ID

30172

Description

Fludarabine and Alemtuzumab or Cyclophosphamide Followed by Peripheral Blood Stem Cell Transplant or Alemtuzumab in Treating Patients With Advanced or Progressive Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00462332

Link

https://clinicaltrials.gov/show/NCT00462332

Keywords

Versions (1)
  1. 5/16/18 5/16/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 16, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Leukemia NCT00462332

English

Eligibility Leukemia NCT00462332

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00462332
Criteria
Description

Criteria

diagnosis of chronic lymphocytic leukemia (cll)
Description

Chronic Lymphocytic Leukemia

Data type

boolean

Alias
UMLS CUI [1]
C0023434
advanced or progressive disease with ≥ 2 active clinical signs
Description

Advanced disease | Progressive Disease | Sign or Symptom Quantity

Data type

boolean

Alias
UMLS CUI [1]
C0679246
UMLS CUI [2]
C1335499
UMLS CUI [3,1]
C3540840
UMLS CUI [3,2]
C1265611
patient characteristics:
Description

Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
fertile patients must use adequate contraception
Description

Fertility Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
no positive coomb's test with signs of hemolysis
Description

Exclusion Criteria | Coombs Test Positive | Signs Hemolysis

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0009961
UMLS CUI [2,2]
C1514241
UMLS CUI [3,1]
C0311392
UMLS CUI [3,2]
C0019054
no active infection
Description

Exclusion Communicable Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0009450
no uncontrolled severe disease
Description

Exclusion Disease Severe Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0205082
UMLS CUI [1,4]
C0205318
no known hypersensitivity or anaphylactic reactions to murine antibodies or proteins
Description

Exclusion Criteria | Hypersensitivity Murine-Derived Monoclonal Antibodies | Anaphylaxis Murine-Derived Monoclonal Antibodies | Hypersensitivity Murine protein | Anaphylaxis Murine protein

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C2916903
UMLS CUI [3,1]
C0002792
UMLS CUI [3,2]
C2916903
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C1699668
UMLS CUI [5,1]
C0002792
UMLS CUI [5,2]
C1699668
no other malignancies within the past 2 years except for adequately treated malignancies
Description

Exclusion Cancer Other | Exception Malignant Neoplasms Treated

Data type

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0006826
UMLS CUI [2,3]
C1522326
no significant traumatic injury within the past 4 weeks
Description

Exclusion Traumatic injury

Data type

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C3263723
no coexisting medical or psychological condition that would limit study compliance
Description

Exclusion Criteria | Medical condition Limiting Protocol Compliance | Mental condition Limiting Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C3840291
UMLS CUI [3,2]
C0439801
UMLS CUI [3,3]
C0525058
prior concurrent therapy:
Description

Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1]
C0087111
see disease characteristics
Description

ID.13

Data type

boolean

no prior treatment for cll
Description

Exclusion Prior Therapy Chronic Lymphocytic Leukemia

Data type

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C0023434
no major surgery within the past 4 weeks
Description

Exclusion Major surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0679637
no prior chemotherapy
Description

Exclusion Prior Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C1514457
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Similar models

Eligibility Leukemia NCT00462332

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00462332
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Chronic Lymphocytic Leukemia
Item
diagnosis of chronic lymphocytic leukemia (cll)
boolean
C0023434 (UMLS CUI [1])
Advanced disease | Progressive Disease | Sign or Symptom Quantity
Item
advanced or progressive disease with ≥ 2 active clinical signs
boolean
C0679246 (UMLS CUI [1])
C1335499 (UMLS CUI [2])
C3540840 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Fertility Contraceptive methods
Item
fertile patients must use adequate contraception
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Exclusion Criteria | Coombs Test Positive | Signs Hemolysis
Item
no positive coomb's test with signs of hemolysis
boolean
C0680251 (UMLS CUI [1])
C0009961 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0311392 (UMLS CUI [3,1])
C0019054 (UMLS CUI [3,2])
Exclusion Communicable Disease
Item
no active infection
boolean
C2828389 (UMLS CUI [1,1])
C0009450 (UMLS CUI [1,2])
Exclusion Disease Severe Uncontrolled
Item
no uncontrolled severe disease
boolean
C2828389 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C0205318 (UMLS CUI [1,4])
Exclusion Criteria | Hypersensitivity Murine-Derived Monoclonal Antibodies | Anaphylaxis Murine-Derived Monoclonal Antibodies | Hypersensitivity Murine protein | Anaphylaxis Murine protein
Item
no known hypersensitivity or anaphylactic reactions to murine antibodies or proteins
boolean
C0680251 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C2916903 (UMLS CUI [2,2])
C0002792 (UMLS CUI [3,1])
C2916903 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C1699668 (UMLS CUI [4,2])
C0002792 (UMLS CUI [5,1])
C1699668 (UMLS CUI [5,2])
Exclusion Cancer Other | Exception Malignant Neoplasms Treated
Item
no other malignancies within the past 2 years except for adequately treated malignancies
boolean
C2828389 (UMLS CUI [1,1])
C1707251 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
Exclusion Traumatic injury
Item
no significant traumatic injury within the past 4 weeks
boolean
C2828389 (UMLS CUI [1,1])
C3263723 (UMLS CUI [1,2])
Exclusion Criteria | Medical condition Limiting Protocol Compliance | Mental condition Limiting Protocol Compliance
Item
no coexisting medical or psychological condition that would limit study compliance
boolean
C0680251 (UMLS CUI [1])
C3843040 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C3840291 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
ID.13
Item
see disease characteristics
boolean
Exclusion Prior Therapy Chronic Lymphocytic Leukemia
Item
no prior treatment for cll
boolean
C2828389 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0023434 (UMLS CUI [1,3])
Exclusion Major surgery
Item
no major surgery within the past 4 weeks
boolean
C2828389 (UMLS CUI [1,1])
C0679637 (UMLS CUI [1,2])
Exclusion Prior Chemotherapy
Item
no prior chemotherapy
boolean
C2828389 (UMLS CUI [1,1])
C1514457 (UMLS CUI [1,2])
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