ID

30323

Description

My-HyperCVAD in the Treatment of Relapsed Refractory Adult Acute Lymphoid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00801580

Link

https://clinicaltrials.gov/show/NCT00801580

Keywords

Versions (1)
  1. 5/29/18 5/29/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 29, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Lymphoid Leukemia NCT00801580

English

Eligibility Lymphoid Leukemia NCT00801580

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of all (any type included), in patients who:
Description

Acute lymphocytic leukemia Type Any

Data type

boolean

Alias
UMLS CUI [1,1]
C0023449
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1552551
have relapsed after conventional chemotherapy* or,
Description

Recurrent disease Post Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0277556
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0392920
are refractory to at least 1 cycle of chemotherapy*
Description

Patients refractory | Chemotherapy cycle Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0205269
UMLS CUI [2,1]
C1302181
UMLS CUI [2,2]
C1265611
ecog performance score of 0-3
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
adequate hepatic and renal function, as defined by serum transaminases <2.5x uln, bilirubin <1.5xuln, and creatinine <1.5x uln.
Description

Liver function | Renal function | Transaminase Assay | Serum total bilirubin measurement | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0919834
UMLS CUI [4]
C1278039
UMLS CUI [5]
C0201976
age 18 years or greater.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
documentation of written informed consent to participate in the trial.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
at least 3 weeks from prior chemotherapy or other investigational anticancer therapy with full recovery from prior toxicities.
Description

Prior Chemotherapy | Cancer treatment Investigational | Toxicity Patient recovered

Data type

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2,1]
C0920425
UMLS CUI [2,2]
C1517586
UMLS CUI [3,1]
C0600688
UMLS CUI [3,2]
C1115804
either men or women, accepting to practice effective contraception during the entire study period unless documentation of infertility exists.
Description

Contraceptive methods Accepting | Exception Infertility Documented

Data type

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C1272684
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0021359
UMLS CUI [2,3]
C1301725
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with any investigational agent within 3 weeks prior to study therapy.
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
major surgeries within 4 weeks from study start or not fully recovered from any previous surgical procedure.
Description

Major surgery | Operative Surgical Procedures Recovery Lacking

Data type

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C2004454
UMLS CUI [2,3]
C0332268
presence of any medical or psychiatric condition which may limit full compliance with the study or increase the risk associated with study participation or study drug administration, including but not limited to:
Description

Medical condition Protocol Compliance Limited | Mental condition Protocol Compliance Limited | Medical condition At risk Study Subject Participation Status | Mental condition At risk Study Subject Participation Status | Medical condition At risk Investigational New Drugs | Mental condition At risk Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0525058
UMLS CUI [1,3]
C0439801
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C0525058
UMLS CUI [2,3]
C0439801
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C1444641
UMLS CUI [3,3]
C2348568
UMLS CUI [4,1]
C3840291
UMLS CUI [4,2]
C1444641
UMLS CUI [4,3]
C2348568
UMLS CUI [5,1]
C3843040
UMLS CUI [5,2]
C1444641
UMLS CUI [5,3]
C0013230
UMLS CUI [6,1]
C3840291
UMLS CUI [6,2]
C1444641
UMLS CUI [6,3]
C0013230
presence of central nervous system (cns) leukemia.
Description

Central nervous system leukaemia

Data type

boolean

Alias
UMLS CUI [1]
C1332884
active uncontrolled bacterial infection.
Description

Bacterial Infection Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0004623
UMLS CUI [1,2]
C0205318
known human immunodeficiency virus (hiv) infection.
Description

HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
significant cardiovascular disease (i.e., uncontrolled arrhythmias, unstable angina), or a major thromboembolic event (myocardial infarction, stroke, transient ischemic attack, pulmonary embolism, or non-catheter-related deep-vein thrombosis) in the last 6 months.
Description

Cardiovascular Diseases | Cardiac Arrhythmia Uncontrolled | Angina, Unstable | Thromboembolism Major | Myocardial Infarction | Cerebrovascular accident | Transient Ischemic Attack | Pulmonary Embolism | Deep Vein Thrombosis Independent of Catheter

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0002965
UMLS CUI [4,1]
C0040038
UMLS CUI [4,2]
C0205164
UMLS CUI [5]
C0027051
UMLS CUI [6]
C0038454
UMLS CUI [7]
C0007787
UMLS CUI [8]
C0034065
UMLS CUI [9,1]
C0149871
UMLS CUI [9,2]
C0332291
UMLS CUI [9,3]
C0085590
pregnancy or breast-feeding.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
malabsorption syndromes
Description

Malabsorption Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0024523
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Similar models

Eligibility Lymphoid Leukemia NCT00801580

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Acute lymphocytic leukemia Type Any
Item
diagnosis of all (any type included), in patients who:
boolean
C0023449 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
Recurrent disease Post Chemotherapy
Item
have relapsed after conventional chemotherapy* or,
boolean
C0277556 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
Patients refractory | Chemotherapy cycle Quantity
Item
are refractory to at least 1 cycle of chemotherapy*
boolean
C0030705 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C1302181 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
ECOG performance status
Item
ecog performance score of 0-3
boolean
C1520224 (UMLS CUI [1])
Liver function | Renal function | Transaminase Assay | Serum total bilirubin measurement | Creatinine measurement, serum
Item
adequate hepatic and renal function, as defined by serum transaminases <2.5x uln, bilirubin <1.5xuln, and creatinine <1.5x uln.
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0919834 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
Age
Item
age 18 years or greater.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
documentation of written informed consent to participate in the trial.
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
boolean
C0525058 (UMLS CUI [1])
Prior Chemotherapy | Cancer treatment Investigational | Toxicity Patient recovered
Item
at least 3 weeks from prior chemotherapy or other investigational anticancer therapy with full recovery from prior toxicities.
boolean
C1514457 (UMLS CUI [1])
C0920425 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
C0600688 (UMLS CUI [3,1])
C1115804 (UMLS CUI [3,2])
Contraceptive methods Accepting | Exception Infertility Documented
Item
either men or women, accepting to practice effective contraception during the entire study period unless documentation of infertility exists.
boolean
C0700589 (UMLS CUI [1,1])
C1272684 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0021359 (UMLS CUI [2,2])
C1301725 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Investigational New Drugs
Item
treatment with any investigational agent within 3 weeks prior to study therapy.
boolean
C0013230 (UMLS CUI [1])
Major surgery | Operative Surgical Procedures Recovery Lacking
Item
major surgeries within 4 weeks from study start or not fully recovered from any previous surgical procedure.
boolean
C0679637 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C2004454 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
Medical condition Protocol Compliance Limited | Mental condition Protocol Compliance Limited | Medical condition At risk Study Subject Participation Status | Mental condition At risk Study Subject Participation Status | Medical condition At risk Investigational New Drugs | Mental condition At risk Investigational New Drugs
Item
presence of any medical or psychiatric condition which may limit full compliance with the study or increase the risk associated with study participation or study drug administration, including but not limited to:
boolean
C3843040 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C1444641 (UMLS CUI [4,2])
C2348568 (UMLS CUI [4,3])
C3843040 (UMLS CUI [5,1])
C1444641 (UMLS CUI [5,2])
C0013230 (UMLS CUI [5,3])
C3840291 (UMLS CUI [6,1])
C1444641 (UMLS CUI [6,2])
C0013230 (UMLS CUI [6,3])
Central nervous system leukaemia
Item
presence of central nervous system (cns) leukemia.
boolean
C1332884 (UMLS CUI [1])
Bacterial Infection Uncontrolled
Item
active uncontrolled bacterial infection.
boolean
C0004623 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
HIV Infection
Item
known human immunodeficiency virus (hiv) infection.
boolean
C0019693 (UMLS CUI [1])
Cardiovascular Diseases | Cardiac Arrhythmia Uncontrolled | Angina, Unstable | Thromboembolism Major | Myocardial Infarction | Cerebrovascular accident | Transient Ischemic Attack | Pulmonary Embolism | Deep Vein Thrombosis Independent of Catheter
Item
significant cardiovascular disease (i.e., uncontrolled arrhythmias, unstable angina), or a major thromboembolic event (myocardial infarction, stroke, transient ischemic attack, pulmonary embolism, or non-catheter-related deep-vein thrombosis) in the last 6 months.
boolean
C0007222 (UMLS CUI [1])
C0003811 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0002965 (UMLS CUI [3])
C0040038 (UMLS CUI [4,1])
C0205164 (UMLS CUI [4,2])
C0027051 (UMLS CUI [5])
C0038454 (UMLS CUI [6])
C0007787 (UMLS CUI [7])
C0034065 (UMLS CUI [8])
C0149871 (UMLS CUI [9,1])
C0332291 (UMLS CUI [9,2])
C0085590 (UMLS CUI [9,3])
Pregnancy | Breast Feeding
Item
pregnancy or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Malabsorption Syndrome
Item
malabsorption syndromes
boolean
C0024523 (UMLS CUI [1])
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