ID

29376

Beschreibung

Vaccination for the Treatment of Previously Untreated or Relapsed Follicular Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00487305

Link

https://clinicaltrials.gov/show/NCT00487305

Stichworte

Versionen (1)
  1. 21.03.18 21.03.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

21. März 2018

DOI

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Creative Commons BY 4.0
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Eligibility Follicular Lymphoma NCT00487305

Englisch

Eligibility Follicular Lymphoma NCT00487305

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed follicular lymphoma
Beschreibung

Lymphoma, Follicular

Datentyp

boolean

Alias
UMLS CUI [1]
C0024301
patients with relapsed follicular lymphoma achieving at least a pr following their most recent systemic chemotherapy and/or immunotherapy regimen.
Beschreibung

Recurrent Follicular Lymphoma | Partial response Post Systemic Chemotherapy | Partial response Post Immunotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C1335701
UMLS CUI [2,1]
C1521726
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C1883256
UMLS CUI [3,1]
C1521726
UMLS CUI [3,2]
C0687676
UMLS CUI [3,3]
C0021083
lymphoma accessible for sampling or existing cryopreserved lymphoma tumor judged suitable for vaccine preparation.
Beschreibung

Lymphoma Access Sampling | Lymphoma Cryopreserved Tissue Vaccine preparation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C0444454
UMLS CUI [1,3]
C0441621
UMLS CUI [2,1]
C0024299
UMLS CUI [2,2]
C1511549
UMLS CUI [2,3]
C0201667
4 weeks must have elapsed between the completion of the the last chemotherapy, immunotherapy, glucocorticoid therapy, radiotherapy, or experimental therapy.
Beschreibung

Chemotherapy Completed | Immunotherapy Completed | Glucocorticoid therapy Completed | Therapeutic radiology procedure Completed | Investigational Therapy Completed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0021083
UMLS CUI [2,2]
C0205197
UMLS CUI [3,1]
C0744425
UMLS CUI [3,2]
C0205197
UMLS CUI [4,1]
C1522449
UMLS CUI [4,2]
C0205197
UMLS CUI [5,1]
C0949266
UMLS CUI [5,2]
C0205197
ecog performance status 0 or 1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
estimated life expectancy of > 6 months
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
35 years of age or older
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
adequate recovery of drug related toxicities, surgery or radiation therapy
Beschreibung

Patient recovered | Status post Toxicity Relationship Pharmaceutical Preparations | Status post Operative Surgical Procedures | Status post Therapeutic radiology procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C1115804
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0600688
UMLS CUI [2,3]
C0439849
UMLS CUI [2,4]
C0013227
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0543467
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C1522449
greater than 6 months since autologous stem cell transplantation
Beschreibung

Transplantation of autologous hematopoietic stem cell

Datentyp

boolean

Alias
UMLS CUI [1]
C1831743
laboratory parameters as outlined in the protocol
Beschreibung

Laboratory Results Consistent with Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C2348563
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
uncontrolled active infection or illness
Beschreibung

Communicable Disease Uncontrolled | Disease Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205318
psychiatric illness/social situation that would limit study compliance
Beschreibung

Mental disorders Protocol Compliance Limited | Social situation Protocol Compliance Limited

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0525058
UMLS CUI [1,3]
C0439801
UMLS CUI [2,1]
C0748872
UMLS CUI [2,2]
C0525058
UMLS CUI [2,3]
C0439801
pregnancy or nursing mothers
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
evidence of infection with hiv or viral hepatitis
Beschreibung

HIV Infection | Viral hepatitis

Datentyp

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0042721
other invasive malignancy
Beschreibung

Invasive cancer

Datentyp

boolean

Alias
UMLS CUI [1]
C0677898
existing autoimmune cytopenia
Beschreibung

Autoimmune cytopenia

Datentyp

boolean

Alias
UMLS CUI [1]
C3274706
previous allogeneic stem cell transplant
Beschreibung

Allogeneic Stem Cell Transplantation

Datentyp

boolean

Alias
UMLS CUI [1]
C2242529
pre-existing autoimmune disease requiring anti-inflammatory therapy
Beschreibung

Autoimmune Disease Pre-existing | Requirement Antiinflammatory therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C2347662
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C1096024
participation in previous vaccine trial
Beschreibung

Study Subject Participation Status | Vaccine Clinical Trial

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C1519888
any component of grade 3 follicular lymphoma or transformed follicular lymphoma
Beschreibung

Follicular Lymphoma Grade | Follicular Lymphoma Transformed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024301
UMLS CUI [1,2]
C0441800
UMLS CUI [2,1]
C0024301
UMLS CUI [2,2]
C1519601
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Ähnliche Modelle

Eligibility Follicular Lymphoma NCT00487305

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Lymphoma, Follicular
Item
histologically confirmed follicular lymphoma
boolean
C0024301 (UMLS CUI [1])
Recurrent Follicular Lymphoma | Partial response Post Systemic Chemotherapy | Partial response Post Immunotherapy
Item
patients with relapsed follicular lymphoma achieving at least a pr following their most recent systemic chemotherapy and/or immunotherapy regimen.
boolean
C1335701 (UMLS CUI [1])
C1521726 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C1883256 (UMLS CUI [2,3])
C1521726 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C0021083 (UMLS CUI [3,3])
Lymphoma Access Sampling | Lymphoma Cryopreserved Tissue Vaccine preparation
Item
lymphoma accessible for sampling or existing cryopreserved lymphoma tumor judged suitable for vaccine preparation.
boolean
C0024299 (UMLS CUI [1,1])
C0444454 (UMLS CUI [1,2])
C0441621 (UMLS CUI [1,3])
C0024299 (UMLS CUI [2,1])
C1511549 (UMLS CUI [2,2])
C0201667 (UMLS CUI [2,3])
Chemotherapy Completed | Immunotherapy Completed | Glucocorticoid therapy Completed | Therapeutic radiology procedure Completed | Investigational Therapy Completed
Item
4 weeks must have elapsed between the completion of the the last chemotherapy, immunotherapy, glucocorticoid therapy, radiotherapy, or experimental therapy.
boolean
C0392920 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0021083 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0744425 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
C1522449 (UMLS CUI [4,1])
C0205197 (UMLS CUI [4,2])
C0949266 (UMLS CUI [5,1])
C0205197 (UMLS CUI [5,2])
ECOG performance status
Item
ecog performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
estimated life expectancy of > 6 months
boolean
C0023671 (UMLS CUI [1])
Age
Item
35 years of age or older
boolean
C0001779 (UMLS CUI [1])
Patient recovered | Status post Toxicity Relationship Pharmaceutical Preparations | Status post Operative Surgical Procedures | Status post Therapeutic radiology procedure
Item
adequate recovery of drug related toxicities, surgery or radiation therapy
boolean
C1115804 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C0600688 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C0013227 (UMLS CUI [2,4])
C0231290 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0231290 (UMLS CUI [4,1])
C1522449 (UMLS CUI [4,2])
Transplantation of autologous hematopoietic stem cell
Item
greater than 6 months since autologous stem cell transplantation
boolean
C1831743 (UMLS CUI [1])
Laboratory Results Consistent with Study Protocol
Item
laboratory parameters as outlined in the protocol
boolean
C1254595 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Communicable Disease Uncontrolled | Disease Uncontrolled
Item
uncontrolled active infection or illness
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Mental disorders Protocol Compliance Limited | Social situation Protocol Compliance Limited
Item
psychiatric illness/social situation that would limit study compliance
boolean
C0004936 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnancy or nursing mothers
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HIV Infection | Viral hepatitis
Item
evidence of infection with hiv or viral hepatitis
boolean
C0019693 (UMLS CUI [1])
C0042721 (UMLS CUI [2])
Invasive cancer
Item
other invasive malignancy
boolean
C0677898 (UMLS CUI [1])
Autoimmune cytopenia
Item
existing autoimmune cytopenia
boolean
C3274706 (UMLS CUI [1])
Allogeneic Stem Cell Transplantation
Item
previous allogeneic stem cell transplant
boolean
C2242529 (UMLS CUI [1])
Autoimmune Disease Pre-existing | Requirement Antiinflammatory therapy
Item
pre-existing autoimmune disease requiring anti-inflammatory therapy
boolean
C0004364 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C1096024 (UMLS CUI [2,2])
Study Subject Participation Status | Vaccine Clinical Trial
Item
participation in previous vaccine trial
boolean
C2348568 (UMLS CUI [1])
C1519888 (UMLS CUI [2])
Follicular Lymphoma Grade | Follicular Lymphoma Transformed
Item
any component of grade 3 follicular lymphoma or transformed follicular lymphoma
boolean
C0024301 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0024301 (UMLS CUI [2,1])
C1519601 (UMLS CUI [2,2])
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