial. appropriate methods of birth control include oral contraceptives, implantable hormonal contraceptives (norplant®), or double barrier method (diaphragm plus condom).
Description

Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test negative | Reproductive potential Contraceptive methods | Contraceptives, Oral | Hormonal contraception | CONTRACEPTION NORPLANT | Barrier Contraception Double | Vaginal contraceptive diaphragm | Condom

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0427780
UMLS CUI [4,1]
C4034483
UMLS CUI [4,2]
C0700589
UMLS CUI [5]
C0009905
UMLS CUI [6]
C2985296
UMLS CUI [7]
C0742782
UMLS CUI [8,1]
C0004764
UMLS CUI [8,2]
C0205173
UMLS CUI [9]
C0042241
UMLS CUI [10]
C0677582
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Similar models

Eligibility Non Hodgkin's Lymphoma NCT00477945

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
types of diseases
Item
1. documentation of disease. patients must have one of the following disease types:
boolean
C0457464 (UMLS CUI [1])
Diffuse Large B-Cell Lymphoma | Mediastinal (Thymic) Large B-Cell Lymphoma | Peripheral T-Cell Lymphoma
Item
diffuse large cell non-hodgkin's lymphoma, mediastinal b-cell lymphoma, or peripheral t-cell lymphoma that is:
boolean
C0079744 (UMLS CUI [1])
C1292754 (UMLS CUI [2])
C0079774 (UMLS CUI [3])
Primary Refractory | Complete response Less Than
Item
primary refractory (achievement less than complete response)
boolean
C2347678 (UMLS CUI [1])
C0677874 (UMLS CUI [2,1])
C0439092 (UMLS CUI [2,2])
Salvage Therapy Quantity Recurrent disease | Salvage Therapy Quantity Refractory | Partial response Less Than
Item
relapsed and refractory (achievement less than a partial response) to at least a single salvage therapy
boolean
C0085405 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0277556 (UMLS CUI [1,3])
C0085405 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0205269 (UMLS CUI [2,3])
C1521726 (UMLS CUI [3,1])
C0439092 (UMLS CUI [3,2])
Recurrent Follicular Lymphoma | Refractory Follicular Lymphoma Primary | Follicular Lymphoma International Prognostic Index High
Item
relapsed or primary refractory follicular lymphoma (fl) with a high fl international prognostic index.
boolean
C1335701 (UMLS CUI [1])
C1335723 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
C4040298 (UMLS CUI [3,1])
C0205250 (UMLS CUI [3,2])
Indolent lymphoma | Lymphoma, Follicular | Marginal zone lymphoma | Lymphoma transformation | Large cell lymphoma
Item
large cell transformation of lymphoma from a more indolent lymphoma (e.g., follicular, marginal zone, etc.)
boolean
C1334170 (UMLS CUI [1])
C0024301 (UMLS CUI [2])
C0242647 (UMLS CUI [3])
C1536010 (UMLS CUI [4])
C0024302 (UMLS CUI [5])
Mantle cell lymphoma
Item
mantle cell lymphoma that is:
boolean
C0334634 (UMLS CUI [1])
Primary Refractory | Complete response Less Than
Item
primary refractory (achievement less than complete response)
boolean
C2347678 (UMLS CUI [1])
C0677874 (UMLS CUI [2,1])
C0439092 (UMLS CUI [2,2])
Recurrent disease | Chemosensitivity Independent of
Item
relapsed (regardless of chemosensitivity of relapsed disease)
boolean
C0277556 (UMLS CUI [1])
C2347610 (UMLS CUI [2,1])
C0332291 (UMLS CUI [2,2])
Transplantation of autologous hematopoietic stem cell Exclusion
Item
2. patients who received prior autologous stem cell transplantation are not eligible.
boolean
C1831743 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
Age
Item
3. patient age 18-70 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
4. performance status ecog 0-1
boolean
C1520224 (UMLS CUI [1])
Laboratory Results Patient need for
Item
5. required baseline laboratory values:
boolean
C1254595 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
Left ventricular ejection fraction Corrected
Item
lvef > 45% corrected
boolean
C0428772 (UMLS CUI [1,1])
C0205202 (UMLS CUI [1,2])
Carbon Monoxide Diffusing Capability Test | Hemoglobin measurement Corrected
Item
dlco > 50% of predicted value (corrected for hemoglobin)
boolean
C1516251 (UMLS CUI [1])
C0518015 (UMLS CUI [2,1])
C0205202 (UMLS CUI [2,2])
Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
serum creatinine ≤ 2.0 mg/dl or estimated creatinine clearance of ≥60 ml/min
boolean
C0201976 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
Serum total bilirubin measurement
Item
bilirubin < 1 x upper limit of normal value.
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
ast and alt < 1 x upper limit of normal value.
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Informed Consent
Item
6. signed written informed consent. patient must be capable of understanding the investigational nature of the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Communicable Disease | Antibiotics Oral Patient need for | Antibiotics Intravenous Patient need for
Item
1. no active infection. patients with active infections requiring oral or intravenous antibiotics are not eligible for enrollment until resolution of infection.
boolean
C0009450 (UMLS CUI [1])
C0003232 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0686904 (UMLS CUI [2,3])
C0003232 (UMLS CUI [3,1])
C1522726 (UMLS CUI [3,2])
C0686904 (UMLS CUI [3,3])
HIV Infection | Immune System Disease High risk of Infection | Therapeutic immunosuppression intense Causing Infection
Item
2. no hiv disease. patients with immune dysfunction are at a significantly higher risk of infection from intensive immunosuppressive therapies.
boolean
C0019693 (UMLS CUI [1])
C0021053 (UMLS CUI [2,1])
C0332167 (UMLS CUI [2,2])
C3714514 (UMLS CUI [2,3])
C0021079 (UMLS CUI [3,1])
C0522510 (UMLS CUI [3,2])
C0678227 (UMLS CUI [3,3])
C3714514 (UMLS CUI [3,4])
Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test negative | Reproductive potential Contraceptive methods | Contraceptives, Oral | Hormonal contraception | CONTRACEPTION NORPLANT | Barrier Contraception Double | Vaginal contraceptive diaphragm | Condom
Item
3. non-pregnant and non-nursing. treatment under this protocol would expose a fetus to significant risks. women of childbearing potential should have a negative pregnancy test prior to study entry. women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial. appropriate methods of birth control include oral contraceptives, implantable hormonal contraceptives (norplant®), or double barrier method (diaphragm plus condom).
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
C4034483 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0009905 (UMLS CUI [5])
C2985296 (UMLS CUI [6])
C0742782 (UMLS CUI [7])
C0004764 (UMLS CUI [8,1])
C0205173 (UMLS CUI [8,2])
C0042241 (UMLS CUI [9])
C0677582 (UMLS CUI [10])
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