ID

14157

Beskrivning

IPA Targeted Adoptive Immunotherapy vs Adult Haplo-identical Cell Infusion During Induction of High Risk Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT02508324

Länk

https://clinicaltrials.gov/show/NCT02508324

Nyckelord

Versioner (1)
  1. 2016-04-01 2016-04-01 -
Uppladdad den

1 april 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Acute Myeloid Leukemia NCT02508324

Engelsk

Eligibility Acute Myeloid Leukemia NCT02508324

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
Patients must be 18 years of age or older
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
Patients with a confirmed diagnosis of aml or mds, according to who classification (excluding acute promyelocytic leukaemia) who have received two or three previous induction/re-induction regimens. one of the (re-)induction regimens could be stem cell transplantation (sct) for achievement of remission. maintenance and consolidation (including sct) may have been given, but are not counted as previous regimens.
Beskrivning

Aml, MDS

Datatyp

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2]
C3463824
have never attained cr or cri (primary refractory)
Beskrivning

Complete remission

Datatyp

boolean

Alias
UMLS CUI [1]
C0677874
Patients have failed initial induction therapy, and have attained cr or cri after salvage therapy(ies), and then relapsed within < 6 months
Beskrivning

Induction Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C1514832
Patients have attained cr or cri after initial induction therapy and relapsed within <12 months, and failed to respond to salvage therapy(ies); or have relapsed after the latest cr or cri within < 6 months
Beskrivning

Relapse

Datatyp

boolean

Alias
UMLS CUI [1]
C0035020
Patients younger than 60 years should have received previous treatment with cytarabine
Beskrivning

Cytarabine

Datatyp

boolean

Alias
UMLS CUI [1]
C0010711
Patients must have ecog performance status (ps) of 0 - 2
Beskrivning

Ecog performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
Women of child-bearing potential must have a negative serum or urine pregnancy test within 2 weeks prior to treatment start
Beskrivning

Pregnancy test negative

Datatyp

boolean

Alias
UMLS CUI [1]
C0427780
Patients must be capable of understanding and complying with protocol requirements, and must be able and willing to sign a written informed consent form
Beskrivning

Complying with protocol

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
Persistent clinically significant toxicities from previous chemotherapy
Beskrivning

Toxicity due to chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C1302255
Known positive status for human immunodeficiency virus (hiv)
Beskrivning

hiv

Datatyp

boolean

Alias
UMLS CUI [1]
C0019682
pregnant and nursing patients
Beskrivning

Patient is pregnant

Datatyp

boolean

Alias
UMLS CUI [1]
C3242212
Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, or psychiatric illness/social situations that would limit compliance with study requirements
Beskrivning

Significant Intercurrent Illness

Datatyp

boolean

Alias
UMLS CUI [1]
C3640977
Iimpairment of hepatic or renal function to such an extent that the patient, in the opinion of the investigator, will be exposed to an excessive risk if entered into this clinical study
Beskrivning

Impairment of hepatic or renal function

Datatyp

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0151746
active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure. any nyha grade 3 or 4.
Beskrivning

Heart Diseases

Datatyp

boolean

Alias
UMLS CUI [1]
C0018799
Any medical condition which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities
Beskrivning

Risk for toxicities

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0013221
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Similar models

Eligibility Acute Myeloid Leukemia NCT02508324

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
Patients must be 18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Aml, MDS
Item
Patients with a confirmed diagnosis of aml or mds, according to who classification (excluding acute promyelocytic leukaemia) who have received two or three previous induction/re-induction regimens. one of the (re-)induction regimens could be stem cell transplantation (sct) for achievement of remission. maintenance and consolidation (including sct) may have been given, but are not counted as previous regimens.
boolean
C0023467 (UMLS CUI [1])
C3463824 (UMLS CUI [2])
Complete remission
Item
have never attained cr or cri (primary refractory)
boolean
C0677874 (UMLS CUI [1])
Induction Therapy
Item
Patients have failed initial induction therapy, and have attained cr or cri after salvage therapy(ies), and then relapsed within < 6 months
boolean
C1514832 (UMLS CUI [1])
Relapse
Item
Patients have attained cr or cri after initial induction therapy and relapsed within <12 months, and failed to respond to salvage therapy(ies); or have relapsed after the latest cr or cri within < 6 months
boolean
C0035020 (UMLS CUI [1])
Cytarabine
Item
Patients younger than 60 years should have received previous treatment with cytarabine
boolean
C0010711 (UMLS CUI [1])
Ecog performance status
Item
Patients must have ecog performance status (ps) of 0 - 2
boolean
C1520224 (UMLS CUI [1])
Pregnancy test negative
Item
Women of child-bearing potential must have a negative serum or urine pregnancy test within 2 weeks prior to treatment start
boolean
C0427780 (UMLS CUI [1])
Complying with protocol
Item
Patients must be capable of understanding and complying with protocol requirements, and must be able and willing to sign a written informed consent form
boolean
C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Toxicity due to chemotherapy
Item
Persistent clinically significant toxicities from previous chemotherapy
boolean
C1302255 (UMLS CUI [1])
hiv
Item
Known positive status for human immunodeficiency virus (hiv)
boolean
C0019682 (UMLS CUI [1])
Patient is pregnant
Item
pregnant and nursing patients
boolean
C3242212 (UMLS CUI [1])
Significant Intercurrent Illness
Item
Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, or psychiatric illness/social situations that would limit compliance with study requirements
boolean
C3640977 (UMLS CUI [1])
Impairment of hepatic or renal function
Item
Iimpairment of hepatic or renal function to such an extent that the patient, in the opinion of the investigator, will be exposed to an excessive risk if entered into this clinical study
boolean
C0086565 (UMLS CUI [1])
C0151746 (UMLS CUI [2])
Heart Diseases
Item
active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure. any nyha grade 3 or 4.
boolean
C0018799 (UMLS CUI [1])
Risk for toxicities
Item
Any medical condition which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities
boolean
C0525058 (UMLS CUI [1,1])
C0013221 (UMLS CUI [1,2])
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