ID

15397

Description

Brentuximab Vedotin in High-Risk CD30+ Lymphoma Post Allogeneic Stem Cell Transplantation (AlloSCT); ODM derived from: https://clinicaltrials.gov/show/NCT02169505

Lien

https://clinicaltrials.gov/show/NCT02169505

Mots-clés

Versions (1)
  1. 30/05/2016 30/05/2016 -
Téléchargé le

30 mai 2016

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Lymphoma NCT02169505

Anglais

Eligibility Lymphoma NCT02169505

1 Formulaires  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT02169505
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with cd30 positive hodgkin lymphoma (hl) or anaplastic large cell lymphoma (alcl) that have undergone allogeneic sct in the past 60 days (matched related or matched unrelated donors only).
Description

Hodgkin Disease CD30 positive | Ki-1+ Anaplastic Large Cell Lymphoma | Allogeneic Stem Cell Transplantation | Match Living related donor | Match Living unrelated donor

Type de données

boolean

Alias
UMLS CUI [1,1]
C0019829
UMLS CUI [1,2]
C3888910
UMLS CUI [2]
C0206180
UMLS CUI [3]
C2242529
UMLS CUI [4,1]
C1708943
UMLS CUI [4,2]
C3494891
UMLS CUI [5,1]
C1708943
UMLS CUI [5,2]
C3494890
2. age 18 to 65 years.
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
3. performance status: zubrod 0-1 or karnofsky 80-100.
Description

Zubrod Performance Status Karnofsky Performance Status

Type de données

boolean

Alias
UMLS CUI [1,1]
C3714786
UMLS CUI [1,2]
C0206065
4. serum creatinine < 1.5 mg/dl or creatinine clearance greater than or equal to 40 cc/min as defined by mdrd method from national kidney disease education program (nkdep).
Description

Creatinine measurement, serum | Creatinine clearance measurement Creatinine-based formula (MDRD)

Type de données

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2,1]
C0373595
UMLS CUI [2,2]
C1980036
5. serum direct bilirubin < 1.5 mg/dl (unless gilbert's syndrome).
Description

Serum bilirubin direct | Gilbert Disease

Type de données

boolean

Alias
UMLS CUI [1]
C0858048
UMLS CUI [2]
C0017551
6. serum glutamate pyruvate transaminase (sgpt) < 200 iu/l unless related to patient's malignancy.
Description

SGPT - Glutamate pyruvate transaminase | Malignant Neoplasms

Type de données

boolean

Alias
UMLS CUI [1]
C0376147
UMLS CUI [2]
C0006826
7. evidence of neutrophil and platelet engraftment, defined as platelet count equal or greater than 50,000 mm3 independent of platelet transfusion and absolute neutrophil count (anc) equal or greater to 1000 without growth factor support for at least 5 days.
Description

Neutrophil Engraftment | Platelet Engraftment | Platelet Count measurement | Platelet Transfusion | Absolute neutrophil count | Growth Factor

Type de données

boolean

Alias
UMLS CUI [1]
C1882078
UMLS CUI [2]
C1882407
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0086818
UMLS CUI [5]
C0948762
UMLS CUI [6]
C0018284
8. patients with previous exposure to brentuximab pre-transplant are eligible for the study.
Description

BRENTUXIMAB Exposure Previous

Type de données

boolean

Alias
UMLS CUI [1,1]
C3247294
UMLS CUI [1,2]
C0332157
UMLS CUI [1,3]
C0205156
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pregnancy or breast-feeding (women of childbearing potential, any female who has experienced menarche and who has not undergone surgical sterilization or is post-menopausal with a positive serum pregnancy test.
Description

Pregnancy | Breast Feeding | Childbearing Potential | Menarche Female Sterilization | Postmenopausal state Serum pregnancy test positive

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C3831118
UMLS CUI [4,1]
C0025274
UMLS CUI [4,2]
C0015787
UMLS CUI [5,1]
C0232970
UMLS CUI [5,2]
C0430063
2. presence of steroid-refractory acute graft-versus-host disease (gvhd).
Description

Acute GVH disease | Steroids Unresponsive to Treatment

Type de données

boolean

Alias
UMLS CUI [1]
C0856825
UMLS CUI [2,1]
C0038317
UMLS CUI [2,2]
C0205269
3. patients that underwent allogeneic transplantation as a treatment of graft failure.
Description

Transplantation, Homologous | Therapeutic procedure Graft failure

Type de données

boolean

Alias
UMLS CUI [1]
C0040739
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1262018
4. dual refractory cmv reactivation to foscarnet and ganciclovir or evidence of cmv disease.
Description

Cytomegalovirus infection reactivation Unresponsive to Treatment Double Foscarnet | Cytomegalovirus infection reactivation Unresponsive to Treatment Double Ganciclovir | Cytomegalovirus Infections

Type de données

boolean

Alias
UMLS CUI [1,1]
C1142560
UMLS CUI [1,2]
C0205269
UMLS CUI [1,3]
C0205173
UMLS CUI [1,4]
C0070895
UMLS CUI [2,1]
C1142560
UMLS CUI [2,2]
C0205269
UMLS CUI [2,3]
C0205173
UMLS CUI [2,4]
C0017066
UMLS CUI [3]
C0010823
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Similar models

Eligibility Lymphoma NCT02169505

1 Formulaires
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT02169505
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Hodgkin Disease CD30 positive | Ki-1+ Anaplastic Large Cell Lymphoma | Allogeneic Stem Cell Transplantation | Match Living related donor | Match Living unrelated donor
Item
1. patients with cd30 positive hodgkin lymphoma (hl) or anaplastic large cell lymphoma (alcl) that have undergone allogeneic sct in the past 60 days (matched related or matched unrelated donors only).
boolean
C0019829 (UMLS CUI [1,1])
C3888910 (UMLS CUI [1,2])
C0206180 (UMLS CUI [2])
C2242529 (UMLS CUI [3])
C1708943 (UMLS CUI [4,1])
C3494891 (UMLS CUI [4,2])
C1708943 (UMLS CUI [5,1])
C3494890 (UMLS CUI [5,2])
Age
Item
2. age 18 to 65 years.
boolean
C0001779 (UMLS CUI [1])
Zubrod Performance Status Karnofsky Performance Status
Item
3. performance status: zubrod 0-1 or karnofsky 80-100.
boolean
C3714786 (UMLS CUI [1,1])
C0206065 (UMLS CUI [1,2])
Creatinine measurement, serum | Creatinine clearance measurement Creatinine-based formula (MDRD)
Item
4. serum creatinine < 1.5 mg/dl or creatinine clearance greater than or equal to 40 cc/min as defined by mdrd method from national kidney disease education program (nkdep).
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2,1])
C1980036 (UMLS CUI [2,2])
Serum bilirubin direct | Gilbert Disease
Item
5. serum direct bilirubin < 1.5 mg/dl (unless gilbert's syndrome).
boolean
C0858048 (UMLS CUI [1])
C0017551 (UMLS CUI [2])
SGPT - Glutamate pyruvate transaminase | Malignant Neoplasms
Item
6. serum glutamate pyruvate transaminase (sgpt) < 200 iu/l unless related to patient's malignancy.
boolean
C0376147 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
Neutrophil Engraftment | Platelet Engraftment | Platelet Count measurement | Platelet Transfusion | Absolute neutrophil count | Growth Factor
Item
7. evidence of neutrophil and platelet engraftment, defined as platelet count equal or greater than 50,000 mm3 independent of platelet transfusion and absolute neutrophil count (anc) equal or greater to 1000 without growth factor support for at least 5 days.
boolean
C1882078 (UMLS CUI [1])
C1882407 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0086818 (UMLS CUI [4])
C0948762 (UMLS CUI [5])
C0018284 (UMLS CUI [6])
BRENTUXIMAB Exposure Previous
Item
8. patients with previous exposure to brentuximab pre-transplant are eligible for the study.
boolean
C3247294 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Childbearing Potential | Menarche Female Sterilization | Postmenopausal state Serum pregnancy test positive
Item
1. pregnancy or breast-feeding (women of childbearing potential, any female who has experienced menarche and who has not undergone surgical sterilization or is post-menopausal with a positive serum pregnancy test.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
C0025274 (UMLS CUI [4,1])
C0015787 (UMLS CUI [4,2])
C0232970 (UMLS CUI [5,1])
C0430063 (UMLS CUI [5,2])
Acute GVH disease | Steroids Unresponsive to Treatment
Item
2. presence of steroid-refractory acute graft-versus-host disease (gvhd).
boolean
C0856825 (UMLS CUI [1])
C0038317 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
Transplantation, Homologous | Therapeutic procedure Graft failure
Item
3. patients that underwent allogeneic transplantation as a treatment of graft failure.
boolean
C0040739 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C1262018 (UMLS CUI [2,2])
Cytomegalovirus infection reactivation Unresponsive to Treatment Double Foscarnet | Cytomegalovirus infection reactivation Unresponsive to Treatment Double Ganciclovir | Cytomegalovirus Infections
Item
4. dual refractory cmv reactivation to foscarnet and ganciclovir or evidence of cmv disease.
boolean
C1142560 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0205173 (UMLS CUI [1,3])
C0070895 (UMLS CUI [1,4])
C1142560 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C0205173 (UMLS CUI [2,3])
C0017066 (UMLS CUI [2,4])
C0010823 (UMLS CUI [3])
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