ID

41199

Description

Study to Evaluate the Safety and Tolerability of Weekly Intravenous (IV) Doses of BMS-906024 in Subjects With Acute T-cell Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01363817

Link

https://clinicaltrials.gov/show/NCT01363817

Keywords

  1. 7/11/20 7/11/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 11, 2020

DOI

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License

Creative Commons BY 4.0

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Eligibility Lymphoblastic Leukemia, Acute T-cell NCT01363817

Eligibility Lymphoblastic Leukemia, Acute T-cell NCT01363817

Criteria
Description

Criteria

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with t-cell acute lymphoblastic leukemia or t-cell lymphoblastic lymphoma refractory to or relapsed from standard therapies
Description

Refractory T Acute Lymphoblastic Leukemia | Refractory T Lymphoblastic Lymphoma | Acute lymphoblastic leukemia recurrent | T-lymphoblastic lymphoma recurrent | Status post Standard therapy

Data type

boolean

Alias
UMLS CUI [1]
C4725790
UMLS CUI [2]
C1335731
UMLS CUI [3]
C1504525
UMLS CUI [4]
C0862284
UMLS CUI [5,1]
C0231290
UMLS CUI [5,2]
C2936643
life expectancy of at least 2 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
performance status (ps) 0-1 (a measure of the ability to carry out activities of daily living); subjects with ps 2 are eligible if due to disease related symptoms
Description

Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C1518965
prior anti-cancer treatment permitted (with specific criteria)
Description

Cancer treatment Previous | Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C1550543
adequate organ function
Description

Organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
infection
Description

Communicable Disease

Data type

boolean

Alias
UMLS CUI [1]
C0009450
elevated triglycerides
Description

Triglyceride increased

Data type

boolean

Alias
UMLS CUI [1]
C5200999
gastro-intestinal disease with increased risk of diarrhea (e.g. inflammatory bowel disease)
Description

Gastrointestinal Disease | High risk of Diarrhea | Inflammatory Bowel Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2,1]
C0332167
UMLS CUI [2,2]
C0011991
UMLS CUI [3]
C0021390
unable to tolerate bone marrow biopsy
Description

Bone marrow biopsy Receive Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0005954
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
taking medications known to increase risk of torsades de pointes (an abnormal heart rhythm)
Description

Pharmaceutical Preparations At risk Torsades de Pointes

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0040479

Similar models

Eligibility Lymphoblastic Leukemia, Acute T-cell NCT01363817

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
Refractory T Acute Lymphoblastic Leukemia | Refractory T Lymphoblastic Lymphoma | Acute lymphoblastic leukemia recurrent | T-lymphoblastic lymphoma recurrent | Status post Standard therapy
Item
subjects with t-cell acute lymphoblastic leukemia or t-cell lymphoblastic lymphoma refractory to or relapsed from standard therapies
boolean
C4725790 (UMLS CUI [1])
C1335731 (UMLS CUI [2])
C1504525 (UMLS CUI [3])
C0862284 (UMLS CUI [4])
C0231290 (UMLS CUI [5,1])
C2936643 (UMLS CUI [5,2])
Life Expectancy
Item
life expectancy of at least 2 months
boolean
C0023671 (UMLS CUI [1])
Performance Status
Item
performance status (ps) 0-1 (a measure of the ability to carry out activities of daily living); subjects with ps 2 are eligible if due to disease related symptoms
boolean
C1518965 (UMLS CUI [1])
Cancer treatment Previous | Criteria Fulfill
Item
prior anti-cancer treatment permitted (with specific criteria)
boolean
C0920425 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0243161 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
Organ function
Item
adequate organ function
boolean
C0678852 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Communicable Disease
Item
infection
boolean
C0009450 (UMLS CUI [1])
Triglyceride increased
Item
elevated triglycerides
boolean
C5200999 (UMLS CUI [1])
Gastrointestinal Disease | High risk of Diarrhea | Inflammatory Bowel Diseases
Item
gastro-intestinal disease with increased risk of diarrhea (e.g. inflammatory bowel disease)
boolean
C0017178 (UMLS CUI [1])
C0332167 (UMLS CUI [2,1])
C0011991 (UMLS CUI [2,2])
C0021390 (UMLS CUI [3])
Bone marrow biopsy Receive Unable
Item
unable to tolerate bone marrow biopsy
boolean
C0005954 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Pharmaceutical Preparations At risk Torsades de Pointes
Item
taking medications known to increase risk of torsades de pointes (an abnormal heart rhythm)
boolean
C0013227 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0040479 (UMLS CUI [1,3])

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