ID

41088

Beskrivning

Bendamustine in Acute Lymphoblastic Leukemia/Lymphoma (ALL); ODM derived from: https://clinicaltrials.gov/show/NCT01649622

Länk

https://clinicaltrials.gov/show/NCT01649622

Nyckelord

Versioner (1)
  1. 2020-06-22 2020-06-22 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

22 juni 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Leukemia NCT01649622

Engelsk

Eligibility Leukemia NCT01649622

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01649622
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with relapsed/ refractory lymphoid t-cell or b-cell acute lymphoblastic leukemia which has been previously treated with at least one line of chemotherapy.
Beskrivning

Adult T Acute Lymphoblastic Leukemia Relapse | Adult B Acute Lymphoblastic Leukemia Relapse | Adult T Acute Lymphoblastic Leukemia refractory | Adult B Acute Lymphoblastic Leukemia refractory | Prior Chemotherapy Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0279592
UMLS CUI [1,2]
C0277556
UMLS CUI [2,1]
C0279593
UMLS CUI [2,2]
C0277556
UMLS CUI [3,1]
C0279592
UMLS CUI [3,2]
C0205269
UMLS CUI [4,1]
C0279593
UMLS CUI [4,2]
C0205269
UMLS CUI [5,1]
C1514457
UMLS CUI [5,2]
C1265611
2. age >/= 18
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
3. patients must have adequate organ function including adequate renal function (calculated creatinine clearance >/= 50ml/min calculated per the cockcroft-gault formula). patients must have adequate hepatic function (ast or alt < 2.5 x uln and total bilirubin < 3x uln) for the reference lab unless due to leukemia.
Beskrivning

Organ function | Renal function | Estimation of creatinine clearance by Cockcroft-Gault formula | Liver function | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement | Exception Due to Leukemia

Datatyp

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C0232804
UMLS CUI [3]
C2711451
UMLS CUI [4]
C0232741
UMLS CUI [5]
C0201899
UMLS CUI [6]
C0201836
UMLS CUI [7]
C1278039
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0678226
UMLS CUI [8,3]
C0023418
4. patients must have adequate performance status (ecog 0-3).
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
5. female patients must not be pregnant or lactating. female patients of childbearing potential must have a negative serum or urine pregnancy test within 2 weeks prior to study enrollment. female patients of childbearing potential (including those <1 year postmenopausal) and male patients must agree to use contraception.
Beskrivning

Pregnancy Absent | Breast Feeding Absent | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Contraceptive methods | Gender Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0430061
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0430057
UMLS CUI [5,1]
C3831118
UMLS CUI [5,2]
C0700589
UMLS CUI [6,1]
C0079399
UMLS CUI [6,2]
C0700589
6. patients must sign an informed consent form indicating that they are aware of the investigational nature of this study, in keeping with the policies of the hospital.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
7. patients with active cns involvement of leukemia may be included and treated concurrently with intrathecal chemotherapy if approved by the pi.
Beskrivning

Central Nervous System Involvement Leukemia | Intrathecal chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4050309
UMLS CUI [1,2]
C0023418
UMLS CUI [2]
C1517560
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine or mannitol.
Beskrivning

Anaphylaxis Bendamustine | Anaphylactoid reaction Bendamustine | Mannitol allergy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0002792
UMLS CUI [1,2]
C0525079
UMLS CUI [2,1]
C0340865
UMLS CUI [2,2]
C0525079
UMLS CUI [3]
C0571922
2. patients with untreated or uncontrolled life-threatening infection.
Beskrivning

Life-threatening infection Untreated | Life-threatening infection Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1859430
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C1859430
UMLS CUI [2,2]
C0205318
3. patients known to be hiv positive or known to have hepatitis b and/or c.
Beskrivning

HIV Seropositivity | Hepatitis B | Hepatitis C

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
4. patients must not have received chemotherapy, monoclonal antibody therapy and/or radiation therapy within 2 weeks of study enrollment unless evidence of rapid disease progression. hydroxyurea or corticosteroids for control of blood counts is allowed.
Beskrivning

Chemotherapy | Monoclonal Antibody Therapy | Therapeutic radiology procedure | Exception Rapid disease progression | Hydroxyurea allowed | Adrenal Cortex Hormones allowed

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0279694
UMLS CUI [3]
C1522449
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1834700
UMLS CUI [5,1]
C0020402
UMLS CUI [5,2]
C0683607
UMLS CUI [6,1]
C0001617
UMLS CUI [6,2]
C0683607
5. patients must not have any other medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient's ability to give informed consent or cooperate and participate in the study or interfere with the interpretation of the results.
Beskrivning

Other medical condition Interferes with Informed Consent | Mental disorder Interferes with Informed Consent | Substance Use Disorder Interferes with Informed Consent | Other medical condition Interferes with Protocol Compliance | Mental disorder Interferes with Protocol Compliance | Substance Use Disorder Interferes with Protocol Compliance | Other medical condition Interferes with Study Subject Participation Status | Mental disorder Interferes with Study Subject Participation Status | Substance Use Disorder Interferes with Study Subject Participation Status | Other medical condition Interferes with Interpretation Research results | Mental disorder Interferes with Interpretation Research results | Substance Use Disorder Interferes with Interpretation Research results

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0021430
UMLS CUI [3,1]
C0038586
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0021430
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0525058
UMLS CUI [5,1]
C0004936
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0525058
UMLS CUI [6,1]
C0038586
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C0525058
UMLS CUI [7,1]
C3843040
UMLS CUI [7,2]
C0521102
UMLS CUI [7,3]
C2348568
UMLS CUI [8,1]
C0004936
UMLS CUI [8,2]
C0521102
UMLS CUI [8,3]
C2348568
UMLS CUI [9,1]
C0038586
UMLS CUI [9,2]
C0521102
UMLS CUI [9,3]
C2348568
UMLS CUI [10,1]
C3843040
UMLS CUI [10,2]
C0521102
UMLS CUI [10,3]
C0459471
UMLS CUI [10,4]
C0683954
UMLS CUI [11,1]
C0004936
UMLS CUI [11,2]
C0521102
UMLS CUI [11,3]
C0459471
UMLS CUI [11,4]
C0683954
UMLS CUI [12,1]
C0038586
UMLS CUI [12,2]
C0521102
UMLS CUI [12,3]
C0459471
UMLS CUI [12,4]
C0683954
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Similar models

Eligibility Leukemia NCT01649622

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01649622
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Adult T Acute Lymphoblastic Leukemia Relapse | Adult B Acute Lymphoblastic Leukemia Relapse | Adult T Acute Lymphoblastic Leukemia refractory | Adult B Acute Lymphoblastic Leukemia refractory | Prior Chemotherapy Quantity
Item
1. patients with relapsed/ refractory lymphoid t-cell or b-cell acute lymphoblastic leukemia which has been previously treated with at least one line of chemotherapy.
boolean
C0279592 (UMLS CUI [1,1])
C0277556 (UMLS CUI [1,2])
C0279593 (UMLS CUI [2,1])
C0277556 (UMLS CUI [2,2])
C0279592 (UMLS CUI [3,1])
C0205269 (UMLS CUI [3,2])
C0279593 (UMLS CUI [4,1])
C0205269 (UMLS CUI [4,2])
C1514457 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
Age
Item
2. age >/= 18
boolean
C0001779 (UMLS CUI [1])
Organ function | Renal function | Estimation of creatinine clearance by Cockcroft-Gault formula | Liver function | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement | Exception Due to Leukemia
Item
3. patients must have adequate organ function including adequate renal function (calculated creatinine clearance >/= 50ml/min calculated per the cockcroft-gault formula). patients must have adequate hepatic function (ast or alt < 2.5 x uln and total bilirubin < 3x uln) for the reference lab unless due to leukemia.
boolean
C0678852 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C2711451 (UMLS CUI [3])
C0232741 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
C0201836 (UMLS CUI [6])
C1278039 (UMLS CUI [7])
C1705847 (UMLS CUI [8,1])
C0678226 (UMLS CUI [8,2])
C0023418 (UMLS CUI [8,3])
ECOG performance status
Item
4. patients must have adequate performance status (ecog 0-3).
boolean
C1520224 (UMLS CUI [1])
Pregnancy Absent | Breast Feeding Absent | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Contraceptive methods | Gender Contraceptive methods
Item
5. female patients must not be pregnant or lactating. female patients of childbearing potential must have a negative serum or urine pregnancy test within 2 weeks prior to study enrollment. female patients of childbearing potential (including those <1 year postmenopausal) and male patients must agree to use contraception.
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0430061 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0430057 (UMLS CUI [4,2])
C3831118 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
C0079399 (UMLS CUI [6,1])
C0700589 (UMLS CUI [6,2])
Informed Consent
Item
6. patients must sign an informed consent form indicating that they are aware of the investigational nature of this study, in keeping with the policies of the hospital.
boolean
C0021430 (UMLS CUI [1])
Central Nervous System Involvement Leukemia | Intrathecal chemotherapy
Item
7. patients with active cns involvement of leukemia may be included and treated concurrently with intrathecal chemotherapy if approved by the pi.
boolean
C4050309 (UMLS CUI [1,1])
C0023418 (UMLS CUI [1,2])
C1517560 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Anaphylaxis Bendamustine | Anaphylactoid reaction Bendamustine | Mannitol allergy
Item
1. patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine or mannitol.
boolean
C0002792 (UMLS CUI [1,1])
C0525079 (UMLS CUI [1,2])
C0340865 (UMLS CUI [2,1])
C0525079 (UMLS CUI [2,2])
C0571922 (UMLS CUI [3])
Life-threatening infection Untreated | Life-threatening infection Uncontrolled
Item
2. patients with untreated or uncontrolled life-threatening infection.
boolean
C1859430 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C1859430 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
HIV Seropositivity | Hepatitis B | Hepatitis C
Item
3. patients known to be hiv positive or known to have hepatitis b and/or c.
boolean
C0019699 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Chemotherapy | Monoclonal Antibody Therapy | Therapeutic radiology procedure | Exception Rapid disease progression | Hydroxyurea allowed | Adrenal Cortex Hormones allowed
Item
4. patients must not have received chemotherapy, monoclonal antibody therapy and/or radiation therapy within 2 weeks of study enrollment unless evidence of rapid disease progression. hydroxyurea or corticosteroids for control of blood counts is allowed.
boolean
C0392920 (UMLS CUI [1])
C0279694 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C1834700 (UMLS CUI [4,2])
C0020402 (UMLS CUI [5,1])
C0683607 (UMLS CUI [5,2])
C0001617 (UMLS CUI [6,1])
C0683607 (UMLS CUI [6,2])
Other medical condition Interferes with Informed Consent | Mental disorder Interferes with Informed Consent | Substance Use Disorder Interferes with Informed Consent | Other medical condition Interferes with Protocol Compliance | Mental disorder Interferes with Protocol Compliance | Substance Use Disorder Interferes with Protocol Compliance | Other medical condition Interferes with Study Subject Participation Status | Mental disorder Interferes with Study Subject Participation Status | Substance Use Disorder Interferes with Study Subject Participation Status | Other medical condition Interferes with Interpretation Research results | Mental disorder Interferes with Interpretation Research results | Substance Use Disorder Interferes with Interpretation Research results
Item
5. patients must not have any other medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient's ability to give informed consent or cooperate and participate in the study or interfere with the interpretation of the results.
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0038586 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
C3843040 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
C0004936 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
C0038586 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
C3843040 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C2348568 (UMLS CUI [7,3])
C0004936 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C2348568 (UMLS CUI [8,3])
C0038586 (UMLS CUI [9,1])
C0521102 (UMLS CUI [9,2])
C2348568 (UMLS CUI [9,3])
C3843040 (UMLS CUI [10,1])
C0521102 (UMLS CUI [10,2])
C0459471 (UMLS CUI [10,3])
C0683954 (UMLS CUI [10,4])
C0004936 (UMLS CUI [11,1])
C0521102 (UMLS CUI [11,2])
C0459471 (UMLS CUI [11,3])
C0683954 (UMLS CUI [11,4])
C0038586 (UMLS CUI [12,1])
C0521102 (UMLS CUI [12,2])
C0459471 (UMLS CUI [12,3])
C0683954 (UMLS CUI [12,4])
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