ID

41047

Beschreibung

Standard Chemotherapy With or Without Nelarabine or Rituximab in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01085617

Link

https://clinicaltrials.gov/show/NCT01085617

Stichworte

Versionen (1)
  1. 16.06.20 16.06.20 -
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See clinicaltrials.gov

Hochgeladen am

16. Juni 2020

DOI

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Eligibility Leukemia NCT01085617

Englisch

Eligibility Leukemia NCT01085617

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01085617
Criteria
Beschreibung

Criteria

newly diagnosed, previously untreated acute lymphoblastic leukemia
Beschreibung

Acute lymphocytic leukemia Untreated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023449
UMLS CUI [1,2]
C0332155
a pre-phase steroid treatment of 5-7 days is required and can be started prior to registration
Beschreibung

Steroid therapy Early treatment phase Required

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0149783
UMLS CUI [1,2]
C0814494
UMLS CUI [1,3]
C1514873
philadelphia chromosome-negative or -positive patients are eligible
Beschreibung

Patients Philadelphia chromosome negative Eligible | Patients Philadelphia chromosome positive Eligible

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C3888511
UMLS CUI [1,3]
C1548635
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0856536
UMLS CUI [2,3]
C1548635
no blast transformation of chronic myeloid leukemia
Beschreibung

Blast Phase Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005699
UMLS CUI [1,2]
C0332197
no mature b-cell leukemia [i.e., burkitt disease t(8,14)(q24 ;q32)] or variant c-myc translocations [e.g., t(2;8)(p12;q24), t(8;22)(q24;q11)]
Beschreibung

Mature B-cell type acute leukaemia Absent | Burkitt Lymphoma Absent | C-Myc Translocation Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0854800
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006413
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1511357
UMLS CUI [3,2]
C0332197
patients who undergo study transplantation must have hla-compatible sibling or unrelated donor
Beschreibung

Transplantation HLA Match Sibling | Transplantation Unrelated Donor

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0040732
UMLS CUI [1,2]
C4330149
UMLS CUI [1,3]
C0037047
UMLS CUI [2,1]
C0040732
UMLS CUI [2,2]
C3179133
8/8 molecular match at -a, -b, -c, and -dr (dq mismatch is permitted)
Beschreibung

HLA Match HLA-A Antigens | HLA Match HLA-B Antigens | HLA Match HLA-C Antigens | HLA Match HLA-DR Antigens | HLA Mismatch HLA-DQ Antigens allowed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4330149
UMLS CUI [1,2]
C0019728
UMLS CUI [2,1]
C4330149
UMLS CUI [2,2]
C0019737
UMLS CUI [3,1]
C4330149
UMLS CUI [3,2]
C0019751
UMLS CUI [4,1]
C4330149
UMLS CUI [4,2]
C0019764
UMLS CUI [5,1]
C4287887
UMLS CUI [5,2]
C0019761
UMLS CUI [5,3]
C0683607
patients meeting ≥ 1 the following criteria are considered high-risk:
Beschreibung

Criteria Quantity Fulfill | Patients High risk

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1550543
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C4319571
over 40 years old
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
wbc ≥ 30 x 10^9/l (precursor-b) or ≥ 100 x 10^9/l (t-lineage)
Beschreibung

White Blood Cell Count procedure | Pre-B Lymphocytes | T-Lymphocyte Lineage

Datentyp

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0312738
UMLS CUI [3,1]
C0039194
UMLS CUI [3,2]
C0282637
any 1 or more of the following cytogenetic abnormalities:
Beschreibung

Cytogenetic abnormalities Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008625
UMLS CUI [1,2]
C1265611
t(4;11)(q21;q23)/mll-af4
Beschreibung

t(4;11)(q21;q23) | MLL/AF4

Datentyp

boolean

Alias
UMLS CUI [1]
C1515769
UMLS CUI [2]
C1706478
low hypodiploidy/near triploidy (30-39 chromosomes/60-78 chromosomes)
Beschreibung

Hypoploidy low | Near Triploidy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0333691
UMLS CUI [1,2]
C0205251
UMLS CUI [2,1]
C1706276
UMLS CUI [2,2]
C3536727
complex karyotype (≥ 5 chromosomal abnormalities)
Beschreibung

Complex Karyotype

Datentyp

boolean

Alias
UMLS CUI [1]
C3273253
philadelphia chromosome t(9;22) (q34;q11)/bcr-abl1 (detected by cytogenetic or molecular methods)
Beschreibung

Philadelphia Chromosome

Datentyp

boolean

Alias
UMLS CUI [1]
C0031526
high-risk minimal-residual disease after completion of part 2 standard induction therapy
Beschreibung

High risk of Residual Neoplasm

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C0242596
patient characteristics:
Beschreibung

Client Characteristics

Datentyp

boolean

Alias
UMLS CUI [1]
C0815172
no known hiv infection
Beschreibung

HIV Infection Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019693
UMLS CUI [1,2]
C0332197
not pregnant or nursing (no nursing during and for 12 months after completion of study therapy)
Beschreibung

Pregnancy Absent | Breast Feeding Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
negative pregnancy test
Beschreibung

Pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1]
C0427780
fertile patients must use effective contraception during and for up to 12 months after completion of study therapy
Beschreibung

Females & males of reproductive potential Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
prior concurrent therapy:
Beschreibung

Prior Therapy Concurrent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0205420
see disease characteristics
Beschreibung

ID.23

Datentyp

boolean

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Ähnliche Modelle

Eligibility Leukemia NCT01085617

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01085617
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Acute lymphocytic leukemia Untreated
Item
newly diagnosed, previously untreated acute lymphoblastic leukemia
boolean
C0023449 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Steroid therapy Early treatment phase Required
Item
a pre-phase steroid treatment of 5-7 days is required and can be started prior to registration
boolean
C0149783 (UMLS CUI [1,1])
C0814494 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
Patients Philadelphia chromosome negative Eligible | Patients Philadelphia chromosome positive Eligible
Item
philadelphia chromosome-negative or -positive patients are eligible
boolean
C0030705 (UMLS CUI [1,1])
C3888511 (UMLS CUI [1,2])
C1548635 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C0856536 (UMLS CUI [2,2])
C1548635 (UMLS CUI [2,3])
Blast Phase Absent
Item
no blast transformation of chronic myeloid leukemia
boolean
C0005699 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Mature B-cell type acute leukaemia Absent | Burkitt Lymphoma Absent | C-Myc Translocation Absent
Item
no mature b-cell leukemia [i.e., burkitt disease t(8,14)(q24 ;q32)] or variant c-myc translocations [e.g., t(2;8)(p12;q24), t(8;22)(q24;q11)]
boolean
C0854800 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006413 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1511357 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Transplantation HLA Match Sibling | Transplantation Unrelated Donor
Item
patients who undergo study transplantation must have hla-compatible sibling or unrelated donor
boolean
C0040732 (UMLS CUI [1,1])
C4330149 (UMLS CUI [1,2])
C0037047 (UMLS CUI [1,3])
C0040732 (UMLS CUI [2,1])
C3179133 (UMLS CUI [2,2])
HLA Match HLA-A Antigens | HLA Match HLA-B Antigens | HLA Match HLA-C Antigens | HLA Match HLA-DR Antigens | HLA Mismatch HLA-DQ Antigens allowed
Item
8/8 molecular match at -a, -b, -c, and -dr (dq mismatch is permitted)
boolean
C4330149 (UMLS CUI [1,1])
C0019728 (UMLS CUI [1,2])
C4330149 (UMLS CUI [2,1])
C0019737 (UMLS CUI [2,2])
C4330149 (UMLS CUI [3,1])
C0019751 (UMLS CUI [3,2])
C4330149 (UMLS CUI [4,1])
C0019764 (UMLS CUI [4,2])
C4287887 (UMLS CUI [5,1])
C0019761 (UMLS CUI [5,2])
C0683607 (UMLS CUI [5,3])
Criteria Quantity Fulfill | Patients High risk
Item
patients meeting ≥ 1 the following criteria are considered high-risk:
boolean
C0243161 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C4319571 (UMLS CUI [2,2])
Age
Item
over 40 years old
boolean
C0001779 (UMLS CUI [1])
White Blood Cell Count procedure | Pre-B Lymphocytes | T-Lymphocyte Lineage
Item
wbc ≥ 30 x 10^9/l (precursor-b) or ≥ 100 x 10^9/l (t-lineage)
boolean
C0023508 (UMLS CUI [1])
C0312738 (UMLS CUI [2])
C0039194 (UMLS CUI [3,1])
C0282637 (UMLS CUI [3,2])
Cytogenetic abnormalities Quantity
Item
any 1 or more of the following cytogenetic abnormalities:
boolean
C0008625 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
t(4;11)(q21;q23) | MLL/AF4
Item
t(4;11)(q21;q23)/mll-af4
boolean
C1515769 (UMLS CUI [1])
C1706478 (UMLS CUI [2])
Hypoploidy low | Near Triploidy
Item
low hypodiploidy/near triploidy (30-39 chromosomes/60-78 chromosomes)
boolean
C0333691 (UMLS CUI [1,1])
C0205251 (UMLS CUI [1,2])
C1706276 (UMLS CUI [2,1])
C3536727 (UMLS CUI [2,2])
Complex Karyotype
Item
complex karyotype (≥ 5 chromosomal abnormalities)
boolean
C3273253 (UMLS CUI [1])
Philadelphia Chromosome
Item
philadelphia chromosome t(9;22) (q34;q11)/bcr-abl1 (detected by cytogenetic or molecular methods)
boolean
C0031526 (UMLS CUI [1])
High risk of Residual Neoplasm
Item
high-risk minimal-residual disease after completion of part 2 standard induction therapy
boolean
C0332167 (UMLS CUI [1,1])
C0242596 (UMLS CUI [1,2])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
HIV Infection Absent
Item
no known hiv infection
boolean
C0019693 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Pregnancy Absent | Breast Feeding Absent
Item
not pregnant or nursing (no nursing during and for 12 months after completion of study therapy)
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Pregnancy test negative
Item
negative pregnancy test
boolean
C0427780 (UMLS CUI [1])
Females & males of reproductive potential Contraceptive methods
Item
fertile patients must use effective contraception during and for up to 12 months after completion of study therapy
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Prior Therapy Concurrent
Item
prior concurrent therapy:
boolean
C1514463 (UMLS CUI [1,1])
C0205420 (UMLS CUI [1,2])
ID.23
Item
see disease characteristics
boolean
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