ID

24576

Description

A Study of Enzastaurin in Patients With Follicular Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00475644

Lien

https://clinicaltrials.gov/show/NCT00475644

Mots-clés

Versions (1)
  1. 07/08/2017 07/08/2017 -
Téléchargé le

7 août 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Lymphoma, Follicular NCT00475644

Anglais

Eligibility Lymphoma, Follicular NCT00475644

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
all patient must:
Description

Criteria Fulfill

Type de données

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. have had a histologically confirmed diagnosis of grade 1 or 2 fl, according to world health organization classification (harris et al. 1999), at the original time of diagnosis. pathology must be confirmed locally prior to enrollment at the investigational site.
Description

Follicular Lymphoma WHO tumor classification

Type de données

boolean

Alias
UMLS CUI [1,1]
C0024301
UMLS CUI [1,2]
C1301142
2. have ann arbor stage iii or iv disease.
Description

Disease Ann Arbor lymphoma staging system

Type de données

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0432516
3. must be chemo-naive or have relapsed disease after receiving only one prior chemotherapy regimen. the chemotherapy must have been completed at least 6 months prior to first dose of study treatment. relapse after one prior course of single-agent rituximab treatment (in the chemo-naive setting) is also allowed if completed at least 6 months prior to first dose of study treatment.
Description

Chemotherapy naive | rituximab | Chemotherapy Quantity Completed | Recurrent disease

Type de données

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0919936
UMLS CUI [2]
C0393022
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0205197
UMLS CUI [4]
C0277556
4. patients must not require cytoreductive therapy for at least 3 months from first dose of study treatment, in the opinion of the investigator.
Description

Therapeutic procedure Cytoreductive effect | Requirement Absent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0864494
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0332197
5. previous radiation therapy is allowed, but should have been limited and must not have included whole pelvis radiation. patients must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia). prior radiotherapy must be completed 30 days before study entry. lesions that have been irradiated cannot be included as sites of measurable disease unless clear tumor progression has been documented in these lesions since the end of radiation therapy.
Description

Therapeutic radiology procedure Limited Completed | Therapeutic radiology procedure Whole-Pelvis Absent | Toxic effect Patient recovered | Alopecia Excluded | Lesion Tumor Progression | Measurable Disease

Type de données

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0205197
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C3827467
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0600688
UMLS CUI [3,2]
C1115804
UMLS CUI [4,1]
C0002170
UMLS CUI [4,2]
C2828389
UMLS CUI [5,1]
C0221198
UMLS CUI [5,2]
C0178874
UMLS CUI [6]
C1513041
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients will be excluded from the study if they meet any of the following criteria:
Description

Criteria Fulfill

Type de données

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. are unable to swallow tablets.
Description

Unable to swallow tablet

Type de données

boolean

Alias
UMLS CUI [1]
C3839225
2. are unable to discontinue use of carbamazepine, phenobarbital, and phenytoin.
Description

Carbamazepine Unable to discontinue | Phenobarbital Unable to discontinue | Phenytoin Unable to discontinue

Type de données

boolean

Alias
UMLS CUI [1,1]
C0006949
UMLS CUI [1,2]
C1548265
UMLS CUI [2,1]
C0031412
UMLS CUI [2,2]
C1548265
UMLS CUI [3,1]
C0031507
UMLS CUI [3,2]
C1548265
3. are receiving concurrent administration of any other antitumor therapy.
Description

cancer treatment

Type de données

boolean

Alias
UMLS CUI [1]
C0920425
4. are pregnant or breastfeeding.
Description

Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
5. have a serious concomitant systemic disorder (including active bacterial, fungal, or viral infection) that, in the opinion of the investigator, would compromise the patient's ability to adhere to the protocol.
Description

Systemic disease Serious compromises Protocol Compliance | Bacterial Infections | Mycoses | Virus Diseases

Type de données

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C2945640
UMLS CUI [1,4]
C0525058
UMLS CUI [2]
C0004623
UMLS CUI [3]
C0026946
UMLS CUI [4]
C0042769
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Similar models

Eligibility Lymphoma, Follicular NCT00475644

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Fulfill
Item
all patient must:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Follicular Lymphoma WHO tumor classification
Item
1. have had a histologically confirmed diagnosis of grade 1 or 2 fl, according to world health organization classification (harris et al. 1999), at the original time of diagnosis. pathology must be confirmed locally prior to enrollment at the investigational site.
boolean
C0024301 (UMLS CUI [1,1])
C1301142 (UMLS CUI [1,2])
Disease Ann Arbor lymphoma staging system
Item
2. have ann arbor stage iii or iv disease.
boolean
C0012634 (UMLS CUI [1,1])
C0432516 (UMLS CUI [1,2])
Chemotherapy naive | rituximab | Chemotherapy Quantity Completed | Recurrent disease
Item
3. must be chemo-naive or have relapsed disease after receiving only one prior chemotherapy regimen. the chemotherapy must have been completed at least 6 months prior to first dose of study treatment. relapse after one prior course of single-agent rituximab treatment (in the chemo-naive setting) is also allowed if completed at least 6 months prior to first dose of study treatment.
boolean
C0392920 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
C0393022 (UMLS CUI [2])
C0392920 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0205197 (UMLS CUI [3,3])
C0277556 (UMLS CUI [4])
Therapeutic procedure Cytoreductive effect | Requirement Absent
Item
4. patients must not require cytoreductive therapy for at least 3 months from first dose of study treatment, in the opinion of the investigator.
boolean
C0087111 (UMLS CUI [1,1])
C0864494 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Therapeutic radiology procedure Limited Completed | Therapeutic radiology procedure Whole-Pelvis Absent | Toxic effect Patient recovered | Alopecia Excluded | Lesion Tumor Progression | Measurable Disease
Item
5. previous radiation therapy is allowed, but should have been limited and must not have included whole pelvis radiation. patients must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia). prior radiotherapy must be completed 30 days before study entry. lesions that have been irradiated cannot be included as sites of measurable disease unless clear tumor progression has been documented in these lesions since the end of radiation therapy.
boolean
C1522449 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2,1])
C3827467 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0600688 (UMLS CUI [3,1])
C1115804 (UMLS CUI [3,2])
C0002170 (UMLS CUI [4,1])
C2828389 (UMLS CUI [4,2])
C0221198 (UMLS CUI [5,1])
C0178874 (UMLS CUI [5,2])
C1513041 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
Criteria Fulfill
Item
patients will be excluded from the study if they meet any of the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Unable to swallow tablet
Item
1. are unable to swallow tablets.
boolean
C3839225 (UMLS CUI [1])
Carbamazepine Unable to discontinue | Phenobarbital Unable to discontinue | Phenytoin Unable to discontinue
Item
2. are unable to discontinue use of carbamazepine, phenobarbital, and phenytoin.
boolean
C0006949 (UMLS CUI [1,1])
C1548265 (UMLS CUI [1,2])
C0031412 (UMLS CUI [2,1])
C1548265 (UMLS CUI [2,2])
C0031507 (UMLS CUI [3,1])
C1548265 (UMLS CUI [3,2])
cancer treatment
Item
3. are receiving concurrent administration of any other antitumor therapy.
boolean
C0920425 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
4. are pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Systemic disease Serious compromises Protocol Compliance | Bacterial Infections | Mycoses | Virus Diseases
Item
5. have a serious concomitant systemic disorder (including active bacterial, fungal, or viral infection) that, in the opinion of the investigator, would compromise the patient's ability to adhere to the protocol.
boolean
C0442893 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C2945640 (UMLS CUI [1,3])
C0525058 (UMLS CUI [1,4])
C0004623 (UMLS CUI [2])
C0026946 (UMLS CUI [3])
C0042769 (UMLS CUI [4])
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