ID

28051

Description

Reduced Intensity Stem Cell Transplantation for Chronic Lymphocytic Leukemia Followed by Vaccination; ODM derived from: https://clinicaltrials.gov/show/NCT00442130

Link

https://clinicaltrials.gov/show/NCT00442130

Keywords

Versions (1)
  1. 12/12/17 12/12/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 12, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Chronic Lymphocytic Leukemia NCT00442130

English

Eligibility Chronic Lymphocytic Leukemia NCT00442130

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
advanced cll, defined as no response or progressive disease during standard nucleoside analogue based regimen; or, evidence of progressive disease within 24 months of completion of nucleoside analogue regimen; or, intolerance to fludarabine; or, failure to achieve complete remission following salvage regimen.
Description

Chronic Lymphocytic Leukemia Advanced | Unresponsive to Treatment | Progressive Disease | Standard of Care Nucleoside Analogs | Treatment completed | Intolerance to fludarabine | Salvage Therapy Complete remission failed

Data type

boolean

Alias
UMLS CUI [1,1]
C0023434
UMLS CUI [1,2]
C0205179
UMLS CUI [2]
C0205269
UMLS CUI [3]
C1335499
UMLS CUI [4,1]
C2936643
UMLS CUI [4,2]
C1579410
UMLS CUI [5]
C0580352
UMLS CUI [6,1]
C1744706
UMLS CUI [6,2]
C0059985
UMLS CUI [7,1]
C0085405
UMLS CUI [7,2]
C0677874
UMLS CUI [7,3]
C0231175
no sites of adenopathy > 5cm
Description

Adenopathy Site Size

Data type

boolean

Alias
UMLS CUI [1,1]
C0497156
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0456389
(8/8) hla matched related or unrelated donor available.
Description

Donor Relative HLA Match Available | Unrelated Donor HLA Match Available

Data type

boolean

Alias
UMLS CUI [1,1]
C0040288
UMLS CUI [1,2]
C0080103
UMLS CUI [1,3]
C0019721
UMLS CUI [1,4]
C1708943
UMLS CUI [1,5]
C0470187
UMLS CUI [2,1]
C3179133
UMLS CUI [2,2]
C0019721
UMLS CUI [2,3]
C1708943
UMLS CUI [2,4]
C0470187
must have prior banked tumor, collected by peripheral blood draw, leukapheresis, bone marrow biopsy or by lymph node dissection, per df/hcc protocol 06-200
Description

Tumor tissue sample Available | Peripheral blood draw | Leukapheresis | Bone marrow biopsy | Lymph Node Dissection

Data type

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0470187
UMLS CUI [2,1]
C0229664
UMLS CUI [2,2]
C0005834
UMLS CUI [3]
C0023416
UMLS CUI [4]
C0005954
UMLS CUI [5]
C0242382
ecog performance status 0-2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
serum creatinine greater than or equal to 2.0mg/dl
Description

Serum creatinine raised

Data type

boolean

Alias
UMLS CUI [1]
C0700225
alt or ast greater than or equal to 3x uln
Description

Alanine aminotransferase increased | Aspartate aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
total bilirubin greater than or equal to 2.0mg/dl (except for patients with gilbert's syndrome)
Description

Serum bilirubin increased | Exception Gilbert Disease

Data type

boolean

Alias
UMLS CUI [1]
C0859062
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0017551
cardiac ejection fraction <30%
Description

Cardiac ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0232174
hiv infection
Description

HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Chronic Lymphocytic Leukemia NCT00442130

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Lymphocytic Leukemia Advanced | Unresponsive to Treatment | Progressive Disease | Standard of Care Nucleoside Analogs | Treatment completed | Intolerance to fludarabine | Salvage Therapy Complete remission failed
Item
advanced cll, defined as no response or progressive disease during standard nucleoside analogue based regimen; or, evidence of progressive disease within 24 months of completion of nucleoside analogue regimen; or, intolerance to fludarabine; or, failure to achieve complete remission following salvage regimen.
boolean
C0023434 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0205269 (UMLS CUI [2])
C1335499 (UMLS CUI [3])
C2936643 (UMLS CUI [4,1])
C1579410 (UMLS CUI [4,2])
C0580352 (UMLS CUI [5])
C1744706 (UMLS CUI [6,1])
C0059985 (UMLS CUI [6,2])
C0085405 (UMLS CUI [7,1])
C0677874 (UMLS CUI [7,2])
C0231175 (UMLS CUI [7,3])
Adenopathy Site Size
Item
no sites of adenopathy > 5cm
boolean
C0497156 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,3])
Donor Relative HLA Match Available | Unrelated Donor HLA Match Available
Item
(8/8) hla matched related or unrelated donor available.
boolean
C0040288 (UMLS CUI [1,1])
C0080103 (UMLS CUI [1,2])
C0019721 (UMLS CUI [1,3])
C1708943 (UMLS CUI [1,4])
C0470187 (UMLS CUI [1,5])
C3179133 (UMLS CUI [2,1])
C0019721 (UMLS CUI [2,2])
C1708943 (UMLS CUI [2,3])
C0470187 (UMLS CUI [2,4])
Tumor tissue sample Available | Peripheral blood draw | Leukapheresis | Bone marrow biopsy | Lymph Node Dissection
Item
must have prior banked tumor, collected by peripheral blood draw, leukapheresis, bone marrow biopsy or by lymph node dissection, per df/hcc protocol 06-200
boolean
C0475358 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0229664 (UMLS CUI [2,1])
C0005834 (UMLS CUI [2,2])
C0023416 (UMLS CUI [3])
C0005954 (UMLS CUI [4])
C0242382 (UMLS CUI [5])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Serum creatinine raised
Item
serum creatinine greater than or equal to 2.0mg/dl
boolean
C0700225 (UMLS CUI [1])
Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
alt or ast greater than or equal to 3x uln
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
Serum bilirubin increased | Exception Gilbert Disease
Item
total bilirubin greater than or equal to 2.0mg/dl (except for patients with gilbert's syndrome)
boolean
C0859062 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0017551 (UMLS CUI [2,2])
Cardiac ejection fraction
Item
cardiac ejection fraction <30%
boolean
C0232174 (UMLS CUI [1])
HIV Infection
Item
hiv infection
boolean
C0019693 (UMLS CUI [1])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
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