ID

4181

Description

Study of ONTAK (Denileukin Diftitox) in Previously Treated Cutaneous T-Cell Lymphoma Patients Inclusion Criteria: - Patient must have been previously enrolled in Protocol 93-04-11 and randomized to the placebo arm; or the patient met all eligibility criteria for protocol 93-04-11 other than the expression of CD25 on CTCL tumor cells. - CTCL disease Stage Ia - III. - History of less than or equal to 3 previous therapies. Repeated use of the same agent is considered to be 1 therapy unless it is part of a different combination regimen. Only 1 prior combination cytotoxic chemotherapy regimen is permitted. Topical or systemic steroids are not considered a therapy. - Patient must have evaluable or measurable disease. Lymph node involvement no greater than LN2. No CTCL involvement of bone marrow. - No significant pulmonary or cardiac disease. No active CNS, kidney, or liver disease. No systemic infections. - ECOG performance status of 0 or 1. Exclusion Criteria: - The 93-04-14 study is no longer open to subjects previously enrolled in 93-04-10 or 92-04-01

Mots-clés

Versions (1)
  1. 10/11/2013 10/11/2013 - Martin Dugas
Téléchargé le

10 novembre 2013

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0 Legacy
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Eligibility NCT00051012 T-Cell Lymphoma

Allemand Anglais

Eligibility

1 Formulaires  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion criteria
Description

Inclusion criteria

Patient must have been previously enrolled in Protocol 93-04-11 and randomized to the placebo arm; or the patient met all eligibility criteria for protocol 93-04-11 other than the expression of CD25 on CTCL tumor cells.
Description

Enrollment in Protocol 93-04-11

Type de données

boolean

CTCL disease Stage Ia - III
Description

Disease stage

Type de données

boolean

History of less than or equal to 3 previous therapies. Repeated use of the same agent is considered to be 1 therapy unless it is part of a different combination regimen. Only 1 prior combination cytotoxic chemotherapy regimen is permitted. Topical or systemic steroids are not considered a therapy
Description

Previous therapy

Type de données

boolean

Patient must have evaluable or measurable disease. Lymph node involvement no greater than LN2. No CTCL involvement of bone marrow.
Description

Disease characteristics

Type de données

boolean

No significant pulmonary or cardiac disease. No active CNS, kidney, or liver disease. No systemic infections.
Description

Other diseases

Type de données

boolean

ECOG performance status of 0 or 1
Description

ECOG

Type de données

boolean

Exclusion criteria
Description

Exclusion criteria

The 93-04-14 study is no longer open to subjects previously enrolled in 93-04-10 or 92-04-01
Description

Other protocols

Type de données

boolean

Medical Concepts
Description

Medical Concepts

Enrollment
Description

Enrollment

Type de données

string

Alias
UMLS CUI
C1516879
Diagnosis
Description

Diagnosis

Type de données

string

Alias
UMLS CUI
C0011900
Diagnostic Neoplasm Staging
Description

Diagnostic Neoplasm Staging

Type de données

string

Alias
UMLS CUI
C0027646
Therapeutic procedure
Description

Therapeutic procedure

Type de données

string

Alias
UMLS CUI
C0087111
Pharmaceutical Preparations
Description

Pharmaceutical Preparations

Type de données

string

Alias
UMLS CUI
C0013227
ECOG performance status finding
Description

ECOG performance status finding

Type de données

string

Alias
UMLS CUI
C1828127
SNOMED CT 2010_0731
424122007
Retour au début de la page

Similar models

Eligibility

1 Formulaires
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Inclusion criteria
Enrollment in Protocol 93-04-11
Item
Patient must have been previously enrolled in Protocol 93-04-11 and randomized to the placebo arm; or the patient met all eligibility criteria for protocol 93-04-11 other than the expression of CD25 on CTCL tumor cells.
boolean
Disease stage
Item
CTCL disease Stage Ia - III
boolean
Previous therapy
Item
History of less than or equal to 3 previous therapies. Repeated use of the same agent is considered to be 1 therapy unless it is part of a different combination regimen. Only 1 prior combination cytotoxic chemotherapy regimen is permitted. Topical or systemic steroids are not considered a therapy
boolean
Disease characteristics
Item
Patient must have evaluable or measurable disease. Lymph node involvement no greater than LN2. No CTCL involvement of bone marrow.
boolean
Other diseases
Item
No significant pulmonary or cardiac disease. No active CNS, kidney, or liver disease. No systemic infections.
boolean
ECOG
Item
ECOG performance status of 0 or 1
boolean
Item Group
Exclusion criteria
Other protocols
Item
The 93-04-14 study is no longer open to subjects previously enrolled in 93-04-10 or 92-04-01
boolean
Item Group
Medical Concepts
Enrollment
Item
Enrollment
string
C1516879 (UMLS CUI)
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
Diagnostic Neoplasm Staging
Item
Diagnostic Neoplasm Staging
string
C0027646 (UMLS CUI)
Therapeutic procedure
Item
Therapeutic procedure
string
C0087111 (UMLS CUI)
Pharmaceutical Preparations
Item
Pharmaceutical Preparations
string
C0013227 (UMLS CUI)
ECOG performance status finding
Item
ECOG performance status finding
string
C1828127 (UMLS CUI)
424122007 (SNOMED CT 2010_0731)
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial